Rancona 450 FS Product code: UBI 4336-01 Active Substance

Part A National Assessment - Federal Republic of Germany

Product code 008398-00/00 Rancona 450 FS

Draft Registration Report –Central Zone Page 1 of 29

Applicant (insert company name) Evaluator Date .2015

REGISTRATION REPORT

Part A

Risk Management

Product name: Rancona 450 FS

Product code: UBI 4336-01

Active Substance: 452 g/L Ipconazole FS

COUNTRY: Germany

All Zones

Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT

Applicant: Arysta LifeScience Edinburgh

(in former times Chemtura Europe Ltd.)

Submission date: 27 February 2015

Finalisation date: 05 October 2020




Applicant (insert company name) Evaluator Date.2014

Table of Contents

PART A – Risk Management 4

1 Details of the application 4

1.1 Application background 4

1.2 Annex I inclusion 4

1.3 Regulatory approach 5

1.4 Data protection claims 5

1.5 Letters of Access 5

2 Details of the authorisation 5

2.1 Product identity 5

2.2 Classification and labelling 6

2.2.1 Classification and labelling under Directive 99/45/EC 6

2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 6

2.2.3 Standard phrases under Regulation (EC) No 547/2011 7

2.3 Other phrases notified under Regulation (EC) No 547/2011 8

2.3.1 Restrictions linked to the PPP 8

2.3.2 Specific restrictions linked to the intended uses 10

2.4 Product uses 11

3 Risk management 13

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform

Principles 13

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 13

3.1.2 Methods of analysis (Part B, Section 2, Point 5) 13

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 13

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 13

3.1.3 Mammalian Toxicology (Part B, Section 6) 14

3.1.3.1 Acute Toxicity 14

3.1.3.2 Operator Exposure 14

3.1.3.3 Bystander Exposure 14

3.1.3.4 Worker Exposure 14

3.1.3.5 Groundwater Metabolites 15

3.1.4 Residues and Consumer Exposure (Part B, Section 7) 16

3.1.4.1 Residues 16

3.1.4.2 Consumer exposure 16

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 17





3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and

9.5) 17

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5,

Point 9.6) 17

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5,

Points 9.7 and 9.8) 17

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)

18

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 19

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 19

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 19

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

20

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)

21

3.1.6.5 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 22

3.1.6.6 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part

B, Section 6, Point 10.8) 22

3.1.7 Efficacy (Part B, Section 7, Point 8) 23

3.2 Conclusions 25

3.3 Further information to permit a decision to be made or to support a review of the conditions

and restrictions associated with the authorisation 25

Appendix 1 – Copy of the product authorisation (see Appendix 4) 26

Appendix 2 – Copy of the product label 27

Appendix 3 – Letter of Access 28

Appendix 4 – Copy of the product authorisation 29





PART A – Risk Management

This document describes the acceptable use conditions required for the registration of Rancona 450 FS

(UBI 4336-01) containing Ipconazole in Germany.

The risk assessment conclusions are based on the information, data and assessments provided in

Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany. The

information, data and assessments provided in Registration Report, Parts B includes assessment of further

data or information as required at national registration by the EU review. It also includes assessment of data

and information relating to Rancona 450 FS (UBI 4336-01) where that data has not been considered in the

EU review. Otherwise assessments for the safe use Rancona 450 FS (UBI 4336-01) have been made using

endpoints agreed in the EU review of Ipconazole.

This document describes the specific conditions of use and labelling required for Germany for the

registration of Rancona 450 FS (UBI 4336-01).

Appendix 1 should include the authorisation of the final product in Germany. Due to technical reasons,

the authorisation of the final product in Germany is inserted under Appendix 4.

Appendix 2: The submitted draft product label has been checked by the competent authority. The

applicant is requested to amend the product label in accordance with the decisions made by the competent

authority. The final version of the label has to fulfil the requirements according to Article 31 of

Regulation (EC9 No 1107/2009.

Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

Appendix 4 of this document provides a copy of the final product authorisation Germany.

1 Details of the application

1.1 Application background

This application was submitted by Chemtura Europe Limited (now Arysta) on 27 February 2015.

The application was for approval of Rancona 450 FS (UBI 4336-01), a FS formulation containing 452 g/L

Ipconazole for use as a seed treatment in maize.

1.2 Annex I inclusion

Ipconazole was included in Regulation (EC) 1107/2009 on 1st September 2014 under Regulation EU

571/2014.

The Annex I Inclusion Directive for Ipconazole (EU 571/2014) provides specific provisions under Part B

which need to be considered by the applicant in the preparation of their submission and by the MS prior to

granting an authorisation:





For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the

active substance Ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 20th March 2014 shall be taken into account. In this

overall assessment:

Member States should/must/may pay particular attention to the:

the protection of workers and operators and ensure that conditions of use prescribe the application

of adequate personal protective equipment where appropriate;

the risk to granivorous birds.

the risk to fish

These concerns have been addressed within the current submission.

The applicant shall submit confirmatory data as regards:

-acceptability of the long-term risk to granivorous birds

-acceptability of the risk to soil-macro-organisms

- the risk of enatio-selective metabolisation or degradation (within 2 years after adoption of GD on

evaluation of isomer mixture)

- the potential encodrine disrupting properties of ipconazole for birds and fish (within 2 years after adoption

of the OECD test guidelines on endocrine disruption or guidelines agreed at EU level).

Information must be submitted to the COM, MS and EFSA by 31 August 2016.

1.3 Regulatory approach

To obtain authorisation the product UBI 4336-01 must meet the conditions of the approval and be supported

by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform

Principles, using approved end-points.

This application was submitted in order to allow the first approval of this product/use in Germany in

accordance with the above.

1.4 Data protection claims

Where the applicant claims protection for information supporting registration of Rancona 450 FS it is

indicated in the reference lists in Appendix 1 of the Registration Report, Part B and Part C.

1.5 Letters of Access

The applicant presented a LoA regarding data for the active substance Ipconazole and another one regarding

data on triazole metabolites. The remaining data requirements were addressed by own data.

2 Details of the authorisation

2.1 Product identity

Product code UBI 4336-01





Product name Rancona 450 FS

Authorization number

(for re-registration)

008398-00

Function fungicide

Applicant Arysta LifeScience

Composition 452 g/L ipconazole

Formulation type flowable concentrate for seed treatment [Code: FS]

Packaging 20 L HDPE jerry cans,

200 L HDPE drums,

1000 L HDPE tanks;

professional unser

2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC

Not proposed.

2.2.2 Classification and labelling under Regulation (EC) No 1272/2008

The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:





Hazard classes and categories:

Repr. 1B, STOT RE 2, Aquatic Chronic 1

Hazard pictograms:

GHS08 health hazard

GHS09 environment

Signal word:

Warning

Hazard statements:

H360D May damage the unborn child.

H373 May cause damage to organs <or state all organs affected, if known> through

prolonged or repeated exposure <state route of exposure if it is conclusively

proven that no other routes of exposure cause the hazard>.

H410 Very toxic to aquatic life with long lasting effects.

Precautionary statemtents:

Not proposed by zRMS Germany, to be decided by applicant

P101 If medical advice is needed, have product container or label at hand.

P102 Keep out of reach of children.

P201 Obtain special instructions before use.

P273 Avoid release to the environment.

P260 Do not breathe dust/fume/gas/mist/vapours/spray.

P280 Wear protective gloves/protective clothing/eye protection/face protection.

P308+P310 IF exposed or concerned: Immediately call a POISON CENTER or a

doctor/physician.

P405 Store locked up.

P391 Collect spillage.

P501 Dispose of contents/container to ...

Special rule for labelling of PPP:

EUH401 To avoid risks to man and the environment, comply with the instructions for use.

Further labelling statements under Regulation (EC) No 1272/2008:

-

2.2.3 Standard phrases under Regulation (EC) No 547/2011

SP 1 Do not contaminate water with the product or its container (Do not clean application

equipment near surface water/Avoid contamination via drains from farmyards and roads).





2.3 Other phrases notified under Regulation (EC) No 547/2011

2.3.1 Restrictions linked to the PPP

The authorization of the PPP is linked to the following conditions (mandatory labelling):

Human health protection

SB001 Avoid any unnecessary contact with the product. Misuse can lead to health

damage.

SB005 If medical advice is needed, have product container or label at hand.

SB010 Keep out of the reach of children.

SB111 Concerning the requirements for personal protective gear for handling the plant

protection product the material safety data sheet and the instructions for use of the

plant protection product as well as the guideline "Personal protective gear for

handling plant protection prod-ucts" of the Federal Office of Consumer Protection

and Food Safety (www.bvl.bund.de) must be observed.

SB166 Do not eat, drink or smoke when using this product.

SF6142-1 Protective gloves and a protective suit against pesticides must be worn when

handling dressed seeds.

SF6161-1 While sacking the treated seed a protective suit against pesticides and protective

gloves (plant protection) must be worn.

SF618-1 While cleaning the seed dressing appliance protective gloves (plant protection)

and a protective suit against pesticides must be worn.

SS1201-1 Protective gloves (plant protection) must be worn when handling/applying the

product.

SS2204 Wear a protective suit for plant protection products and sturdy shoes (e.g. rubber

boots) when applying/handling the product.

ST1202 Wear particle-filtering half mask FFP2 or half mask with particle filter P2

(identification colour: white) according to the BVL guideline "Personal protective

equipment for handling plant protection products", current version, when

applying/handling the product.


(identification colour: white) according to the BVL guideline "Personal

protective equipment for handling plant protection products", current version,

when bagging the seeds.


(identification colour: white) according to the BVL guideline "Personal protective

equipment for handling plant protection products", current version, when cleaning

the seed-dressing equipment.

Integrated pest management (IPM)/sustainable use

WMFG1 Mode of action (FRAC-group): G1 (for ipconazol)

NB663 Due to the manner in which authorisation governs application of the product, bees

are not endangered.(B3)





Ecosystem protection

NW262 The product is toxic for algae.

NW264 The product is toxic for fish and aquatic invertebrates.

NW470 Where applicable, fluids left over from application, granules and their remains as

well as cleansing and rinsing fluids must not be dumped in water. This also

applies to indirect entry via the urban or agrarian drainage system and to rain-

water and sewage canals.

NH677 On packaging containing dressed seeds, the following label is necessary: "Sweep

up and remove spilled seeds immediately ".

NH679 On packaging containing dressed seeds, the following label is necessary: "This

product is poisonous for birds. For this reason, do not leave seeds exposed.

Switch off the dosing equipment on time before lifting out the shares to prevent

trickling afterwards".

NH680 On packaging containing dressed seeds, the following label is necessary: "Do not

allow treated seeds and remains such as broken grain and dust, empty containers

or packaging or rinsing liquid to come into contact with water. This also applies

to indirect entry via the urban or agrarian drainage system and to rainwater and

sewage canals".


sew treated seeds at wind speeds of more than 5 m/s".

NH682 On packaging containing dressed seeds, the following label is necessary: "The

treated seeds, including any dust they contain, or dust which is produced during the

sowing process, has to be incorporated completely into the soil".

NH684 On packages of treated seeds the maximum seed rate per hectare must be indicated

as specified in the authorisation. For a combination of several seed protectants, the

lowest admissible seed rate must be stated.

NH6831-1 The following label must be printed on the seed package: "Treated seeds may only

be sown by using a pneumatic seeding machine which operates with negative

pressure, if this machine is registered in the "List of drift reducing sowing

equipment" of the Julius Kühn-Institute (this can be seen on the Julius Kühn-

Institute's website.)".

NT699-1 The seed treatment shall only be performed in professional seed treatment facilities,

which are registered in the index of "Seed Treatment Facilities with Quality

Assurance Systems to Minimise Dust" of the Julius Kühn-Institute (visit the

homepage of the Julius Kühn-Institute)

NT714-1 At the beginning of the production process it must be demonstrated and

documented for each formulation that the amount of active substance which might

be abraded by dust (Heubach a.s. value) does not exceed 0.05 g Ipconazole per

100,000 seeds. This evidence must be submitted and documented for all

formulations once every calendar year or at the beginning of the treatment season

after intermission of the production. Retention samples of treated seeds from the

production process allowing the determination of the Heubach-a.s. value must be

taken from new seed batches or every two weeks at the latest. These retention





samples shall be retained for at least 12 months. Changes in the nature and quantity

of the adjuvants used or changes in the use of new dressing equipment technology

require new evidence. When the Heubach a.s. value exceeds 0.05 g ipconazole per

100,000 seeds, treated seeds may not be marketed.

The authorization of the PPP is linked to the following conditions (voluntary labelling):


NN1001 The product is classified as non-harmful for populations of relevant beneficial insects.

NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory

mites and spiders.

2.3.2 Specific restrictions linked to the intended uses

Some of the authorised uses are linked to the following conditions (mandatory labelling):

See 2.4 (Product uses)


-

Ecosystem protection

-





2.4 Product uses

GAP-Table of intended uses for Germany GAP rev. (1), date: 2015-12-18

PPP (product name/code): Rancona 450 FS (UBI 4336-01)

Active substance : ipconazole

Formulation type: Flowable Concentrate (FS)

Conc. of as: 452 g/L

Applicant: Arysta (informer times CHEMTURA Europe Ltd)

Zone(s): Central/Sourthern/Northern /EU

Professional use: Yes

Non-professional use: No

Verified by MS: Yes

1 2 3 4 5 6 7 8 9 10 11 12 13

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I

Pests or Group of pests

controlled

(additionally: developmental stages of

the pest or pest group)

Application Application rate PHI (days)

Remarks:

e.g. safener/synergist per ha

e.g. recommended or mandatory tank mixtures

Method / Kind

Timing / Growth stage of crop & season

Max. number (min. interval

between applications)

a) per use

b) per crop/ season

kg, L product / ha

a) max. rate per appl.

b) max. total rate per crop/season

g, kg as/ha


b) max. total

rate per crop/season

Water L/ha min / max

001 DE Maize

ZEAMX

F Fusarium spp.

FUSASP

seed treatment

before sowing

1

a) 0.77 mL/ha **

b) 0.77 mL/ha **

0.35 g as/ha F* * The PHI is covered by the

conditions of use and/or the

vegetation period remaining between the application of

the plant protection product

and the use of the product (e. g. harvest) or the setting of a

PHI in days is not required resp.

** maximum application rate

1.925 mL/ha (equivalent to a

maximum of 2.5 seed units per ha; 1 unit includes 50 000 grains)





Use withdrawn by the applicant

002 DE Maize

ZEAMX

F Rhizoctonia solani

RHIZSO

seed treatment

before sowing

1

a) 0.77 mL/ha **

b) 0.77 mL/ha **

0.35 g as/ha F ** maximum application rate 1.925 mL/ha (equivalent to a

maximum of 2.5 seed units

per ha; 1 unit includes 50 000 grains)


003 DE Maize

ZEAMX

for seed production

F head smut of maize Sphacelotheca reiliana

SPHTRE

seed treatment

before sowing

1

a) 2.52 mL/ha **

b) 2.52 mL/ha **

1.14 g as/ha F ** maximum application rate

6.3 mL/ha (equivalent to a maximum of 2.5 seed units

per ha; 1 unit includes 50 000

grains); limited 225-375 g/1000 single grains

Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (2) Member State(s) or zone for which use is applied for

(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use

situation should be described (e.g. fumigation of a structure) (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)

(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages

(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of

equipment used must be indicated

(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of

application

(8) The maximum number of applications possible under practical conditions of use for each single application and per year (permanent crops) or crop (annual crops) must be provided

Min. interval between applications (days) where relevant

(9) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. kg or L product / ha)

(10) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha)

(11) The range (min/max) of water volume under practical conditions of use must be given (L/ha)

(12) PHI - minimum pre-harvest interval

(13) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.





3 Risk management

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform

Principles

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4)

Overall Summary:

All studies have been performed in accordance with the current requirements and the results are deemed to

be acceptable.

The appearance of the product is that of a dark beige to brown opaque liquid. It is not explosive, has no

oxidising properties. A flash point is not detected up to 110 °C. In aqueous solution, it has a pH value

around 8.7. The stability data indicate a shelf life of at least two years at ambient temperature.

The technical characteristics are acceptable for a flowable concentrate for seed treatment (FS) formulation.

Implications for labelling:

CLP: none

Others: Do not store at higher temperatures

(no data are available on the seed treatment properties after storage of the formulation).

Compliance with FAO guidelines:

The product Rancona 450 FS complies with the general requirements for FS formulations according to the

FAO/WHO manual (2016).

Compatibility of mixtures:

No tank mixtures are recommended for Rancona 450 FS.

Nature and characteristics of the packaging:

Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,

leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents

of the packaging, have been submitted, evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment:

Information regarding the required protective clothing and equipment for the safe handling of Rancona 450

FS has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)

An adequate analytical method for the determination of the active substance ipconazole in the formulation

is available.

No relevant impurities are to be considered.

There is no CIPAC method available for ipconazole.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)





The analytical methods are active substance data and were provided in the EU review of ipconazole. They

were considered adequate for food of plant, soil, water and air. However, a data gap was reported in the

EFSA conclusion (EFSA Journal 2013;11(4):3181) concerning a validated method for 1,2,4-triazole in soil

and surface water. Analytical methods for animal matrices are not necessary, because no MRLs are set, and

methods for body fluids and tissues are not required, because ipconazole is not considered to be toxic or

very toxic (T / T+) nor is it classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat. 1)

or STOT (cat. 1). The applicant has got access to the EU dossier by the notifier.

A new submitted independent laboratory validation for dry crops (wheat grain) and commodities of high

water content (cucumber fruit) was evaluated and accepted.

The following data gaps still exist, but they are considered of minor relevance:

A primary method for the determination of 1,2,4-triazole in surface water is missing.

A confirmatory method for the determination of 1,2,4-triazole in surface water is missing.

As the application was submitted before 31 December 2015, the data requirements of Reg. (EU) No.

544/2011 and 545/2011 are still applicable. Taking the data requirements of Reg. (EU) No. 283/2013 and

284/2013 into account, the following additional data gaps are noticed:

An independent laboratory validation of the method by Brewin (2006) for the determination of ipconazole

in drinking water is missing.

A primary method for the determination of ipconazole in body fluids is missing.

A confirmatory method for the determination of ipconazole in body fluids is missing.

The applicant is informed about these data gaps.

3.1.3 Mammalian Toxicology (Part B, Section 6)

3.1.3.1 Acute Toxicity

Rancona 450 FS, containing 452 g/L ipconazole has a low toxicity in respect to oral and dermal toxicity.

Its acute inhalation toxicity does not result in a classification according to Regulation (EC) No. 1272/2008.

It has no sensitizing properties. It is not irritating to skin and eyes.

3.1.3.2 Operator Exposure

Operator exposure was assessed against the AOEL agreed in the EU review (ipconazole 0.015 mg/kg bw/d).

Dermal absorption data of studies conducted with a formulation identical to Rancona 450 FS was used. The

detailed evaluation is provided in Part B.

According to the model calculations, it can be concluded that the risk for the operator using Rancona 450

FS in maize is acceptable with the use of personal protective equipment described in 2.2.4.1.

3.1.3.3 Bystander Exposure

The bystander and/or resident exposure estimations indicated that the acceptable operator exposure level

(AOEL) for Ipconazole will not be exceeded under conditions of intended uses.

3.1.3.4 Worker Exposure

The worker exposure was estimated using the model “SEED TROPEX”. The risk for the workers is

acceptable with the use of personal protective equipment described in 2.2.4.1.

Implications for labelling resulting from operator, worker, bystander assessments:





See 2.2

3.1.3.5 Groundwater Metabolites

No metabolites are predicted above 0.1 µg/L in the groundwater.





3.1.4 Residues and Consumer Exposure (Part B, Section 7)

3.1.4.1 Residues

Fundamental residue data on ipconazole like metabolism are already evaluated previously and is described

in detail in the respective DARs.

The data available are considered sufficient for risk assessment. An exceedance of the current MRL of

0.01* mg/kg for ipconazole as laid down in Reg. (EC) 396/2005 is not expected.

The chronic and the short-term intakes of ipconazole residues are unlikely to present a public health

concern. Concerning the presence of triazole derived metabolites (TDM) in foods, it is referred to EFSA

Peer Review of the pesticide risk assessment of the triazole derivate metabolites (EFSA, 2018, ASB2018-

8816), providing a comprehensive assessment of these compounds common to multiple active substances.

3.1.4.2 Consumer exposure

An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the respective

ADI/ARfD below 100 %.

Substance ADI/ARfD Model / Diet ADI/ARfD

Consumption

Ipconazole ADI: 0.015 mg/kg

bw/d

TMDI, EFSA PRIMo rev.

3.1, NL toddlers

4 %

ARfD: 0.015 mg/kg

bw

IESTI, EFSA PRIMo rev.

3.1, UK infants

< 1 %

The chronic and the short-term intake of ipconazole residues are unlikely to present a public health concern.





3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points

9.4 and 9.5)

PECsoil was calculated for the active substance ipconazole considering a soil depth of 1 cm. Due to the slow

degradation of the active substance ipconazole in soil the accumulation potential of ipconazole was

considered. Therefore PECsoil used for risk assessment comprises background concentration in soil

(PECaccu) considering a tillage depth of 20 cm (arable crop) or 5 cm (permanent crops) and the maximum

annual soil concentration PECact.

The PECsoil values for the active substance were used in the eco-toxicological risk assessment for the

intended uses of the plant protection product Rancona 450 FS in Germany.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,

Section 5, Point 9.6)

Direct leaching into groundwater

As indicated in the core assessment results of modelling with FOCUS PELMO show that the active

substance ipconazole is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the

intended uses of Rancona 450 FS in Germany according to use No.001 to 003.

The simulated concentrations of <0.001 µg/L 1,2,4-triazole in groundwater are also below the limit of

0.1 µg/L for active substances and relevant metabolites. However, 1,2,4-triazole is formed as metabolite of

several active substances of plant protection products, which are used in different crops against a wide

range of crop deceases. It is therefore possible that several 1,2,4-triazole forming active substances will be

applied onto the same agricultural field in the same year and season, which may result in a summation of

groundwater entries of 1,2,4-triazole from different active substances and could finally lead to 1,2,4-triazole

entries into the groundwater in concentrations ≥0.1 µg/L. But as the application rate of Rancona 450 FS

and the simulated concentrations of 1,2,4-triazole (<0.001µg/L) are extremely low, a relevant entry of 1,2,4-

triazole from Rancona 450 FS in the groundwater is not expected.

Consequences for authorization:

None

Groundwater contamination by bank filtration due to surface water exposure via runoff and

drainage

According modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the

active substance ipconazole due to surface runoff and drainage into the adjacent ditch with subsequent bank

filtration can be excluded.


None

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B,

Section 5, Points 9.7 and 9.8)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of

surface water consider two routes of entry (i) spray drift and volatilization with subsequent deposition and





(ii) runoff, drainage separately.

As the product Rancona 450 FS is used as a seed treatment, surface water exposure by spray drift and

volatilization with subsequent deposition can be excluded as relevant pathways, whereas predicted off-field

exposure concentrations following dust drift deposition needs to be considered.

Surface water exposure including effects of risk mitigation via surface runoff and drainage was estimated

using the model EXPOSIT 3 and the relevant exposure values for non-target organisms in different off-

field structures were calculated according to the draft "Guidance Document on the Authorization of Plant

Protection Products for Seed Treatment” (SANCO/10553/2012, January 2014).

The results of the specific national exposure assessment for the active substance were used in the eco-

toxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point

9.9)

The vapour pressure at 20 °C of the active substance ipconazole is < 10-5 Pa. Hence the active substance

ipconazole is regarded as non-volatile. Therefore exposure of adjacent surface waters and terrestrial

ecosystems by the active substance ipconazole due to volatilization with subsequent deposition was not

considered.

Implications for labelling resulting from environmental fate assessment:

Required label phrases for treated seeds to avoid a higher exposure than considered in risk assessment.

NH681 On packaging containing dressed seeds, the following label is necessary: "Do not sew

treated seeds at wind speeds of more than 5 m/s".

NH682 On packaging containing dressed seeds, the following label is necessary: "The treated

seeds, including any dust they contain, or dust which is produced during the sowing

process, has to be incorporated completely into the soil".

NH6831-1 The following label must be printed on the seed package: "Treated seeds may only be

sown by using a pneumatic seeding machine which operates with negative pressure,

if this machine is registered in the "List of drift reducing sowing equipment" of the

Julius Kühn-Institute (this can be seen on the Julius Kühn-Institute's website.)".

NH684 On packages of treated seeds the maximum seed rate per hectare must be indicated as

specified in the authorisation. For a combination of several seed protectants, the

lowest admissible seed rate must be stated.





3.1.6 Ecotoxicology (Part B, Section 6, Point 10)

The risk assessment for indirect effects for birds and arthropods via trophic interactions as outlined in

chapter 9.3.1 in the national addendum is not harmonized on EU level yet. According to Art. 4 (3) (e) (iii)

of Regulation (EC) No 1107/2009 the availability of scientific methods accepted by EFSA for assessing

the impact on biodiversity is a prerequisite for making those aspects part of the authorisation procedure for

PPPs. For the time being, such methods are not available. That is why, amongst other reasons, the BVL is

of the opinion that biodiversity must not be part of the risk assessment or, respectively, of the risk

management. This was confirmed by the Administrative Court of Braunschweig in its latest judgment of

4th September 2019 in first instance.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

The results of the core assessment indicate an acceptable risk for birds and mammals due to the intended

use of Rancona 450 FS as seed treatment for maize according to the label.

Consequences for authorisation:

NH677 On packaging containing dressed seeds, the following label is necessary: "Sweep up and

remove spilled seeds immediately".

NH679 On packaging containing dressed seeds, the following label is necessary: "This product is

poisonous for birds. For this reason, do not leave seeds exposed. Switch off the dosing

equipment on time before lifting out the shares to prevent trickling afterwards".

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)

Exposure due to run-off and drainage

TER values for aquatic organisms were calculated, taking into account the relevant toxicity data for

Ipconazole and calculated exposure levels, according to the intended uses of the product Rancona 450 FS

as seed treatment for maize. The calculated TER values do achieve the acceptability criterion TER ≥ 10

for chronic effects on aquatic organisms, according to Commission Regulation (EU) No 546/2011,

Annex, Part I C, point 2.5.2.2. The results of the assessment indicate an acceptable risk for aquatic

organisms due to the intended use of Rancona 450 FS as seed treatment for maize according to the label.

Exposure due to dust drift

TER values for aquatic organisms were calculated, taking into account the relevant toxicity data for

Ipconazole and calculated exposure levels, according to the intended uses of the product Rancona 450 FS

as seed treatment for maize. The calculated TER values do achieve the acceptability criterion TER ≥ 10

for chronic effects on aquatic organisms, according to Commission Regulation (EU) No 546/2011,

Annex, Part I C, point 2.5.2.2. The results of the assessment indicate an acceptable risk for aquatic

organisms due to the intended use of Rancona 450 FS as seed treatment for maize (due to dust drift)

according to the label.






Classification and labelling of Rancona 450 FS

Relevant toxicity The classification of ipconazole is based on chronic toxicity data for

fish Pimephales promelas NOEC = 0.00044 mg a.s./L

Classification and labelling according to Regulation 1272/2008

Hazard symbol GHS09

Signal word Warning

Hazard statement H410 - Very toxic to aquatic life with long lasting effects.

Precautionary Statements: P273 - Avoid release to the environment.

P391 - Collect Spillage

P501 - Dispose of contents/ container to an approved waste disposal

plant.

Additional national label phrases

NW262 The product is toxic for algae.

NW264 The product is toxic for fish and aquatic invertebrates.

NW470 Where applicable, fluids left over from application, granules and their remains as

well as cleansing and rinsing fluids must not be dumped in water. This also applies to

indirect entry via the urban or agrarian drainage system and to rain-water and sewage

canals.


allow treated seeds and remains such as broken grain and dust, empty containers or

packaging or rinsing liquid to come into contact with water. This also applies to

indirect entry via the urban or agrarian drainage system and to rainwater and sewage

canals".

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and

10.5)

Bees

Exposure

The formulation Rancona 450 FS (ipconazole 452 g/L) is a maize seed treatment formulation and applied

to the soil at a rate of up to 0.0063 L product/ha. This maximum single application rate is equivalent to

6.9 g product/ha (2.85 g a.s./ha).

Due to the type of application, direct oral or contact exposure to bees with the formulation can be

excluded. However, bees may be exposed to residues from systemic compounds, present in nectar, pollen

or drift of dust during drilling. But this exposure is considered to be far below a spray application at

similar rates.

Toxicity

The following table presents the results of laboratory bee toxicity studies with the active substance.





Test substance Exposure route LD50

ipconazole tech.

oral 48 h > 100 µg a.s./bee *

contact 48 h > 100 µg a.s./bee *

* EU agreed endpoint

Hazard quotients

Due to the type of formulation as a seed treatment, calculation of hazard quotients according to EPPO

Environmental Risk Assessment Scheme does not seem to be appropriate.

Risk assessment

Rancona 450 FS is considered to be practically non-toxic to bees, due to results of laboratory tests with

the active substances. In addition, exposure to bees with Rancona 450 FS can widely be excluded due to

the type of formulation as a seed treatment.

Bee brood testing is not required since the test item is not an IGR.

Overall conclusion:

It is concluded that Rancona 450 FS will not adversely affect bees or bee colonies when used as

recommended.

Other non-target arthropods

The results of the core assessment indicate an acceptable risk for non-target arthropods in off-field

habitats due to the dust drift of intended use of Rancona 450 FS as seed treatment for maize according to

the label.


NT699-1 The seed treatment shall only be performed in professional seed treatment facilities,

which are registered in the index of "Seed Treatment Facilities with Quality

Assurance Systems to Minimise Dust" of the Julius Kühn-Institute (visit the

homepage of the Julius Kühn-Institute <http://www.jki.bund.de)/>).

NT714-1 At the beginning of the production process it must be demonstrated and documented

for each formulation that the amount of active substance which might be abraded by

dust (Heubach a.s. value) does not exceed 0.05 g Ipconazole per 100,000 seeds. This

evidence must be submitted and documented for all formulations once every calendar

year or at the beginning of the treatment season after intermission of the production.

Retention samples of treated seeds from the production process allowing the

determination of the Heubach-a.s. value must be taken from new seed batches or

every two weeks at the latest. These retention samples shall be retained for at least 12

months. Changes in the nature and quantity of the adjuvants used or changes in the

use of new dressing equipment technology require new evidence. When the Heubach

a.s. value exceeds 0.05 g ipconazole per 100,000 seeds, treated seeds may not be

marketed.

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point





10.6)

Earthworms

TER values for earthworms were calculated, taking into account the relevant toxicity data for Ipconazole

and calculated exposure concentrations in soil, according to the intended uses of the product Rancona 450

FS as seed treatment for maize. The calculated TER values do achieve the acceptability criterion TER ≥

10 for acute effects / the acceptability criterion TER ≥ 5 for chronic effects on earthworms, according to

Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.5. The results of the assessment

indicate an acceptable risk for earthworms due to the intended use of Rancona 450 FS as seed treatment

for maize according to the label.

Other organisms of the soil macro- and mesofauna

TER values for other organisms of the soil macro- and mesofauna were calculated, taking into account the

relevant toxicity data for Ipconazole and calculated exposure concentrations in soil, according to the

intended uses of the product Rancona 450 FS as seed treatment for maize. The calculated TER values do

achieve the acceptability criterion TER ≥ 5 for chronic effects (as adopted from the risk assessment for

earthworms) on other organisms of the soil macro- and mesofauna, according to Commission Regulation

(EU) No 546/2011, Annex, Part I C, point 2.5.2.5. The results of the assessment indicate an acceptable

risk for other organisms of the soil macro- and mesofauna due to the intended use of Rancona 450 FS as

seed treatment for maize according to the label.

Consequences for authorisation

None

3.1.6.5 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)

Concentrations of Ipconazole in soil were determined where effects on nitrogen and carbon mineralisation

processes remained ≤ 25 % and were compared to calculated exposure concentrations in soil, according to

the intended uses of the product Rancona 450 FS as seed treatment for maize. The comparison indicates

no exceedance of the acceptability criterion ≤ 25 % effects on soil microorganisms, according to


indicate an acceptable risk for soil microorganisms due to the intended use of Rancona 450 FS as seed

treatment for maize according to the label.

3.1.6.6 Assessment of Potential for Effects on Other Non-target Organisms (Flora and

Fauna) (Part B, Section 6, Point 10.8)

Terrestrial non-target plants are not considered to be at risk from the use of the product Rancona 450 FS

as seed treatment in maize. Although exposure to residues of Ipconazole can occur due to deposition of

abraded dust from maize seeds during sowing, there are no indications that such deposits with fungicidal

a.s. would have significant adverse effects on terrestrial plants. Therefore, no quantitative risk assessment

is required.

Other non-target species (Flora and Fauna)

Not relevant.

Implications for labelling resulting from ecotoxicological assessment:





See above under 2.3 and the respective chapters.

3.1.7 Efficacy (Part B, Section 7, Point 8)

Information on the use and the necessity to control the organism applied for

Information about the disease in Europe is given. The applicant stated that the disease only occurs

sporadically. Potentially increasing infection levels are only expected under favourable climatic

conditions. No information about the relevance of the disease in Germany is provided. Additional

information was provided during the authorisation process. Nevertheless, from the zRMS point of view

the organism Sphacelotheca reiliana does not play a role in DE. The organism is unworthy of control in

maize.

Preliminary tests:

The applicant conducted 2 trials to demonstrate the need of ipconazole. The trials were carried out in

France in 2001. Three different formulations at rates of 1, 2 and 4 g active substance per 100 kg seed

were included in the Preliminary tests. The requested dose rate of 8.1 g active substance per 100 kg seed

was not tested. The experimental design of the preliminary tests was non-orthogonal, not all rates were

tested for all formulations. A reliable evaluation of the results was therefore hardly possible.

The results of these preliminary tests show clear differences in the efficacy of the formulations. The

formulation UBI 6726 shows an efficacy of 89.5%, while the formulation UBI 6774 shows an efficacy of

45.7%, both with 4 g a.s.

The highest level of control was achieved at 4 g a.s. (89.5%). The efficacy level of the reference product

was 97.4%. It remains unclear and questionable why the applicant concluded that disease control of the

product and the reference product is comparable.

The two trials presented by the applicant do not show that the different formulations are comparable.

Minimum effective dose rate tests (Dose justification)

The core assessment was revised during the authorisation process. The applicant provided 11 MED trials

with the requested formulation.

In one trial from the maritime zone application rates from 2.5 – 10.9 g a.s. per 100 kg seed were tested.

The efficacy between the different application rates do not differ significantly.

In the mediterranean zone application rates from 2.55 –12.2 g a.s. per 100 kg seed were tested in 8 trials.

Infection level of the untreated control was 6.8 – 42.5%. The efficacy between the application rates 5.8-

6.1 g a.s./100kg and the applied rate of 8.1 g a.s./100 kg does not differ significantly (72.17% and

74.64%).

In the south-east EPPO zone, 2 trails were carried out. Application rates ranged from 4.1 – 12.2 g a.s. per

100 kg seed. The infection level of the untreated control was 12.7 – 21.1%. The dose reduction from 8.1g

a.s . per 100 kg seeds to 6.1 g per 100 kg seeds caused a decrease of disease control by 12.6%.

It can be concluded to accept the data provided by the applicant to demonstrate the minimum effective

dose for the control of Sphacelotheca reiliana in maize.

Efficacy

The core assessment was revised during the authorisation process. In the first version twenty-five field

trials were carried out between 2005 and 2017 within 3 different climate zones (maritime, mediterranean

and southeast). Five different formulations have been tested at rates of 2.55 – 20.1 g a.s. /100 kg seed.

The version revised by the applicant now shows 11 efficacy trials with the requested formulation.

One trial from the maritime EPPO zone was conducted with the applied conditions such as the

formulation UBI 4336 with 8.1 g a.s. /100 kg seed. The efficacy was 99.1%.

In the mediterranean EPPO zone, 8 trials with the applied conditions were conducted with an efficacy on

average of 74.6%.





In the southeast EPPO zone, 2 trials with the applied conditions were conducted with an efficacy on

average of 89.3%.

Summarizing the results of the efficacy trials (11 trials) from all 3 zones, the efficacy is satisfactory

(79.5%).

It can be concluded that the data provided by the applicant to demonstrate the effectiveness against

Sphacelotheca reiliana in maize is sufficient sufficient.

Effects on yield and quality

Five out of 25 efficacy trials and 7 selectivity trials were harvested. The applicant mentioned, that quality

parameters have been tested on some of these trials, but no details have been presented. The applicant

presented some quality parameters, grain yield and silage yield results.

The presented data correspond with the requirements of the EPPO Standards PP 1/181 (Conduct and

reporting of efficacy evaluation trials, including Good Experimental Practice), PP 1/214 (Principles of

acceptable efficacy) and PP 1/223 (Introduction to the efficacy evaluation of plant protection products).

No negative effect was observed by applying this fungicide.

Phytotoxicity

The presented data corresponds with the requirements of the EPPO Standard PP 1/135 (Phytotoxicity

assessment). The applicant assessed phytotoxicity across 14 maize cultivars in 37 efficacy and crop

selectivity trials. In three trials (1 efficacy and 2 crop selectivity) minor symptoms have been recorded.

Furthermore, specific crop safety trials for seed treatments and germination tests after treatment and after

storage (e.g. 12 month) were conducted. No negative impact in these tests were reported by the applicant. Based on the submitted data and expert knowledge about ipconazole it can be concluded to accept the

data provided by the applicant.

Risk of resistance

The presented data corresponds with the requirements of the EPPO Standard PP 1/213 (Resistance risk

analysis). The applicant addresses all points of the EPPO Standard to evaluate the possible actual

resistance risk of ipconazole. Based on FRAC assessment the applicant determined the risk of resistance

due to the mode of action for DMI fungicides (SBI-class I; Triazole) as low to medium depending on the

pathogen (combined resistance risk = 2-4). Based on the submitted data and expert knowledge about ipconazole it can be concluded to accept the

data provided by the applicant.

Adverse effects

The applicant did not present any data especially for this annex point. No negative effects of the product

on parts of plant used for propagating purposes are expected.

Based on long-term experience in the practical field use with ipconazole and on expert knowledge it can

be concluded to accept the information provided by the applicant.

Impact on succeeding crops:

The applicant has not conducted an assessment according to EPPO Standard PP 1/207 (Effects on

succeeding crops), however the submitted explanation and results of a confined rotational crop study

attempts to demonstrate the absence of effects and therefore the levels of active substance in the soil are

not important.

It can be concluded to accept the information provided by the applicant.

Impact on other plants including adjacent crops:

The applicant has not conducted an assessment to EPPO Standard PP 1/256 (Effects on adjacent crops).

He referred to a Heubach dust-study in section IIIA1 6.5.1. The section IIIA1 6.5.1 does not exist in this

dRR. The study under section IIIA1 6.5 “Dust” may give a clue that the applied plant protection product

does not have a negative impact to adjacent crops.





DE as zRMS accepts the submitted information.

Rancona 450 FS can be classified as non-harmful for populations of relevant beneficial insects and

predatory mites and spiders.

3.2 Conclusions

With regard to identity, physical, chemical and technical properties, further information and analytical

methods (product and residues), an authorisation can be granted.

With respect to efficacy and sustainable use an authorisation can be granted if the application is restricted

to maize used for seed production.

Rancona 450 FS can be classified as non-harmful for populations of relevant beneficial insects and

predatory mites and spiders.

Rancona 450 FS is considered to be practically non-toxic to bees, due to results of laboratory tests with the

active substances. In addition, exposure to bees with Rancona 450 FS can widely be excluded due to the

type of formulation as a seed treatment.

Considering an application of the product in accordance with the intended and evaluated use pattern and

good agricultural practice as well as compliance with imposed risk mitigation measures no harmful effects

on groundwater or unacceptable effects on non-target organisms are to be expected

With respect to toxicology, residues and consumer protection an authorisation can be granted.

An authorisation is granted for use 003. Uses 001 and 002 are withdrawn by applicant.

3.3 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation

No further information is required.





Appendix 1 – Copy of the product authorisation (see Appendix 4)


Product code XXX



Appendix 2 – Copy of the product label

The submitted draft product label has been checked by the competent authority. The applicant is

requested to amend the product label in accordance with the decisions made by the competent

authority. The final version of the label has to fulfil the requirements according to Article 31 of

Regulation (EU) No 1107/2009.





Appendix 3 – Letter of Access

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.


Product code XXX



Appendix 4 – Copy of the product authorisation

Bundesamt für Verbraucherschutz und LebensmittelsicherheitDienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig

Dr. Birgit SchreiberReferentin

Arysta LifeScience Great Britain Limited3-5 Melville StreetEH3 7PE EdinburghVEREINIGTES KÖNIGREICH (UK)

TELEFON +49 (0)531 299-3457TELEFAX +49 (0)531 299-3002

E-MAIL [email protected]

IHR ZEICHEN

IHRE NACHRICHT VOM

AKTENZEICHEN 200.22100.008398-00/00.122706(bitte bei Antwort angeben)

DATUM 5. Oktober 2020

ZV1 008398-00/00

Rancona 450 FS

Zulassungsverfahren für Pflanzenschutzmittel

Bescheid

Das oben genannte Pflanzenschutzmittel

mit dem Wirkstoff: 452 g/l Ipconazole

Zulassungsnummer: 008398-00

Versuchsbezeichnungen: AYT-00001-F-0-FS

Antrag vom: 27. Februar 2015

wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen

Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzen-

schutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates

(ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:

Zulassungsende

Die Zulassung endet am 31. August 2025.

Festgesetzte Anwendungsgebiete bzw. Anwendungen

Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1):

Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de

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Anwendungs-

nummer

Schadorganismus/

Zweckbestimmung

Pflanzen/-erzeugnisse/

Objekte

Verwendungszweck

008398-00/00-003 Kopfbrand (Sphace-

lotheca reiliana)

Mais Zur Saatguterzeugung

Festgesetzte Anwendungsbestimmungen

Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum

Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I

S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 84 des Gesetzes vom 18. Juli 2016

(BGBl. I S. 1666), festgesetzt:

(NH677)

Auf Packungen mit gebeiztem Saatgut ist folgende Kennzeichnung anzubringen: "Verschüt-

tetes Saatgut sofort zusammenkehren und entfernen."

Begründung:

Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff Ipconazole weist ein hohes

Gefährdungspotenzial für terrestrische Vertebraten auf. Da vor allem die Risikobewertung für

granivore Kleinsäuger/Vögel Annahmen berücksichtigt, die mit einer gewissen Unsicherheit

belastet sind, sollte die Exposition gegenüber gebeiztem Saatgut so gering wie möglich

gehalten werden. Um dies bei der Ausbringung des behandelten Saatgutes zu erreichen, ist

vorsorglich die Anwendungsbestimmung NH677 zu vergeben, um eine entsprechende Kenn-

zeichnung des behandelten Saatgutes sicherzustellen.

(NH679)

Auf Packungen mit gebeiztem Saatgut ist folgende Kennzeichnung anzubringen: "Das Mittel

ist giftig für Vögel; deshalb dafür sorgen, dass kein Saatgut offen liegen bleibt. Vor dem Aus-

heben der Schare Dosiereinrichtung rechtzeitig abschalten, um Nachrieseln zu vermeiden."

Begründung:

siehe Begründung zur NH677.

(NH680)

Auf Packungen mit gebeiztem Saatgut ist folgende Kennzeichnung anzubringen: "Behandel-

tes Saatgut und Reste wie Bruchkorn und Stäube, entleerte Behältnisse oder Packungen

sowie Spülflüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Ein-

träge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle."

Begründung:

Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff Ipconazole weist aufgrund seiner Toxi-

zität ein hohes Gefährdungspotenzial für aquatische Organismen auf. Jeder Eintrag von

Rückständen in Oberflächengewässer, der den Eintrag als Folge der bestimmungsgemäßen

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und sachgerechten Anwendung des o.g. Pflanzenschutzmittel entsprechend der guten fachli-

chen Praxis übersteigt, würde daher zu einer Gefährdung des Naturhaushaltes aufgrund von

nicht akzeptablen Auswirkungen auf Gewässerorganismen führen. Da ein erheblicher Anteil

der in Oberflächengewässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge

aus kommunalen Kläranlagen zurückzuführen ist, muss dieser Gefährdung durch die buß-

geldbewehrte Anwendungsbestimmung durchsetzbar begegnet werden.

(NH681)

Auf Packungen mit gebeiztem Saatgut ist folgende Kennzeichnung anzubringen: "Keine Aus-

bringung des behandelten Saatgutes bei Wind mit Geschwindigkeiten über 5 m/s."

Begründung:

Bei der Ausbringung des mit dem o.g. Pflanzenschutzmittel behandelten Saatgutes kann ent-

haltener sowie durch Abrieb in der Sämaschine entstehender Staub, der den Wirkstoff Ipco-

nazole in hohen Konzentrationen enthält, emittiert und durch Abdrift aus der Applikationsflä-

che ausgetragen werden. Aufgrund der hohen Toxizität des Wirkstoffs gegenüber verschie-

denen Gruppen der Nichtziel-Organismen ist eine derartige Exposition von Nichtziel-Flächen

auf ein Mindestmaß zu reduzieren. Zur Vermeidung unvertretbarer Auswirkungen auf Nicht-

ziel-Organismen ist demzufolge sicherzustellen, dass eine Emission und Verfrachtung von

enthaltenen bzw. durch Abrieb im Aussaatgerät entstehenden Stäuben verhindert wird. Die

Expositionsabschätzung der Umweltrisikobewertung basiert auf Depositionsdaten, die bei

Einhaltung der guten fachlichen Praxis erhoben wurden. Bei Nichteinhaltung dieser Bedin-

gungen kann keine Aussage über das zu erwartende Risiko getroffen werden. Aus diesem

Grund sollte die Auflage NH681 vergeben werden.

(NH682)

Auf Packungen mit gebeiztem Saatgut ist folgende Kennzeichnung anzubringen: "Das

behandelte Saatgut einschließlich enthaltener oder beim Sävorgang entstehender Stäube

vollständig in den Boden einbringen."

Begründung:

Bei der Ausbringung des mit o.g. MIttel behandelten Saatgutes kann enthaltener sowie durch

Abrieb in der Sämaschine entstehender Staub, der den Wirkstoff Ipconazole in hohen Kon-

zentrationen enthält, emittiert und durch Abdrift aus der Applikationsfläche ausgetragen wer-

den. Aufgrund der hohen Toxizität des Wirkstoffs gegenüber verschiedenen Gruppen der

Nichtziel-Organismen ist eine derartige Exposition von Nichtziel-Flächen auf ein Mindestmaß

zu reduzieren. Zur Vermeidung unvertretbarer Auswirkungen auf Nichtziel-Organismen ist

demzufolge sicherzustellen, dass eine Emission und Verfrachtung von enthaltenen bzw.

durch Abrieb im Aussaatgerät entstehenden Stäuben verhindert wird.

(NH6831-1)

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Auf Packungen mit gebeiztem Saatgut ist folgende Kennzeichnung anzubringen: "Die Aus-

saat von behandeltem Saatgut darf nur dann mit einem pneumatischen Gerät, das mit Unter-

druck arbeitet, erfolgen, wenn dieses in der "Liste der abdriftmindernden Sägeräte" des

Julius Kühn-Instituts aufgeführt ist (einzusehen auf der Homepage des Julius Kühn-

Instituts.).

Begründung:

Siehe Begründung zur NH682.

(NH684)

Auf Packungen mit behandeltem Saatgut ist die im Rahmen der Zulassung festgelegte maxi-

mal zulässige Aussaatstärke pro Hektar anzugeben. Bei einer Kombination mehrerer Saat-

gutbehandlungsmittel ist die niedrigste zulässige Aussaatstärke maßgeblich.

Begründung:

Diese Anwendungsbestimmung ist erforderlich um die Voraussetzung der Risikobewertung

entsprechend der beantragten Anwendung sicherzustellen und so mögliche unvertretbare

Auswirkungen auf den Naturhaushalt oder schädliche Auswirkungen auf das Grundwasser

weitestgehend zu vermeiden.

(NT699-1)

Die Anwendung des Mittels auf Saatgut darf nur in professionellen Saatgutbehandlungsein-

richtungen vorgenommen werden, die in der Liste "Saatgutbehandlungseinrichtungen mit

Qualitätssicherungssystemen zur Staubminderung" des Julius Kühn-Instituts aufgeführt sind

(einzusehen auf der Homepage des Julius Kühn-Instituts).

Begründung:

Das Pflanzenschutzmittel Rancona 450 FS bzw. der darin enthaltene Wirkstoff Ipconazole

weist ein hohes Gefährdungspotenzial für aquatische Organismen und terrestrische Nicht-

zielarthropoden auf. Bewertungsbestimmend für Gewässerorganismen ist hier die NOEC für

Pimephales promelas von 0,44 µg/L. Bewertungsbestimmend für Nichtzielarthropoden ist

hier die LR50 von 17,4 g/ha für Typhlodromus pyri im 2D Test.

Ausgehend von den regulatorischen Szenarien zur Bewertung des Eintragspfades "Staub-

drift und Deposition" aus dem Dokument SANCO/10553/2012 ("Draft Guidance Document

for the Authorisation of Plant Protection Products for Seed Treatment") sind die Anwendungs-

bestimmungen NT699-1 und NT714-1 erforderlich, um einen ausreichenden Schutz von

aquatische Organismen, insbesondere Fischen, in Oberflächengewässern sowie Nichtzielar-

thropoden in angrenzenden Flächen vor Auswirkungen des Mittels Rancona 450 FS bzw.

des darin enthaltene Wirkstoffs Ipconazole zu gewährleisten.

Weitere Informationen hierzu sind dem Draft registration Report, Part B, Core Assessment

und dem nationalen Addendum für Sektion 5 und Sektion 6 zu entnehmen.

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(NT714-1)

Für jede Rezeptur muss am Anfang des Produktionsprozesses mit Hilfe der Heubach-Me-

thode nachgewiesen und dokumentiert werden, dass die Wirkstoffmenge im Staub, die vom

behandelten Saatgut abgerieben werden kann (Heubach a.s.-Wert), den Wert von 0,05 g

Ipconazole pro 100.000 Samen nicht überschreitet. Dieser Nachweis ist für alle Rezepturen

einmal im Kalenderjahr oder zu Beginn der Beizsaison nach einer Produktionspause zu

erbringen und zu dokumentieren. Es sind bei neuen Saatgutpartien und spätestens alle 2

Wochen Rückstellproben des behandelten Saatgutes aus dem Produktionsprozess zu zie-

hen, die eine Bestimmung des Heubach a.s.-Wertes ermöglichen. Diese Rückstellproben

sind mindestens 12 Monate aufzubewahren. Änderungen in der Art und Menge der einge-

setzten Zusatzstoffe oder beim Einsatz neuer Beizgerätetechnik erfordern einen neuen

Nachweis. Behandeltes Saatgut, dessen Heubach a.s.-Wert den Wert von 0,05 g Ipconazole

pro 100.000 Samen überschreitet, ist als nicht verkehrsfähig anzusehen.

Begründung:

Siehe Begründung der Anwendungsbestimmung NT699-1.

(NW470)

Etwaige Anwendungsflüssigkeiten, Granulate und deren Reste sowie Reinigungs- und Spül-

flüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Einträge über

die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle.

Begründung:

Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff Ipconazole weist aufgrund seiner Toxi-

zität ein hohes Gefährdungspotenzial für aquatische Organismen auf. Jeder Eintrag von

Rückständen in Oberflächengewässer, der den Eintrag als Folge der bestimmungsgemäßen

und sachgerechten Anwendung des Mittels entsprechend der guten fachlichen Praxis über-

steigt, würde daher zu einer Gefährdung des Naturhaushaltes aufgrund von nicht akzepta-

blen Auswirkungen auf Gewässerorganismen führen. Da ein erheblicher Anteil der in Ober-

flächengewässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge aus kommu-

nalen Kläranlagen zurückzuführen ist, muss dieser Gefährdung durch die bußgeldbewehrte

Anwendungsbestimmung durchsetzbar begegnet werden.

(SF6142-1)

Beim Umgang mit gebeiztem Saatgut sind Schutzhandschuhe (Pflanzenschutz) und Schutz-

anzug gegen Pflanzenschutzmittel zu tragen.

Begründung:

Im Ergebnis der Expositionsbewertung für den Anwender ist die Anwendungsbestimmung

erforderlich, um den Referenzwert bei bestimmungsgemäßer Anwendung nicht zu über-

schreiten. Nur in Verbindung mit dieser Expositionsminderungsmaßnahme wird das Risiko

als vertretbar beurteilt.

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(SF6161-1)

Beim Absacken des Saatgutes sind Schutzhandschuhe (Pflanzenschutz) und Schutzanzug

gegen Pflanzenschutzmittel zu tragen.

Begründung:





Darüber hinaus ist die Anwendungsbestimmung aufgrund der Einstufung und Kennzeich-

nung des Mittels erforderlich (vgl. Bundesanzeiger: "Bekanntmachung über die Ableitung von

gefahrenbasierten Kennzeichnungsauflagen zur Anwendungssicherheit im Zulassungsver-

fahren für Pflanzenschutzmittel nach Inkrafttreten der CLP-Verordnung für Gemische (BVL

15/02/13) vom 23. September 2015 " (BAnz AT 19.10.2015 B2)).

(SF618-1)

Beim Reinigen der Beizgeräte sind Schutzhandschuhe (Pflanzenschutz) und Schutzanzug

gegen Pflanzenschutzmittel zu tragen.

Begründung:





(SS1201-1)

Bei der Ausbringung/Handhabung des Mittels sind Schutzhandschuhe (Pflanzenschutz) zu

tragen.

Begründung:










(SS2204)

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Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z. B. Gummistiefel) tragen

bei der Ausbringung/Handhabung des Mittels.

Begründung:










(ST1202)

Partikelfiltrierende Halbmaske FFP2 oder Halbmaske mit Partikelfilter P2 (Kennfarbe: weiß)

gemäß BVL-Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflan-

zenschutz, in der jeweils geltenden Fassung, tragen bei der Ausbringung/Handhabung des

Mittels.

Begründung:





(ST1261)



zenschutz, in der jeweils geltenden Fassung, tragen beim Absacken des Saatgutes.

Begründung:





(ST1271)



zenschutz, in der jeweils geltenden Fassung, tragen beim Reinigen des Beizgerätes.

Begründung:

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Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.

Verpackungen

Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend

näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:

Verpackungs-

art

Verpackungs-

material

Anzahl Inhalt

von bis von bis Einheit

Kanister HDPE 1 20,00 l

Tank HDPE 1 1000,00 l

Trommel, Fass,

Tonne

HDPE 1 200,00 l

Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen:

Anwendung nur durch berufliche Anwender zulässig.

Auflagen

Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden:

Kennzeichnungsauflagen:

(EB001-2)

SP 1: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsge-

räte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen./Indirekte Einträge über

Hof- und Straßenabläufe verhindern.)

(NW262)

Das Mittel ist giftig für Algen.

(NW264)

Das Mittel ist giftig für Fische und Fischnährtiere.

(SB001)

Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschä-

den führen.

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(SB005)

Ist ärztlicher Rat erforderlich, Verpackung oder Etikett des Produktes bereithalten.

(SB010)

Für Kinder unzugänglich aufbewahren.

(SB111)

Für die Anforderungen an die persönliche Schutzausrüstung beim Umgang mit dem Pflan-

zenschutzmittel sind die Angaben im Sicherheitsdatenblatt und in der Gebrauchsanweisung

des Pflanzenschutzmittels sowie die BVL-Richtlinie "Persönliche Schutzausrüstung beim

Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebens-

mittelsicherheit (www.bvl.bund.de) zu beachten.

(SB166)

Beim Umgang mit dem Produkt nicht essen, trinken oder rauchen.

(SS206)

Arbeitskleidung (wenn keine spezifische Schutzkleidung erforderlich ist) und festes Schuh-

werk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung von Pflanzenschutzmit-

teln.

(WMFG1)

Wirkungsmechanismus (FRAC-Gruppe): G1

Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.

Sonstige Auflagen:

(WH952)

Auf der Verpackung und in der Gebrauchsanleitung ist die Angabe zur Kennzeichnung des

Wirkungsmechanismus als zusätzliche Information direkt jedem entsprechenden Wirkstoffna-

men zuzuordnen.

Vorbehalt

Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder

Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.

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Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/2008

Signalwort:

(S1) Achtung

Gefahrenpiktogramme:

(GHS08) Gesundheitsgefahr

(GHS09) Umwelt

Gefahrenhinweise (H-Sätze):

(H360D)

Kann das Kind im Mutterleib schädigen.

(H373)

Kann die Organe schädigen <alle betroffenen Organe nennen, sofern bekannt> bei längerer

oder wiederholter Exposition <Expositionsweg angeben, wenn schlüssig belegt ist, dass

diese Gefahr bei keinem anderen Expositionsweg besteht>.

(H410)

Sehr giftig für Wasserorganismen mit langfristiger Wirkung.

(EUH 401)

Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.

Sicherheitshinweise (P-Sätze):

(P101)

Ist ärztlicher Rat erforderlich, Verpackung oder Kennzeichnungsetikett bereithalten.

(P102)

Darf nicht in die Hände von Kindern gelangen.

(P201)

Vor Gebrauch besondere Anweisungen einholen.

(P260)

Staub/Rauch/Gas/Nebel/Dampf/Aerosol nicht einatmen.

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Freisetzung in die Umwelt vermeiden.

(P280)

Schutzhandschuhe/Schutzkleidung/Augenschutz/Gesichtsschutz tragen.

(P308+P310)

BEI Exposition oder falls betroffen: Sofort GIFTINFORMATIONSZENTRUM oder Arzt anru-

fen.

(P391)

Verschüttete Mengen aufnehmen.

(P405)

Unter Verschluss aufbewahren.

(P501)

Inhalt/Behälter ... zuführen.

Abgelehnte Anwendungsgebiete bzw. Anwendungen

Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe

Anlage 2):

- keine -

Hinweise

Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden:

(NB663)

Aufgrund der durch die Zulassung festgelegten Anwendungen des Mittels werden Bienen

nicht gefährdet (B3).

(NN1001)

Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft.

(NN1002)

Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen

eingestuft.

Weitere Hinweise und Bemerkungen

Zu den Anwendungen 008398-00/00-003

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Es kommt durch den Organismus Sphacelotheca reiliana an Mais nur unter sehr speziellen

Bedingungen (warm und trocken im Frühjahr) zu einem ernsthaften Befall. In DE spielt Spha-

celotheca reiliana an Mais bislang keine Rolle und ist nicht bekämpfungsbedürftig.

Daher wird die Zulassung auf Mais beschränkt, der zum Zwecke der Saatguterzeugung

angebaut wird.

Auf dem Etikett muss ein Hinweis enthalten sein, dass die Formulierung nicht bei höherer

Temperatur gelagert werden darf.

Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben,

soweit sie noch nicht erfüllt sind.

Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu

schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulas-

sungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.

Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid.

Rechtsbehelfsbelehrung

Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben

werden. Der Widerspruch ist beim Bundesamt für Verbraucherschutz und Lebensmittelsicherheit,

Braunschweig einzulegen.

Mit freundlichen Grüßen

im Auftrag

gez. Dr. Martin Streloke

Abteilungsleiter

Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.

Anlage

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Anlage 1 zugelassene Anwendung: 008398-00/00-003

1 Anwendungsgebiet

Schadorganismus/Zweckbestimmung: Kopfbrand (Sphacelotheca reiliana)

Pflanzen/-erzeugnisse/Objekte: Mais

Verwendungszweck: Zur Saatguterzeugung

2 Kennzeichnungsauflagen

2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Ackerbau

Anwendungsbereich: Freiland

Anwendung im Haus- und

Kleingartenbereich: Nein

Anwenderkategorie: Beruflich

Anwendungszeitpunkt: Vor der Saat

Maximale Zahl der Behandlungen

- in dieser Anwendung: 1

Anwendungstechnik: Saatgutbehandlung

Aufwand:

- 2,52 ml pro Einheit Saatgut in 5 bis 70 ml Wasser pro

Einheit Saatgut

- Erläuterungen: maximaler Mittelaufwand 6,3 ml/ha (entsprechend

maximal 2,5 Saatgut-Einheiten pro ha; 1 Einheit

umfasst 50.000 Korn)

2.2 Sonstige Kennzeichnungsauflagen

- keine -

2.3 Wartezeiten

(F) Freiland: Mais

Die Wartezeit ist durch die Anwendungsbedingungen

und/oder die Vegetationszeit abgedeckt, die zwischen

Anwendung und Nutzung (z. B. Ernte) verbleibt bzw.

die Festsetzung einer Wartezeit in Tagen ist nicht

erforderlich.

3 Anwendungsbezogene Anwendungsbestimmungen

- keine -

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Part B – Section 1

Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)

Registration Report – Central Zone

Page 1 of 32

Applicant Arysta LifeSciences Evaluator: DE

Date: July 2020

REGISTRATION REPORT

Part B

Section 1: Identity, physical and chemical

properties, other information

Detailed summary of the risk assessment

Product code: UBI 4336-01

(Rancona 450 FS)

Active Substance: Ipconazole 452.0 g/L

Central Zone

Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Arysta LifeScience

Submission Date: 27/02/2015

Date: July 2020


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 2 of 32


Date: July 2020

Table of Contents

Introduction 6

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT .............................. 7

IIIA 1.1 Applicant ................................................................................................................ 7

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the

Active Substance(s) ............................................................................................... 7

IIIA 1.2.1 Manufacturer(s) of the preparation .................................................................... 7

IIIA 1.2.2 Manufacturer(s) of the active substance(s) ......................................................... 7

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the

active substance(s) ................................................................................................. 7

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation .......... 7

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition

of the Preparation .................................................................................................. 7

IIIA 1.4.1 Content of active substance and formulants ....................................................... 7

IIIA 1.4.2 Certified limits of each component ...................................................................... 8

IIIA 1.4.3 Common names and code numbers for the active substance(s) ........................ 8

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name,

specification and function. .................................................................................... 8

IIIA 1.4.5 Formulation process .............................................................................................. 8

IIIA 1.4.5.1 Description of formulation process ...................................................................... 8

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern .................. 9

IIIA 1.5 Type of Preparation and Code ............................................................................. 9

IIIA 1.6 Function .................................................................................................................. 9

IIIA 1.7 Other/Special Studies ............................................................................................ 9

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF

THE PLANT PROTECTION PRODUCT ....................................................... 10

IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15.......... 20


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 3 of 32


Date: July 2020

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION

PRODUCT ........................................................................................................... 20

IIIA 3.1 Field of Use ........................................................................................................... 20

IIIA 3.2 Nature of the Effects on Harmful Organisms ................................................... 20

IIIA 3.3 Details of Intended Use ....................................................................................... 20

IIIA 3.3.1 Details of existing and intended uses ................................................................. 20

IIIA 3.3.2 Details of harmful organisms against which protection is afforded ............... 20

IIIA 3.3.3 Effects achieved ................................................................................................... 20

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ................. 20

IIIA 3.5 Concentration of the Active Substance in the Material Used ......................... 20

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of

Diluent .................................................................................................................. 20

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop

and Harmful Organism) and Duration of Protection ...................................... 20

IIIA 3.7.1 Maximum number of applications and their timings ...................................... 21

IIIA 3.7.2 Growth stages of crops or plants to be protected ............................................. 21

IIIA 3.7.3 Development stages of the harmful organism concerned ................................ 21

IIIA 3.7.4 Duration of protection afforded by each application ....................................... 21

IIIA 3.7.5 Duration of protection afforded by the maximum number of

applications .......................................................................................................... 21

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic

Effects on Succeeding Crops .............................................................................. 21

IIIA 3.8.1 Minimum waiting periods or other precautions between last application

and sowing or planting succeeding crops .......................................................... 21

IIIA 3.8.2 Limitations on choice of succeeding crops ........................................................ 21

IIIA 3.8.3 Description of damage to rotational crops ........................................................ 21

IIIA 3.9 Proposed Instructions for Use as Printed on Labels ........................................ 21

IIIA 3.10 Other/Special Studies .......................................................................................... 21


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 4 of 32


Date: July 2020

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION

PRODUCT ........................................................................................................... 21

IIIA 4.1 Packaging and Compatibility with the Preparation ........................................ 21

IIIA 4.1.1 Description and specification of the packaging ................................................ 21

IIIA 4.1.2 Suitability of the packaging and closures .......................................................... 22

IIIA 4.1.3 Resistance of the packaging material to its contents ........................................ 23

IIIA 4.2 Procedures for Cleaning Application Equipment ............................................ 23

IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing ....... 23

IIIA 4.2.2 Effectiveness of the cleaning procedures ........................................................... 23

IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment ............... 23

IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop ...................................... 24

IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed ......................... 24

IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces

treated ................................................................................................................... 24

IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs ................................... 24

IIIA 4.3.5 Waiting period (in days) between application and handling of treated

products ................................................................................................................ 24

IIIA 4.3.6 Waiting period (in days) between last application and sowing or

planting succeeding crops ................................................................................... 24

IIIA 4.3.7 Information on specific conditions under which the preparation may or

may not be used ................................................................................................... 24

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and

Precautions and Handling Procedures to Minimise Those Risks ................... 24

IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During

Transport, Storage or Use .................................................................................. 24

IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage........... 24

IIIA 4.6.1 Details of proposed procedures for small quantities ........................................ 24

IIIA 4.6.2 Evaluation of products of neutralization (small quantities) ............................ 24

IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste ................... 25


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 5 of 32


Date: July 2020

IIIA 4.6.4 Details of proposed procedures for large quantities ........................................ 25

IIIA 4.6.5 Evaluation of products of neutralization (large quantities) ............................ 25

IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste.................... 25

IIIA 4.7 Pyrolytic Behaviour of the Active Substance .................................................... 25

IIIA 4.8 Disposal Procedures for the Plant Protection Product .................................... 25

IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging ............. 25

IIIA 4.8.2 Methods other than controlled incineration for disposal ................................ 25

IIIA 4.9 Other/Special Studies .......................................................................................... 25

IIIA 11 FURTHER INFORMATION............................................................................. 25

IIIA 11.1 Information of Authorisations in Other Countries .......................................... 25

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other

Countries .............................................................................................................. 26

IIIA 11.3 Justified Proposals for Classification and Labelling ........................................ 26

IIIA 11.4 Proposals for Risk and Safety Phrases .............................................................. 26

IIIA 11.5 Proposed Label .................................................................................................... 26

IIIA 11.6 Specimens of Proposed Packaging ..................................................................... 26

Appendix 1: List of data used in support of the evaluation .................................................. 27

Appendix 2: Critical Uses – Justification and GAP tables .................................................... 30

Appendix 3: Experimental testing of the product's physico-chemical and technical

characteristics: ..................................................................................................... 32


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 6 of 32


Date: July 2020

Introduction

This document summarises the information related to the identity, the physical and chemical properties,

the data on application, further information and the classification for the UBI 4336-01 (Rancona 450 FS)

containing the active substance ipconazole which was approved according to Regulation (EC)

No 1107/2009.

This product was not the representative formulation. The product has not been previously evaluated

according to Uniform Principles.

The following table provides the EU endpoints to be used in the evaluation.

Agreed EU End-points

End-Point Ipconazole

(Reg. (EU) No. 571/2014)

Purity of active substance min 955 g/kg

Ipconazole cc: 875 – 930 g/kg

Ipconazole ct: 65 – 95 g/kg

Appendix 1 of this document contains the list of references included in this document for support of the

evaluation.

Information on the detailed composition of UBI 4336-01 (Rancona 450 FS) can be found in the

confidential dossier of this submission (Registration Report - Part C).


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 7 of 32


Date: July 2020

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT

IIIA 1.1 Applicant

Arysta LifeScience

Kennet House

4 Langley Quay

Slough, Berkshire, SL3 6EH

UK

Contact person: Mrs Christel Wake

Tel.No.: +44 (0)782 4334 312

Fax No: +44 (0)175 3603 077

e-mail: [email protected]

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active

Substance(s)

IIIA 1.2.1 Manufacturer(s) of the preparation

Confidential information - data provided separately (Part C).

IIIA 1.2.2 Manufacturer(s) of the active substance(s)

Confidential information - data provided separately (Part C).

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active

substance(s)

Ipconazole min 955 g/kg

Further information/justification is provided in Part C.

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation

Trade name: Rancona 450 FS in Germany

Company code number: UBI 4336-01

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the

Preparation

IIIA 1.4.1 Content of active substance and formulants

The formulation UBI 4336-01 (Rancona 450 FS) was not the representative formulation.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 8 of 32


Date: July 2020

Pure active substance:

content of pure ipconazole: 452 g/L

limits ipconazole: 429.4 – 474.6 g/L

Technical active substance:

content of technical ipconazole

at minimum purity (95.5 %):

473.3 g/L (43.42 % w/w)

The active substance is not present in the formulation in the form of a salt, ester, anion or cation.

Further information on the active substance and on the certified limits of formulants is considered

confidential and is provided separately (Part C).

IIIA 1.4.2 Certified limits of each component

This is not an EC data requirement/ not required by regulation (EU) no. 545/2011.

IIIA 1.4.3 Common names and code numbers for the active substance(s)

Data

Point

Type

1.4.3.1 ISO common name Ipconazole

1.4.3.2 CAS No. 125225-28-7 (mixture of diastereoisomers)

115850-69-6 (ipconazole cc, cis isomer)

115937-89-8 (ipconazole ct, trans isomer)

1.4.3.2 EINECS No. –

1.4.3.2 CIPAC No. 798

1.4.3.2 ELINCS –

1.4.3.3 Salt, ester anion or

cation present

–

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification

and function.

CONFIDENTIAL information - data provided separately (Part C).

IIIA 1.4.5 Formulation process

IIIA 1.4.5.1 Description of formulation process


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 9 of 32


Date: July 2020

This is not an EC data requirement/ not required regulation (EU) 2011/545.

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern

Ipconazole does not contain any impurities of toxicological or ecotoxicological concern.

IIIA 1.5 Type of Preparation and Code

Type : Flowable concentrate for Seed treatment Code : FS

IIIA 1.6 Function

The product will be used as seed treatment fungicide.

IIIA 1.7 Other/Special Studies

None.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 10 of 32


Date: July 2020

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT

All physical and chemical studies have been carried out with the formulation Rancona 450 FS (UBI 4336-00). It is acceptable to bridge from UBI 4336-00

to UBI 4336-01 as all co-formulants are identical. For formulation statement for UBI 4336-00 and a full explanation see RR Part C.

Recommended dilution with water: minimum 1:2, max dilution 0,055 L in 5 L = 1.1 % to 33 %

Table 1: Summary of the physical, chemical and technical properties of the plant protection product

Test or study & Annex

point

Method used /

deviations

Test material purity

and specification

Findings GLP

Y/N

Reference Acceptability /

comments

Colour, odour and

physical state

(IIIA 2.1)

Visual assessment and

organoleptic

determination

Rancona 450 FS:

UBI 4336-00 batch:

906882: ipconazole

40.3% w/w

The preparation is a dark beige to

light brown opaque mobile flowable

liquid.

Y Dunn, N.L., 2010,

GRL-12834

Dickins, M., 2012,

FSP 191

Black, H.M., 2010b,

GRL-12835

Acceptable

Explosive properties

(IIIA 2.2.1)

Structual evaluation

Rancona 450 FS:

UBI 4336-00 Based on the structure of the active

ingredient and the co-formulants the

formulation has no explosive

properties.

Y Black, H.M., 2010a,

GRL-12836

Acceptable.

Oxidizing properties

(IIIA 2.2.2)

Structual evaluation

Rancona 450 FS:

UBI 4336-00 Based on the structure of the active

ingredient and the co-formulants the

formulation has no oxidising

properties.

Y Black, H.M., 2010a,

GRL-12836

Acceptable.

Flash point EEC A 9 Rancona 450 FS:

UBI 4336-00 No flash (point) at 110 °C. Y Dunn, N.L., 2009, Acceptable.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 11 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

(IIIA 2.3.1) batch: 906882 GRL-12833

Flammability

(IIIA 2.3.2)

Not required by regulation (EU)

2011/545. Acceptable.

Auto-flammability

(IIIA 2.3.3)

EC A.15 Rancona 450 FS

batch CJ7227P04,

41.2 % w/w

ipconazole

422 ± 3 °C Y Demangel, B., 2018

18-901080-001

Acceptable

Study submitted on

request

Acidity or alkalinity

and pH

(IIIA 2.4.1)

not required, as pH is in the range 4

… 10

Acceptable

pH of a 1% aqueous

dilution, emulsion or

dispersion

(IIIA 2.4.2)

CIPAC MT 75.3 Rancona 450 FS:

UBI 4336-00

batch: 906882

Before storage:

neat, 23.4 °C: 8.44

1 % dilution: 8.43

After 2 weeks, 54 °C:

neat, 23.6 °C: 8.37

Y Dunn, N.L., 2010,

GRL-12834

Acceptable.

Before storage:

neat: 8.2

destilled water: 8.6

After 2 years, ambient:

neat: 8.0

destilled water: 8.4

Y Dickins, M., 2012,

FSP 191


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 12 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

Kinematic viscosity

(IIIA 2.5.1)

see 2.5.2 Acceptable.

Dynamic viscosity

(IIIA 2.5.2)

OECD 114 Rancona 450 FS:

UBI 4336-00

batch: 906882

20 °C, shear rate = 12 s-1:

225 mPa s

40 °C, shear rate = 12 s-1:

164 mPa s

Y Dunn, N.L., 2009,

GRL-12833

Viscosity has to be

determined at

different shear-rates,

as the formulation is

not supposed to be a

Newtonian liquid.

Surface tension

(IIIA 2.5.3)

OECD 115 Rancona 450 FS:

UBI 4336-00

batch: 906882

90 % saturated, ASTM type I water,

25.8 °C: 51.6 mN/m

Y Riggs, S.A., 2010,

GRL-12837

Acceptable.

Relative density

(IIIA 2.6.1)

EEC A 3 Rancona 450 FS:

UBI 4336-00

batch: 906882

d420 = 1.090 Y Dunn, N.L., 2009,

GRL-12833

Acceptable.

Bulk or tap density

(IIIA 2.6.2)

- -

not required for liquid formulations - - Acceptable.

Storage Stability after

14 days at 54º C

(IIIA 2.7.1)


UBI 4336-00

batch: 906882:

Storage material: HDPE (1 L)

Content of ipconazole:

before storage: 40.7 % w/w

after storage: 40.7 % w/w

The changes of the physical and

chemical properties appearance, pH,

pourability, wet sieve test and

Y Dunn, N.L., 2010,

GRL-12834

Acceptable.

No information on

adhesion to seed after

storage.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 13 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

suspensibility are negligible.

Stability after storage

for other periods

and/or temperatures

(IIIA 2.7.2)

Please refer to 2.7.1 Acceptable.

Minimum content

after heat stability

testing (IIIA 2.7.3)

Not necessary, since the decrease of

the active substance did not exceed

5 %.

Acceptable.

Effect of low

temperatures on

stability

(IIIA 2.7.4)


UBI 4336-00 batch:

906882: ipconazole

40.3% w/w

Storage material: HDPE.

No separated material,

homogeneous liquid with slightly

darker brown steaks near the top of

the liquid.

The product shows good low

temperature stability, the effects on

pH and wet sieve residue are

negligible.

Y Black, H.M., 2010b,

GRL-12835

Acceptable.

Ambient temperature

shelf life

(IIIA 2.7.5)

Rancona 450 FS:

UBI 4336-00

batch: 906882:

storage material: HDPE (20 L)


before storage: 41.1 %

after storage: 41.0 %



pourability, wet sieve test ans


FSP 191

Acceptable.

No information on


storage.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 14 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments


No deterioration of the packaging

was observed.

storage for 36 month in HDPE

(20 L)


before storage: 41.1 %

after storage: 40.8 %



pourability, wet sieve test ans


No deterioration of the packaging

was observed.


FSP 192

Acceptable

No information on


storage.

Shelf life in months

(if less than 2 years)

(IIIA 2.7.6)

Please refer to 2.7.5

The formulation is stable for 36

month at ambient temperature.

- Acceptable.

Wettability

(IIIA 2.8.1)

not required for liquid formulations Acceptable.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 15 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

Persistence of

foaming

(IIIA 2.8.2)


UBI 4336-00

batch: 906882:

CIPAC water C, 1.8 %:

10 s: 36 mL

1 min: 32 mL

3 min: 29 mL

12 min: 27 mL

CIPAC water C, 4.5 %:

10 s: 35 mL

1 min: 32 mL

3 min: 30 mL

12 min: 27 mL

Y Dunn, N.L., 2009,

GRL-12833

Acceptable.

Suspensibility

(IIIA 2.8.3.1)

CIPAC MT 184 Rancona 450 FS:

UBI 4336-00

batch: 906882:

CIPAC water D, 2 %:

Before storage:

ipconazole 98 %


ipconazole 97 %

CIPAC water D, 5 %:

Before storage:

ipconazole 99 %


ipconazole 97 %

Y Dunn, N.L., 2010,

GRL-12834

Acceptable.

Spontaneity of

dispersion (IIIA

2.8.3.2)

not required for FS formulations - Acceptable.

Dilution stability

(IIIA 2.8.4)

- - not required for FS formulations

- - Acceptable.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 16 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

Dry sieve test

(IIIA 2.8.5.1)

- - not required for liquid formulations

- - Acceptable.

Wet sieve test

(IIIA 2.8.5.2)


UBI 4336-00

batch: 906882

Before storage:

< 0.1 % on 75 µm sieve


< 0.1 % on 75 µm sieve

Y Dunn, N.L., 2010,

GRL-12834

Acceptable.

Before storage:

0.01 % on 75 µm sieve

After 7 days, 0 °C:

0.00 % on 75 µm sieve

Y Black, H.M., 2010b,

GRL-12835

Particle size

distribution (IIIA

2.8.6.1)


- - Acceptable.

Nominal size range of

granules (IIIA

2.8.6.2)


- - Acceptable.

Dust content

(IIIA 2.8.6.3)


- - Acceptable.

Particle size of dust

(IIIA 2.8.6.4)


- - Acceptable.

Friability and attrition - - not required for liquid formulations

- - Acceptable.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 17 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

(IIIA 2.8.6.5)

Emulsifiability

(IIIA 2.8.7.1)


- - Acceptable.

Dispersibility

(IIIA 2.8.7.1)


- - Acceptable.

Flowability

(IIIA 2.8.8.1)


- - Acceptable.

Pourability

(IIIA 2.8.8.2)


UBI 4336-00

batch: 906882:

Before storage:

remaining residue: 2.47 %


remaining residue: 2.04 %

Y Dunn, N.L., 2010,

GRL-12834

Acceptable.

Dustability following

accelerated storage

(IIIA 2.8.8.3)


- - Acceptable.

Physical

compatibility of tank

mixes (IIIA 2.9.1)

no tank mixtures are intended

Acceptable.

Chemical

compatibility of tank

mixes (IIIA 2.9.2)

no tank mixtures are intended

Acceptable.

Distribution to seed CIPAC MT 147.1

(BCPC modified jetts

Rancona 450 FS:

UBI 4336-00 The mean chemical bulk loading of

UBI 4336.00 applied as 0.18 mL

Y Littlewood, K.M.,

2012, Acceptable


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 18 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

(IIIA 2.10.1) method) batch: 906882: product/ kg seed to maize seed at

time zero was 94.6 % for

ipconazole.

No sample < 50 % of mean loading

No sample > 150 % of mean

loading

RSD: 13.4 %

after 18 month storage of treated

seeds: 16.0 %

ESP11/04 No information on

results after storage of

the formulation and

seed treatment

afterwards.

Adhesion to seeds

(IIIA 2.10.2)


UBI 4336-00

batch: 906882:

initial: 99.7 %

after 18 month storage of treated

seeds:: 98.2 %

Y Littlewood, K.M.,

2012,

ESP11/04

Acceptable

No information on

results after storage of

the formulation and

seed treatment

afterwards.

Miscibility

(IIIA 2.11)

- - Not required by regulation (EU)

2011/545.

- - Acceptable.

Dielectric breakdown

(IIIA 2.12)


2011/545.

- - Acceptable.

Corrosion

characteristics

(IIIA 2.13)


2011/545.

- - Acceptable.

Container material - - Not required by regulation (EU) - - Acceptable.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 19 of 32


Date: July 2020


point

Method used /

deviations


and specification

Findings GLP

Y/N


comments

(IIIA 2.14) 2011/545.

Other/special studies

(IIIA 2.15)

Rancona 450 FS

UBI 4336-00

Ipconazole 452 g/L

(nominal)

When maize seed (Revolver) treated

with ipconazole at 8.0 g a.s./100 kg

seed was run through a barnlett

roller meter mechanism the flow-

rate was reduced compared to

untreated seed. However, the RSD

values indicated that the variability

of the flow-rate was similar to

untreated seed.

Y Littlewood, K., 2010,

ESP09/03 additional

information

Heubach Dustmeter

Type II

Rancona 450 FS

UBI 4336-01

Ipconazole 452 g/L

(nominal)

Maize seed (cv. Algans) treated at

2.5 and 8.1 g ai/100 kg seed.

Mean free dust untreated maize seed

was 0.2997 g/100 kg seed.

Mean free dust treated maize seed

(2.5 g) was 0.1998 g/100 kg seed

Mean free dust treated maize seed

(8.1 g ) was 0.3996 g /100 kg seed

Y Littlewood, K.M.,

2013,

ESP13-03

additional

information


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 20 of 32


Date: July 2020

IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15

All studies have been performed in accordance with the current requirements and the results are deemed

to be acceptable.

The appearance of the product is that of a dark beige to brown opaque mobile liquid. It is not explosive,

has no oxidising properties. A flash point is not detected at 110 °C. In aqueous solution, it has a pH value

around 8.7. The stability data indicate a shelf life of at least two years at ambient temperature.

The technical characteristics are acceptable for a flowable concentrate for seed treatment (FS)

formulation.

Experimental testing of the product's physico-chemical and technical characteristics:

See Appendix 3

Implications for labelling:

No labelling necessary due to physical or chemical properties described above.

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT

IIIA 3.1 Field of Use

Insert information.

IIIA 3.2 Nature of the Effects on Harmful Organisms

Insert information on mode of action and effects.

IIIA 3.3 Details of Intended Use

IIIA 3.3.1 Details of existing and intended uses

Please refer to Appendix 2 - Critical Uses - and Part B Section 7.

IIIA 3.3.2 Details of harmful organisms against which protection is afforded


IIIA 3.3.3 Effects achieved

Please refer to Part B Section 7.

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation)


IIIA 3.5 Concentration of the Active Substance in the Material Used


IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent


IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 21 of 32


Date: July 2020

Harmful Organism) and Duration of Protection

IIIA 3.7.1 Maximum number of applications and their timings


IIIA 3.7.2 Growth stages of crops or plants to be protected


IIIA 3.7.3 Development stages of the harmful organism concerned


IIIA 3.7.4 Duration of protection afforded by each application


IIIA 3.7.5 Duration of protection afforded by the maximum number of applications


IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects

on Succeeding Crops

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and

sowing or planting succeeding crops


IIIA 3.8.2 Limitations on choice of succeeding crops


IIIA 3.8.3 Description of damage to rotational crops


IIIA 3.9 Proposed Instructions for Use as Printed on Labels

Please refer to Registration Report – Part A, Appendix 2 for the relevant country.


This is not an EC data requirement/ not required by Directive 91/414/EEC.

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT

IIIA 4.1 Packaging and Compatibility with the Preparation

Packaging Summary

Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,

leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents

of the packaging, have been submitted, evaluated and is considered to be acceptable.

IIIA 4.1.1 Description and specification of the packaging


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 22 of 32


Date: July 2020

Rancona 450 FS (UBI 4336-01) is to be marketed in high-density polyethylene (HDPE) containers. They

are induction sealed and fitted with a tamper evident screw cap.

1 L bottles: material: HDPE/ EVOH or PA

shape/size: Round bottle/ 88.5 mm diameter x 234 mm hight

opening: KS 50 (DIN 6063)

closure: tamper evident screw cap

seal: induction sealed

5 L pails: material: HDPE

shape/size: 193 mm x 142 mm x 306 mm














220 L drums: material: HDPE

shape/size: Round / 581 mm diameter x 935 mm

opening: 52.5 mm



1000 L IBC’s: material: HDPE in steel grid box


opening: DN 150

closure: screw cap, G-2-plug;

butterfly valve DN 50 with handle and safety guard

seal: vent sealed with gasket;

Alu-lined PE foil, outlet noozle enclosed

IIIA 4.1.2 Suitability of the packaging and closures

Report: Dickins, M., 2012

Title: Determination of the shelf life (24...) of Rancona 450 FS in 20 L HDPE containers

with evaluation of pack stability, weight change, appearance ..., suspensibility, pH

value, wet sieve test, pourability and analysis of a.s. content

Document No: FSP 191


Core Assessment –

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UBI 4336-01

(Rancona 450 FS)


Page 23 of 32


Date: July 2020

Guidelines: UN 3H1/Y1.9/200/--

GLP Yes

Storage stability studies with UBI 4336-01 in HDPE bottles indicated that after twenty four months of

storage at ambient temperature there were no signs of panelling, cracking or other noticeable changes in

the bottles. After being emptied, cleaned and cut open, there were no differences in the shape, inner

reflectivity, outer colour or cracking of the bottles.

IIIA 4.1.3 Resistance of the packaging material to its contents







GLP Yes

Storage stability studies with Rancona 450 FS (UBI 4336-01) in HDPE bottles indicated that after twenty

four months of storage at ambient temperature there were no signs of leakage, panelling, cracking or other

noticeable changes in the bottles. After being emptied, cleaned and cut open, there were no differences in

the shape, inner reflectivity, outer colour or cracking of the bottles.

IIIA 4.2 Procedures for Cleaning Application Equipment

IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing

Seed treatment machinery should be cleaned out at the normal intervals recommended by the

manufacturer. Operators should wear protective clothing as indicated on the Material Safety Data Sheet.

Contaminated seed debris removed from the machinery should be disposed of as chemical waste.

Slightly contaminated personal protective equipment should be washed separately with water and

detergent before re-use, and it is expected that this cleaning procedure will be effective under these

conditions. Heavily contaminated clothing should be disposed of by burning or burying

IIIA 4.2.2 Effectiveness of the cleaning procedures







GLP Yes

Pourability testing indicated that there was a residue of 2.9 % after pouring. after rinsing. As the

formulation is water based there should be no issue with rinsing the container after use.

IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 24 of 32


Date: July 2020

IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop

See section 4.

IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed

See section 4.

IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces

treated

See section 4.

IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs

See section 4.

IIIA 4.3.5 Waiting period (in days) between application and handling of treated

products

See section 4.

IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting

succeeding crops

See section 4.

IIIA 4.3.7 Information on specific conditions under which the preparation may or may

not be used

See section 4.

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and

Precautions and Handling Procedures to Minimise Those Risks

The safety data sheet complies with actual EC regulations and is based on the present state of knowledge.

The points 4.4.1 to 4.5.6 are all covered in the safety data sheet of the product and thus cross reference

can be made to the safety data sheet in document H.

IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport,

Storage or Use

The points 4.5.1 to 4.5.5 are all covered in the safety data sheet of the product and thus cross reference

can be made to the safety data sheet in document H.

IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage

IIIA 4.6.1 Details of proposed procedures for small quantities

Disposal should be in accordance with local, state or national legislation.

IIIA 4.6.2 Evaluation of products of neutralization (small quantities)

There is no specific neutralisation method available.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 25 of 32


Date: July 2020

IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste

Small quantities of spilled product can be absorbed onto inert material and disposed of as hazardous

waste.

IIIA 4.6.4 Details of proposed procedures for large quantities

Disposal should be in accordance with local, state or national legislation.

IIIA 4.6.5 Evaluation of products of neutralization (large quantities)

There is no specific neutralisation method available.

IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste

Large quantities of spilled product can be absorbed onto inert material and disposed of as hazardous

waste.

IIIA 4.7 Pyrolytic Behaviour of the Active Substance

Ipconazole the active substance of Rancona 450 FS (UBI 4336-01) does not contain greater than 60 %

halogens. Therefore, information on the pyrolytic behaviour of the active substance under controlled

incineration conditions at 800 °C is not applicable.

IIIA 4.8 Disposal Procedures for the Plant Protection Product

IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging

The product and packaging should be disposed of at a suitable waste incineration plant in accordance with

official local regulations. Controlled incineration should occur at a temperature between 800 and 950 °C.

Incineration should occur away from roads, livestock, domestic and farm buildings, watercourses,

hedgerows and wildlife areas. Incineration at the recommended temperature will reduce the colour of the

smoke produced and ensure thorough combustion of all material, with only minimal ash resulting. The

ash produced can be disposed of by soil incorporation, burying or by normal waste disposal contractors.

IIIA 4.8.2 Methods other than controlled incineration for disposal

Containers should be cleaned before disposal.

Surplus product that cannot be used and cleaned containers should be disposed of by a licensed waste

disposal contractor.


Thereare no other studies available to support the authorisation of Rancona 450 FS (UBI 4336-01).

IIIA 11 FURTHER INFORMATION

IIIA 11.1 Information of Authorisations in Other Countries

see EU pesticide data base (http://ec.europa.eu/sanco_pesticides/public/ )


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 26 of 32


Date: July 2020

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other

Countries

MRLs are set at European level, see Regulation (EC) No. 396/2005.

IIIA 11.3 Justified Proposals for Classification and Labelling

Proposals for classification and labelling of BAS 512 16 F in accordance with the EC Directive on

dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below:

Physico-chemical properties

Table 11.3-1 Physico-chemical properties

Study Type

Findings

(triggered risk phrase)

Reference

Explosivity Not explosive (-) Black, H.M., 2010a,

GRL-12836

Oxidizing

properties

Not oxidizing (-) Black, H.M., 2010a,

GRL-12836

Flammability No flash point at 110 ºC

No information on auto-ignition

Dunn, N.L., 2009,

GRL-12833

Toxicology

see section 3.

Ecotoxicology/Environment

see section 6.

IIIA 11.4 Proposals for Risk and Safety Phrases

Please refer to Registration Report – Part A.

IIIA 11.5 Proposed Label

Please refer to Registration Report – Part A.

IIIA 11.6 Specimens of Proposed Packaging

Specimens of the packaging were not provided as there was no request.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 27 of 32


Date: July 2020

Appendix 1: List of data used in support of the evaluation

Annex point/

reference No.

OECD

Author(s) Year Title

Source (where different from company)

Report-No.

GLP or GEP status (where relevant)

Data

protection

claimed

Owner How

considered

in dRR

Study-

Status /

Usage*

KIIIA1 2.1,

2.4.2,

2.7.1,

2.8.3,

2.8.5

Dunn,

N.L.

2010 Determination of the accelerated

storage stability of Rancona 450 FS,

lot# 906882, over 2 weeks at 54°C in

1 litre high density polyethylene

bottles with evaluation of packaging,

stability, physical state, colour, pH

determination, pourability, wet sieve,

suspensibility and active ingredient

content,

GRL-12834,

GLP: Yes, unpublished

Y Arysta 1

KIIIA1 2.1,

2.4.2,

2.7.5,

2.8.3,

2.8.5,

2.8.8.2

Dickins,

M.

2012 Determination of the Shelf Life (24

months at ambient) of Rancona 450

FS in 20 Litre High Density Polythene

Containers with Evaluation of Pack

Stability, Weight Change, Appearance

(Physical State and Colour),

Suspensibility, pH Value, Wet Sieve

Test, Pourability and Analysis of

Active Substance Content,

FSP 191,


Y Arysta 1

KIIIA1 2.1,

2.4.2,

2.7.4

Black,

H.M.

2010b Determination of the low temperature

storage stability of Rancona 450 FS at

7 days at 0°C in 100 mL centrifuge

tubes with evaluation of physical state,

colour, pH and wet sieve analysis ,

GRL-12835,


Y Arysta 1

IIIA, 2.2./01 Black,

H.M.

2010a Explosive properties and oxidizing

properties of Rancona 450 FS,

GRL-12836,


Y Arysta 1

KIIIA1 2.3.1,

2.5.2,

2.6.1,

2.8.2

Dunn,

N.L.

2009 Determination of the viscosity,

density, persistent foam, flash point of

Rancona 450 FS,

GRL-12833,


Y Arysta 1


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 28 of 32


Date: July 2020

Annex point/

reference No.

OECD



Report-No.


Data

protection

claimed

Owner How

considered

in dRR

Study-

Status /

Usage*

KIIIA1 2.3.3 Demangel,

B.

2018 Auto-ignition temperature of liquids

test on RANCONA 450 FS

Report R18-901080-001

GLP, unpublished

Y Arysta 1

submitted

on request

KIIIA1 2.5.3,

Rigg, S.A. 2010 The surface tension of Rancona 450

FS,

GRL-12837,


Y Arysta 1

KIIIA1 2.7.5 Dickins,

M.

2013 Determination of the Shelf Life (36

months at Ambient) of Rancona 450

FS in 20 Litre High Density Polythene

Containers with Evaluation of Pack

Stability, Weight Change, Appearance

(physical state and colour),

Suspensibility, pH Value, Wet Sieve

Test and Analysis of Active Substance

Content,

FSP 192,


Y Arysta 1

KIIIA1 2.10 Littlewoo

d, K.

2012 A study to determine the physical

characteristics of Rancona 450FS on

maize before and after storage

(interim report after 6 month storage),

ESP11/04,


Y Arysta 5

KIIIA1 2.15 Littlewoo

d, K.

2010 A study to determine the effect of

maize seed treated with UBI 4336.00

through a seed drill,

ESP09/03,


Y Arysta 5

KIIIA1 4.1.1 Anonymo

us

2007 Packaging component specification

product bottle 1 L Coex, Chemtura,

504969,

GLP: no, unpublished

Y Arysta 1


us


product 5 L pail HDPE, Chemtura,

504993,


Y Arysta 1


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 29 of 32


Date: July 2020

Annex point/

reference No.

OECD



Report-No.


Data

protection

claimed

Owner How

considered

in dRR

Study-

Status /

Usage*


us



None,


Y Arysta 1


us



505080,


Y Arysta 1


us


product 220 L drum HDPE,

Chemtura,

505045,


Y Arysta 1


us


product 1000 L IBC HDPE,

Chemtura,

505073,


Y Arysta 1

* 1 accepted (study valid and considered for evaluation)

2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation)

4 not submitted but necessary (study not submitted by applicant but necessary for evaluation)

5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 30 of 32


Date: July 2020

Appendix 2: Critical Uses – Justification and GAP tables

GAP rev. (1), date: 2015-12-18

PPP (product name/code): Rancona 450 FS (UBI 4336-01)

Active substance : ipconazole


Conc. of as: 452 g/L

Applicant: CHEMTURA Europe Ltd

Zone(s): Central/Sourthern/Northern /EU

Professional use: Yes

Non-professional use: No

Verified by MS: Yes

1 2 3 4 5 6 7 8 9 10 11 12 13

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:

developmental stages of



Remarks: e.g. safener/synergist per ha

e.g. recommended or mandatory tank mixtures

Method / Kind

Timing / Growth

stage of crop & season

Max. number

(min. interval

between applications)

a) per use

b) per crop/ season

kg, L product / ha



g, kg as/ha


b) max. total


Water L/ha

min / max

001 DE Maize

ZEAMX

F Fusarium spp.

FUSASP

seed treatment

before sowing

1

a) 0.77 mL/ha **

b) 0.77 mL/ha **

0.35 g as/ha F* * The PHI is covered by the

conditions of use and/or the

vegetation period remaining between the application of

the plant protection product

and the use of the product (e. g. harvest) or the setting of a

PHI in days is not required resp.

** maximum application rate




Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 31 of 32


Date: July 2020


002 DE Maize

ZEAMX


RHIZSO

seed treatment

before sowing

1

a) 0.77 mL/ha **

b) 0.77 mL/ha **

0.35 g as/ha ** maximum application rate


per ha; 1 unit includes 50 000 grains)


003 DE Maize

ZEAMX


SPHTRE

seed treatment

before sowing

1

a) 2.52 mL/ha **

b) 2.52 mL/ha **

1.14 g as/ha ** maximum application rate



Remarks: (1) Numeration of uses in accordance with the application/as verified by MS

(2) Member State(s) or zone for which use is applied for

(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure)

(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)

(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of

equipment used must be indicated (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of

application

(8) The maximum number of applications possible under practical conditions of use for each single

application and per year (permanent crops) or crop (annual crops) must be provided

Min. interval between applications (days) where relevant

(9) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. kg or L product / ha)

(10) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha)

(11) The range (min/max) of water volume under practical conditions of use must be given (L/ha)

(12) PHI - minimum pre-harvest interval

(13) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.


Core Assessment –

Germany

UBI 4336-01

(Rancona 450 FS)


Page 32 of 32


Date: July 2020

Appendix 3: Experimental testing of the product's physico-chemical and technical

characteristics:

The following physical, chemical and technical properties of the plant protection product were

experimentally tested:

density, colour, pH, storage stability at high temperatures (14 d at 54 °C), low temperature stability (7 d at

0 °C), pourability, distribution and adhesion to seeds.

No significant deviations from the data submitted by the applicant were detected, with exception of pH-

value, but the differences is not considered as critical.

The formulation complies with the chemical, physical and technical criteria which are stated for this type

of formulation in the FAO/WHO manual (2016).


Core Assessment –

Germany

Product Code

UBI 4336-01 (Rancona 450 FS)


Page 1 of 16

Applicant: Arysta LifeScience Evaluator: DE

Date: July 2020

REGISTRATION REPORT

Part B

Section 2: Analytical Methods


Product code: UBI 4336-01 (Rancona 450 FS)

Active Substance: Ipconazole 452.0 g/L

Central Zone

Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Arysta LifeScience

Submission Date: 27/02/2015

Date: July 2020


Core Assessment –

Germany

Product Code



Page 2 of 16


Date: July 2020

Table of Contents

IIIA 5 METHODS OF ANALYSIS ............................................................. 4

IIIA 5.1 Analytical Standards and Samples ................................................... 4

IIIA 5.1.1 Samples of the preparation ................................................................ 4

IIIA 5.1.2 Analytical standards for the pure active substance ........................ 4

IIIA 5.1.3 Samples of the active substance as manufactured ........................... 4

IIIA 5.1.4 Analytical standards for relevant metabolites and all other

components included in the residue definition ................................ 4

IIIA 5.1.5 Samples of reference substances for relevant impurities ............... 4

IIIA 5.2 Methods for the Analysis of the Plant Protection Product ............. 5

IIIA 5.2.1 Description of the analytical methods for the determination

of the active substance in the plant protection product .................. 5

IIIA 5.2.2 For preparations containing more than one active substance,

description of method for determining each in the presence of

the other ............................................................................................... 6

IIIA 5.2.3 Applicability of existing CIPAC methods ........................................ 6

IIIA 5.2.4 Description of analytical methods for the determination of

relevant impurities .............................................................................. 6

IIIA 5.2.5 Description of analytical methods for the determination of

formulants ........................................................................................... 6

IIIA 5.3 Description of Analytical Methods for the Determination of

Residues ............................................................................................... 6

IIIA 5.3.1 Overview of residue definitions and levels for which compliance is

required .................................................................................................................. 6

IIIA 5.3.2 Description of analytical methods for the determination of residues in

plant matrices (KCP 5.2) ...................................................................................... 7

IIIA 5.3.3 Description of analytical methods for the determination of residues in

animal matrices (KCP 5.2) ................................................................................... 8

IIIA 5.3.4 Description of methods for the analysis of soil (KCP 5.2) ................................. 9

IIIA 5.3.5 Description of methods for the analysis of water (KCP 5.2) ............................. 9


Core Assessment –

Germany

Product Code



Page 3 of 16


Date: July 2020

IIIA 5.3.6 Description of methods for the analysis of air (KCP 5.2) ................................ 10

IIIA 5.3.7 Description of methods for the analysis of body fluids and tissues (KCP

5.2) ......................................................................................................................... 10

IIIA 5.3.8 Other studies/ information ................................................................................. 10

IIIA 5.4 Conclusion on the availability of analytical methods for the

determination of residues ................................................................................... 11

Appendix 1 Lists of data considered in support of the evaluation ................... 12

Appendix 2 Detailed evaluation of submitted analytical methods ................... 15

A 2.1.1 Analytical methods for Ipconazole Methods used for the generation of

pre-authorization data (KCP 5.1) ...................................................................... 15

A 2.1.2 Methods for post-authorization control and monitoring purposes (KCP

5.2) ......................................................................................................................... 15

A 2.1.2.1 Description of analytical methods for the determination of residues in plant

matrices (KCP 5.2) .......................................................................................................... 15


Core Assessment –

Germany

Product Code



Page 4 of 16


Date: July 2020

IIIA 5 METHODS OF ANALYSIS

General comment of zRMS

Germany as zRMS has written this section of the dRR as part of the evaluation of the application for

authorisation of the present product in accordance with article 33 of Regulation (EC) No 1107/2009.

Thus, the document represents completely the results of the assessment conducted by the zRMS

regarding the present product in the intended uses according to the application submitted by the

applicant, unless stated otherwise.

A commenting box and a conclusion box were used by zRMS only for the detailed evaluation of the

study in Appendix 2 of the dRR. The description of the studies is based on the dRR originally

submitted by the applicant. Some text passages therefore may be taken from the applicant´s dRR,

however, the text will be adapted such that it in the end reflects the assessment of the zRMS.

This document summarises the information related to the analytical methods for the product UBI 4336-01

(Rancona 450 FS) containing the active substance ipconazole which was approved according to

Regulation (EC) No 1107/2009.

This product was not the representative formulation.

The product has not been previously evaluated according to Uniform Principles.


evaluation.

Information on the detailed composition of UBI 4336-01 (Rancona 450 FS) can be found in the

confidential dossier of this submission (Registration Report - Part C).

IIIA 5.1 Analytical Standards and Samples

IIIA 5.1.1 Samples of the preparation

A sample of the preparation was provided by the applicant but no analysis of the contents of the active

substance was performed.

IIIA 5.1.2 Analytical standards for the pure active substance

Analytical standards of ipconazole were provided by the applicant.

IIIA 5.1.3 Samples of the active substance as manufactured

No samples were provided because there was no request.

IIIA 5.1.4 Analytical standards for relevant metabolites and all other components

included in the residue definition


IIIA 5.1.5 Samples of reference substances for relevant impurities


Ipconazole does not contain any impurity of toxicological or ecotoxicological concern.


Core Assessment –

Germany

Product Code



Page 5 of 16


Date: July 2020

IIIA 5.2 Methods for the Analysis of the Plant Protection Product

Analytical methods for the determination of ipconazole and its impurities and relevance of CIPAC

methods were evaluated as part in the EU review. The respective data are considered adequate and are not

included in this submission. Additional studies to support the registration of UBI 4336-01

(Rancona 450 FS) not previously assessed are given below. All relevant data are provided and are

considered adequate.

IIIA 5.2.1 Description of the analytical methods for the determination of the active

substance in the plant protection product

The following analytical method for the determination of the active substances in the plant protection

product performed on UBI 4336-01 (Rancona 450 FS) has not previously been reviewed.

Report: KIIIA1 5.2.1/1 Black, H.M., 2009

Title: Validation of an analytical method for the determination of ipconazole

in Ipconazole 3.8FS

Document No: GRL-12767

Guidelines: SANCO/3030/99 rev. 4

GLP Yes

Method description:

After homogenization, the sample is dissolved in methanol and a solution of 2-benzoylnaphthalene in

methanol is added as internal standard. Ipconazole is determined by HPLC-UV using external standard

calibration. The ratio of the analyte (combined peak areas of the two isomers ipconazole cc and

ipconazole ct) and internal standard peak areas are used for quantification.

Column: Zorbax Eclipse XDB-C18, 4.6 mm x 30 mm

Mobile phase: Methanol/water (gradient)

Detector wavelength: 220 nm

Method validation:

Table B.5.2.1 1: Determination of ipconazole in the plant protection product

Analyte Specificity/

interferences

Linearity

(r)

(n = 5)

(conc. range)

Accuracy

(n = 5)

Repeatability

(% RSD)

(n = 6) fortification

level

(mg/L)

mean

recovery

(%)

Ipconazole demonstrated;

no interferences

0.9997

(49.4 mg/L –

245.7 mg/L)

131 99.6 0.43

(at 41 %)

Chromatograms of the formulation with and without active substance present were submitted. The

specificity of the method was demonstrated by retention time match and by comparison of the UV spectra

with reference standard of the active substance.

Conclusion:

The method is considered acceptably validated and allows the determination of ipconazole in the

formulation UBI 4336-01 (Rancona 450 FS).


Core Assessment –

Germany

Product Code



Page 6 of 16


Date: July 2020

IIIA 5.2.2 For preparations containing more than one active substance, description of

method for determining each in the presence of the other

Please refer to chapter 5.2.1 as UBI 4336-01 (Rancona 450 FS) contains only one active substance.

IIIA 5.2.3 Applicability of existing CIPAC methods

There is no CIPAC method available for the determination of ipconazole in FS formulations like UBI

4336-01 (Rancona 450 FS).

IIIA 5.2.4 Description of analytical methods for the determination of relevant

impurities

Ipconazole does not contain any impurity of toxicological or ecotoxicological concern.

IIIA 5.2.5 Description of analytical methods for the determination of formulants

No formulants with toxicological or ecotoxicological relevant compounds are present in the formulation.

Therefore, no analytical methods for the determination of formulants are necessary.

IIIA 5.3 Description of Analytical Methods for the Determination of Residues

IIIA 5.3.1 Overview of residue definitions and levels for which compliance is required

The current legal residue definition for food of plant and animal origin is the same as the one proposed in

the Draft Assessment Report (incl. its addenda) and the respective EFSA conclusion.

Table 5.4-1: Relevant residue definitions for monitoring/enforcement and levels for which

compliance is required

Matrix Residue definition MRL / limit Reference for MRL/level

Remarks

Plant, high water content Ipconazole 0.01 mg/kg Regulation (EC) No

839/2008, annex III part A

EFSA Journal 2013;

11(4):3181; ASB2013-5383

Plant, high acid content 0.01 mg/kg

Plant, high protein/high

starch content (dry

commodities)

0.01 mg/kg

Plant, high oil content 0.01 mg/kg

Muscle Not defined Such MRLs do not exist

mg/kg

Regulation (EC) No

839/2008, annex III part A

EFSA Journal 2013;

11(4):3181; ASB2013-5383

Milk

Eggs

Fat

Liver, kidney

Soil Ipconazole and 1,2,4

triazole

0.05 mg/kg Common limit

EFSA Journal 2013;

11(4):3181; ASB2013-5383

Drinking water Ipconazole 0.1 µg/L general limit for drinking

water


Core Assessment –

Germany

Product Code



Page 7 of 16


Date: July 2020

Matrix Residue definition MRL / limit Reference for MRL/level

Remarks

Surface water Ipconazole and 1,2,4

triazole

0.44 µg/L (ipconazole)

3200 µg/L (1,2,4 triazole)

NOEC Pimephales promelas

NOEC Fish,

EFSA Journal 2013;

11(4):3181; ASB2013-5383

Air Ipconazole 4.5 µg/m3 AOEL sys: 0.015 mg/kg bw/d

EFSA Journal 2013;

11(4):3181; ASB2013-5383

Tissue (meat or liver) Ipconazole 0.1 mg/kg not classified as T / T+, but

required according to Reg.

(EU) No. 283/2013 Body fluids 0.05 mg/L

IIIA 5.3.2 Description of analytical methods for the determination of residues in plant

matrices (KCP 5.2)

An overview on the acceptable methods for analysis of ipconazole in plant matrices is given in the

following tables. For the detailed evaluation of new/additional studies it is referred to Appendix 2.

Table 5.4-2: Validated methods for food and feed of plant origin (required for all matrix

types, “difficult” matrix only when indicated by intended GAP)

Component of residue definition: ipconazole

Matrix type Method type Method LOQ Principle of method Author(s), year / missing

/ EU agreed

High water

content

Primary 0.01 mg/kg LC-MS/MS, Acquity UPLC BEH

C18 column, ESI+, m/z 334→70,

m/z 336→70

Confirmation included

Miller, 2012/EU

agreed/ASB2014-10885

LC-MS/MS, C8 column, ESI+, m/z

334→70

No confirmation, chromatograms at

LOQ missing

Brewin, 2005/EU

agreed/ASB2008-8299

ILV 0.01 mg/kg LC-MS/MS, Acquity UPLC BEH


m/z 336→70

ILV of ASB2014-10885

Love, 2012/see Appendix

2/ ASB2014-10887


334→70

ILV of ASB2008-8299

McLean, 2006/EU agreed/

ASB2008-8300

Confirmatory 0.01 mg/kg See primary method Miller, 2012/EU agreed/

ASB2014-10885

High acid

content



m/z 336→70


Miller, 2012/EU agreed/

ASB2014-10885

ILV -- -- Not necessary


ASB2014-10885


Core Assessment –

Germany

Product Code



Page 8 of 16


Date: July 2020



/ EU agreed

High oil

content



m/z 336→70



ASB2014-10885

ILV -- -- Not necessary


ASB2014-10885

High

protein/high

starch content

(dry)



m/z 336→70



ASB2014-10885


334→70

No confirmation, chromatograms at

LOQ missing

Brewin, 2005/EU agreed/

ASB2008-8299

ILV 0.01 mg/kg LC-MS/MS, Acquity UPLC BEH


m/z 336→70

ILV of ASB2014-10885

Love, 2012/see Appendix

2/ ASB2014-10887


334→70

ILV of ASB2008-8299

McLean, 2006/EU agreed/

ASB2008-8300


ASB2014-10885

GC-NPD, DB-17 column

Confirmation by LC-MS/MS,

Phenyl column, ESI+, m/z 334→70,

L.00.00-34 method

Olzewski, 2007/EU

agreed/ ASB2008-8301

Difficult Not required for the intended GAP

For any special comments or remarkable points concerning the analytical methods for the determination

of residues in plant matrices, please refer to Appendix 2.

Table 5.4-3: Statement on extraction efficiency

Method for products of plant origin

Not required, because: No residues of ipconazole >0.01 mg/kg are expected from the

intended use as seed treatment.

IIIA 5.3.3 Description of analytical methods for the determination of residues in animal

matrices (KCP 5.2)

Methods for animal matrices are not required, because neither a residue definition nor MRLs have been

set.


Core Assessment –

Germany

Product Code



Page 9 of 16


Date: July 2020

IIIA 5.3.4 Description of methods for the analysis of soil (KCP 5.2)

An overview on the acceptable methods for analysis of ipconazole in soil is given in the following tables.

New studies were not provided.

Table 5.4-4: Validated methods for soil


Method type Method LOQ Principle of method Author(s), year / missing

Primary 0.001 mg/kg LC-MS/MS, Acquity UPLC

BEH C18 column, ESI+,

m/z 334→70, m/z 336→70



ASB2014-10890 Confirmatory

Component of residue definition: 1,2,4 triazole


Primary 0.001 mg/kg LC-MS/MS, Zorbax 300-

SCX column, ESI+, m/z m/z

70→43, m/z 70→70


Krainz, 2007/EU agreed/


IIIA 5.3.5 Description of methods for the analysis of water (KCP 5.2)

An overview on the acceptable methods and the data gaps for analysis of ipconazole in surface and

drinking water is given in the following tables. New studies were not provided.

Table 5.4-5: Validated methods for water



Drinking water Primary 0.05 μg/L LC-MS/MS, C8

column, ESI+, m/z

334→70, m/z 336→70



ASB2008-8303

ILV -- -- missing

Confirmatory 0.05 μg/L See primary method Brewin, 2006/EU agreed/

ASB2008-8303

Surface water Primary 0.05 μg/L LC-MS/MS, C8

column, ESI+, m/z

334→70, m/z 336→70




Component of residue definition: 1,2,4 triazole


Surface water Primary -- -- missing

Confirmatory -- -- missing


Core Assessment –

Germany

Product Code



Page 10 of 16


Date: July 2020

IIIA 5.3.6 Description of methods for the analysis of air (KCP 5.2)

An overview on the acceptable methods for analysis of ipconazole in air is given in the following tables.

New studies were not provided.

Table 5.4-6: Validated methods for air



Primary 0.4 μg/m3 LC-MS/MS, C8 column,

ESI+, m/z 334→70,

336→70




IIIA 5.3.7 Description of methods for the analysis of body fluids and tissues (KCP 5.2)

An overview on the acceptable methods and the data gaps for analysis of ipconazole in body fluids and

tissues is given in the following table. New studies were not provided.

Table 5.4-7: Methods for body fluids



Primary -- -- missing

Confirmatory -- -- missing

Table 5.4-8: Methods for body tissues



Primary 0.01 mg/kg / mg/L LC-MS/MS, C8 column,

ESI+, m/z 334→70,

336→70


Airs, 2009/EU agreed/


IIIA 5.3.8 Other studies/ information

None.


Core Assessment –

Germany

Product Code



Page 11 of 16


Date: July 2020

IIIA 5.4 Conclusion on the availability of analytical methods for the determination of

residues

Sufficiently sensitive and selective analytical methods are not available for all analytes included in the

residue definitions.

Noticed data gaps are:

A primary method for the determination of 1,2,4 triazole in surface water

A confirmatory method for the determination of 1,2,4 triazole in surface water

These data gaps are identified also as result of the peer review and mentioned in the EFSA conclusion.

Additionally, the following data gaps were noticed:

An independent laboratory validation of the method by Brewin (2006) for the determination of

ipconazole in drinking water.

A primary method for the determination of ipconazole in body fluids

A confirmatory method for the determination of ipconazole in body fluids

Commodity/crop Supported/

Not supported

Maize supported


Core Assessment –

Germany

Product Code



Page 12 of 16


Date: July 2020

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

Annex point/

reference No.

OECD


Source (where different from

company)

Report-No.

GLP or GEP status (where

relevant),

Published or not

Data

protection

claimed

Owner How considered

in dRR

Study-Status /

Usage*

KIIIA1 5.2.1 Black, H.M. 2009 Validation of an analytical method

for the determination of ipconazole

in Ipconazole 3.8FS

GRL-12767

GLP: Y, published: N

2838087

Y Chemtura 1

* 1 accepted (study valid and considered for evaluation)

2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation)

4 not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

References

EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of

the active substance Ipconazole. EFSA Journal 2013;11(4):3181 (ASB2013-5383)

United Kingdom, 2011. Ipconazole: Draft Assessment Report, Volume 1-3 (ASB2012-2329)

United Kingdom, 2012. Ipconazole: Draft Assessment Report, Volume3: Addendum B2, B5 (ASB2013-1830)


Data

point Author(s) Year

Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP

5.2

Love, I. 2012 Ipconazole: Independent laboratory validation of methodology for

the determination of residues of Ipconazole in foods of plant origin

(wheat grain and cucumber fruit)

IP-159-A ! OPB0057

GLP: Open Published: Open

BVL-2550998, ASB2014-10887

N Kureha


Core Assessment –

Germany

Product Code



Page 13 of 16


Date: July 2020

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU

peer review

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP

5.2

Airs, D. 2009 Ipconazole: Validation of methodology for the determination of

residues in bovine tissues (liver, kidney, fat and muscle), milk and

in chicken eggs

IP-150-A ! OPB0008


BVL-2597787, ASB2012-9125

N Kureha

KCP

5.2

McLean, N. 2006 Independent laboratory validation of KRA/119-02R,

"Determination of Ipconazole, Triazolylalanine, Triazolylacetic

acid and Triazolylpyruvate in wheat and maize (plant, grain and

straw)"

IP-036-A ! ETL05CHEMT01 ! 2005-031 ! 05CHMT01.REP


BVL-2550997, ASB2008-8300

N Kureha

KCP

5.2

Miller, C. 2012 Ipconazole: Validation of methodology for the determination of

residues in wheat grain, cucumber fruit, orange fruit and oilseed

rape seeds

OPB0054


BVL-2550996, ASB2014-10885

N Kureha

KCP

5.2

Olszewski,

K.

2007 Development and validation of a residue analytical method for the

determination of Ipconazole in wheat grain by DFG S19

IP-121-A ! B20924


BVL-2550999, ASB2008-8301

N Kureha

KCP

5.2

Brewin, S. 2005 Ipconazole, Triazolylalanine, Triazolylacetic acid and

Triazolypyruvate: Validation and radiovalidation of methodology

for the determination of residues in wheat and maize commodities

IP-035-A ! KRA119/053261 ! KRA/119


BVL-2550995, BVL-2551078, ASB2008-8299

N Kureha

KCP

5.2

Krainz, A. 2007 Validation of a residue analytical method for the determination of

1,2,4-Triazole in soil

IP-039-A ! A34874


BVL-2551004, ASB2012-9124

N Kureha

KCP

5.2

Miller, C. 2012 Ipconazole: Validation of methodology for the determination of

residues in soil

IP-154-A ! OPB0055


BVL-2551003, ASB2014-10890

N Kureha

KCP

5.2

Brewin, S. 2006 Ipconazole: Validation of methodology for its determination in

drinking, ground and surface water

IP-040-A ! KRA 0142/063942 ! KRA/0142


BVL-2551005, ASB2008-8303

N Kureha


Core Assessment –

Germany

Product Code



Page 14 of 16


Date: July 2020

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP

5.2

Brewin, S. 2007 Ipconazole: Validation of methodology for its determination in air

IP-041-A ! KRA 0143/064041 ! KRA/0143


BVL-2551006, ASB2008-8304

N Kureha

List of data submitted by the applicant and not relied on

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP

5.2

Watson, G. 2012 Ipconazole - Independent laboratory validation of the multi-

residue method DFG S 19 for the determination of Ipconazole in

crop matrices by LC-MS/MS

S12-03811


BVL-2551001, ASB2014-10889

N Kureha

KCP

5.2

Yozgatli, H.

P., Winkler,

K.

2012 Validation of multi-residue method DFG S 19 for the

determination of Ipconazole in crop matrices by LC-MS/MS

IP-157-A ! S12-03351 ! KUR-1201V


BVL-2551000, ASB2014-10888

N Kureha

KCP

5.2

Krainz, A. 2006 Development and validation of a residue analytical method for the

determination of Ipconazole in soil

IP-038-A ! 852081


BVL-2551002, ASB2008-8302

N Kureha

List of data relied on not submitted by the applicant but necessary for evaluation

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

- - - - - -


Core Assessment –

Germany

Product Code



Page 15 of 16


Date: July 2020

Appendix 2 Detailed evaluation of submitted analytical methods

A 2.1.1 Analytical methods for Ipconazole Methods used for the generation of pre-

authorization data (KCP 5.1)

No new or additional studies have been submitted.

A 2.1.2 Methods for post-authorization control and monitoring purposes (KCP

5.2)

A 2.1.2.1 Description of analytical methods for the determination of residues in

plant matrices (KCP 5.2)

A 2.1.2.1.1 Independent laboratory validation of the method of Miller (2012)

Comments of zRMS: Acceptable as ILV of the method of Miller (2012).

Reference: OECD KIIA 4.3

Report Love, I. (2012) Ipconazole: Independent laboratory validation of

methodology for the determination of residues of Ipconazole in foods of

plant origin (wheat grain and cucumber fruit), Project ID: OPB0057, IP-

159-A, ASB2014-10887

Guideline(s): Yes (SANCO/825/00 rev. 8.1; SANCO/3029/99 rev. 4)

Deviations: No

GLP: Yes

Acceptability: Yes

Materials and methods

Samples were homogenized with acetonitrile/water/acetic acid (50/50/0.1, v/v/v) using an Ultra-Turrax

and additional mechanical shaking, followed by centrifugation and re-extraction with acetonitrile/acetic

acid (100/0.1, v/v). After addition of 0.5 M hydrochloric acid to an extract aliquot, SPE on a SCX

cartridge was performed and ipconazole was eluted with ammonia/methanol (2/98, v/v). After addition of

octanol, the extract was evaporated to near dryness, and the remainder dissolved in methanol/water (1/1,

v/v). The sample concentration in the final extract was equal to 0.05 g/mL. Final quantification was done

by LC-MS/MS using an Acquity UPLC BEH C18 column, electrospray ionization in positive mode and

monitoring the MS/MS transitions m/z 334→70 and m/z 336→70.


Core Assessment –

Germany

Product Code



Page 16 of 16


Date: July 2020

Results and discussions

Table A 1: Recovery results from method validation of wheat grain and cucumber using

the analytical method. Standards were prepared in methanol/water (1+1, v/v)

Matrix Analyte Fortification

level (mg/kg)

(n = x)

Mean

recovery (%)

RSD (%) Comments

Wheat grain ipconazole 0.01 (n = 5)

0.1 (n = 5)

84.3

82.0

6.0

4.3

m/z 334→70

Cucumber ipconazole 0.01 (n = 5)

0.1 (n = 5)

84.4

80.9

3.5

2.6

Wheat grain ipconazole 0.01 (n = 5)

0.1 (n = 5)

93.8

83.8

13.4

4.4

m/z 336→70

Cucumber ipconazole 0.01 (n = 5)

0.1 (n = 5)

84.9

80.9

3.7

0.9

Table A 2: Characteristics for the analytical method used for validation of ipconazole

residues in wheat grain and cucumber

Ipconazole

m/z 334→70 Ipconazole

m/z 336→70

Specificity mass spectrum is provided

blank value < 30 % LOQ

mass spectrum is provided

blank value < 30 % LOQ

Calibration (type, number of data points) y = 174000x + 517

r = 0.9995

9 calibration points

y = 59444x – 189

r = 0.9998

9 calibration points

Calibration range Accepted calibration range

0.1 – 10 ng/mL

0.002 – 0.2 mg/kg

Accepted calibration range

0.1 – 10 ng/mL

0.002 – 0.2 mg/kg

Assessment of matrix effects is presented yes yes

Limit of determination/quantification 0.01 mg/kg 0.01 mg/kg

Conclusion by zRMS

The method is considered as an independent laboratory validation of the method described by Miller

(2012) in plant commodities with high water content and dry commodities. The validated limit of

quantification is 0.01 mg/kg. A confirmation of the results is included by a fully validated second

transition.

Rancona 450 FS – 008398-00/00

Part B – Section 3 - Core Assessment zRMS version

Page 1 / 30

REGISTRATION REPORT

Part B

Section 6 3: Mammalian Toxicology


Product code/name: Rancona 450 FS

Active Substance: Ipconazole, 452 g/L

Central Zone


CORE ASSESSMENT

Applicant: Chemtura Europe Limited

Date: August 2019

Rancona 450 FS – 008398-00/00


Page 2 / 30

Version history

When What

August 2019 Draft Registration Report: zRMS assessment

Rancona 450 FS – 008398-00/00


Page 3 / 30

Table of Contents

6 Mammalian Toxicology (KCP 7) ................................................................ 4

6.1 Summary ........................................................................................................ 4

6.2 Toxicological Information on active substance ............................................. 6

6.3 Toxicological Evaluation of Plant Protection Product ................................... 7

6.4 Toxicological Evaluation of Groundwater Metabolites ................................. 8

6.5 Dermal Absorption (KCP 7.3) ....................................................................... 8

6.5.1 Justification for proposed values - Ipconazole ............................................... 8

6.6 Exposure Assessment of Plant Protection Product (KCP 7.2) ....................... 9

6.6.1 Selection of critical use and justification ....................................................... 9

6.6.2 Operator exposure (KCP 7.2.1) ..................................................................... 9

6.6.2.1 Estimation of operator exposure .................................................................... 9

6.6.2.2 Measurement of operator exposure .............................................................. 10

6.6.3 Worker exposure (KCP 7.2.3) ..................................................................... 10

6.6.3.1 Estimation of worker exposure .................................................................... 10

6.6.3.2 Measurement of worker exposure ................................................................ 11

6.6.4 Resident and bystander exposure (KCP 7.2.2) ............................................ 11

6.6.4.1 Estimation of resident and bystander exposure ........................................... 11

6.6.4.2 Measurement of resident and/or bystander exposure ................................... 12

6.6.5 Combined exposure ..................................................................................... 12

Appendix 1 Reference list .............................................................................................. 13

Appendix 2 Detailed evaluation of the studies relied upon ......................................... 15

A 2.1 Statement on bridging possibilities .............................................................. 15

A 2.2 Acute oral toxicity (KCP 7.1.1) ................................................................... 15

A 2.3 Acute percutaneous (dermal) toxicity (KCP 7.1.2) ..................................... 16

A 2.4 Acute inhalation toxicity (KCP 7.1.3) ......................................................... 18

A 2.5 Skin irritation (KCP 7.1.4) ........................................................................... 19

A 2.6 Eye irritation (KCP 7.1.5) ............................................................................ 20

A 2.7 Skin sensitisation (KCP 7.1.6) ..................................................................... 22

A 2.8 Data on co-formulants (KCP 7.4) ................................................................ 23

A 2.8.1 Material safety data sheet for each co-formulant ......................................... 23

A 2.8.2 Available toxicological data for each co-formulant ..................................... 23

A 2.9 Studies on dermal absorption (KCP 7.3) ..................................................... 24

A 2.9.1 Study 1 – Concentrate of Ipconazole in Rancona 450 FS/UBI 4336-01 ..... 24

A 2.9.2 Study 2 – Dilutions of Ipconazole in Rancona 450 FS/ UBI 4336-01 ......... 26

Appendix 3 Exposure calculations ................................................................................ 29

A 3.1 Operator exposure calculations (KCP 7.2.1.1) ............................................ 29

A 3.1.1 Calculations for Ipconazole ......................................................................... 29

A 3.2 Worker exposure calculations (KCP 7.2.3.1) .............................................. 29

A 3.2.1 Calculations for Ipconazole ......................................................................... 29

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6 Mammalian Toxicology (KCP 7)

6.1 Summary

Table 6.1-1: Information on Rancona 450 FS/UBI 4336-01*

Product name and code Rancona 450 FS/UBI 4336-01 (BVL-Code: AYT-00001-

F-0-FS)

Formulation type Flowable concentrate for seed treatment (FS)

Active substance(s) (incl. content) Ipconazole; 452 g/L

Function Fungicide

Product already evaluated as the ‘representative

formulation’ during the approval of the active

substance(s)

No

Product previously evaluated in another MS according

to Uniform Principles

No

* Information on the detailed composition of Rancona 450 FS/UBI 4336-01 can be found in the confidential dRR Part C.

Justified proposals for classification and labelling

According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the

Council of 16 December 2008, the following classification and labelling with regard to toxicological data

is proposed for the preparation:


Germany as zRMS has written this section of the dRR as part of the evaluation of the application for

authorisation of the present product in accordance with article 33 of Regulation (EC) No 1107/2009.

Thus, the document represents completely the results of the exposure and risk assessment conducted by

the zRMS regarding the present product in the intended uses according to the application submitted by the

applicant, unless stated otherwise.

Commenting boxes and conclusion boxes were used by zRMS only for the detailed evaluation of studies

in Appendix 2 of the dRR. The description of the studies in Appendix 2 is based on the dRR originally

submitted by the applicant. Some text passages therefore may be taken from the applicant´s dRR,

however, the text will be adapted such that it in the end reflects the assessment of the zRMS based on the

original studies.

Rancona 450 FS – 008398-00/00


Page 5 / 30

Table 6.1-2: Justified proposals for classification and labelling for Rancona 450 FS/UBI

4336-01 according to Regulation (EC) No 1272/2008

Hazard class(es), categories Repr. 1B, STOT RE 2

Hazard pictograms or Code(s) for hazard pictogram(s) GHS08

Signal word Danger

Hazard statement(s) H360D, H373

Precautionary statement(s) P101-102-201-260-280-308+310-405-501

Additional labelling phrases To avoid risks to man and the environment, comply with

the instructions for use. [EUH401]

Table 6.1-3: Summary of risk assessment for operators, workers, residents and bystanders

for Rancona 450 FS/UBI 4336-01

Result PPE / Risk mitigation measures

Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to

health damage. [SB001]

- Concerning the requirements for personal protective gear for handling

the plant protection product the material safety data sheet and the

instructions for use of the plant protection product as well as the

guideline "Personal protective gear for handling plant protection prod-

ucts" of the Federal Office of Consumer Protection and Food Safety

(www.bvl.bund.de) must be observed. [SB111]

- Do not eat, drink or smoke when using this product. [SB166]

- While sacking the treated seed a protective suit against pesticides and

protective gloves (plant protection) must be worn. [SF6161-1]

- While cleaning the seed dressing appliance protective gloves (plant

protection) and a protective suit against pesticides must be worn.

[SF618-1]

- Protective gloves (plant protection) must be worn when

handling/applying the product. [SS1201-1]

- Wear a protective suit for plant protection products and sturdy shoes

(e.g. rubber boots) when applying/handling the product. [SS2204]

- Wear particle-filtering half mask FFP2 or half mask with particle filter

P2 (identification colour: white) according to the BVL guideline

"Personal protective equipment for handling plant protection products",

current version, when applying/handling the product. [ST1202]




current version, when bagging the seeds. [ST1261]




current version, when cleaning the seed-dressing equipment. [ST1271]

Workers Acceptable - Protective gloves and a protective suit against pesticides must be worn

when handling dressed seeds. [SF6142-1]

Residents and

Bystanders

Acceptable None

No unacceptable risk for operators, workers, residents and bystanders was identified when the product is

used as intended and provided that the PPE/ risk mitigation measures stated in Table 6.1-3 are applied.

Rancona 450 FS – 008398-00/00


Page 6 / 30

Table 6.1-4 Critical uses and overall conclusion of exposure assessment

1 2 3 4 5 6 7 8 9 10

Use-

No.*

Crops and

situation

(e.g. growth

stage of crop)

F,

Fn,

Fpn

G,

Gn,

Gpn,

I, In,

Ipn**

Application Application rate PHI

(d)

Remarks:

(e.g.

safener/synergist

[L/ha])

critical gap for

operator, worker,

bystander or

resident exposure

based on

[Exposure model]

Acceptability of

exposure

assessment

Method /

Kind

(incl.

application

technique

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

Max.

application

rate

per application

/ per crop and

season

[kg as/ha]

Water

min –

max

[L/ha]

Op

era

tor

Wo

rk

er

Resi

den

ts

By

sta

nd

er

003 Maize F Seed treatment 1 ; 1 a) 0.00285

b) 0.00285

0.005 –

0.070

n.a. 0.00114 kg/seed

unit

n.a. n.a.

* Use number(s) in accordance with the list of all intended GAPs in Part A/Part B, Section 0 should be given in column 1

** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional

greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor

application, In: non-professional indoor use; Ipn: professional and non-professional indoor use

Explanation for column 10 “Acceptability of exposure assessment”

A Exposure acceptable without PPE / risk mitigation measures

R Further refinement and/or risk mitigation measures required

N Exposure not acceptable/ Evaluation not possible

6.2 Toxicological Information on active substance

The active substance was evaluated under regulation (EC) No 1107/2009 (as amended). Information

regarding classification of the active substance and on EU endpoints identified during the EU review is

given in the following table(s). Further information on active substances is included in the reports on the

results of the peer review process and in the respective background documents.

Table 6.2-1: Information on active substance(s)

Ipconazole

Classification and labelling

With regard to toxicological

endpoints (according to the

criteria in Regulation (EC) No

1272/2008, as amended)

No legal classification

Proposals for additional

classification and labelling

Acute Tox. 4, H302; Repr. 1B, H360D; STOT RE 2, H373, eyes, skin, liver

RAC opinion: CLH-O-0000001412-86-198/F; 9 March 2018

Agreed EU endpoints

AOEL systemic 0.015 mg/kg bw/d

Reference SANCO/11789/2013 rev 1; 20 March 2014

Rancona 450 FS – 008398-00/00


Page 7 / 30

6.3 Toxicological Evaluation of Plant Protection Product

A summary of the toxicological evaluation for Rancona 450 FS/UBI 4336-01 is given in the following

tables. Full summaries of studies on the product that have not been previously considered within an EU

peer review process are described by the zRMS in detail in Appendix 2. The applicant provided acute

toxicity as well as skin and eye irritancy and skin sensitisation studies for the previous formulation

Ipconazole 480 FL/UBI 4336-00 and furthermore a bridging statement in part C of his dRR. This is

accepted by the zRMS Germany.

Table 6.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and

skin sensitisation for Rancona 450 FS/UBI 4336-01

Type of test, species, model

system (Guideline)

Result

Acceptability

Classification and

labelling

(acc. to the criteria

in Reg. 1272/2008)

Reference

Acute oral toxicity study on

Rancona 450 FL in rats (OECD

401)

> 2000 mg/kg bw Yes None XXXXX,

2001,

ASB2016-3596

Acute dermal toxicity study on


402)

> 2000 mg/kg bw Yes None XXXXX,

2001,

ASB2016-3597

Acute inhalative toxicity study on


401)

> 2.59 mg/kg bw Yes None XXXXX,

2001,

ASB2016-3598

Skin irritation study on Rancona

450 FL in rabbits (OPPTS

870.1200)

Not irritant Yes None XXXXX,

2001,

ASB2016-3599

Eye irritation study on Rancona

450 FL in rabbits (OECD 405)

Not irritant Yes None XXXXX,

2001,

ASB2016-3600

Skin sensitisation study on

Rancona 450 FL in guinea pigs,

Buehler 3 x (OECD 406)

Not sensitising Yes None XXXXX,

2001,

ASB2016-3601

Table 6.3-2: Additional toxicological information relevant for classification/labelling of

Rancona 450 FS/UBI 4336-01

Substance

(Concentration

in product,

% w/w)*

Classification and

labelling of the substance

(acc. to the criteria in

Reg. 1272/2008)

Reference Classification and

labelling of product (acc.

to the criteria in Reg.

1272/2008)

Toxicological

properties of active

substance(s) (relevant

for classification of

Rancona 450 FS/UBI

4336-01)

Ipconazole

(41.42 % (w/w))

Acute Tox. 4, H302; Repr.

1B, H360D (c ≥ 0.3%);

STOT RE 2, H373, eyes,

skin, liver (c ≥ 10%)

RAC opinion:

CLH-O-

0000001412-

86-198/F; 9

March 2018

Acute Tox. 4, H302; Repr.

1B, H360D; STOT RE 2,

H373, eyes, skin, liver

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6.4 Toxicological Evaluation of Groundwater Metabolites

All metabolite concentrations are predicted to stay below 0.1 µg/L – no groundwater assessment is

required.

6.5 Dermal Absorption (KCP 7.3)

A summary of the dermal absorption rates used in the exposure assessment of the present application are

presented in the following table.

Table 6.5-1: Dermal absorption rates for active substances in Rancona 450 FS/UBI 4336-01

Ipconazole

Value Reference

Concentrate 0.4% Kane, 2009; ASB2016-3602

Dilution: 64.6 g/L

Dilution: 41.1 g/L

1.2%

1.6%

Kerin, 2017; ASB2019-10330

6.5.1 Justification for proposed values - Ipconazole

Proposed dermal absorption rates for Ipconazole are based on dermal absorption studies on a formulation

identical to Rancona 450 FS/UBI 4336-01. The study results are summarised in the following table. Full

summaries of studies on the dermal absorption of ipconazole that have not previously been evaluated

within an EU peer review process are described in detail in Appendix 2.

Table 6.5-2: Summary of the results of submitted dermal absorption studies

Test Concen-

trate/Dil

ution 1

Dilution 2

Formulation

in study

Acceptability

of study

Justification

provided on

representativity

of study

formulation for

current product

Acceptability

of justification

Reference*

In vitro

(human)

0.4%* Rancona 450

FS

Yes Not required n.a. Kane, 2009;

ASB2016-

3602

In vitro

(human)

64.6 g/L:

1.2%**

41.1 g/L:

1.6%**

Rancona 450

FS

Yes Not required n.a. Kerin,

2017;

ASB2019-

10330

* evaluation according to EFSA guidance on dermal absorption (2012)

** evaluation according to EFSA guidance on dermal absorption (2017)

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6.6 Exposure Assessment of Plant Protection Product (KCP 7.2)

Table 6.6-1: Product information and toxicological reference values used for exposure

assessment

Product name and code Rancona 450 FS/UBI 4336-01

Formulation type FS

Category Fungicide

Container size(s), short description 1 L bottle with screw cap, COEX

5 – 20 L jerrycans with screw cap, HDPE

20 – 1000 L bottle with screw cap, HDPE

200 L barrel, HDPE

1000 L tank, HDPE

Active substance (incl. content) Ipconazole (452 g/L)

AOEL systemic 0.015 mg/kg bw/d

Inhalation absorption 100%

Oral absorption 100 %

Dermal absorption

Concentrate: 0.4%

Dilution 1: 1.2% (64.6 g/L)

Dilution 2: 1.6% (41.1 g/L)

6.6.1 Selection of critical use and justification

Not applicable as only one application is applied for.

6.6.2 Operator exposure (KCP 7.2.1)

6.6.2.1 Estimation of operator exposure

A summary of the exposure models used for estimation of operator exposure to the active substance

during application of Rancona 450 FS/UBI 4336-01 according to the critical use is presented in

Table 6.6-2. The outcome of the estimation is presented in Table 6.6-3 (longer term exposure). Detailed

calculations are in Appendix 3.

Table 6.6-2: Exposure models for intended uses

Critical use Maize (max. 0.0063 L product/ha or 2.52 mL product/seed unit

Model SEED TROPEX - Calculation (Report TMF 4896, 1996 revised by PSD), based on Chester, G.,

Wiseman, M., Pontal, P-G., Worker Exposure During Seed Treatment and Sowing of Treated

Seed in the UK and France: An Overview. Zeneca Agrochemicals, Fernhurst, Haslemere. Report

No. TMF 4896

Rancona 450 FS – 008398-00/00


Page 10 / 30

Table 6.6-3: Estimated operator exposure (longer term exposure)

Ipconazole

Model data Level of PPE Total absorbed dose

(mg/kg/day)

% of systemic

AOEL

Seed treatment

Application rate: 0.00114 kg a.s./seed unit

Body weight:

60 kg

Protective suit + gloves for application and handling

Protective suit for bagging + cleaning 0.055635 370.90

Protective suit + gloves for application and handling

Protective suit for bagging + cleaning

Respiratory protection for application and handling +

bagging + cleaning

0.0063288 42.19

6.6.2.2 Measurement of operator exposure

Since the operator exposure estimations carried out indicated that the acceptable operator exposure level

(AOEL) will not be exceeded under conditions of intended uses and considering above mentioned

personal protective equipment (PPE), a study to provide measurements of operator exposure was not

necessary and was therefore not performed.

6.6.3 Worker exposure (KCP 7.2.3)

6.6.3.1 Estimation of worker exposure

Table 6.6-4 shows the exposure model used for estimation of worker exposure after entry into a

previously treated area or handling a crop treated with Rancona 450 FS/UBI 4336-01 according to the

critical use. Outcome of the estimation is presented in Table 6.6-5 (longer term exposure). Detailed

calculations are in Appendix 3.



Model SEED TROPEX - Calculation (Report TMF 4896, 1996 revised by PSD), based on Chester, G.,

Wiseman, M., Pontal, P-G., Worker Exposure During Seed Treatment and Sowing of Treated

Seed in the UK and France: An Overview. Zeneca Agrochemicals, Fernhurst, Haslemere. Report

No. TMF 4896

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Table 6.6-5: Estimated worker exposure (longer term exposure)

Ipconazole

Model data Level of PPE Total absorbed dose

(mg/kg bw/day)

% of systemic

AOEL

Loading and sowing of seeds

Outdoor

Work rate: 8 hours/day

Number of applications and application rate: 1 x 0.00114 kg a.s./seed unit

Body weight:

60 kg

Suit + gloves for handling the dressed seeds 0.004041 26.94

6.6.3.2 Measurement of worker exposure

Since the worker exposure estimations carried out indicated that the acceptable operator exposure level

(AOEL) will not be exceeded under conditions of intended uses and considering above mention PPE, a

study to provide measurements of worker exposure was not necessary and was therefore not performed.

6.6.4 Resident and bystander exposure (KCP 7.2.2)

6.6.4.1 Estimation of resident and bystander exposure

Table 6.6-6 shows the exposure model(s) used for estimation of resident exposure to ipconazole. The

outcome of the estimation is presented in Table 6.6-7 (longer term bystander and resident exposure). Due

to the very low exposure the detailed calculations are not presented in Appendix 3.



Model Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and

Residents Exposed to Plant Protection Products During and After Application; J. Verbr.

Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06

January 2012, Issue No. 4, pp. 75-76

Table 6.6-7: Estimated resident and bystander exposure

Ipconazole

Model data Total absorbed dose

(mg/kg bw/day)

% of systemic AOEL

Number of applications and application rate: 1 x 0.00114 kg a.s./seed unit

Assumed Attrition rate 10 %

Bystanders (adult)

Drift rate: 15.73 % (1 m)

Body weight: 60 kg

0.0000334 0.22

Rancona 450 FS – 008398-00/00


Page 12 / 30

Bystanders (children)


Body weight: 16.15 kg

0.000061 0.41

Residents (adult)


Body weight: 60 kg 0.0000006 0.004

Residents (children)


Body weight: 16.15 kg 0.0000051 0.034

6.6.4.2 Measurement of resident and/or bystander exposure

Since the resident and/or bystander exposure estimations carried out indicated that the acceptable operator

exposure level (AOEL) for ipconazole will not be exceeded under conditions of intended uses and

considering above mentioned risk mitigation measures, a study to provide measurements of

resident/bystander exposure was not necessary and was therefore not performed.

6.6.5 Combined exposure

Not relevant. The product contains only one active substance.

Rancona 450 FS – 008398-00/00


Page 13 / 30

Appendix 1 Reference list


Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KIIIA1 7.1.1

XXXXX 2001 Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Acute oral toxicity study in rats - Defined

LD50

10223 ! M-285723-02-1 GLP: Yes Published: No

BVL-2838278, ASB2016-3596

Yes Chemtura

KIIIA1 7.1.2

XXXXX 2001 Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Acute dermal toxicity study in rats - Limit test

10224 ! M-285724-02-1

GLP: Yes Published: No BVL-2838279, ASB2016-3597

Yes Chemtura

KIIIA1

7.1.3 XXXXX 2001 Ipconazole 480 FL (VORTEX TM seed treatment

fungicide) - Acute inhalation toxicity study in rats - Limit

test 10225 ! M-285725-01-1

GLP: Yes Published: No

BVL-2838280, ASB2016-3598

Yes Chemtura

KIIIA1 7.1.4

XXXXX 2001 Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Primary skin initation study in rabbits

10227 ! M-285727-02-1


Yes Chemtura

KIIIA1

7.1.5 XXXXX 2001 Ipconazole 480 FL (VORTEX TM seed treatment

fungicide) - Primary eye irritation study in rabbits 10226 ! M-285726-02-1


BVL-2838282, ASB2016-3600

Yes Chemtura

KIIIA1 7.1.6

XXXXX 2001 Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Dermal sensitization study in Guinea Pigs

(Buehler Method)

10228 ! M-285728-02-1 GLP: Yes Published: No

BVL-2838283, ASB2016-3601

Yes Chemtura

KIIIA1

7.6.2

Kane, T 2009 Ipconazole (Rancona 450 FS) - In vitro dermal absorption

study using human skin and rat skin FDD0037


Yes Chemtura

KIIIA1

7.6.2

Kerin, T. 2018 Rancona 450 FS: the in vitro percutaneous absorption of

radiolabelled Ipconazole in two in-use dilutions through

human split-thickness skin 781702 ! 39664 ! 2017-341


BVL-3790031, ASB2019-10330

Yes Arysta LifeScience

Edinburgh

Rancona 450 FS – 008398-00/00


Page 14 / 30

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU

peer review

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

- - - - - -


Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

- - - - - -

List of data relied on not submitted by the applicant but necessary for evaluation

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

- - - - - -

Rancona 450 FS – 008398-00/00


Page 15 / 30

Appendix 2 Detailed evaluation of the studies relied upon

A 2.1 Statement on bridging possibilities

Comments of zRMS: The applicant provided acute toxicity as well as skin and eye irritancy and skin

sensitisation studies for the previous formulation Ipconazole 480 FL/UBI 4336-00

and furthermore a bridging statement in part C of his dRR. He argues that the

chemical composition did not change and only tradename and suppliers if some

co-formulants changed between UBI 4336-00 and UBI 4336-01. This is accepted

by the zRMS Germany.

A 2.2 Acute oral toxicity (KCP 7.1.1)

Comments of zRMS: Study acceptable according to mentioned guidelines, used in evaluation

Reference: OECD KIIIA1 7.1.1

Report Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Acute oral

toxicity study in rats - Defined LD50

XXXXX, 2001, 10223 ! M-285723-02-1,

ASB2016-3596

Guideline(s): EPA OPPTS 870.1100 (1998)

OECD Guideline 401

Deviations: Yes

Room temperature fell below 19 °C by 1 °C. No information on room

humidity is given. The mentioned deviations are not thought to influence

study outcome.

GLP: Yes

Acceptability: Yes

Duplication

(if vertebrate study)

No, according to available information.


Test material (Lot/Batch No.) Ipconazole 480 FL (T104:32-1)

Species Rat, Sprague-Dawley

No. of animals (group size) 5 rats/sex (2000, 4000 mg/kg bw), 5 females (5000 mg/kg bw), 5

males (7000 mg/kg bw)

Dose(s) 2000, 4000, 5000, and 7000 mg/kg bw

Exposure Once by gavage

Vehicle/Dilution None

Post exposure observation period 14 days

Remarks None

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Page 16 / 30


Table A 1: Results of acute oral toxicity study in rats of Ipconazole 480 FL

Dose

(mg/kg bw)

Toxicological results * Duration of signs Time of death LD50 (mg/kg bw)

(14 days)

Male rats

2000 0/5/5 Day 0-3 -

5284 4000 1/5/5 Day 0-6 Day 3

7000 3/5/5 Day 0-11 Days 2 (2) and 9 (1)

Female rats

2000 1/5/5 Day 0-5 Day 2

3666 4000 3/5/5 Day 0-9 Day 1-2

5000 5/5/5 Day 1-2 Day 1-2

* Number of animals which died/number of animals with clinical signs/number of animals used

Table A 2: Summary of findings of acute oral toxicity study in rats of Ipconazole 480 FL

Mortality: Yes, mortality occurred.

Clinical signs: Yes, clinical signs of toxicity were observed (diarrhea, ano-genital staining, hypoactivity,

hunched posture, reduced fecal volume, irregular respiration).

Body weight: Body weight gain was considered to be normal.

Macroscopic

examination:

Apparent abnormalities in 1/10 (2000 mg/kg bw), 4/10 (4000 mg/kg bw), 5/5 (5000 mg/kg

bw) and 3/5 (7000 mg/kg bw) animals (reddened lungs, discoloured liver, red and gaseously

distended intestines).

Conclusion by zRMS

Under the experimental conditions, the oral LD50 of Ipconazole 480 FL is 5284 and 3666 mg/kg bw in

male and female rats, respectively. Thus, no classification is required according to Regulation (EC) No.

1272/2008.

A 2.3 Acute percutaneous (dermal) toxicity (KCP 7.1.2)



Report Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Acute dermal

toxicity study in rats - Limit test

XXXXX, 2001, 10224 ! M-285724-02-1,

ASB2016-3597

Guideline(s): OECD Guideline 402 (1998)

EPA OPPTS 870.1200

Deviations: Yes

No information on room humidity is given. The mentioned deviation is not

thought to influence study outcome.

Rancona 450 FS – 008398-00/00


Page 17 / 30

GLP: Yes

Acceptability: Yes

Duplication






No. of animals (group size) 5 rats/sex

Dose(s) 5000 mg/kg bw

Exposure 24 hours (dermal, semi-occlusive)



Remarks After 24 hours, test substance was removed by gentle wiping with

towel and water.


Table A 3: Results of acute dermal toxicity study in rats of Ipconazole 480 FL

Dose

(mg/kg bw)

Toxicological results * Duration of signs Time of death LD50 (mg/kg bw)

(14 days)

Male rats

5000 0/0/5 - - > 5000

Female rats

5000 0/0/5 - - > 5000


Table A 4: Summary of findings of acute dermal toxicity study in rats of Ipconazole 480

FL

Mortality: No mortality occurred.

Clinical signs: No clinical signs of toxicity were observed.


Macroscopic

examination:

The necropsies performed at the end of the study revealed no apparent findings.

Conclusion by zRMS

Under the experimental conditions, the dermal LD50 of Ipconazole 480 FL is higher than 5000 mg/kg bw

in rats. Thus, no classification is required according to Regulation (EC) No. 1272/2008.

Rancona 450 FS – 008398-00/00


Page 18 / 30

A 2.4 Acute inhalation toxicity (KCP 7.1.3)



Report Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Acute

inhalation toxicity study in rats - Limit test

XXXXX, 2001, 10225 ! M-285725-01-1,

ASB2016-3598

Guideline(s): OECD Guideline 403

EPA OPPTS 870.1300 (1998)

Deviations: Yes

Room temperature exceeded 25 °C by 1°C on one occasion. No information

on room humidity is given. The mentioned deviations are not thought to

influence study outcome.

GLP: Yes

Acceptability: Yes

Duplication






No. of animals (group size) 5 rats/sex

Concentration(s) 2.59 mg/L air

Exposure 4 hours (whole body)



Remarks Actual exposure duration 4.25 hours due to an estimated maximum

of 13.6 minutes chamber equilibration time. Afterwards, chamber

operated with clean air for 16 minutes.


Table A 5: Concentration(s) and exposure conditions

Target conc.

(mg/L air)

Nominal conc.

(mg/L air)

Actual conc.

(mg/L air)

MMAD *

(µm)

GSD **

(µm)

2.5 100.46 2.59 3.5 2.3

* MMAD = Mass Median Aerodynamic Diameter

** GSD = Geometric Standard Deviation

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Page 19 / 30

Table A 6: Results of acute inhalation toxicity study in rats of Ipconazole 480 FL

Concentration

(mg/L air)

Toxicological results * Duration of signs Time of death LC50 (mg/L air)

(14 days)

Male rats

2.59 0/0/5 - - >2.59

Female rats

2.59 0/0/5 - - >2.59


Table A 7: Summary of findings of acute inhalation toxicity study in rats of Ipconazole

480 FL

Mortality: No mortality occurred.

Clinical signs: Yes, clinical signs of toxicity were observed (hypoactivity on exposure day).


Macroscopic

examination:

The necropsies performed at the end of the study revealed no apparent findings.

Conclusion by zRMS

Under the experimental conditions, the inhalation LC50 of Ipconazole 480 FL is higher than 2.59 mg/L air

in rats. Although the maximum attainable concentration was not tested, we propose not to classify

Ipconazole 480 FL according to Regulation (EC) No. 1272/2008, as neither the active substance is

classified for inhalation toxicity, nor are there signs for apparent toxicity in this study.

A 2.5 Skin irritation (KCP 7.1.4)



Report Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Primary skin

initation study in rabbits

XXXXX, 2001, 10227 ! M-285727-02-1,

ASB2016-3599

Guideline(s): EPA OPPTS 870.2500 (1998)

OECD guideline 404

Deviations: Yes

Animal housing room humidity not given. The mentioned deviation is not

thought to impact study outcome.

GLP: Yes

Acceptability: Yes

Duplication



Rancona 450 FS – 008398-00/00


Page 20 / 30



Species Rabbit, New Zealand White

No. of animals (group size) 3 males, 3 females

Initial test using one animal No

Exposure 0.5 mL (4 hours, semi-occlusive)


Post exposure observation period Unknown

Remarks After exposure, test sites were wiped clean with water and towel.


Table A 8: Skin irritation of Ipconazole 480 FL

Animal

No.

Scores after treatment * Mean scores

(24-72 h)

Reversible

(day) 1 h 24 h 48 h 72 h

1, m Erythema

Oedema

2

0

1

0

0

0

0

0

0.33

0

2

-

2, m Erythema

Oedema

2

1

1

0

0

0

0

0

0.33

0

2

1

3, m Erythema

Oedema

2

1

1

0

0

0

0

0

0.33

0

2

1

1, f Erythema

Oedema

2

1

1

0

0

0

0

0

0.33

0

2

1

2, f Erythema

Oedema

2

1

1

0

0

0

0

0

0.33

0

2

1

3, f Erythema

Oedema

2

1

1

0

0

0

0

0

0.33

0

2

1

* scores in the range of 0 to 4


Conclusion by zRMS

Under the experimental conditions, Ipconazole 480 FL is not a skin irritant. Thus, no classification is

required according to Regulation (EC) No. 1272/2008.

A 2.6 Eye irritation (KCP 7.1.5)



Report Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Primary eye

Rancona 450 FS – 008398-00/00


Page 21 / 30

irritation study in rabbits

XXXXX, 2001, 10226 ! M-285726-02-1,

ASB2016-3600


EPA OPPTS 870.2400 (1998)

Deviations: Yes

Animal housing room humidity is not given. The mentioned deviation is not

thought to influence study outcome.

GLP: Yes

Acceptability: Yes

Duplication





Species Rabbit, New Zealand White

No. of animals (group size) 2 males, 4 females

Initial test using one animal No

Exposure 0.1 mL (single instillation in conjunctival sac)

Irrigation (time point) No


Post exposure observation period Unknown, not specified

Remarks None


Table A 9: Eye irritation of Ipconazole 480 FL

Animal

No.

Scores after treatment * Mean scores

(24-72 h)

Reversible

(day) 1 h 24 h 48 h 72 h

1, m Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

1

-

2, m Corneal opacity

Iritis



0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

1

-

1, f Corneal opacity

Iritis



0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

1

-


Iritis

0

0

0

0

0

0

0

0

0

0

-

-

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Page 22 / 30



1

0

0

0

0

0

0

0

0

0

1

-


Iritis



0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-


Iritis



0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

-

-

1

-

* scores in the range of 0 to 4 for cornea opacity and chemosis, 0 to 3 for redness of conjunctivae and 0 to 2 for iritis


Conclusion by zRMS

Under the experimental conditions, Ipconazole 480 FL is not an eye irritant. Thus, no classification is


A 2.7 Skin sensitisation (KCP 7.1.6)



Report Ipconazole 480 FL (VORTEX TM seed treatment fungicide) - Dermal

sensitization study in Guinea Pigs (Buehler Method)

XXXXX, 2001, 10228 ! M-285728-02-1,

ASB2016-3601


EPA OPPTS 870.2600

Deviations: Yes

Animal housing room humidity is not given. The mentioned deviation is not

thought to alter study outcome.

GLP: Yes

Acceptability: Yes

Duplication





Species Guinea pig, Hartley albino

No. of animals (group size) Test substance group: 20 male guinea pigs

Vehicle control goup: 10 male guinea pigs

Range finding: Yes

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Page 23 / 30

Exposure (concentration(s), no. of

applications)

Topical induction: Undiluted (3 x)

Challenge: Undiluted

Vehicle None

Pretreatment prior to topical application No

Reliability check 1-Chloro-2,4-dinitrobenzene (0.08 % topical induction and 0.04 %

challenge)

Remarks None


Table A 10: Skin sensitisation of Ipconazole 480 FL

24 hours 48 hours

After challenge

Ipconazole 480 FL 0/20 0/20

Test Vehicle Control

Group

0/10 0/10

Positive control 7/10 4/10

1) Number of animals with positive dermal response (scores of 1-3) /number of animals in dose group

Clinical signs: Not stated.

Conclusion by zRMS

Under the experimental conditions, Ipconazole 480 FL is not a skin sensitiser. Thus, no classification is


A 2.8 Data on co-formulants (KCP 7.4)

A 2.8.1 Material safety data sheet for each co-formulant

Information regarding material safety data sheets of the co-formulants can be found in the confidential

dossier of this submission (Registration Report - Part C).

A 2.8.2 Available toxicological data for each co-formulant

Available toxicological data for each co-formulant can be found in the confidential dossier of this

submission (Registration Report - Part C).

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Page 24 / 30

A 2.9 Studies on dermal absorption (KCP 7.3)

A 2.9.1 Study 1 – Concentrate of Ipconazole in Rancona 450 FS/UBI 4336-01

Comments of zRMS: Study acceptable according to mentioned guidelines, used in evaluation.


Report Ipconazole (Rancona 450 FS) - In vitro dermal absorption study using

human skin and rat skin

Kane, T, 2009, FDD0037, ASB2016-3602

Guideline(s): OECD 428 (2004)

Deviations: No

GLP: Yes

Acceptability: Yes

Duplication No, according to available information.


Test material Name (Lot/Batch No.) [14C]-Ipconazole

Test preparation spiking

Radiochemical purity > 97%

Product Name (Lot/Batch No.) Rancona 450 FS (LOT EL8G14P001)

Company code -

Concentration a.s. 450 g/L

Formulation type suspension

Blank product Name (Lot/Batch No.) -

Concentration a.s. -

Formulation type -

Test system

Diffusion cell Type of diffusion cell dynamic

(if dynamic) Flow rate 1.5 mL/h

Exposed skin area 0.64 cm²

Cover open

Membrane Skin type dermatomed

Skin thickness range 200-400 µm

Skin donors age 61-73 years

Skin donors sex male/female

Site abdomen/back

Source post mortem

Integrity test yes (T2O)

Receptor Receptor medium 5 w/v bovine serum albumin in 0.01 M phosphate

buffered saline at pH 7.4

Solubility in receptor medium >80

Sampling Exposure time 6 h

Sampling duration 24 h

Sample intervals 1; 2;…23; 24

Skin wash/Swabbing post exposure (1 v/v Tween 80 in distilled water)

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Page 25 / 30

Final Procedure Tape stripping yes

Type of tape strips used 3 M Scotch Magic tape

TS1-2 analysed separately yes

Tested doses Concentrate

Target concentration [mg/mL] 450.0

Area dose [µg/cm²] 4500

Total dose [µg/cell] 2880

No. of donors 3

No. of cells used/valid cells* 7/5

* Justification for excluded cells, if applicable


Table A 11: In-vitro dermal penetration of Ipconazole formulated as Rancona 450 FS/ UBI

4336-01 through human skin - Recovery data

Dose group Concentrate

Target concentration [mg/mL] 450.0

Target dose [µg/cm²] 4500

Mean actual applied

dose [µg/cm²]

4500

Recovery [%]

Mean SD

Dislodgeable dose

Skin wash after x hours 99.0 2.63

Donor chamber wash 0.39 0.15

Dose associated to skin

Tape strips: 1st sample, strips 1 + 2 0.71 0.51

Tape strips: 2nd sample; strips 3 - n 0.16 0.1

Skin preparation 0.066 0.036

Absorbed dose

Receptor fluid 0.098 0.024

Receptor chamber wash N/A N/A

Total recovery1 100.0 1.96

Absorption essentially complete at end of

study (>75% absorption within half the study

duration) [%Absorption at t0.5]

No

[39.3% ± 5.64]

If no:

Absorption estimates

= absorbed dose + skin preparation + tape

strips sample 2)2

0.32 0.1

If yes:


= absorbed dose + skin preparation

N/A N/A

Absorption estimate normalised3 0.32 0.1

Relevant absorption estimate4 0.42

Absorption estimates used for risk

assessment5

0.4

1 Values may not calculate exactly due to rounding of figures 2 In accordance with the EFSA Guidance on Dermal Absorption (EFSA Journal 2012;10(4):2665) the radioactivity

in the second tape-strip pool (3rd to nth tape strip) is considered potentially absorbable if less than 75% of the

Rancona 450 FS – 008398-00/00


Page 26 / 30

absorption occurred in the first half of the study (see Table 7.6.2-1) Finally, the skin preparation is also

considered potentially absorbable. 3 According to the EFSA Guidance on Dermal Absorption, cells with insufficient recovery (< 95%) can be

corrected by normalisation of absorption estimate to 100% recovery; explanation should be included. 4. In accordance with the EFSA Guidance on Dermal Absorption, one standard deviation was added to the mean%

dermal penetration in cases where the standard deviation was ≥ 25% of the mean value. 5 Relevant absorption estimate was rounded to the required number of significant figures.

N/A: not applicable

Conclusion by zRMS

The dermal penetration of ipconazole formulated as Rancona 450 FS/UBI 4336-01 through human

dermatomed skin was determined in vitro.

Based on the EFSA guidance criteria, the amount of applied dose penetrating within 24 hours was

determined to be 0.42 (0.32 ± 0.1) for the formulation.

The dermal penetration estimates to be used for risk assessment were set at 0.4% for the formulation

concentrate.

A 2.9.2 Study 2 – Dilutions of Ipconazole in Rancona 450 FS/ UBI 4336-01

Comments of zRMS: Study acceptable according to mentioned guidelines, used in evaluation.


Report Rancona 450 FS: the in vitro percutaneous absorption of radiolabelled

Ipconazole in two in-use dilutions through human split-thickness skin

Kerin, T., 2018, 781702 ! 39664 ! 2017-341, ASB2019-10330

Guideline(s): OECD 428 (2004), EFSA guidance on dermal absorption (2017)

Deviations: No

GLP: Yes

Acceptability: Yes

Duplication No, according to available information.


Test material Name (Lot/Batch No.) [14C]-Ipconazole

Test preparation spiking

Radiochemical purity 99.0

Blank product Name (Lot/Batch No.) [14C]-Ipconazole 452 g/L Blank (Batch No. EF

9277)

Concentration a.s. 0 g/L

Rancona 450 FS – 008398-00/00


Page 27 / 30

Test system

Diffusion cell Type of diffusion cell static

(if dynamic) Flow rate n.a.

Exposed skin area 0.64 cm2

Cover open

Membrane Skin type dermatomed

Skin thickness range 400.0 µm

Skin donors age 32-67 years

Skin donors sex male/female

Site abdomen

Source samples from Tissue Solutions and NHS

Integrity test yes (electrical resistance)

Receptor Receptor medium PBS with polyoxyethylene 20 oleyl ether (PEG, ca

6, w/v), sodium azide (ca 0.01, w/v),

streptomycin (ca 0.1 mg/mL) and penicillin (ca

100 units/mL)

Solubility in receptor medium (90 of 0,0823 g/L = 74,07 mg/L solved in 1 h)

Sampling Exposure time 8.0 hours

Sampling duration 24.0 hours

Sample intervals 1; 2; 4; 8; 12; 24 h

Skin wash/Swabbing 8 h post exposure, two times (50 µL concentrated

commercial handwash soap and rinsing with 10 x

0.5 mL of a dilute soap solution, 2 V/V, drying

with a tissue paper

Final Procedure Tape stripping yes

Type of tape strips used D-Squame tape discs

TS1-2 analysed separately yes

Tested doses Concentrate Dilution 1

Target concentration [mg/mL] 64.6 41.1

Area dose [µg/cm²] 646.0 411.0

Total dose [µg/cell] 413.4 263.0

No. of donors 4 4

No. of cells used/valid cells* 8/8 8/8


Table A 12: In-vitro dermal penetration of Ipconazole formulated as Rancona 450 FS/ UBI

4336-01 through human skin - Recovery data

Dose group Concentrate Dilution 1

(1:11)

Target concentration [mg/mL] 64.6 41.1

Target dose [µg/cm²] 646.0 411.0

Mean actual applied dose [µg/cm²]

Recovery [%] Recovery [%]

Mean SD Mean SD

Dislodgeable dose

Skin wash after x hours 92.2 5.6 80.0 23.8

Donor chamber wash 4.03 4.33 7.2 7.71

Dose associated to skin

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Page 28 / 30

Tape strips: 1st sample, strips 1 + 2 0.67 0.48 0.62 0.43

Tape strips: 2nd sample; strips 3 - n 0.42 0.39 0.51 0.31

Skin preparation 0.19 0.12 0.57 0.52

Absorbed dose

Receptor fluid 0.12 0.06 0.13 0.06

Receptor chamber wash 0.03 0.03 0.03 0.03

Total recovery1 97.6 1.48 97.4 1.86

Lower limit of confidence of T1/2 47.3 6.18 49.0 9.0

Absorption essentially complete at end of study

(>75% absorption within half the study

duration)

No

No

If no:


= absorbed dose + skin preparation + tape strips

sample 2)2

0.76 0.53 1.06 0.6

If yes:


= absorbed dose + skin preparation

N/A N/A N/A N/A

Absorption estimate normalised3 0.76 0.53 1.06 0.6

Relevant absorption estimate4 1.2 1.57

Absorption estimates used for risk

assessment5

1.2 1.6

1 Values may not calculate exactly due to rounding of figures 2 In accordance with the EFSA Guidance on Dermal Absorption (EFSA Journal 2017;15(6):4873) the radioactivity

in the second tape-strip pool (3rd to nth tape strip) is considered potentially absorbable if less than 75% of the

absorption occurred in the first half of the study (see Table 7.6.2-1) Finally, the skin preparation is also

considered potentially absorbable. 3 According to the EFSA Guidance on Dermal Absorption, cells with insufficient recovery (< 95%) can be

corrected by normalisation of absorption estimate to 100% recovery; explanation should be included. 4. In accordance with the EFSA Guidance on Dermal Absorption, a multiple of the standard deviation was added to

the mean% dermal penetration to account for the 95th percent confidence interval. 5 Relevant absorption estimate was rounded to the required number of significant figures.

N/A: not applicable

Conclusion by zRMS

The dermal penetration of ipconazole formulated as Rancona 450 FS/UBI 4336-01 through human

dermatomed skin was determined in vitro.

Based on the EFSA guidance criteria, the amount of applied dose penetrating within 24 hours was

determined to be 1.2% (0.76% ± 0.53) for the formulation, 1.57% (1.06% ± 0.6) for the (1:11) spray

dilution.

The dermal penetration estimates to be used for risk assessment were set at 1.2% for the formulation

concentrate, 1.6% for the (1:11) spray dilution.

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Appendix 3 Exposure calculations

A 3.1 Operator exposure calculations (KCP 7.2.1.1)

A 3.1.1 Calculations for Ipconazole

Table A 13: Input parameters for Seed TROPEX model for Ipconazole

Concentration of as 452 g/L

Application rate: 0.00114 kg a.s./kg Saatgut

Treatment capacity: 80000 kg/day

Packaging: 5 L (worst case)

Amount a.s. handled per day: 9.12 kg a.s./day

Dilution factor 3

Mixing/Loading-System: Fast-couple

Standard operator body weight: 60 kg

Personal protective equipment (PPE): In the Seed Tropex studies workers wore coveralls and gloves for all tasks except for bagging when only coveralls were worn; therefore, the estimated

actual dermal exposure values reflect this level of PPE.

Dermal absorption: 1.2 % for calibration, mixing/loading and bagging

1.6 % for cleaning

Table A 14: Estimated operator exposure towards Ipconazole

CALIBRATION, MIXING/LOADING, BAGGING (8 hrs/d) and CLEANING % AOEL-S

Absorbed dose (mg/kg bw/day, dermal /

inhalation): 0.002041 0.053594

Absorbed dose (mg/kg bw/day, total): 0.055635 370.9

Absorbed dose with RPE (mg/kg bw/day,

dermal / inhalation): 0.002041 0,004287487

Absorbed dose with RPE (mg/kg bw/day, total): 0,006328762 42,2

A 3.2 Worker exposure calculations (KCP 7.2.3.1)

A 3.2.1 Calculations for Ipconazole

Table A 15: Input parameters considered for the estimation of worker exposure

Working time per day: 8 hours

Worker body weight: 60 kg

Personal protective equipment (PPE): In the Seed Tropex studies workers wore coveralls and gloves during that task;

therefore, the estimated actual dermal exposure value reflects this level of PPE.

Dermal absorption: 1.6 % for loading / sowing

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Table A 16: Estimation of longer term worker exposure towards Ipconazole according to

EFSA guidance

LOADING / SOWING (8 hrs/d) % AOEL-S

Absorbed dose (mg/kg bw/day, derm. / inhal.): 0.001564 0.002478

Absorbed dose (mg/kg bw/day, total): 0.004041

26.9

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Part B – Section 7 - Core Assessment

zRMS version

REGISTRATION REPORT

Part B

Section 7 4: Metabolism and Residues


Product name: Rancona 450 FS

Active Substance: Ipconazole, 452 g/L

Central Zone


CORE ASSESSMENT

Applicant: Chemtura Europe Limited

Date: June 2020

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zRMS version

Version history

When What

August 2019 Draft Registration Report: zRMS assessment

June 2020 Registration Report: the information regarding the critical GAP in Table 7.1-1 has been revised

by zRMS considering the statement of applicant (ASB2020-13389)

The assessment result of zRMS is not affected by this change.

(changes are marked in yellow)

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Table of Contents

7 Metabolism and residue data (KCA section 6) .......................................... 5

7.1 Summary and zRMS Conclusion ................................................................... 5

7.1.1 Critical GAP and overall conclusion ............................................................. 5

7.1.2 Summary of the evaluation ............................................................................ 7

7.1.2.1 Summary for ipconazole ................................................................................ 7

7.1.2.2 Summary for Rancona 450 FS ....................................................................... 8

7.2 Ipconazole ...................................................................................................... 8

7.2.1 Stability of Residues (KCA 6.1) .................................................................... 9

7.2.1.1 Stability of residues during storage of samples ............................................. 9

7.2.1.2 Stability of residues in sample extracts .......................................................... 9

7.2.2 Nature of residues in plants, livestock and processed commodities ............ 10

7.2.2.1 Nature of residue in primary crops (KCA 6.2.1) ......................................... 10

7.2.2.2 Nature of residue in rotational crops (KCA 6.6.1) ....................................... 11

7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1) ......................... 12

7.2.2.4 Conclusion on the nature of residues in commodities of plant origin

(KCA 6.7.1) ................................................................................................. 12

7.2.2.5 Nature of residues in livestock (KCA 6.2.2-6.2.5) ...................................... 14

7.2.2.6 Conclusion on the nature of residues in commodities of animal origin

(KCA 6.7.1) ................................................................................................. 15

7.2.3 Magnitude of residues in plants (KCA 6.3) ................................................. 16

7.2.4 Magnitude of residues in livestock .............................................................. 17

7.2.4.1 Dietary burden calculation ........................................................................... 17

7.2.4.2 Livestock feeding studies (KCA 6.4.1-6.4.3) .............................................. 18

7.2.5 Magnitude of residues in processed commodities (Industrial Processing

and/or Household Preparation) (KCA 6.5.2-6.5.3) ...................................... 18

7.2.6 Magnitude of residues in representative succeeding crops .......................... 18

7.2.7 Other / special studies (KCA6.10, 6.10.1) ................................................... 18

7.2.8 Estimation of exposure through diet and other means (KCA 6.9) ............... 18

7.2.8.1 Input values for the consumer risk assessment ............................................ 18

7.2.8.2 Conclusion on consumer risk assessment .................................................... 19

7.3 Combined exposure and risk assessment ..................................................... 19

7.4 References .................................................................................................... 19

Appendix 1 Lists of data considered in support of the evaluation ............................. 20

Appendix 2 Detailed evaluation of the additional studies relied upon ...................... 24

A 2.1 Stability of residues ...................................................................................... 24

A 2.2 Nature of residue in plants ........................................................................... 24

A 2.2.1 Nature of residue in primary crops .............................................................. 24

A 2.2.2 Nature of residue in rotational crops ............................................................ 25

A 2.2.3 Nature of residues in processed commodities .............................................. 25

A 2.3 Nature of residues in livestock ..................................................................... 25

A 2.4 Magnitude of residues in plants ................................................................... 26

A 2.4.1 Maize ............................................................................................................ 26

A 2.5 Livestock feeding studies ............................................................................. 39

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A 2.6 Magnitude of residues in processed commodities (Industrial Processing

and/or Household Preparation) .................................................................... 39

A 2.7 Magnitude of residues in representative succeeding crops .......................... 39

A 2.8 Other/Special Studies ................................................................................... 39

Appendix 3 Pesticide Residue Intake Model (PRIMo) ................................................ 39

A 3.1 TMDI calculation ......................................................................................... 39

A 3.2 IEDI calculation ........................................................................................... 40

A 3.3 IESTI calculation - Raw commodities ......................................................... 40

A 3.4 IESTI calculations - Processed commodities ............................................... 40

Appendix 4 Additional information provided by the applicant ................................. 40

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Germany as zRMS has written this section of the dRR/RR as part of the evaluation of the

application for authorisation of the present product in accordance with article 33 of Regulation (EC)

No 1107/2009. Thus, the document represents completely the results of the exposure and risk

assessment conducted by the zRMS regarding the present product in the intended uses according to

the application submitted by the applicant, unless stated otherwise.

Commenting boxes and a conclusion box were used by zRMS only for the detailed evaluation of

studies in Appendix 2 of the dRR/RR. The description of the studies in Appendix 2 is based on the

dRR originally submitted by the applicant. Some text passages therefore may be taken from the

applicant´s dRR, however, the text will be adapted such that it in the end reflects the assessment of

the zRMS based on the original studies.

7 Metabolism and residue data (KCA section 6)

7.1 Summary and zRMS Conclusion

7.1.1 Critical GAP and overall conclusion

Selection of critical use and justification

The critical GAP with respect to consumer intake and risk assessment for the preparation Rancona 450 FS

is presented in Table 7.1-1.

Overall conclusion

The data available are considered sufficient for risk assessment. An exceedance of the current MRL of

0.01* mg/kg for ipconazole as laid down in Reg. (EC) 396/2005 is not expected.

The chronic and the short-term intakes of ipconazole residues are unlikely to present a public health

concern. Concerning the presence of triazole derived metabolites (TDM) in foods, it is referred to EFSA

Peer Review of the pesticide risk assessment of the triazole derivate metabolites (EFSA, 2018, ASB2018-

8816), providing a comprehensive assessment of these compounds common to multiple active substances.

As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the

intended use.

Data gaps

None.

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Table 7.1-1: Acceptability of critical GAPs (and respective fall-back GAPs, if applicable)

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F,

Fn,

Fpn

G,

Gn,

Gpn

or

I


controlled

(additionally:

developmental stages of



Conclusion /

Remarks: e.g. g safener/synergist

per ha

Method / Kind

Timing / Growth stage of crop &

season

Max. number a) per use

b) per crop/

season

Min. interval between

applications

(days)


b) max. total rate

per crop/season

g as/ha

a) max. rate per

appl. b) max. total rate

per crop/season

Water L/ha

min / max

Zonal uses (field or outdoor uses, certain types of protected crops)

1 DE Maize F Head smut of maize

Sphacelotheca reiliana SPHTRE

Seed

treatment

Before sowing a) 1

b) 1

Not

applicable

a) 2.52

mL/unit seed*

b) 2.52

mL/unit seed*

a) 1.14 2.85

b) 1.14 2.85

5-70

mL/unit seed

F * 0.18 L /ton seed in

0.36 – 5 L/seed unit (= 0.0081 kg as/100 kg

seeds, calculated by

BfR) Acceptable

Remarks

columns:

1 Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1.

2 Use official codes/nomenclatures of EU Member States

3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use situation should be described (e.g. fumigation of a structure). Use also code numbers

according to Annex I of Regulation (EU) No 396/2005.

4 F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse

use, Gpn: professional and non-professional greenhouse use, I: indoor application

5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar

fungi, weeds) and the developmental stages of the pests and pest groups at the moment of

application must be named. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants -

type of equipment used must be indicated.

7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of

application

8 The maximum number of application possible under practical conditions of use must be provided. 9 Minimum interval (in days) between applications of the same product

10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty

rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g,

kg or L product / ha).

12 If water volume range depends on application equipments (e.g. ULVA or LVA), it should be mentioned under “application: method/kind”.

13 PHI - minimum pre-harvest interval

14 Remarks may include: Extent of use/economic importance/restrictions

Explanation for Column 14 “Conclusion”

A Sufficient data available, exposure acceptable, safe use

R Data gap

N Exposure not acceptable, no safe use

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7.1.2 Summary of the evaluation

The preparation Rancona 450 FS contains the active substance ipconazole.

Table 7.1-2: Toxicological reference values for the dietary risk assessment of ipconazole

Reference

value

Source Year Value Study relied upon Safety factor

Ipconazole

ADI EFSA

Conclusion

ASB2013-5383

2013 0.015 mg/kg

bw/d

One-year dog 100

ARfD EFSA

Conclusion

ASB2013-5383

2013 0.015 mg/kg bw Rat developmental 200

1,2,4-Triazole – Triazole derivative metabolite (TDM)

ADI EFSA

Conclusion

ASB2018-8816

2018 0.023 mg/kg

bw/d

rat 12-months study 300

ARfD 2018 0.1 mg/kg bw Rabbit developmental study 300

Triazole alanine and triazole lactic acid* – Triazole derivative metabolites (TDM)

ADI EFSA

Conclusion

ASB2018-8816

2018 0.3 mg/kg bw/d Rabbit developmental study 100

ARfD 2018 0.3 mg/kg bw Rabbit developmental study 100

Triazole acetic acid – Triazole derivative metabolite (TDM)

ADI EFSA

Conclusion

ASB2018-8816

2018 1 mg/kg bw/d Rat 2-generation and rabbit

developmental study

100

ARfD 2018 1 mg/kg bw Rat 2-generation and rabbit

developmental study

100

* bridging from triazole alanine

7.1.2.1 Summary for ipconazole

Table 7.1-3: Summary for ipconazole

Use-

No.* Crop

Plant

metabolism

covered?

Sufficient

residue

trials?

PHI

sufficiently

supported?

Sample

storage

covered by

stability

data?

MRL

compliance

Chronic

risk for

consumers

identified?

Acute risk

for

consumers

identified?

1 Maize Yes Yes (11) Yes Yes Yes No No

* Use number(s) in accordance with the list of all intended GAPs in Part A / Part B, Section 0 should be given in column 1

As residues of ipconazole do not exceed the trigger values defined in Reg. (EU) No 283/2013, there is no

need to investigate the effect of industrial and/or household processing.

Residues in succeeding crops have been sufficiently investigated taking into account the specific

circumstances of the cGAP uses being considered here. It is very unlikely that residues will be present in

succeeding crops.

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Considering dietary burden and based on the intended uses, no significant modification of the intake was

calculated for livestock. Further investigation of residues as well as the modification of MRLs in

commodities of animal origin is therefore not necessary.

7.1.2.2 Summary for Rancona 450 FS

Table 7.1-4: Information on Rancona 450 FS (KCA 6.8)

Crop

PHI for Rancona

450 FS

proposed by

applicant

PHI sufficiently supported for

ipconazole

PHI for Rancona

450 FS

proposed by

zRMS

zRMS

Comments

(if different PHI

proposed)

Maize F Yes F None

F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop)

Assessment

7.2 Ipconazole

General data on ipconazole are summarized in the table below (last updated 2019/08/22).

Table 7.2-1: General information on ipconazole

Active substance (ISO Common Name) Ipconazole

IUPAC (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-

isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

Chemical structure

HO

N

N

N

Cl

Molecular formula C18H24ClN3O

Molar mass 333.9 g/mol

Chemical group Conazole fungicides

Mode of action (if available) EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitor

Systemic No

Company * Kureha GmbH

Rapporteur Member State (RMS) United Kingdom

Approval status Approved (01/09/2014)

COMMISSION REGULATION (EU) No 571/2014

Restriction see Approval Directive / Regulation

Review Report SANCO/11789/2013 – rev. 1

20/03/2014

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Current MRL regulation Regulation (EC) No 839/2008

Peer review of MRLs according to Article 12 of Reg. No

396/2005 EC performed

No

EFSA Journal: Conclusion on the peer review Yes (EFSA, 2013, ASB2013-5383)

Current MRL applications on intended uses No

* Notifier in the EU process to whom the a.s. belong(s)

7.2.1 Stability of Residues (KCA 6.1)

7.2.1.1 Stability of residues during storage of samples

Available data

A brief summary of the storage stability data on ipconazole is given in the following table. Data have

been previously evaluated at EU level and are described in detail in the DAR (UK, 2011, ASB2012-2329)

and EFSA’s Conclusion on the peer review (EFSA, 2013, ASB2013-5383).

Table 7.2-2: Summary of stability data achieved at ≤ - 18°C (unless stated otherwise)

Matrix Characteristics of the

matrix

Acceptable Maximum

Storage duration Reference

Data relied on in EU

Plant products

Wheat grain

Maize, cob with husks

High starch content >13 months EFSA, 2013

ASB2008-8337 Wheat forage

Maize forage

High water content >13 months

Wheat hay, straw

Maize straw

Not specified >13 months

Conclusion on stability of residues during storage

Ipconazole was stable for up to 13 months in wheat (grain, forage, hay and straw) and maize (cobs, forage

and straw) matrices.

Residues of the triazole metabolites (TA and TAA) were investigated in the same study and found to be

sufficiently stable in wheat grain and maize cobs for 13 months. Residues of TP are unstable. However;

none of these components are part of the residue definition(s) for ipconazole yet.

7.2.1.2 Stability of residues in sample extracts

Available data

No data available.

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7.2.2 Nature of residues in plants, livestock and processed commodities

7.2.2.1 Nature of residue in primary crops (KCA 6.2.1)

Available data

A brief summary of the metabolism of ipconazole in plants is given in the following table. Data have been

previously evaluated at EU level and are described in detail in the DAR (UK, 2011, ASB2012-2329) and

EFSA’s Conclusion on the peer review (EFSA, 2013, ASB2013-5383).

Table 7.2-3: Summary of plant metabolism studies

Crop Group Crop Label

position

Application and sampling details

Reference Method,

F or G (a)

Rate

(kg

a.s./ha)

No Sampling

(DAT)

Remarks

EU data

Fruits and

fruiting

vegetables

- - - - - - - -

Leafy vegetables - - - - - - - -

Root and tuber

vegetables

- - - - - - - -

Pulses and

oilseeds

Soya [14C-

triazole]-

label

Seed

treatment

2.5 g or 25

g as per

100 kg

seeds

1 BBCH 15

(forage)

BBCH 75

(hay)

Maturity

(seed)

None EFSA, 2013

ASB2012-

9201

Cereals Wheat [14C-

benzyl

methylene]

and [14C-

triazole]-

label

Seed

treatment

2.5 g or 25

g as per

100 kg

seeds

1 49-111 None EFSA, 2013

ASB2008-

8338

Wheat [14C-

benzyl

methylene]

and [14C-

triazole]-

label

Foliar

spraying

108 g as/ha 2 1h and 13

d (after 1st

treatment)

12 d and

41 d (after

2nd

treatment)

None EFSA, 2013

ASB2008-

8339

New data

Cereals Maize [14C-

triazole]-

label

Seed

treatment

2.5, 2.5 g

or 10 g as

per 100 kg

seeds

1 49-111 No

identification

conducted

ASB2016-

3588

Summary of plant metabolism studies reported in the EU

“Wheat grain and soybean seeds following seed treatment showed similar residue profiles with triazole

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alanine (TA) (56-68%TRR), triazole acetic acid (TAA) (10-32% TRR) and triazole pyruvic acid (TPA)

(3-4% TRR) present as major metabolites, and with parent ipconazole not detected. Absolute residue

levels were low, and none of the identified compounds is expected to largely exceed 0.01 mg/kg at the

cGAP application rate. In foliar treated wheat plants, ipconazole was present at low levels and proportions

in the grain (3-9% TRR, <0.01 mg/kg) while the major metabolites were triazole alanine (29%TRR),

triazole acetic acid (14% TRR) and the O-glycoside of ipconazole (18% TRR). No metabolites specific to

the benzyl methylene portion of the molecule were detected.

The metabolic picture in wheat straw, forage and soy bean forage and hay was very similar, with few

exceptions. Parent ipconazole was present in slightly higher proportions when compared to grains/seeds,

and ipconazole was also found to be hydroxylated and conjugated to hydroxy ipconazole conjugates. The

cis-cis (cc) and cis-trans (ct) isomers ratio investigated in wheat straw did not change significantly

between application and harvest, and it can be concluded that there is no diastereoisomer specific

metabolism of ipconazole in wheat. It is unknown whether or not there was a change in the ratio of

enantiomers.” (EFSA, 2013, ASB2013-5383)

Summary of new plant metabolism studies

In the new study involving seed treatment on maize only TRR levels were measured. In view of the high

uptake rates of triazole-based metabolites from soil, the information is only supportive without

identification of the composition.

Conclusion on metabolism in primary crops

See EU summary.

7.2.2.2 Nature of residue in rotational crops (KCA 6.6.1)

Available data

A brief summary of the metabolism studies in rotational crops on ipconazole is given in the following

table. Data have been previously evaluated at EU level and are described in detail in the DAR (UK, 2011,

ASB2012-2329) and EFSA’s Conclusion on the peer review (EFSA, 2013, ASB2013-5383).

Table 7.2-4: Summary of metabolism studies in rotational crops

Crop group Crop Label

position


Reference Method,

F or G *

Rate

(kg

a.s./ha)

PBI**

(DAT)

Harvest

Intervals

(DAT)

Remarks

EU data

Fruits and

fruiting

vegetables

- - - - - - - -

Leafy vegetables Lettuce [14C-

benzyl

methylene]

and [14C-

triazole]-

label

G 0.216 (bare

soil)

30, 120

and 365

d

121-562

d

none EFSA, 2013

ASB2008-

8345

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Crop group Crop Label

position


Reference Method,

F or G *

Rate

(kg

a.s./ha)

PBI**

(DAT)

Harvest

Intervals

(DAT)

Remarks

Root and tuber

vegetables

Carrots [14C-

benzyl

methylene]

and [14C-

triazole]-

label

G 0.216 (bare

soil)

30, 120

and 365

d

121-562

d

none EFSA, 2013

ASB2008-

8345

Pulses and

oilseeds

- - - - - - - -

Cereals Wheat [14C-

benzyl

methylene]

and [14C-

triazole]-

label

G 0.216 (bare

soil)

30, 120

and 365

d

121-562

d

none EFSA, 2013

ASB2008-

8345

* Outdoor/field application (F) or glasshouse/protected/indoor application (G)

** PBI: Plant-back interval

Summary of rotational crop metabolism studies reported in the EU

“The metabolism of ipconazole was also investigated in succeeding leafy, root and cereal crops with

radio-labelled ipconazole. The findings indicated preferential uptake by all of the crops of the triazole

ring-containing metabolites, and uptake of these metabolites was generally increased at each successive

plant back interval. Triazole acetic acid and triazole alanine were the predominant residues, ipconazole

was not detected.” (EFSA, 2013, ASB2013-5383)

7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1)

Available data

No data available and none required. Residues in raw commodities and dietary exposure were below the

respective trigger values.

7.2.2.4 Conclusion on the nature of residues in commodities of plant origin

(KCA 6.7.1)

Table 7.2-5: Summary of the nature of residues in commodities of plant origin

Endpoints

Plant groups covered - Wheat (ASB2008-8338): seed treatment, 2.5 g or 25

as/100 kg seed, [14C-benzyl methylene] and [14C-

triazole]-labelled ipconazole, sampling of forage at 49

DAT, hay at 69 DAT, grain and straw at 103-111 DAT

Uptake of radioactivity was higher in wheat treated with the

[14C-triazole] ipconazole than from that treated with [14C-

benzyl methylene] ipconazole. Besides parent ipconazole,

hydroxyl-ipconazole-glycoside and tert-hydroxyisopropyl-

ipconazole were identified in the benzyl methylene labelled

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study. Besides theses substances the triazole metabolites

triazolylpyruvate (TP), triazolyl acetic acid (TAA) and

triazolylalanine (TA) were identified in the triazole labelled

study.

- Wheat (ASB2008-8339): foliar treatment, 2 x 108 g

as/ha, [14C-benzyl methylene] and [14C-triazole]-labelled

ipconazole , sampling of forage, hay, grain and straw 1 h

A1T, 13 DA1T, 12 and 41 DA2T

Parent compound was one of the main components of the

radioactivity. In the [14C-triazole]-grain there were higher

levels of aqueous-soluble radioactivity (21.8 % TRR)

compared to the [14C-benzyl methylene] label (4.0 % TRR)

indicating the presence of polar, triazole-specific metabolites.

Benzyl methylene specific metabolites were not detected.

- Soyabean (ASB2012-9201): seed treatment, 2.5 or 25 g

as/100 kg seed, triazole label , sampling of forage (at

BBCH 14-15), hay (at BBCH 75) and seed (at maturity)

The major components in forage were ipconazole;

ipconazole-O-glycoside and hydroxy-ipconazole

glutamylcysteine while in hay a large fraction of polar

material (tentatively assigned as 1,2,4-triazole, triazole

pyruvate triazole acetic acid and triazolylalanine) was also

found. The residues in seed were entirely comprised of polar

material which was tentatively assigned as triazole pyruvate,

triazole acetic acid and triazolylalanine

- Maize (ASB2016-3588): seed treatment, 1.5, 2.5 or 10 g

as/100 kg seed, triazole label , sampling of kernel and

cobs with husks removed (85 DAP), forage (soft dough

stage) and grain plus stover (at maturity)

In this study only TRR levels were measured, no identify-

cation of the radioactivity was conducted. For the treatment

regimes (in increasing order) TRR levels were:

Forage: 1.25, 1.78 and 6.35 µg/kg

Kernels and cobs with husks removed: 1.73, 2.18

and 5.79 µg/kg

Stover: 1.17, 1.59 and 6.36 µg/kg

Grain: 5.5, 9.7 and 24.4 µg/kg

Rotational crops covered Confined study (ASB2008-8345): [14C-benzyl methylene]

and [14C-triazole]-labelled ipconazole, 216 g as/ha,

application to bare soil, PBIs of 30, 120 and 365 d, rotational

crops carrot, lettuce and wheat

Higher levels of radioactive residues were present in plants

grown in [14C-triazole] ipconazole treated soil than in soil

treated with [14C-benzyl methylene] ipconazole indicating

preferential uptake by all of the crops of the triazole ring-

containing metabolites. Uptake of these metabolites generally

increased at each successive plant-back interval indicating

their continued formation in soil. Triazolylacetic acid and

triazolylalanine were the predominant residues in the triazole

label plants samples. Other residues in both of the radiolabel

studies were non-cleaved metabolites which contained both

radio-labelling positions (glutamylcysteine and glucose

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conjugates of hydroxylated ipconazole).

Metabolism in rotational crops similar to metabolism

in primary crops?

Yes

Processed commodities Not available

Residue pattern in processed commodities similar to

pattern in raw commodities?

Not applicable

Plant residue definition for monitoring Ipconazole according to Reg. (EC) No 396/2005 (last

amendment: Regulation (EC) No 839/2008

Plant residue definition for risk assessment Proposal by EFSA (EFSA Conclusion ASB2013-5383)

Two separate residue definitions (provisional):

1) Ipconazole

2) Triazole derivative metabolites (TDMs)

In addition, the following residue definitions were proposed

for TDM (EFSA, 2018, ASB2018-8816):

- TA and TLA

- TAA

- 1,2,4-T

Conversion factor from enforcement to RA Not concluded

7.2.2.5 Nature of residues in livestock (KCA 6.2.2-6.2.5)

Available data

A brief summary of the metabolism of ipconazole in livestock is given in the following table. Data have

been previously evaluated at EU level and are described in detail in the DAR (UK, 2011, ASB2012-2329)

and EFSA’s Conclusion on the peer review (EFSA, 2013, ASB2013-5383).

Table 7.2-6: Summary of animal metabolism studies

Group Species Label

position

No of

animal

Application details Sample details

Reference Rate

(mg/kg bw/d)

Duration

(days)

Commodity Time of

samp-

ling

EU data

Lactating

ruminants

Goat [14C-

triazole] or

[14C-

benzyl

methylene]

2 20

mg/animal/day

(total intake =

10 mg/kg diet,

equivalent to

0.33 mg/kg

bw/day for the

average 60 kg

goat)

5 Milk twice

daily

EFSA,

2013

ASB2012-

9204

Urine and faeces daily

Tissues at

sacrifice

Laying

poultry

- - - - - - - -

Summary of animal metabolism studies reported in the EU and conclusion

“Investigation of residues in livestock was not triggered by the representative uses due to insignificant

livestock dietary exposure, and hence no MRLs for food of animal origin are proposed. However, the

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metabolism of ipconazole was studied in goats. In view of the very low total residue levels recovered in

the study, the residue definition could be set as ipconazole by default. Data on poultry were not available.

If in the future additional uses as feed items are supported, a global residue data package addressing the

TDMs in animal matrices might be necessary.” (EFSA, 2013, ASB2013-5383)

7.2.2.6 Conclusion on the nature of residues in commodities of animal origin

(KCA 6.7.1)

Table 7.2-7: Summary on the nature of residues in commodities of animal origin

Endpoints

Animals covered Lactating goats (ASB2012-9204), [14C-triazole] or [14C-benzyl

methylene], dose rate of 20 mg/animal/day (total intake = 10 mg/kg

diet, equivalent to 0.33 mg/kg bw/day for the average 60 kg goat).

The bulk of the radioactivity was excreted in the faeces (40.1-61.1 %)

and the urine (30.9-41.1 %), with ≤ 1 % of the total dose retained in

the tissues (including the milk).The highest residues in tissues were

found in the liver (0.31 and 0.82 % TRR for the benzyl methylene and

triazole labels respectively. Ipconazole was extensively metabolised to

a number of components. The major metabolites in the liver were

identified as parent (< 10.9 % TRR; 0.056 mg/kg) metabolites KNF-

317-M5 (< 6.8 % TRR; 0.025 mg/kg), KNF-317-M6 (< 3.4 % TRR;

0.020 mg/kg) and UM-4 (19.7 % TRR; 0.130 mg/kg). In kidney

unchanged ipconazole was the major component (< 6.7 % TRR; 0.006

mg/kg) with numerous minor metabolites in amounts of max. 2.5 %

TRR.

Laying hens

No data, not necessary

Time needed to reach a plateau

concentration

3-5 days in milk

-

Animal residue definition for monitoring Ipconazole according to Reg. (EC) No 396/2005 (Reg. (EC) No

839/2008)

Animal residue definition for risk

assessment

A residue definition for ipconazole was not proposed by EFSA

(ASB2013-5383) due to the low intake by animals (<0.1 mg/kg diet)

In addition, the following residue definitions were proposed for TDM

(EFSA, 2018, ASB2018-8816):

- TA and TLA

- TAA

- 1,2,4-T

Conversion factor Not applicable

Metabolism in rat and ruminant similar Not concluded

Fat soluble residue no (although log Pow = 4.44 (ct isomer) and 4.65 (cc isomer)

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7.2.3 Magnitude of residues in plants (KCA 6.3)

Available data

A summary of the magnitude of residues of ipconazole is given in the following table. Data have been previously evaluated at EU level and are described in detail in

the DAR (UK, 2011, ASB2012-2329) and EFSA’s Conclusion on the peer review (EFSA, 2013, ASB2013-5383). For the detailed evaluation of new/additional

studies on the magnitude of residues it is referred to Appendix 2.

Table 7.2-8: Summary of EU reported and new data supporting the intended uses of Rancona 450 FS and conformity to existing MRL

Commodity Source

Residue

zone (N-

EU, S-

EU, EU,

outside

EU)

Evaluation

GAP

Residue levels (mg/kg)

E = according to enforcement residue definition

RA = according to risk assessment residue definition

STMR

(mg/kg)

HR

(mg/kg)

Unrounded

OECD

calculator

MRL

(mg/kg)

Current

EU MRL

(mg/kg)

*

MRL

compliance

Maize, grain New trials

ASB2016-3583

ASB2016-3584 ASB2016-3585

ASB2016-3586

ASB2016-3587

EU (seed

treatment)

E/RA: <0.01(5), <0.1(4) E/RA: 0.01 E/RA: 0.1 N/A 0.01* Yes

Maize, cobs

with husks

E/RA: <0.01(6), <0.1(2) E/RA: 0.01 E/RA: 0.1 N/A N/A N/A

Maize,

forage

E/RA: <0.01(3), <0.1(8) E/RA: 0.01 E/RA: 0.1 N/A N/A N/A

Maize, stover E/RA: <0.01(3), <0.1(8) E/RA: 0.01 E/RA: 0.1 N/A N/A N/A

* Source of EU MRL: Reg. (EC) No 839/2008

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Conclusion on the magnitude of residues in plants

In addition to European trials, three supervised field trials from the USA at rates of 11 g as/100 kg seed

were submitted and included in the assessment.

In several whole plant samples, residues of triazole-alanine slightly above the LOQ were detected.

However, since control samples contained positive findings in the same range, it is unclear whether the

source of the residue is the seed dressing or uptake from soil due to the application of triazole fungicides

in previous years.

The maximum storage period of deep-frozen samples in the supervised residue trials is covered by the

storage stability studies.

According to the available data, the intended uses on maize are considered acceptable. The data submitted

show that no exceedance of the MRL is likely.

7.2.4 Magnitude of residues in livestock

7.2.4.1 Dietary burden calculation

Table 7.2-9: Input values for the dietary burden calculation (considering the uses

authorized in the country of the zRMS and the uses under consideration)

Feed Commodity

Median dietary burden Maximum dietary burden

Input value

(mg/kg) Comment

Input value

(mg/kg) Comment

Ipconazole

Grains (barley, oat, rye,

wheat, triticale and maize)

0.01 Median residue (National

authorisations and use

under consideration)




Cereal straws 0.01 Median residue (National






Maize stover 0.01 Median residue (Use


0.1 Highest residue (Use


Table 7.2-10: Results of the dietary burden calculation

Animal species Median

dietary burden

(mg/kg bw/d)

Maximum

dietary burden

(mg/kg bw/d)

Highest

contributing

commodity

Max dietary

burden (mg/kg

DM)

Trigger

exceeded

(Y/N)

Ipconazole

Beef cattle* <0.001 0.001 Maize, stover 0.04 N

Dairy cattle* <0.001 0.001 Maize, stover 0.03 N

Ram/ewe <0.001 <0.001 Barley, grain 0.01 N

Lamb <0.001 <0.001 Barley, grain 0.01 N

Breeding swine <0.001 0.001 Maize, stover 0.03 N

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Animal species Median

dietary burden

(mg/kg bw/d)

Maximum

dietary burden

(mg/kg bw/d)

Highest

contributing

commodity

Max dietary

burden (mg/kg

DM)

Trigger

exceeded

(Y/N)

Finishing swine* <0.001 <0.001 Barley, grain 0.01 N

Broiler poultry 0.001 0.001 Barley, grain 0.01 N

Layer poultry* 0.001 0.001 Wheat, grain 0.01 N

Turkey <0.001 <0.001 Rye, grain 0.01 N

* These categories correspond to those (formerly) assessed at EU level.

7.2.4.2 Livestock feeding studies (KCA 6.4.1-6.4.3)

No data available and none necessary, since the feed trigger value is not exceeded.

7.2.5 Magnitude of residues in processed commodities (Industrial Processing

and/or Household Preparation) (KCA 6.5.2-6.5.3)

No data available and none necessary due to the no residue situation in the RAC.

7.2.6 Magnitude of residues in representative succeeding crops

“Based on the total radioactive residues in the rotational crop metabolism study it is unlikely that

significant residues (> 0.01 mg/kg) would result from the intended use.” (EFSA, 2013, ASB2013-5383)

7.2.7 Other / special studies (KCA6.10, 6.10.1)

None.

7.2.8 Estimation of exposure through diet and other means (KCA 6.9)

Toxicological reference values relevant for dietary risk assessment are reported in the summary of the

evaluation (see 7.1.2).

7.2.8.1 Input values for the consumer risk assessment

Table 7.2-11: Input values for the consumer risk assessment

Commodity

Chronic risk assessment Acute risk assessment

Input value

(mg/kg) Comment

Input value

(mg/kg) Comment

Ipconazole

All MRL Reg. (EC) No 839/2008 MRL Reg. (EC) No 839/2008

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7.2.8.2 Conclusion on consumer risk assessment

Extensive calculation sheets are presented in Appendix 3.

Table 7.2-12: Consumer risk assessment

TMDI (% ADI) according to EFSA PRIMo rev. 3.1 4% (based on NL toddlers, mean body weight)

IEDI (% ADI) according to EFSA PRIMo rev. 3.1 Not necessary

IESTI (% ARfD) according to EFSA PRIMo rev. 3.1 Maize:<1% (based on UK infants, mean body weight)

NTMDI (% ADI) according to NVS II model 3% (based on DE children aged 2-4 years, individual

consumption/body weight ratio)

NEDI (% ADI) according to NVS II model Not necessary

NESTI (% ARfD) according to NVS II model Maize: <1% (based on DE children aged 2-4 years,

individual consumption/body weight ratio)

The proposed use of ipconazole in the formulation Rancona 450 FS does not represent unacceptable acute

and chronic risks for consumers.

7.3 Combined exposure and risk assessment

Not relevant. The product contains only one active substance.

7.4 References

EFSA, 2013, Conclusion on the peer review of the pesticide risk assessment of the active substance

Ipconazole, EFSA Journal 2013;11(4):3181, ASB2013-5383

EFSA, 2018, Peer Review of the pesticide risk assessment of the triazole derivate metabolites, EFSA

Journal 2018; 16(7):5376; ASB2018-8816

United Kingdom, 2011, Ipconazole: Draft Assessment Report, Volume 1-3, ASB2012-2329

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Data point Author(s) Year

Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP 6.2.1 Fathulla, R. N. 2000 Determination of the otal radioactive residues of 14C-labeled Ipconazole in corn

2000-060


BVL-3053104, ASB2016-3588

N Chemtura

KCP 6.3 Bartolome, J. 2010 UBI 4336:0 - Residue study (at harvest) with UBI 4336:0 applied to maize seed drilled in Northern and

Southern France in spring 2009

FDD0030


BVL-2838298, ASB2016-3583

N Chemtura


Southern France inspring 2009 - Report amendment 1

FDD0030


BVL-2838299, ASB2016-3584

N Chemtura


Southern France in spring 2010

FDD0041


BVL-2838300, ASB2016-3585

N Chemtura

KCP 6.3 Dzialo, D. G; Yu,

W. C

2006 Determination of residues of Ipconazole and its metabolites in corn and processed corn (seed treatment):

Magnitude of the residue study

2005-016


BVL-2838301, ASB2016-3586

N Chemtura

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Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP 6.3 Dzialo, D. G; Yu, W.

C

2007 Determination of residues of Ipconazole and its metabolites in corn and processed corn (seed treatment):

Magnitude of the residue study - Amended final report #1 -

2005-016


BVL-2838302, ASB2016-3587

N Chemtura

KCP 6.3 Anonymous 2020 Statement to 6.3 Residue Trials

BVL-4003528; ASB2020-13389

N Arysta

LifeScience

Edinburgh

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP 6.2.1 Banijamali, A. R. 2006 Distribution and metabolism of [14C-Triazolyl] Ipconazole and [14C-Benzylmethylene] Ipconazole used

as a seed treatment for spring wheat

IP-074-M ! 2005-002

GLP: Open (2) Yes (1) Published: No (1) Open (2)

BVL-2551079, BVL-2551079, BVL-2551079, ASB2008-8338

N Chemtura

KCP 6.2.1 Corden, M. T. 2006 Ipconazole: Metabolism in wheat after foliar application

IP-075-M ! KRA 079/053703 ! KRA/079


BVL-2551080, BVL-2551080, BVL-2551080, ASB2008-8339

N Chemtura

KCP 6.2.1 Crowe, A. 2010 Ipconazole: Metabolism in soybeans

IP-151-M ! OPB0006


N Chemtura

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Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

BVL-2551081, BVL-2551081, BVL-2551081, ASB2012-9201

KCP 6.6.1 Shaw, D. 2007 Ipconazole: Accumulation in confined rotational crops

IP-077-M ! CPI 002/062241 ! CPI/002


BVL-2551088, BVL-2551088, BVL-2551088, ASB2008-8345

N Chemtura

KCP 6.1.2 Brewin, S. 2006 Ipconazole, Triazolylalanine, Triazolylacetic acid and Triazolylpyruvate: Storage stability of residues in

wheat and maize commodities when stored at approximately -20ºC for thirteen months

IP-073-M ! KRA 120/063509 ! KRA/120


BVL-2551076, BVL-2551076, BVL-2551076, ASB2008-8337

N Chemtura

KCP 6.2.2 Haynes, L. M. 2007 Ipconazole: Metabolism in the lactating goat - incl. Amendment No. 1 dated 22.01.2007 and Amendment

No. 2 dated 22.11.2010

IP-076-M ! KRA 092/053949 ! KRA/092


BVL-2551082, BVL-2551082, BVL-2551082, ASB2012-9204

Y Chemtura


Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

- - - - - -

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List of data relied on and not submitted by the applicant but necessary for evaluation

Data


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

- - - - - -

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Appendix 2 Detailed evaluation of the additional studies relied upon

A 2.1 Stability of residues

No new study submitted/required.

A 2.2 Nature of residue in plants

A 2.2.1 Nature of residue in primary crops

Study 1

Comments of zRMS: The study is valid, however only TRR levels were measured and no identification

of the composition of the radioactive residues was made. The information

provided has only supplemental character.

Reference: KCA 6.2.1

Report Determination of the total radioactive residues of 14C-labeled Ipconazole in

corn, Fathulla, R. N., 2000, 2000-060, ASB2016-3588

Guideline(s): OPPTS Residue Chemistry Test Guidelines Series 860

Deviations: None

GLP: Yes

Acceptability: Supplemental


In this study maize grain was treated by seed dressing at rates of 1.5, 2.5 or 10 g as/100 kg seed using 14C-

triazole labelled ipconazole. After the application the plants were planted and grown to maturity. Samples

of kernel and cobs with husks removed (85 days after planting), forage (soft dough stage, 93 days after

planting) and grain plus stover (each at maturity, 135 days after planting) were taken.

In this study only TRR levels were measured by combustion analysis, no identification of the

radioactivity was conducted.

Results and discussion

For the treatment regimes (in increasing order) TRR levels were:

- Forage: 1.25, 1.78 and 6.35 µg/kg

- Kernels and cobs with husks removed: 1.73, 2.18 and 5.79 µg/kg

- Stover: 1.17, 1.59 and 6.36 µg/kg

- Grain: 5.5, 9.7 and 24.4 µg/kg

In the following table the TRR levels found in the different matrices are summarized:

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Table A 1: Total Radioactive Residues (TRRs) in maize.

Matrix Timing and Applic. No. PHI (days) TRR (ppm)

Kernels and cobs with husks

removed

1.5 g as/100 kg 85 0.00173

2.5 g as/100 kg 85 0.00218

10 g as/100 kg 85 0.00579

Forage 1.5 g as/100 kg 93 0.00125

2.5 g as/100 kg 93 0.00178

10 g as/100 kg 93 0.00635

Stover 1.5 g as/100 kg 135 0.00117

2.5 g as/100 kg 135 0.00159

10 g as/100 kg 135 0.00636

Grain 1.5 g as/100 kg 135 0.0055

2.5 g as/100 kg 135 0.0097

10 g as/100 kg 135 0.0244

Conclusions by zRMS

The submitted study is of limited use for the evaluation of the metabolism of ipconazole in plant matrices.

However, it clearly shows that transfer of residues within maize plants is very limited following seed

dressing application. Only in maize grain TRRs higher than 0.01 mg eq/kg were found, but of unknown

composition.

A 2.2.2 Nature of residue in rotational crops


A 2.2.3 Nature of residues in processed commodities


A 2.3 Nature of residues in livestock


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A 2.4 Magnitude of residues in plants

A 2.4.1 Maize

Table A 2: Comparison of intended and critical EU GAPs

Type of GAP Number of

applications

Application rate

per treatment

Interval between

applications

Growth stage at

last application

PHI (days)

Intended cGAP

(number 1)

1 0.0081 kg as/100

kg seeds

Not applicable Not applicable F

* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0

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Reference: OECD KIIA 6.3

Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid

down in the reference list)

Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box

Deviations: no relevant deviations unless stated otherwise in the commenting box

GLP: see reference list

Acceptability: acceptable unless stated otherwise in the commenting box

Table A 3: Summary of residue trials with ipconazole in maize

RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : ipconazole

(Application on agricultural and horticultural crops) Crop / crop group : maize

Crop Code : ZEAMX Federal Institute for Risk Assessment, Berlin

Federal Republic of Germany Submission date : 2016-04-21

Content of a.i. (g/kg or g/l) : 450 g/L Indoors / Outdoors : Outdoors (European South)

Formulation (e.g. WP) : FS (flowable concentrate for seed treatment) Other a.i. in formulation

Commercial product (name) : UBI 4336:0 (content and common name) : Applicant : Chemtura Europe Limited House Berkshire Residues calculated as : 8.1 ipconazole

8.2 triazole-acetic-acid (TAA)

8.3 triazole-alanine (TA) 8.4 triazolyl pyruvate (TP)

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1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or

planting 2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

or no. of treatments

and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0030,

trial FDD0030-

04, plot 2

France (FR)

31600 Buzet sur Tarn

2010-02-16

Hawk 1) 2009-06-03

(sowing)

2) 2009-07-14 - 2009-07-26

3) 2009-09-20

0.0081 2009-04-154) BBCH 00 whole plant

without root

<0.10 <0.010 0.020 <0.10 20 4) seed treatment

analytical method: Huntingdon Life

Sciences method

KRA/119-03R (LC-MS/MS),

LOQ(s):

8.1; 8.4: 0.01 mg/kg (maize cob with

husks), 0.1 mg/kg

(whole plant without root, rest of plant

without root), 8.2; 8.3: 0.01 mg/kg

(whole plant without

root, maize cob with husks), 0.1 mg/kg

(rest of plant without

root), max. sample storage time

in month(s): 6

test item application rate 3.417 mL/ha

ASB2016-3583 ASB2016-3584

(amendment)

rest of plant

without root

<0.10 <0.10 <0.10 <0.10 89

maize cob with husks

<0.010 <0.010 0.10 <0.010 89

controls > LOQ whole plant

without root

0.020 20

maize cob

with husks

0.070 89

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1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0041,

trial FDD0041-

02, plot 2

France (FR)

47500 Monsempron

Libos

2011-04-19

Revolver 1) 2010-05-14

(sowing)

2) 2010-07-23 - 2010-07-30

3) 2010-10-14

0.0081 2010-02-274) BBCH 00 whole plant

without root

<0.10 <0.10 <0.10 <0.10 41 4) seed treatment


Sciences method


LOQ(s):

0.01 mg/kg (grain), 0.1 mg/kg (whole

plant without root,

rest of plant without root, maize cob with

husks, straw), max. sample storage time

in month(s): 7


ASB2016-3585

rest of plant

without root

<0.10 <0.10 <0.10 <0.10 101


<0.10 <0.10 <0.10 <0.10 101

grain <0.010 <0.010 0.060 <0.010 153 straw <0.10 <0.10 <0.10 <0.10 153

controls > LOQ grain 0.080 153

Rancona 450 FS / 008398-00/00


zRMS version

Page 30 / 40

1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0030,

trial FDD0030-

05, plot 2

France (FR)

31390 Carbonne

2010-02-16

Hawk 1) 2009-06-10

(sowing)

2) 2009-08-01 - 2009-08-11

3) 2009-11-05

0.0081 2009-04-154) BBCH 00 whole plant

without root

<0.10 <0.010 <0.010 <0.10 27 4) seed treatment


Sciences method


LOQ(s):


husks), 0.1 mg/kg


without root, grain, straw),

8.2; 8.3: 0.01 mg/kg

(whole plant without root, maize cob with

husks), 0.1 mg/kg

(rest of plant without root, grain, straw),

max. sample storage time

in month(s): 5 test item application rate

3.272 mL/ha

ASB2016-3583

ASB2016-3584

(amendment)

rest of plant

without root

<0.10 <0.10 <0.10 <0.10 84


<0.010 <0.010 0.020 <0.010 84

grain <0.10 <0.10 <0.10 <0.10 118 straw <0.10 <0.10 <0.10 <1.0 118

controls > LOQ maize cob

with husks

0.020 84

Rancona 450 FS / 008398-00/00


zRMS version

Page 31 / 40

1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0030,

trial FDD0030-

06, plot 2

France (FR)

33810 Ambes

2010-02-16

Hawk 1) 2009-06-03

(sowing)

2) 2009-07-15 - 2009-07-25

3) 2009-09-20

- 2009-10-15

0.0081 2009-04-154) BBCH 00 whole plant

without root

<0.10 <0.010 0.010 <0.10 23 4) seed treatment


Sciences method


LOQ(s):


husks), 0.1 mg/kg



8.2; 8.3: 0.01 mg/kg


husks), 0.1 mg/kg

(rest of plant without root, grain, straw),



3.652 mL/ha

ASB2016-3583

ASB2016-3584

(amendment)

rest of plant

without root

<0.10 <0.10 <0.10 <0.10 86


<0.010 <0.010 0.080 <0.010 86

grain <0.10 <0.10 0.10 <0.10 113 straw <0.10 <0.10 <0.10 <1.0 113

controls > LOQ maize cob

with husks

0.14 86

grain 0.13 113

Rancona 450 FS / 008398-00/00


zRMS version

Page 32 / 40





Content of a.i. (g/kg or g/l) : 450 g/L Indoors / Outdoors : Outdoors (European North)

Formulation (e.g. WP) : FS (flowable concentrate for seed treatment) Other a.i. in formulation

Commercial product (name) : UBI 4336:0 (content and common name) : Applicant : Chemtura Europe Limited House Berkshire Residues calculated as : 8.1 ipconazole



1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No. Location

incl.

Postal code and date

Commodity/ Variety

Date of 1) Sowing or

planting

2) Flowering 3) Harvest

Application rate per treatment

Dates of treatments

or no. of

treatments and last date

Growth stage

at last

treatment or date

Portion analysed

Residues (mg/kg)

Residues (mg/kg)

Residues (mg/kg)

Residues (mg/kg)

PHI (days)

Remarks

kg

a.i./100

kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0030, trial FDD0030-

01, plot 2

France (FR)

51140

Treslon

2010-02-16

Hawk 1) 2009-06-26 (sowing)

2) 2009-09-15

- 2009-09-30 3)

0.0081 2009-04-154) BBCH 00 whole plant without

root

<0.10 <0.010 <0.010 <0.10 48 4) seed treatment

analytical method:

Huntingdon Life Sciences method

KRA/119-03R (LC-

MS/MS), LOQ(s):

8.1; 8.4: 0.01 mg/kg

(maize cob with husks), 0.1 mg/kg (whole plant

without root, rest of plant without root),

8.2; 8.3: 0.01 mg/kg


husks), 0.1 mg/kg (rest

of plant without root), max. sample storage time

in month(s): 4


ASB2016-3583

ASB2016-3584 (amendment)

rest of plant

without root

<0.10 <0.10 <0.10 <0.10 139

maize cob

with husks

<0.010 <0.010 <0.010 <0.010 139

Rancona 450 FS / 008398-00/00


zRMS version

Page 33 / 40

1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0030,

trial FDD0030-

02, plot 2

France (FR)

37330 Courcelles de

Touraine

2010-02-16

Hawk 1) 2009-05-28

(sowing)

2) 2009-07-30 - 2009-08-17

3) 2009-10-01

- 2009-10-08

0.0081 2009-04-154) BBCH 00 whole plant

without

root

<0.10 <0.010 0.010 <0.10 29 4) seed treatment


Sciences method


LOQ(s):


husks), 0.1 mg/kg



8.2; 8.3: 0.01 mg/kg



of plant without root, grain, straw),



3.87 mL/ha

ASB2016-3583

ASB2016-3584

(amendment)

rest of plant without

root

<0.10 <0.10 <0.10 <0.10 98

maize cob

with husks

<0.010 <0.010 0.020 <0.010 98

grain <0.10 <0.10 <0.10 <0.10 126 straw <0.10 <0.10 <0.10 <1.0 126

controls > LOQ

whole plant without

root

0.020 29


0.070 98

grain 0.13 126

Rancona 450 FS / 008398-00/00


zRMS version

Page 34 / 40

1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0041,

trial FDD0041-

01, plot 2

France (FR)

10800 St Leger-Pres-

Troyes

2011-04-19

Revolver 1) 2010-05-04

(sowing)

2) 2010-07-05 - 2010-08-10

3) 2010-10-20

0.0081 2010-02-274) BBCH 00 whole plant

without

root

<0.10 <0.10 <0.10 <0.10 38 4) seed treatment


Sciences method


LOQ(s):

0.01 mg/kg (grain), 0.1 mg/kg (whole plant

without root, rest of

plant without root, maize cob with husks,

straw), max. sample storage time

in month(s): 7


ASB2016-3585


root

<0.10 <0.10 <0.10 <0.10 133

maize cob

with husks

<0.10 <0.10 <0.10 <0.10 133

grain <0.010 <0.010 0.050 <0.010 169 straw <0.10 <0.10 <0.10 <0.10 169

controls > LOQ grain 0.050 169

Rancona 450 FS / 008398-00/00


zRMS version

Page 35 / 40

1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study FDD0030,

trial FDD0030-

03, plot 2

France (FR)

37330 Breches

2010-02-16

Hawk 1) 2009-05-06

(sowing)

2) 2009-07-21 - 2009-08-05

3) 2009-09-29

- 2009-09-30

0.0081 2009-04-154) BBCH 00 whole plant

without

root

<0.10 <0.010 <0.010 <0.10 36 4) seed treatment


Sciences method


LOQ(s):


husks), 0.1 mg/kg



8.2; 8.3: 0.01 mg/kg



of plant without root, grain, straw),



3.815 mL/ha

ASB2016-3583

ASB2016-3584

(amendment)


root

<0.10 <0.10 <0.10 <0.10 120

maize cob

with husks

<0.010 <0.010 0.010 <0.010 120

grain <0.10 <0.10 <0.10 <0.10 146 straw <0.10 <0.10 <0.10 <1.0 146

Rancona 450 FS / 008398-00/00


zRMS version

Page 36 / 40





Content of a.i. (g/kg or g/l) : 407 g/L Indoors / Outdoors : Outdoors (NAFTA)

Formulation (e.g. WP) : SC (suspension concentrate (= flowable concentrate)) Other a.i. in formulation

Commercial product (name) : VORTEX (content and common name) : Applicant : Chemtura Europe Limited House Berkshire Residues calculated as : 8.1 ipconazole



1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study 2005-016,

trial KAG-05-

001

United States of

America (US) 58790

Carrington,

North Dakota

2006-11-30

DKC29-98

(04C7742)

1) 2005-06-04

(sowing)

2) 3)

0.011 2005-05-314) BBCH 00 forage <0.010

<0.010

<0.010

<0.010

0.011

<0.010

<0.010

<0.010

89

89

4) seed treatment

replicate field sample(s), analytical method:

Huntingdon Life

Sciences method KRA/119-02R (LC-

MS/MS),

LOQ: 0.01 mg/kg, max. sample storage time

in month(s): 4 test item application rate:

0.0277 L/100 kg seed;

seeding rate: 71712 seeds/ha

ASB2016-3586 ASB2016-3587

(amendment)

grain <0.010

<0.010

<0.010

<0.010

<0.010

0.010

<0.010

<0.010

129

129 stover <0.010

<0.010 <0.010 <0.010

<0.010 <0.010

<0.010 <0.010

129 129

Rancona 450 FS / 008398-00/00


zRMS version

Page 37 / 40

1 2 3 4 5 6 7 8.1 8.2 8.3 8.4 9 10

Report-No.

Location

incl. Postal code

and date

Commodity/

Variety

Date of

1) Sowing or


3) Harvest

Application

rate per treatment

Dates of

treatments


and last date

Growth

stage

at last treatment

or date

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./100 kg seed

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study 2005-016,

trial KAG-05-

002

United States of

America (US) 50026

Bagley, Iowa

2006-11-30

35P17 1) 2005-06-07

(sowing)

2) 3)

0.011 2005-05-314) BBCH 00 forage <0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

86

86

4) seed treatment


Huntingdon Life


MS/MS),


in month(s): 4

test item application rate: 0.0277 L/100 kg seed;

seeding rate: 61628 seeds/ha

ASB2016-3586 ASB2016-3587

(amendment)

grain <0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

115

115 stover <0.010

<0.010 <0.010 <0.010

<0.010 <0.010

<0.010 <0.010

115 115

study 2005-016,

trial KAG-05-

003

United States of

America (US) 68467

York, Nebraska

2006-11-30

35P17 1) 2005-06-09

(sowing)

2) 3)

0.011 2005-05-314) BBCH 00 forage <0.010

<0.010

<0.010

<0.010

<0.010

0.011

<0.010

<0.010

84

84

4) seed treatment


Huntingdon Life


MS/MS),


in month(s): 4

test item application rate: 0.0277 L/100 kg seed;

seeding rate: 78651

seeds/ha

ASB2016-3586

ASB2016-3587 (amendment)

grain <0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

120

120 stover <0.010

<0.010 <0.010 <0.010

<0.010 <0.010

<0.010 <0.010

120 120

Rancona 450 FS / 008398-00/00


zRMS version

Page 38 / 40

(a) According to CODEX Classification / Guide

(b) Only if relevant

(c) Year must be indicated

(d) Days after last application (Label pre-harvest interval, PHI, underline)

(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included

Comments of zRMS: Acceptable.

Rancona 450 FS / 008398-00/00


zRMS version

Page 39 / 40

A 2.5 Livestock feeding studies


A 2.6 Magnitude of residues in processed commodities (Industrial Processing

and/or Household Preparation)


A 2.7 Magnitude of residues in representative succeeding crops


A 2.8 Other/Special Studies


Appendix 3 Pesticide Residue Intake Model (PRIMo)

A 3.1 TMDI calculation

Rancona 450 FS / 008398-00/00


zRMS version

Page 40 / 40

A 3.2 IEDI calculation

Not necessary

A 3.3 IESTI calculation - Raw commodities

A 3.4 IESTI calculations - Processed commodities

Appendix 4 Additional information provided by the applicant

None.

--- ---

IESTI IESTI

Highest % of

ARfD/ADI Commodities

MRL / input

for RA

(mg/kg)

Exposure

(µg/kg bw)

Highest % of

ARfD/ADI Commodities

MRL / input

for RA

(mg/kg)

Exposure

(µg/kg bw)

0,4% Maize/corn 0,01 / 0,01 0,07 0,1% Maize/corn 0,01 / 0,01 0,02

Expand/collapse list

Total number of commodities exceeding the ARfD/ADI in

children and adult diets

(IESTI calculation)

Results for children

No. of commodities for which ARfD/ADI is

exceeded (IESTI):

Results for adults

No. of commodities for which ARfD/ADI is

exceeded (IESTI):

--- ---

IESTI IESTI

Highest % of

ARfD/ADI Processed commodities

MRL / input

for RA

(mg/kg)

Exposure

(µg/kg bw)

Highest % of

ARfD/ADI Processed commodities

MRL / input

for RA

(mg/kg)

Exposure

(µg/kg bw)

1% Maize / oil 0,01 / 0,25 0,23 0,8% Maize / oil 0,01 / 0,25 0,13

0,1% Maize / processed (not spec0,01 / 0,01 0,02

Expand/collapse list

Results for adults

No of processed commodities for which

ARfD/ADI is exceeded (IESTI):

Pro

ce

ss

ed

co

mm

od

itie

s Results for children

No of processed commodities for which

ARfD/ADI is exceeded (IESTI):

REGISTRATION REPORT

Part B

Section 5

Environmental Fate


Product code: ZV1 008398-00/00

Product name(s): Rancona 450 FS

Chemical active substance:

Ipconazole 452 g/L

Central Zone


CORE ASSESSMENT(authorization)

Applicant: Arysta LifeScience Great Britain Ltd. (former

CHEMTURA Europe Ltd)

Submission date: 27.02.2015

MS Finalisation date: September 2019

ZV1 008398-00/00 / Rancona 450 FS


zRMS version

Page 2 / 32

Template for chemical PPP

Version April 2015

Version history

When What

[Sept 2019] First Draft RR by UBA

ZV1 008398-00/00 / Rancona 450 FS


zRMS version

Page 3 / 32


Version April 2015

Table of Contents

5 Fate and behaviour in the environment (KCP 9) ...................................... 5

5.1 Critical GAP and overall conclusions ............................................................ 6

5.1.1 Table of critical GAPs ................................................................................... 6

5.1.2 Overall conclusion ......................................................................................... 8

5.1.3 Grouping of intended uses for risk assessment .............................................. 8

5.2 Metabolites considered in the assessment ...................................................... 9

5.3 Rate of degradation in soil (KCP 9.1.1) ....................................................... 10

5.3.1 Aerobic degradation in soil (KCP 9.1.1.1) .................................................. 10

5.3.1.1 Ipconazole .................................................................................................... 10

5.3.2 Anaerobic degradation in soil (KCP 9.1.1.1) ............................................... 11

5.4 Field studies (KCP 9.1.1.2) .......................................................................... 11

5.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) . 11

5.4.1.1 Ipconazole and its metabolites ..................................................................... 11

5.4.2 Soil accumulation testing (KCP 9.1.1.2.2) .................................................. 12

5.5 Mobility in soil (KCP 9.1.2) ........................................................................ 12

5.5.1 Adsorption and desorption in soil (KCP 9.1.2.1) ......................................... 12


5.5.2 Column leaching (KCP 9.1.2.1) ................................................................... 13

5.5.3 Lysimeter studies (KCP 9.1.2.2) .................................................................. 13

5.5.4 Field leaching studies (KCP 9.1.2.3) ........................................................... 13

5.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP

9.2.2, KCP 9.2.3) ......................................................................................... 14

5.6.1 Water/sediment study (KCP 9.2.2) .............................................................. 14

5.6.1.1 Ipconazole .................................................................................................... 14

5.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 14

5.7.1 Justification of new endpoints ..................................................................... 14

5.7.2 Active substance and relevant metabolite(s) ................................................ 14

5.7.2.1 PECsoil ........................................................................................................ 15

5.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP

9.2.4.1) ......................................................................................................... 16


5.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1) ........................ 16


5.8.3 Additional field test (KCP 9.2.4.2) .............................................................. 19

5.8.4 Summary of the risk assessment for groundwater ....................................... 19

5.9 Predicted Environmental Concentrations in surface water (PECsw)

(KCP 9.2.5) .................................................................................................. 19


5.9.2 PECsw and PECoff-field after exposure by dust drift ....................................... 19

5.9.3 PECsw after exposure by surface runoff and drainage for the active

substance, relevant metabolite(s) and the formulation (KCP 9.2.5) ............ 23


5.9.3.2 PECsw/sed of formulation ............................................................................... 28

5.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ......................................... 28


ZV1 008398-00/00 / Rancona 450 FS


zRMS version

Page 4 / 32


Version April 2015

Appendix 2 Detailed evaluation of the new Annex II studies ..................................... 31

A 2.1 Littlewood, 2013 .......................................................................................... 31

ZV1 008398-00/00 / Rancona 450 FS


zRMS version

Page 5 / 32


Version April 2015

5 Fate and behaviour in the environment (KCP 9)

ZV1 008398-00/00 / Rancona 450 FS


zRMS version

Page 6 / 32


Version April 2015

5.1 Critical GAP and overall conclusions

5.1.1 Table of critical GAPs

Table 5.1-1: Critical use pattern of the formulated product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Use-No.

*

Member state(s)

Crop and / or situation

(crop destina-

tion / purpose of crop)

F, Fn, Fpn

G, Gn,

Gpn or

I **

Pests or Group of pests con-

trolled

(additionally: developmental

stages of the

pest or pest group)


Remarks: e.g. g safener/

synergist per ha

Conclusion

Method /

Kind

Timing /

Growth stage of crop & season

Max. number

a) per use b) per crop/

season

Min. interval

between applications

(days)

kg or L

product/ha a) max. rate per appl.

b) max. total rate per

crop/season

g or kg as/ha

a) max. rate per

appl.


Water

L/ha min/max

Groundwater


001 DE,

FR,

HU,

IT,

RO

Maize

ZEAMX

F Fusarium spp.

FUSASP

seed treatment

before sowing

BBCH 00

a.) 1

b.) 1

- 1.925 mL/ha (0.77 mL/seed unit)

0.875 g a.s /ha (0.35 g as/seed unit)

maximum appli-

cation rate 1.925 mL/ha (equiva-

lent to a maxi-

mum of 2.5 seed units per ha***; 1

unit includes 50000 grains)

A

002 DE,

FR,

HU,

IT,

PL,

RO

Maize

ZEAMX


RHIZSO

seed treatment

before sowing

BBCH 00

a.) 1

b.) 1


0.875 g a.s /ha (0.35 g as/seed unit)

maximum appli-cation rate 1.925

mL/ha (equiva-

lent to a maxi-mum of 2.5 seed

units per ha*** ;

1 unit includes 50000 grains)

A

ZV1 008398-00/00 / Rancona 450 FS


zRMS version

Page 7 / 32


Version April 2015

003 DE,

FR,

HU,

IT,

RO

Maize

ZEAMX

F head smut of

maize Sphace-lotheca reiliana

SPHTRE

seed treatment

before sowing

BBCH 00

a.) 1

b.) 1


2.85 g a.s./ha (1.14 g as/seed unit)

maximum appli-

cation rate 6.3 mL/ha (equiva-

lent to a maxi-

mum of 2.5 seed units per ha***; 1

unit includes 50000 grains)

A

* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1

** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn:

professional and non-professional greenhouse use, I: indoor application

*** maximum seed rate: 35 kg/ha

Explanation for column 15 “Conclusion” A Safe use


C To be confirmed by cMS

N No safe use

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5.1.2 Overall conclusion

Results of FOCUS groundwater modelling show that ipconazole is not expected to penetrate into

groundwater at concentrations of ≥ 0.1 µg/L in the intended uses of Rancona 450 FS in maize in all FO-

CUS groundwater scenarios.

5.1.3 Grouping of intended uses for risk assessment

The following table documents the grouping of the intended uses to support application of the risk enve-

lope approach (according to SANCO/11244/2011

Table 5.1-2: Critical use pattern of Rancona 450 FS grouped according to soil

Grouping according to soil

Group Intended uses Application rate (g/ha) (inter-

ception, %)

Soil-relevant effective applic.

rate, cumulative (g/ha)

A 003 2.85 (0%) 2.85

B 001 & 002 0.875 (0%) 0.875

Table 5.1-3: Critical use pattern of Rancona 450 FS grouped according to spray drift

Grouping according to spray drift

Group Intended uses Application rate (g/ha) (inter-

val, d)

Drift scenario

A 003 2.85 (-) Arable crops

B 001 & 002 0.875 (-) Arable crops

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5.2 Metabolites considered in the assessment

Metabolites of ipconazole

Metabolites of ipconazole occuring in the environment and requiring further assessment according to the

results of the assessment of ipconazole for EU approval are summarized in Table 5.2-1.

No new study on the fate and behaviour of ipconazole or Rancona 450 FS has been performed. Hence no

Potential groundwater contamination by the soil metabolites 1,2,4-Triazole was evaluated for EU approv-

al of ipconazole. PECgw modelled with FOCUS PEARL v.4.4.4 was less than 0.01 µg/L for the metabolite

in all scenarios based on an application of 7 g as/ha in spring and winter cereals at BBCH 00 (seed treat-

ment).

However, the leaching potential into groundwater of the soil metabolite 1,2,4-Triazole will be assessed

for the application of the plant protection product and its intended uses.

Table 5.2-1: Metabolites of ipconazole potentially relevant for exposure assessment

Metabolite Molar

mass

(g/mol)

Chemical structure Maximum observed

occurrence in com-

partments

Exposure assess-

ment required

due to

1,2,4-Triazole 69.1

NH

N

N

Soil:

max. 23.7 % at day

31

soil photolysis:

10.4% at day 8

PECgw:

PECsoil:

PECsw/sed:

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5.3 Rate of degradation in soil (KCP 9.1.1)

Studies on degradation in soil with the formulation were not performed, since it is possible to extrapolate

from data obtained with the active substance.

5.3.1 Aerobic degradation in soil (KCP 9.1.1.1)

5.3.1.1 Ipconazole

No new studies have been submitted regarding route and rate of degradation in soil of ipconazole. The

environmental exposure assessment is based on the EU agreed DT50 values from the laboratory as sum-

marized in Table 5.3-1.

Table 5.3-1: Summary of aerobic degradation rates for ipconazole - laboratory studies

Soil name pH

(CaCl2)

T

(oC)

MWHC

(%)

DT50 / DT90

(d)

DT50 (d)

20°C

pF2/10kPa

Chi2

(%)

Method of

calculation Reference

Sandy loam1 5.3 20°C pF2 294 / 977 294 2.8 SFO LoEP (2013)

Sandy clay

loam1

7.2 20°C pF2 170 / 564 170 3.5 SFO LoEP (2013)

Silt loam1 5.4 20°C pF2 225 / 748 225 4.1 SFO LoEP (2013)

Clay loam1 6.5 20°C pF2 184 / 612 184 5.6 SFO LoEP (2013)

Sandy loam2 7.7* 25°C 75% 1/3

bar

194 / 998 391 2.5 DFOP (SFO

for 20°C)

LoEP (2013)

Geometric mean (n=5) 240

Maximum 391

pH-dependency No 1 = EU soil; 2 = US soil,

* pH measured in water

Table 5.3-2: Summary of aerobic degradation rates for metabolite 1,2,4-triazole - labora-

tory studies

Soil name pH

(H2O)

T

(oC)

MWHC

(%)

DT50 / DT90

(d)

f.f DT50 (d)

20°C

pF2/10kPa

Chi2

(%)

Method of


Sandy loam

(US soil)

7.7 25°C 75% 1/3

bar 136 / 453

76 / 251

0.62

1.0

213 / 711

119 / 394 20.4

42.9

DFOP-SFO

SFO-SFO

LoEP (2013)

Geometric mean (n=…) - not used / field data was used in risk

assessment pH-dependency -

As the degradation of 1,2,4-triazole was studied in only one soil, a geometric mean on the aerobic degra-

dation rates of the metabolite 1,2,4-triazole is not available from laboratory studies. Hence, field data, as

presented in Chapter 5.4, is used for PEC-calculations.

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5.3.2 Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

5.4 Field studies (KCP 9.1.1.2)

5.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)

5.4.1.1 Ipconazole and its metabolites

The field dissipation rates of ipconazole were evaluated during EU assessment. No additional studies

have been performed. The DT50 values are summarized in the tables below.

Table 5.4-1: Summary of aerobic degradation rates for ipconazole - field studies

Soil type Location pH a) Depth

(cm)

DissT50

(d)

actual

DT90

(d)

actual

Chi²

(%)

DT50

(d)

Norm.

Method of


Silt loam

(bare soil,

incorporated)

Hesse, Germany 7.2 0-20 96.3 320 16.42 - SFO LoEP (2013)

Loam Bavaria, Germany1 6.5 0-20 66 219 27.54 - SFO LoEP (2013)

Clay Italy1 7.4 0-20 135 264.3 10.15 - HS2 LoEP (2013)

Sandy Loam Spain1 7.5 0-20 228* 757* 19.46* - SFO LoEP (2013)

Maximum (n=4) - - - -

Geometric mean** (n=-) - - - -

pH-dependency No a) medium not stated 1 application made to bare soil followed by incorporation 2 HS kinetics calculated including initial lag phase where no degradation occurs (k1 = 0.000, k2 = 0.012, tb =79.361

*dry soil conditions

** not calculated for non-normalised DT50/DT90 values as not all calculated using the same kinetics.

Table 5.4-2: Summary of aerobic degradation rates for metabolite 1,2,4-triazole - field

studies: Triggering endpoints


(cm)

DissT50

(d)

actual

DT90

(d)

actual

Kinetic

parameters

Chi²

(%)

Method

of calc.

Reference

Silt loam Höfchen (DE) 6.4 0-30 7.8 366.7 α 0.4454

β 2.0966 15.2 FOMC

LoEP

(2013)

Silty clay

loam Albaro (IT) 7.6 0-40 21.2 207.4

k1 0.3500

k2 0.0086

g 0.4000

10.7 DFOP LoEP

(2013)

Sandy loam Little Shelford

(UK) 7.4 0-40 6.8 109.3

k1 0.4863

k2 0.0154

g 0.4633

17.8 DFOP LoEP

(2013)

Loam Vilobi (SP) 5.8 0-30 28.1 717.6 k1 0.0632

k2 0.0020 13.3 DFOP

LoEP

(2013)

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g 0.5732

Maximum (n=4) 28.1 717.6 a) medium not stated

Table 5.4-3: Summary of aerobic degradation rates for metabolite 1,2,4-triazole - field

studies: Modelling endpoints


(cm)

DT50 (d) (20°C, pF2) gb Chi²

(%)

Method of

calculation

Reference

Fast phase Slow

phase

Silt loam Höfchen (DE) 6.4 0-30 2.5 70.7 0.655c 18.8 DFOP LoEP (2013)

Silty clay loam Albaro (IT) 7.6 0-40 1.4 59.8 0.364 10.6 DFOP LoEP (2013)

Sandy loam Little Shelford (UK) 7.4 0-40 0.5 25.1 0.458 18.1 DFOP LoEP (2013)

Loam Vilobi (SP) 5.8 0-30 4.6 126.0 0.477 12.7 DFOP LoEP (2013)

Arithmetric mean (n=4) 0.489

Geometric mean (n=4) 1.68 60.5

pH-dependency No a) medium not stated b proportion of the substance described by k1; c estimated and then fixed

5.4.2 Soil accumulation testing (KCP 9.1.1.2.2)

No data available, not required.

5.5 Mobility in soil (KCP 9.1.2)

Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate


5.5.1 Adsorption and desorption in soil (KCP 9.1.2.1)


No new studies have been submitted regarding adsorption/desorption in soil of ipconazole. The exposure

modelling is based on the EU KFoc values as summarized for ipconazole and its soil metabolites 1,2,4-

Triazole in the tables below.

Table 5.5-1: Summary of soil adsorption/desorption for ipconazole

Soil name/soil type OC

(%)

pH a) KF

(mL/g)

KFoc

(mL/g)

1/n

(-)

Reference

Sandy loam 2.8 5.2 90 3214 0.7842 LoEP (2013)

Sandy loam 5.6 7.1 107 1911 0.8073 LoEP (2013)

Clay loam 4.3 7.1 108 2512 0.8077 LoEP (2013)

Sandy loam 1.6 5.9 45 2813 0.8121 LoEP (2013)

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Silt loam 1.95 5.9 47 2410 0.8582 LoEP (2013)

Loamy sand 0.3 6.2 5.2 1724 0.792 LoEP (2013)

Arithmetic mean (n=6) 2431 0.81

Geometric mean (n=-) -

pH-dependency No a) medium not stated

Table 5.5-2: Summary of soil adsorption/desorption for metabolite 1,2,4-Triazole

Soil type OC

(%)

pH

(CaCl2)

KF

(mL/g)

KFoc

(mL/g)

1/n

(-)

Reference: in LoEP (2013)

Silty clay 0.70 8.8 0.83 120 0.897 Hawkins, 1988

Clay loam 1.74 6.9 0.58 43 0.827 Hawkins, 1988

Sand* 0.12 4.8 0.23 201 0.885 Hawkins, 1988

Silty clay loam 0.70 7.0 0.72 104 0.922 Hawkins, 1988

Sandy loam 0.81 6.9 0.72 89 1.016 Hawkins, 1988

Arithmetic mean (n=4) 89 0.92

Geometric mean (n=4) 83.1 -

pH-dependency No

* Value excluded due to very low organic carbon%

5.5.2 Column leaching (KCP 9.1.2.1)

No data, not required for assessment.

5.5.3 Lysimeter studies (KCP 9.1.2.2)

No data available from EU assessment of ipconazole.

5.5.4 Field leaching studies (KCP 9.1.2.3)

No data available from EU assessment of ipconazole.

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5.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2,

KCP 9.2.3)

Studies on degradation in water/sediment systems with the formulation were not performed, since it is

possible to extrapolate from data obtained with the active substance.

5.6.1 Water/sediment study (KCP 9.2.2)

5.6.1.1 Ipconazole

No new water/sediment study has been submitted. The exposure modelling is based on the results of the

water/sediment studies of ipconazole reviewed in the EU assessment summarized in the table below.

Table 5.6-1: Summary of degradation in water/sediment of ipconazole

Distribution: ipconazole max in water 92.3 % after 0 d. Max. sed. 87.7 % after 30 d

Wa-

ter/sediment

system

pH

water

pH

sed.

DegT50/90

whole

syst.

(d)

Method

of calcu-

lation, r2

DissT50/90*

water

(d)

Method

of calcu-

lation, r2

DissT50/90

sed.

(d)

Method

of calcu-

lation, r2

Refer-

ence

Clay loam (Bury

Pond)

7.44 7.7 241 / 799 0.93 2.0 / 17.6 FOMC

>0.99

244 / 810 0.99 LoEP

(2013)

Sandy loam

(Emperor Lake)

7.72 6.4 490 / 1628 0.85 2.8 / 19.3 FOMC

>0.99

441 / 1466 >0.99 LoEP

(2013)

Geometric mean (n=2) 344 / 1141 2.4 / 18.4 328 / 1098

* represents dissipation from water phase, calculated using FOMC kinetics. χ2 values not available. Pseudo SFO DT50 (FOMC

DT90/3.322) for water phase dissipation are 5.3 days (clay loam) and 5.8 days (sandy loam).

5.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

5.7.1 Justification of new endpoints

Not applicable as no new endpoints used.

5.7.2 Active substance and relevant metabolite(s)

PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation kinetics.

A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 20 cm (arable crop)/5 cm

(permanent crops) were assumed. The PECsoil calculations were performed by zRMS with ESCAPE 2.0

based on the input parameters as presented in the tables below.

Table 5.7-1: Input parameters related to application for PECsoil calculations

Use No 003 001 & 002

Crop maize maize

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Application rate (g as/ha) 2.85 0.875

Number of applications/interval 1× / - 1× / -

Crop interception (%) 0 0

Density of formulation (kg/L) 1.090 1.090

Depth of soil layer (relevant for plateau concentration) (cm) 20 20

Table 5.7-2: Input parameter for active substance and relevant metabolite(s) for PECsoil

calculation

Compound Molecular weight

(g/mol)

Max. occurrence

(%)

DT50

(days)

EU endpoint

DT50

(days)

updated endpoint

ipconazole 333.9 - 391 (SFO, Maximum,

laboratory studies, see

Table 5.3-1)

-

1,2,4-Triazole 69.1 100* DT50,fast: 10.97;

DT50, slow: 346.6;

g: 0.5732 (DFOP,

field, studies, see

Table 5.4-3)

* worst case assumption

Due to the slow degradation of ipconazole in soil (DT90 > 365 d, laboratory and field data) the accumula-

tion potential of ipconazole needs to be considered. Therefore an accumulated soil concentration (PECac-

cu) is used for risk assessment that comprises background concentration in soil (PECbkgd) and the maxi-

mum annual soil concentration PECact.

5.7.2.1 PECsoil

To achieve a concise exposure assessment, the risk envelope approach is applied. Here, the assessment

for the use No 003 also covers the exposure from all other intended uses in maize (see 5.1.3).

Besides PECact values also PECtwa, 21 d values are required for risk assessment (see Part B, Section 6).

PECtwa,21 d values are presented in the Table below.

Table 5.7-3: PECsoil for Rancona 450 FS in maize according to use group/use No.003

Active

substance/

formulation

Soil relevant

application

rate (g/ha)

PECact

(mg/kg)

PECtwa21 d

(mg/kg)

Tillage depth

(cm)

PECsoil,plateau

(mg/kg)

PECaccu = PE-

Cact +

PECsoil,plateau

(mg/kg)

ipconazole 2.85 0.0038 0.0037 20 0.0010* 0.0048

1,2,4-Triazole 0.6 0.0008 0.0006 20 0.0001** 0.0009

Rancona 450

FS

6.9 0.0092 - - - -

* estimated to occur after 11 years without crop rotation

** estimated to occur after 10 years without crop rotation

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9.2.4.1)

Groundwater contamination by direct leaching of the active substance and its metabolites, degradation or

reaction products through soil is generally assessed by groundwater model calculations.



5.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1)

The PECs of active substance and its metabolites in groundwater have been assessed with standard FO-

CUS scenarios to obtain outputs from the FOCUS models. The FOCUS calculation was performed by the

zRMS.

Table 5.8-1: Input parameters related to application of Rancona 450 FS for PECgw calcula-

tions

Use No. 003

Crop maize

Application rate (g as/ha) ipconazole: 2.85

Number of applica-

tions/interval (d)

1 × / -

Application depth 5 cm

Crop interception (%) 0

Frequency of application annual

Models used for calculation FOCUS PELMO 5.5.3

In adapting the risk envelope approach PECgw for use No 003 is covered by PECgw for use No 001 and

002 due to the higher application rate for use No. 003. Therefore only PECgw for use No 003 (maize) is

documented below.

Table 5.8-2: Application dates used for groundwater risk assessment

Crop Scenario Application dates (absolute)

Maize /use No 003 Châteaudun 20.04

Hamburg 20.04

Jokioinen -

Kremsmünster 20.04

Okehampton 07.05

Piacenza 30.04

Porto 20.04

Sevilla 28.02

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Crop Scenario Application dates (absolute)

Thiva 01.04


Table 5.8-3: Input parameters related to active substance ipconazole for PECgw calcula-

tions

Parent Ipconazole

EU endpoint (EFSA conclusion

2013)

Ipconazole

Updated endpoint

Molecular weight (g/mol) 333.9 Not applicable

DT50 in soil (d) 240 (geomean)

KFoc (mL/g) 2431 (arithm mean)

1/n 0.81

Plant uptake factor 0

Table 5.8-4: Input parameters for the metabolites of ipconazole for PECgw calculations

EU endpoint (EFSA conclusion 2013) Updated endpoint

Metabolite 1,2,4-triazole

Molecular weight (g/mol) 69.1

Formation fraction 0.2 (transformation rate: 0.0006)

DT50 in soil (d) 1.68 (fast phase, separately)

60.5 (slow phase, separately)

g: 0.49

KFoc (mL/g) 83.1

1/n 0.916

Plant uptake factor 0

The groundwater modelling was carried out in three parts. First only the parent was modelled using the

inputs in Table 5.8-1 and Table 5.8-3. Then, a bi-exponential approach was implemented using two sepa-

rate calculations in accordance with the guidance document FOCUS kinetics (version 1.1, 2014; Chap-

ter 7.1.2.2.2, p. 122) to model PECgw for the metabolite 1,2,4-triazole (see figures below). In this DFOP

approach, a fraction of the active substance (1.40 g a.s./ha= 2.85 × 0.49, which is the effective application

rate multiplied by the ‘g’ kinetic parameter) is placed in the rapidly degrading compartment and the rest

(1.45g a.s./ha = 2.85 × 0.51, which is the effective application rate multiplied by (1-g)) is placed in the

slowly degrading compartment and calculated subsequently. The concentrations resulting from these two

separate calculations were then summed to get the total predicted environmental concentration in ground

water. Furthermore, as the Freundlich exponent of the substances in question does not equal to one and

therefore breaking the pesticide into two fractions introduces a small error, a conservative approach was

considered by doubling both application rates (=2.80 and 2.90 g a.s./ha, respectively) and then dividing

the final results by two (FOCUS kinetcs, 2014; Chapter 7.1.2.2.2, p. 122).

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Figure 5-1: Scheme for the groundwater-simulation of 1,2,4-Triazole

PECgw of ipconazole and its metabolites

Table 5.8-5: PECgw for ipconazole and its metabolite(s) for the application of Rancona 450

FS in maize

(based on geom. mean for DT50 value and arithm mean for KFoc)

use No. Scenario 80th percentile PECgw at 1 m soil depth (g L-1)

groundwater model: FOCUS PELMO 5.5.3

ipconazole Metabolite

1,2,4-Triazole

003 Châteaudun <0.001 <0.001

Hamburg <0.001 <0.001

Kremsmünster <0.001 <0.001

Okehampton <0.001 <0.001

Piacenza <0.001 <0.001

Porto <0.001 <0.001

Sevilla <0.001 <0.001

Thiva <0.001 <0.001

According to the PECgw modelling a groundwater contamination of the active substance ipconazole at a

concentration of ≥ 0.1 µg/L is not expected for the FOCUS groundwater scenarios Châteaudun, Hamburg,

Kremsmünster, Okehampton, Piacenza, Porto, Sevilla and Thiva.

For the metabolite 1,2,4-Triazole a groundwater concentration of ≥ 0.1 µg/L can be excluded in the all

FOCUS groundwater scenarios for maize.

In adapting the risk envelope approach the PECgw for use No. 001 and 002 is covered by PECgw for use

No. 003 due to the higher application rate of use No. 003. Hence also for all intended uses in maize a

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concentration of the active substance ipconazole and its soil metabolite 1,2,4-Triazole ≥ 0.1 µg/L in the

groundwater is not expected.

5.8.3 Additional field test (KCP 9.2.4.2)

Not required.

5.8.4 Summary of the risk assessment for groundwater

Results of modelling with PELMO 5.5.3 show that the active substance ipconazole and its metabolite

1,2,4-Triazole is not expected to penetrate into groundwater at concentrations of ≥ 0.1 µg/L in the in-

tended uses in maize.

5.9 Predicted Environmental Concentrations in surface water (PECsw)

(KCP 9.2.5)

PECsw and PECsed calculations are provided according to the recommendations of the FOCUS working

group on surface water scenarios in a stepwise approach considering the pathways spray drift, drainage

and run-off.

The results of the FOCUSsw modelling provided below were calculated by the applicant of the EU ap-

proval of ipconazole. The zRMS Germany has reviewed the input parameters of the PECsw/sed modelling,

but has did not checked the calculations in detail, nor performed own modelling runs.



5.9.2 PECsw and PECoff-field after exposure by dust drift

The intended use is a seed treatment, therefore exposure of surface water and off-field habitats by the

active substance ipconazole due to dust drift has to be considered as well.

The relevant exposure values for non-target organisms in different off-field structures were calculated

according to the draft "Guidance Document on the Authorization of Plant Protection Products for Seed

Treatment” (SANCO/10553/2012, January 2014).

The Table 5.9-1 below from the draft "Guidance Document on the Authorization of Plant Protection

Products for Seed Treatment” lists reference and worst case values for the amount of dust released during

sowing (‘Heubach value’; g dust/ha), the content of active substance in the fine Heubach dust (% a.s. in

dust)’ and the aggregate parameter amount of active substance released during sowing (‘Heubach a.s.’; g

a.s. in dust/ha) for maize.

If no legal requirements apply and no quality data are available or certified regarding the treated seeds to

be assessed, the worst case values are used for the assessment of the seed treatment product Rancona 450

FS. As the sowing rate of the maize seeds treated with Rancona 450 FS (max. 2.85 g a.s./ha) is 35 kg/ha

(see Table 5.1-1) the intended uses are covered by the seed dressing data presented in the draft "Guidance

Document on the Authorization of Plant Protection Products for Seed Treatment” (Maize: seed dressing

rate below 150 g a.s./100 000 seeds) and the presented values could be used.

For Rancona 450 FS a Heubach test (Littlewood, 2013; Report ESP13-03) was submitted, which demon-

strate that the mean measurement free dust obtained from the untreated maize seed was

0.2997 g/100 kg seed. Following applications of Rancona 450 FS UBI 4336-01 at 2.5 g and

8.1 g a.i./100 kg seed the levels of free dust were 0.1998 and 0.3996 g/100 kg seed respectively. There-

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fore a Heubach value (abraded fine dust <200µm) of 0.1119 g dust/100 000 seeds (assuming 35 kg seeds

correspond to 2.5 seed units or 125 000 seeds) can be used for the PEC-calculation.

Table 5.9-1 Seed quality parameters determinant for dust drift during sowing: Amount of

easily abraded dust (‘Heubach value’; g fine dust /seed unit or ha) and content

of active substance in abraded fine dust (% a.s. in dust) for maize

Crop Regulatory

scenario

Abraded fine dust:

Heubach-value

(<200µm)

Content of active

substance in dust

Active substance in

abraded dust per hectare: Heubach a.s. (= Heubach-

value x a.s.content)

[g dust/100,000 seeds] [% a.s. in dust] [g a.s. in dust/ha]

Maize

A) Realistic worst

case 1 1.50 50 0.75

B) Reference value 2

0.75 35 0.26

C) Measured product

specific 3 Measured: 0.1119* Measured** ‘Heubach a.s.’ values

measured: 0.0392 1 realistic worst case (see background document, Appendix II for list of studies) 2 crop specific reference values are laid down by legal requirements and certified 3 sufficient and reliable product specific data on seed quality parameter are submitted and considered (see Littlewood, 2013

* product specific value for Rancona 450 FS, only applicable for this product

* as no measured data regarding the content of active substance in dust is available the reference value of 35% was used for

PEC-calculation

The dust deposition values in two dimensional structures describe the exposure of non-target species in

terrestrial habitats and is also the input in surface water bodies located at 1 m distance from the field edge.

According to the respective values from the table above, calculations of the exposure values for non-

target organisms in different off-field structures in three scenarios “Realistic worst case” (seeds do not

comply with quality requirements), “Reference value” (seeds comply with quality requirements compara-

ble to reference values) and “product specific” (product specific Heubach value in combination with the

reference value for the active substance content in dust) have been conducted. These scenarios give the

exposure of off-field area after sowing maize seeds with different qualities.

Table 5.9-2 (taken from the draft "Guidance Document on the Authorization of Plant Protection Products

for Seed Treatment”) shows the experimentally determined ground dust drift deposition values from

treated seeds at 1 m distance from field edge (defined as PEC 2D dust ground deposition) for maize. The

PEC 2D dust ground deposition can be calculated using this relationship as expressed in the following

equation.

where

PEC 2D = Predicted Environmental concentration (g a.s./ha)

a.s. = active substance

Heubach a.s = g active substance in abraded Heubach dust per ha of sown area

Deposition factor = deposition factor determined in field studies with different crop types. The

deposition factor was calculated by regression analyses.(Appendix V of draft

"Guidance Document on the Authorization of Plant Protection Products for Seed

Treatment”)

Furthermore investigations after the bee incidents in Europe have shown that species living or foraging in

3-dimensional structures like hedgerows, trees or other crops are exposed to higher deposition rates of

contaminated dust than the species living on the ground. To address this issue, an extrapolation factor

between 2-D and 3-D deposition was derived. Based on the experimental results from several studies in

different crops (see Appendix VI of the draft "Guidance Document on the Authorization of Plant Protec-

tion Products for Seed Treatment” for further details), a factor of 13 has been determined to exist between

residue levels of active substances in petri dishes on the soil surface and the vertical projection area of

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gaze net as surrogate for natural structures. The PEC 3D dust deposition can be calculated as follows:

where

PEC 3D = Predicted Environmental dust Drift Deposition Rate in vertical 3-dimensional structures

(g a.s./ha)


3D factor = extrapolation factor was determined in field studies with different crop types to be 13.

The 3D extrapolation factor describes the ratio between dust deposition in 3D structures

(measured in gauze netting) and 2D structures (measured in Petri dishes).

Please note that the listed exposure values are valid only if pneumatic suction drillers (vacuum type) are

equipped with deflectors.

Table 5.9-2 Ground dust drift values (PEC 2D dust ground deposition) (PEC 3D dust dep-

osition)for the risk assessment of contaminated dust in non-target areas at 1 m

distance from field edge as a function of the amount of active substance re-

leased with dust per sown area (‘Heubach a.s.’)

Regulatory

scenario

‘Heubach a.s.‘ values,

active substance in dust

per sown area

(g a.s.in dust/ha)

PEC 2D dust ground

deposition of active sub-

stance in off-crop areas

(g a.s./ha)

PEC 3D dust deposition

of active substance in

off-crop areas

(g a.s./ha)

Maize

(100 000

seeds/ha) A) Product specific 1)

‘Heubach a.s.’ values

measured

=0.0392


x 1.6

= 0.06

measured

PEC 2D dust ground

deposition

x 13

= 0.81

B) Reference value 2) 0.26 0.42 5.46

C) Worst case 3) 0.75 1.20 15.6

1) Sufficient and reliable product specific data on seed quality parameter are submitted and considered (see Littlewood, 2013 2) Crop specific reference values are laid down by legal requirements and certified (e.g. legislations on treated maize seed

quality –independent from applied active substances) 3) worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of

available data

As the applied seed unit to be sown for Rancona 450 FS is 125 000 seeds/ha and therefore different from

the used standard of 100.000 seeds/ha, a recalculation of the PEC 2D and PEC 3D values according to the

seed densities is necessary:

�� = �� ∗ �� 100000

The adapted PEC are presented in Table 5.9-3, below.

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Table 5.9-3 Predicted dust drift ground deposition (PEC 2D) and in vertical structures

(PEC 2D) in off-crop areas after sowing maize with a seed density of 125 000

seeds/ha

Regulatory

scenario

PEC 2D dust ground deposition

in off-crop areas

(g a.s./ha)

PEC 3D dust deposition in off-

crop areas

(g a.s./ha)

Maize

(125 000

seeds/ha) A) Product specific 1)


x 1.6

=0.08

measured

PEC 2D dust ground deposition

x 13

=1.02

B) Reference value 2) 0.53 6.89

C) Worst case 3) 1.5 19.5

The predicted environmental concentrations in a water body located 1 m from field edge can be calculat-

ed via the PEC 2D dust ground deposition deposited in the non-target area (in g a.s./ha) converted into a

PEC surface water dust (µg a.s./L) in a standard water body as follows:

�� µ� �.�. ∗ �−1= �2� �� .�.

∗ ℎ�−1∗100�� !�"�#� (�∗ #−2)

where PEC = Predicted Environmental Concentration


water volume = 300 L/m² surface area in a ditch of 1 m width, 0.3 m depth at a 1 m distance from

the field edge.

PEC 2D = Predicted Environmental concentration (g a.s. /ha)

For steps 1 and 2, it is suggested to use FOCUS SW and to take the scenarios without spray drift and to

calculate the dust drift according to the equation above1.

For Tier 3 and 4 of FOCUS SW, PEC surface water dust could be calculated accordingly. This would

give a worst case calculation since it does not account for dilution between dust drift and run-off and

drainage. EFSA (2004)2 indicates also how to integrate dust drift in FOCUS SW higher tier calculations,

in order to have the dust drift entry resolved in time. However, the fate behaviour of active substance in

particles deposited on surface water bodies as a dry and fine dust as opposed to liquid droplets is at the

moment not fully understood. As the applicant does not submitted a calculation of Predicted Environmen-

tal Concentrations in surface water bodies (PECsw) incorporating dust drift deposition, the (worst case)

calculation presented above was also used for Step 3.

PECsw dust (worst case) = 0.500 µg a.s./L

PECsw dust (reference value/certificated seeds) = 0.175 µg a.s./L

PECsw dust (product specific) =0.026 µg a.s./L

As proposed in the draft "Guidance Document on the Authorization of Plant Protection Products for Seed

Treatment”, the calculated values for PECsw dust were added to the PECsw values obtained from FOCUS

SW. The resulting PECsw total are presented in Table 5.9-8.

1 choose 'no drift (incorp or seed trtmt)' under 'crop type' and take the sum of PECsw from the respective Tier and

the PECsw_dust according the equation above 2 EFSA Journal (2004) 145, 1-31, Appendix 4, Dust drift (Table 3)

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5.9.3 PECsw after exposure by surface runoff and drainage for the active

substance, relevant metabolite(s) and the formulation (KCP 9.2.5)

To achieve a concise exposure assessment, the risk envelope approach is applied. Here, the assessment

for the EU Representative use in winter and spring cereals (EFSA Journal 2013; 11 (4):3181) also covers

the exposure from all intended uses in maize. The only exception is that exposure following dust drift

deposition was not considered in the EU assessment. As for seed treatments exposure following dust drift

deposition is a relevant route of exposure to surface water and off-field habitats, this pathway should be

considered. Therefore the relevant exposure values for non-target organisms in surface water and off-field

habitats were calculated according to the draft "Guidance Document on the Authorization of Plant Protec-

tion Products for Seed Treatment” (SANCO/10553/2012). The calculation was provided by the

zRMS/Applicant and is presented below.

In the EU assessment the EFSA PPR Panel opinion giving guidance on the FOCUS surface water model-

ling of non-spray application3 were took into account. As it was unclear for the applicant of the EU ap-

proval whether a single application should be assumed for seed treatments (as stated in Table 6 and 8 of

the cited EFSA Panel opinion) or the application should be divided over the germination period of the

seed (as stated in the text below the tables), Step 3 simulations using both approaches (i) a single applica-

tion of 7 g a.s/ha and (ii) 8 applications of 0.875 g a.s./ha (rounded up in SWASH to 0.9 g a.s/ha; one day

apart) were submitted. In the DAR Vol 3 B8 (2011) and the EFSA conclusion (EFSA Journal 2013; 11

(4):3181) only the results from the split application approach (ii) were reported as these resulted in slight-

ly higher PECs than from a single application (i). For more details please refer to the DAR (2011) of ip-

conazole (Vol 3 B8.6, page 556 ff).

Table 5.9-4: Input parameters related to application for PECsw/sed calculations

Use No 003* EU Representative use (EFSA

Journal 2013; 11 (4):3181)

EU Representative use (EFSA

Journal 2013; 11 (4):3181)

Crop maize Winter cereals Spring cereals

Application rate

(kg as/ha)

ipconazole: 0.00285 ipconazole: 0.007 ipconazole: 0.007

Number of appli-

cations/interval

(d)

1 × / - (i) 1 × / -

(ii) 8 × / 1

(i) 1 × / -

(ii) 8 × / 1

Season of applica-

tion (step 2)

March – May March - May

June - Sept

Oct-Feb

March - May

June - Sept

Oct-Feb

Crop interception

(step 2)

No interception No interception No interception

Application meth-

od (step 3)

soil incorporation soil incorporation soil incorporation

CAM (Chemical

application meth-

od)

See EU Representative use CAM 8 option, DEPI 1 cm CAM 8 option, DEPI 1 cm

Soil depth (cm) 1 ** 1 *

Models used for

calculation

- FOCUS SWASH v3.1,

FOCUS PRZM v1.5.6,

FOCUS MACRO v 4.4.2,

FOCUS TOXWA v3.3.1

FOCUS SWASH v3.1,

FOCUS PRZM v1.5.6,

FOCUS MACRO v 4.4.2,

FOCUS TOXWA v3.3.1

3 EFSA (2004) Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a

Request from EFSA on the Appropriateness of Using the Current FOCUS Surface Water Scenarios for Estimating

Exposure for Risk Assessment in Aquatic Ecotoxicology in the Context of Council Directive 91/414/EEC. The EF-

SA Journal (2004) 145, 1 – 31.

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* it was considered that the intended use in maize is covered by the EU Representative use in winter and spring cereals, as the

application rate of the EU Representative use is higher than for the intended use in maize

** PECsw/sed for 2 cm application depth were also modelled, but as the PECs for 1cm are higher than those from 2cm, only the

PECs for 2cm are reported. Running this model for ipconazole with a seed depth (DEPI) of 4 cm obtained PEC values of

zero.

Table 5.9-5: FOCUS Step 3 Scenario related input parameters for PECsw/sed calculations

for the application of Rancona 450 FS according to the EU Representative use

(spring and winter cereals)

Crop Scenario Application window used in modelling

Spring cereals D1 28 Apr – 4 Jun

D3 25 Mar – 1 May

D4 19 Apr – 26 May

D5 8 Mar – 14 Apr

R4 8 Mar – 14 Apr

Winter cereals D1 18 Sep – 25 Oct

D2 18 Oct – 24 Nov

D3 14 Nov – 21 Dec

D4 15 Sep – 22 Oct

D5 3 Nov – 10 Dec

D6 23 Nov – 30 Dec

R1 5 Nov – 12 Dec

R3 24 Nov – 31 Dec

R4 3 Nov – 10 Dec


Table 5.9-6: Input parameters related to active substance ipconazole for PECsw/sed calcula-

tions

Compound Ipconazole

EU endpoint (EFSA Journal

2013; 11 (4):3181)

Remarks


Saturated vapour pressure (Pa) not required for Step 1+2 /

3 × 10-6

at 25°C

Water solubility (mg/L) 11.0 at 20°C

Diffusion coefficient in water (m²/d) not required for Step 1+2/

4.3 x 10-5

default

Diffusion coefficient in air (m²/d) not required for Step 1+2 /

0.43

default

KFoc (mL/g) 2431 Arithmetic mean (see Table 5.5-1)

Freundlich Exponent

1/n

not required for Step 1+2 /

0.81

Arithmetic mean (see Table 5.5-1)

Plant Uptake not required for Step 1+2/ default for non-systemic substances

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0

Wash-off factor from Crop (1/cm) not required for Step 1+2/

0.04

calculated from the water solubility,

according to FOCUS SW scenarios

Report, 2001, SANCO /4802/2001 rev 2*

DT50,soil (d) 240 Geomean (SFO, pF2,20°C) Laboratory

data (see Table 5.3-1)

DT50,water (d) 1000a Default value

DT50,sed (d) 344 Geomean of whole system (SFO, 20°C) -

(see Table 5.6-1)

DT50,whole system (d) 344 Geomean of whole system (SFO, 20°C) -

(see Table 5.6-1) a Default 1000 days used for water to represent no degradation in that compartment, as measured DT50 in study reflected rapid

dissipation rather than degradation, (B.8.4.4). In accordance with FOCUS Degradation Kinetics Guidance, chapter 10

* Parameter had no effect on Step 3 PECs as application is seed treatment

Table 5.9-7: Input parameters related to the metabolite 1,2,4-triazole of the active sub-

stance ipconazole for PECsw/sed calculations

1,2,4-triazole

EU endpoint (EFSA Journal

2013; 11 (4):3181)

Remarks


Water solubility (mg/L) 700,000

KFoc (mL/g) Arithmetic mean (seeTable 5.5-2)

DT50,soil (d) 60.5

Geomean DT50,slow normalised field

studies(see Table 5.4-3)

DT50,water (d) 300 Default value (see LoeP 2013)

DT50,sed (d) 300 Default value (see LoeP 2013)

DT50,whole system (d) 300 Default value (see LoeP 2013)

Maximum occurrence observed in total water

and sediment (%)

0.001% a)

Maximum occurrence observed in soil (%) 23.7 a) 1,2,4-triazole was not detected in water/sediment studies. As FOCUSsw Steps 1-2 cannot accept a value of 0 for occurrence in

studies, a nominal value of 0.001% was input

PECsw/sed-FOCUS SW Step 1, 2 and 3

PEC surface water dust has been calculated according to “Draft Guidance document for the Authorisation of

Plant Protection Products for Seed Treatment SANCO/10553/2012, January 2014” separately (see 5.9.2).

In the table below, the sums of PEC surface water dust (0.500 µg a.s./L for the realistic worst case scenario and

0.175 µg a.s./L for the “reference value”-scenario) and FOCUS Step 1, 2 and 3 PECsw as well as the

PECsed are displayed.

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Table 5.9-8: FOCUS Step 1, 2 and 3 PECsw and PECsed for ipconazole following multiple

application(s) of the EU Representative use in winter and spring cereals

Sce-

nario

FO-

CUS

Application

window (Step

2)/

Water body

(Step 3)

Max

PECsw

(μg/L)

PECsw, total Max PECsw

+ PECsw dust

drift

(μg/L)

Realistic

worst case1


+ PECsw dust

drift

(μg/L)

Reference

value2


+ PECsw dust

drift

(μg/L)

Product

specific

value3

21 d-

PECsw,twa

(µg/L)* (without

dust drift

deposition)

28 d-

PECsw,twa

(µg/L)* (without

dust drift

deposition)

Max

PECsed

(μg/kg)

Step 1 --- 0.5501 1.050 0.725 0.576 0.5387 - 13.3739

Step 2 0.026 - -

Northe

rn

Europ

e

March-May 0.2719 0.772 0.447 0.298 - - 6.6102

June-Sept 0.1088 0.609 0.284 0.135 - - 2.6441

Oct-Feb 0.1088 0.609 0.284 0.135 - - 2.6441

Southe

rn

Europ

e

March-May 0.2175 0.718 0.393 0.244 - - 5.2881

June-Sept 0.2175 0.718 0.393 0.244 - - 5.2881

Oct-Feb 0.1631 0.663 0.338 0.189 - - 3.9661

Step 3 Winter cereals

D1 ditch <0.00000

1

0.500 0.175

0.026

Not calculable <0.000001

D1 stream <0.00000

1

0.500 0.175

0.026


D2 ditch 0.000009 0.500 0.175 0.026 0.000001 0.000001 0.000045

D2 stream 0.000005 0.500 0.175 0.026 <0.000001 <0.000001 0.000016

D3 ditch <0.00000

1

0.500 0.175

0.026


D4 pond <0.00000

1

0.500 0.175

0.026

<0.000001 <0.000001 0.000003

D4 stream 0.000003 0.500 0.175 0.026 <0.000001 <0.000001 0.000001

D5 pond <0.00000

1

0.500 0.175

0.026

<0.000001 <0.000001 0.000002

D5 stream** Failed 0.500 0.175 0.026 Failed Failed

D6 ditch** Failed 0.500 0.175 0.026 Failed Failed

R1# pond 0.00469 0.505 0.180 0.031 0.00343 0.00317 0.0909

R1# stream 0.0318 0.532 0.207 0.058 0.00166 0.00127 0.0330

R3# stream 0.0372 0.537 0.212 0.063 0.00178 0.00134 0.0428

R4# stream 0.0489 0.549 0.224 0.075 0.00213 0.00205 0.0515

Step 3 Spring cereals

D1 ditch <0.00000

1

0.500 0.175 0.026 Not calculable <0.000001

D1 stream <0.00000

1

0.500 0.175 0.026 <0.000001 <0.000001 <0.000001

D3 ditch <0.00000

1

0.500 0.175 0.026 Not calculable <0.000001

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Sce-

nario

FO-

CUS

Application

window (Step

2)/

Water body

(Step 3)

Max

PECsw

(μg/L)


+ PECsw dust

drift

(μg/L)

Realistic

worst case1


+ PECsw dust

drift

(μg/L)

Reference

value2


+ PECsw dust

drift

(μg/L)

Product

specific

value3

21 d-

PECsw,twa

(µg/L)* (without

dust drift

deposition)

28 d-

PECsw,twa

(µg/L)* (without

dust drift

deposition)

Max

PECsed

(μg/kg)

D4 pond <0.00000

1

0.500 0.175 0.026 <0.000001 <0.000001 0.000007

D4 stream 0.000003 0.500 0.175 0.026 <0.000001 <0.000001 0.000002

D5 pond <0.00000

1

0.500 0.175 0.026 <0.000001 <0.000001 0.000002

D5 stream** Failed 0.500 0.175 0.026 Failed Failed

R4# stream 0.0430 0.543 0.218 0.069 0.00595 0.00447 0.0837 1 worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of available

data (see background document of the draft "Guidance Document on the Authorization of Plant Protection Products for

Seed Treat-ment”, Appendix II for list of studies) 2 European or national regulation/ requirements are in place that prescribe a quality standard for maize seeds 3 based on the product specific data form Littlewood, 2013 on seed quality parameter (e.g. Heubach value)

* twa-time as required by ecotox

** Failed simulations: no PECs reported. Relevant TOXSWA reports showed substance concentration in drained water was 0.00

μg/l. Given the relative vulnerabilities of D5s and D6d and the relatively strong soil adsorption of ipconazole, the RMS

considers is extremely unlikely that surface water concentrations as a result of drainage from these two sites would be

greater than those predicted at D2 # Results shown for Run-off (R) scenarios simulated assuming 1 cm seed depth

Highest global maximum PECsw/sed and TWA 21 and 28 day PECsw values highlighted in bold.

Not calculable = ‘simulated period too short’

FOCUS Step 4

Not required and therefore not submitted by applicant.

Metabolite of ipconazole

Table 5.9-9: FOCUS Step 1 and 2 PECsw and PECsed for the metabolite 1,2,4-triazole of

ipconazole following multiple application(s) of the EU Representative use in

winter and spring cereals

Scenario

FOCUS

Application window (Step

2)/

Water body (Step 3)

Max PECsw

(μg/L)

Dominant entry rou-

te*

Max PECsed

(μg/kg)

Step 1 --- 0.1023 0.0910

Step 2

Northern

Europe

March-May 0.0195 0.0174

Oct-Feb 0.0489 0.0435

Southern

Europe

March-May 0.0391 0.0348

Oct-Feb 0.0391 0.0348

* no contamination of surface water via spray drift is assumed as the application ipconazole is simulated as ‘incorporated into the

soil’ (seed treatment)

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5.9.3.2 PECsw/sed of formulation

Not relevant.

5.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Table 5.10-1 Summary of atmospheric degradation and behaviour for ipconazole

Compound ipconazole

Direct photolysis in air No data submitted. None are required, based on intended use

of ipconazole as a seed treatment, limiting exposure to air.

Quantum yield of direct phototransformation No data submitted. None are required.

Photochemical oxidative degradation in air DT50 (h): 5.1 derived by the Atkinson model (version 1.88).

OH (12h) concentration assumed = 1.5 × 106 per cm3

Volatilisation Vapour pressure (Pa): of 3 × 10-6 Pa at 25°C

Henry's Law Constant (Pa.m3/mol): 3 × 10-5 Pa.m3.mol-1


ipconazole is regarded as non-volatile. Therefore exposure of adjacent surface waters and terrestrial eco-

systems by the active substance ipconazole due to volatilization with subsequent deposition is unlikely to

occur.

Please that as the exposure following dust drift is a relevant route of exposure to off-field habitats and

was considered in the assessment. The relevant exposure values for non-target organisms in different off-


Protection Products for Seed Treatment” (SANCO/10553/2012, January 2014) and presented above (see

5.9.2 and Table 5.9-2).

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Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KIIIA1

10.2.5;

KIIIA1

10.5;

KIIIA1 6.5

Littlewood, KM 2013 A study to determine the application quality of Rancona 450 FS UBI 4336-01, when applied to maize

seed, in terms of free dust measure-ments using the Heubach Dustmeter Type II,

Document number: ESP13-03

GLP

Unpublished

N Crompton

(Uniroyal

Chemical


None.



Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

IIIA,

9.6.1/01

Thandi, K. 2014 Predicted environmental concentrations of ipconazole and 1,2,4-triazole following application to cereals

and maize as a seed dressing (EU FOCUS groundwater assessment) using PEARL 4.4.4 and PRZM 3.5.2.

LSR Associates., UK

Report No. FDD0129-1

GLP: No

N CHE

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Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

Published: No

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Appendix 2 Detailed evaluation of the new Annex II studies

A 2.1 Littlewood, 2013

Comments of zRMS: The study is considered acceptable.

The study shows that Heubach value (abraded fine dust) of Rancona 450 FS is

lower than the reference values from the Draft Seed treatment guidance document

(version January 2014) and the determined Heubach-value can be used to calculate

the Heubach a.s. value for ipconazole in Rancona 450 FS. For the determination of

the Heubach a.s. value the reference value of 35% active substance in dust from

the Draft Seed Treatment Guidance document (version January 2014) should be

used as the content of active substance in dust was not measured in the study.

Furthermore it is necessary to define conditions of use (e.g. monitoring of the seed

quality) which ensure that the treated seeds do not exceed the calculated Heubach

a.s. value of 0.0392 g a.s. in dust/100 000 seeds. These conditions of use are nec-

essary as only two charges of Rancona 450 FS were analysed and no market anal-

ysis were made.

Reference: KIIIA1 10.2.5; KIIIA1 10.5; KIIIA1 6.5

Report A study to determine the application quality of Rancona 450 FS UBI 4336-

01, when applied to maize seed, in terms of free dust measurements using

the Heubach Dustmeter Type II,

Littlewood, KM;

08.10.2013;

Document number: ESP13-03

Guideline(s): No guideline avaible

Deviations: No

GLP: Yes

Acceptability: Yes


Table A.2- 1: Seed treatment application

Trt

No.

Trade name Active sub-

stance

Nominal

g a.i./L

g a.i./100kg

seed

mL/kg seed* Water

mL/kg

1 n/a Untreated seed n/a 0.00 0.00 0.00

2 Rancona 450 FS ipconazole 452 2.50 0.06 4.98

3 Rancona 450 FS ipconazole 452 8.10 0.18 4.82 * Formula to calculate application rate = (g a.i./100 kg seed x 10) / formulation amount = ml/kg seed

The test item Rancona 450 FS with a nominal concentration of 452 g ipconazole/L FS was pre-diluted

with water at the rates in the table above. The test item was applied to a 500 g batch of maize seed (culti-

var: Algans; source: Grainseed, France) using the Rotogard R300.

The samples of untreated and treated seed were stored in for 48 hours, after test item application, to pre-

condition the seed. The mean temperature over this period was recorded as 19.8°C and the mean relative

humidity was recorded at 46.8%.

Analysis of the free dust was carried out using the Heubach Dustmeter Type II. The laboratory condition

during the test was recorded as 23°Cand the relative humidity was recorded at 41%.

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The free dust levels results (g/100 kg seed) were analysed using the following conversion calculations:

&2−&1&'×100 000 =�� /100*� �� W2 = weight of the filter unit after testing.

W1 = weight of the filter unit before testing

WS= weight of the seed

Multiplied by 100000 (g per 100 kg)

The results (see Table A.2- 2: Results of dust measurementTable A.2- 2) showed that the mean measure-

ment of free dust obtained from the untreated maize seed was 0.2997 g/100 kg seed. Following applica-

tions of Rancona 450 FS UBI 4336-01 @ 2.5 g and 8.1 g a.i./100 kg seed the levels of free dust were

0.1998 and 0.3996 g/100 kg seed respectively.

Table A.2- 2: Results of dust measurement

Treatment Sample Conversion calculation Dust levels

[g/100kg seed]

Mean Standard

deviation

Coefficient

Variation

[%]

1. untreated seed RI (92.5541−92.5544)100.20

×100000

0.2994

0.2997 0.00 0.13 RII (92.5521−92.5524)100.01

×100000

0.3000

2. Rancona

450FS @

2.5 g a.i./100kg

RI (92.5554−92.5556)100.05

×100000

0.1999

0.1998 0.00 0.09 RII (92.5543−92.5545)100.18

×100000

0.1996

3. Rancona

450FS @

8.1 g a.i./100kg

RI (92.5512−92.5516)100.03

×100000

0.3999

0.3996 0.00 0.11 RII (92.5542−92.5546)100.19

×100000

0.3992

RI = Replicate I; RII = Replicate II

Conclusion

In conclusion, the free dust levels produced from maize seed following applications of Rancona 450 FS

UBI 4336-01 @ 2.5 g and 8.1 g a.i./100 kg seed were extremely low.

REGISTRATION REPORT

Part B

Section 5

Environmental Fate





Ipconazole 452 g/L

Central Zone


NATIONAL ADDENDUM – GERMANY (authorisation)




MS Finalisation date: September 2019

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Part B – Section 5 – National Addendum

Germany

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Version history

When What

[Sept. 2019] First Draft RR by UBA

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Table of Contents

5 Fate and behaviour in the environment (KCP 9) ........................................ 5

5.1 Critical GAP and overall conclusions .............................................................. 6

5.1.1 Table of critical GAPs ...................................................................................... 6

5.1.2 Overall conclusion ............................................................................................ 8

5.1.2.1 Predicted environmental concentrations in soil (PECsoil) ................................. 8

5.1.2.2 Predicted environmental concentrations in groundwater (PECgw) ................... 8

5.1.2.3 Predicted environmental concentrations in surface water (PECsw) .................. 8

5.1.2.4 Fate and behaviour in air .................................................................................. 9

5.2 Metabolites considered in the assessment ........................................................ 9

5.3 Rate of degradation in soil (KCP 9.1.1) ........................................................... 9

5.3.1 Aerobic degradation in soil (KCP 9.1.1.1) ....................................................... 9

5.3.2 Anaerobic degradation in soil (KCP 9.1.1.1) ................................................... 9

5.4 Field studies (KCP 9.1.1.2) .............................................................................. 9

5.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) ..... 9

5.4.2 Soil accumulation testing (KCP 9.1.1.2.2) ....................................................... 9

5.5 Mobility in soil (KCP 9.1.2) ............................................................................. 9

5.5.1 Adsorption and desorption in soil (KCP 9.1.2.1) ........................................... 10

5.5.2 Column leaching (KCP 9.1.2.1) ..................................................................... 10

5.5.3 Lysimeter studies (KCP 9.1.2.2) .................................................................... 10

5.5.4 Field leaching studies (KCP 9.1.2.3) .............................................................. 10

5.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1,

KCP 9.2.2, KCP 9.2.3) ................................................................................. 10

5.6.1 Water/sediment study (KCP 9.2.2) ................................................................ 10

5.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ......... 11

5.7.1 Justification of new endpoints ........................................................................ 11

5.7.2 Active substance and relevant metabolite(s) .................................................. 11

5.7.2.1 PECsoil ............................................................................................................. 11


9.2.4) ............................................................................................................ 13


5.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1) Direct Leaching

into groundwater .......................................................................................... 13

5.8.3 Groundwater contamination by bank filtration due to surface water

exposure via runoff and drainage ................................................................. 14

5.8.3.1 Ipconazole and its metabolites ....................................................................... 14

5.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP

9.2.5) ............................................................................................................ 16


5.9.2 PECsw after exposure by spray drift and volatilization with subsequent

deposition ..................................................................................................... 16

5.9.3 PECsw and PECoff-field after exposure by dust drift .......................................... 16

5.9.4 PECsw after exposure by surface runoff and drainage .................................... 16

5.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ............................................ 18

5.11 Classification and labelling ............................................................................ 18

5.11.1 GHS Classification and labelling ................................................................... 18

5.11.2 National labelling and conditions of use ........................................................ 18

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Appendix 1 Lists of data considered in support of the evaluation ............................... 19

Appendix 2 Detailed evaluation of the new Annex II studies ....................................... 20

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5 Fate and behaviour in the environment (KCP 9)

The exposure assessment of the plant protection product Rancona 450 FS in its intended uses in maize is

documented in detail in the core assessment of the plant protection product Rancona 450 FS dated from

September 2019 performed by Germany.

This national addendum has been produced to support a national decision on the authorisation of the

product Rancona 450 FS in Germany for the uses listed below. It reflects the impact of specific German

environmental or agricultural circumstances on the exposure and risk assessment for Rancona 450 FS

including risk mitigation measures.

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5.1.1 Table of critical GAPs

Table 5.1-1: Critical use pattern of the formulated product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Use-No.

*

Member state(s)

Crop and/or

situation

(crop destination

/ purpose

of crop)

F, Fn, Fpn

G, Gn,

Gpn or

I **

Pests or Group of pests controlled

(additionally:

developmental stages of the pest

or pest group)

Application Application rate PHI (day

s)

Remarks: e.g. g safener/ synergist

per ha

Conclu-

sion

Method / Kind

Timing / Growth

stage of

crop & season

Max. number

a) per use

b) per crop/

season

Min. interval

between

applica-tions

(days)

kg or L product/ha



g or kg as/ha



Water L/ha min/max

Groundwa-ter

Intended for uses in Germany

001 DE Maize

ZEAMX

F Fusarium spp.

FUSASP

seed

treatment before sowing

BBCH 00

a.)

b.)

- 1.925 mL/ha

(0.77 mL/seed unit) a) 0.875 g a.s /ha

(0.35 g as/seed unit)

maximum application rate

1.925 mL/ha (equivalent to

a maximum of 2.5 seed units per ha; 1 unit includes 50000 grains)

Withdrawn by the applicant in phase II

A

002 DE Maize

ZEAMX


RHIZSO

seed


BBCH 00

a.)

b.)

- 1.925 mL/ha

(0.77 mL/seed unit) a) 0.875 g a.s /ha

(0.35 g as/seed unit)

maximum application rate

1.925 mL/ha (equivalent to

a maximum of 2.5 seed units per ha; 1 unit includes 50000 grains)

Withdrawn by the applicant in phase II

A

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003 DE Maize

ZEAMX

F head smut of

maize Sphace-

lotheca reiliana

SPHTRE

seed


BBCH 00

a.)

b.)

- 6.3 mL/ha

(2.52 mL/seed unit)* 2.85 g a.s./ha (1.14 g as/seed unit)*

10-140 mL

(5-70 mL/seed unit)**

*maximum application rate


per ha; 1 unit includes 50000 grains)

**0.18L/tonne seed in 0.36-5L/uni seed

A


** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn:

professional and non-professional greenhouse use, I: indoor application

Explanation for column 15 “Conclusion” A Safe use


N No safe use

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5.1.2 Overall conclusion

5.1.2.1 Predicted environmental concentrations in soil (PECsoil)

PECsoil was calculated for the active substance ipconazole considering a soil depth of 1 cm. Due to the

slow degradation of the active substance ipconazole in soil the accumulation potential of ipconazole was

considered. Therefore PECsoil used for risk assessment comprises background concentration in soil (PE-

Caccu) considering a tillage depth of 20 cm (arable crop) or 5 cm (permanent crops) and the maximum

annual soil concentration PECact.

The PECsoil values for the active substance were used in the eco-toxicological risk assessment for the in-

tended uses of the plant protection product Rancona 450 FS in Germany.

5.1.2.2 Predicted environmental concentrations in groundwater (PECgw)

Direct leaching into groundwater

As indicated in the core assessment results of modelling with FOCUS PELMO show that the active sub-

stance ipconazole is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the in-

tended uses of Rancona 450 FS in Germany according to use No.001 to 003.

The simulated concentrations of <0.001 µg/L 1,2,4-triazole in groundwater are also below the limit of

0.1 µg/L for active substances and relevant metabolites. However, 1,2,4-triazole is formed as metabolite

of several active substances of plant protection products, which are used in different crops against a wide

range of crop deceases. It is therefore possible that several 1,2,4-triazole forming active substances will

be applied onto the same agricultural field in the same year and season, which may result in a summation

of groundwater entries of 1,2,4-triazole from different active substances and could finally lead to 1,2,4-

triazole entries into the groundwater in concentrations ≥0.1 µg/L. But as the application rate of Rancona

450 FS and the simulated concentrations of 1,2,4-triazole (<0.001µg/L) are extremely low, a relevant

entry of 1,2,4-triazole from Rancona 450 FS in the groundwater is not expected.


None

Groundwater contamination by bank filtration due to surface water exposure via runoff and drain-

age


active substance ipconazole due to surface runoff and drainage into the adjacent ditch with subsequent

bank filtration can be excluded.


The authorization of the plant protection product Rancona 450 FS is linked with following labelling:

None

5.1.2.3 Predicted environmental concentrations in surface water (PECsw)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure

of surface water consider two routes of entry (i) spray drift and volatilization with subsequent deposition

and (ii) runoff, drainage separately.

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volatilization with subsequent deposition can be excluded as relevant pathways, whereas predicted off-

field exposure concentrations following dust drift deposition needs to be considered.

Surface water exposure including effects of risk mitigation via surface runoff and drainage was estimated

using the model EXPOSIT 3 and the relevant exposure values for non-target organisms in different off-


Protection Products for Seed Treatment” (SANCO/10553/2012, January 2014).

The results of the specific national exposure assessment for the active substance were used in the eco-

toxicological risk assessment.

5.1.2.4 Fate and behaviour in air


ipconazole is regarded as non-volatile. Therefore exposure of adjacent surface waters and terrestrial eco-

systems by the active substance ipconazole due to volatilization with subsequent deposition was not con-

sidered.

5.2 Metabolites considered in the assessment

Please refer to the core assessment.

5.3 Rate of degradation in soil (KCP 9.1.1)

Studies on degradation in soil with the formulation were not performed, since it is possible to extrapolate


5.3.1 Aerobic degradation in soil (KCP 9.1.1.1)


5.3.2 Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

5.4 Field studies (KCP 9.1.1.2)

5.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)


5.4.2 Soil accumulation testing (KCP 9.1.1.2.2)


5.5 Mobility in soil (KCP 9.1.2)

Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate

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5.5.1 Adsorption and desorption in soil (KCP 9.1.2.1)


5.5.2 Column leaching (KCP 9.1.2.1)


5.5.3 Lysimeter studies (KCP 9.1.2.2)


5.5.4 Field leaching studies (KCP 9.1.2.3)


5.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2,

KCP 9.2.3)

Studies on degradation in water/sediment systems with the formulation were not performed, since it is

possible to extrapolate from data obtained with the active substance.

5.6.1 Water/sediment study (KCP 9.2.2)

Please refer to the core assessment

Table 5.6-1: Accumulation of active substance ipconazole and relevant metabolites in the sedi-

ment

Active substance ipconazole

Accumulation potential in sediment yes (DT90,whole system > 1 year, maximum, see core assessment)

Accumulation factor (SFO)

faccu = e-kt/(1 – e-kt)

1.48 based on DT50, whole system = 490 (maximum, see core assessment,

Part B, Section 5, chapter 5.6.1), t = 365 d

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5.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

Results of PECsoil calculation for Rancona 450 FS and its intended for uses in maize according to EU

assessment considering 5 cm soil depth are given in the core assessment, part B, section 5, chapter 5.7.In

the German exposure assessment, the considered soil layer depth is based on experimental data.1 General-

ly, a soil layer depth of 2.5 cm is applied in the calculation for active substances with a KFoc <500, where-

as a soil layer depth of 1 cm is applied for active substances with a KFoc >500. A soil bulk density of

1.5 g/cm³ is assumed as in the core assessment.



5.7.2 Active substance and relevant metabolite(s)

The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented in

the tables below.

Table 5.7-1: Input parameters for active substance and relevant metabolite(s) for PECsoil calcu-

lation

Compound Molecular weight

(g/mol)

Max. oc-

currence

(%)

DT50

(days)

EU endpoint

DT50

(days)

updated endpoint

ipconazole 333.9 - 391 (SFO, Maximum, laboratory

studies, see chapter 5.7.2.1 in the core

assessment)

1,2,4-Triazole 69.1 100* DT50,fast: 10.97;

DT50, slow: 346.6;

g: 0.5732 (DFOP, field, studies, see

chapter 5.7.2.1 in the core assessment)

* worst case assumption

Due to the slow degradation of ipconazole in soil (DT90 > 365 d, laboratory and field data) the accumula-

tion potential of ipconazole needs/ to be considered. Therefore an accumulated soil concentration (PECac-

cu) is used for risk assessment that comprises background concentration in soil (PECbkgd) and the maxi-

mum annual soil concentration PECact.

5.7.2.1 PECsoil

The calculated PECsoil used for German risk assessment for ipconazole as well as for the formulation Ran-

cona 450 FS are summarised in Table 5.7-2.

1 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in

den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin

1999

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Table 5.7-2: Results of PECsoil calculation for the intended use in maize used for German risk

assessment

Plant protection product: Rancona 450 FS

Use: 003

Density of formulation (kg/L) 1.090

Application depth (cm) 5

Number of applications/interval: 1× / -

Application rate (g/ha): Rancona 450 FS: 6.3 mL/ha (=5.8

ipconazole: 2.85 g/ha

Crop interception (%): 0

Active substance/

formulation

Soil relevant

application rate

(g/ha)

Soil depthact

(cm)

PECact

(mg/kg)

Tillage

depth (cm)

PECbkgd

(mg/kg)

PECaccu =

PECact +

PECbkgd

(mg/kg)

Rancona 450 FS 6.9 1 0.0460 - - -

ipconazole 2.85 1 0.0190 20 0.0010* 0.0200

1,2,4-Triazole 0.6 2.5 0.0184 20 0.0009** 0.0193

* estimated to occur after 11 years without crop rotation

** estimated to occur after 10 years without crop rotation

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9.2.4)

Results of the PECgw calculation of ipconazole for the intended uses of Rancona 450 FS in maize accord-

ing to EU assessment using FOCUS PELMO are given in the core assessment, part B, section 5, chapter

5.8.

Risk assessment for groundwater for authorisation of plant protection products in Germany considers two

pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) sur-

face runoff and drainage of the active substance into an adjacent ditch with subsequent bank filtration into

the groundwater. The latter pathway was not addressed neither by core assessment nor for EU assessment

of the active substances.

The risk assessment for groundwater of the pathway direct leaching after soil passage follows the recom-

mendation of the Ground Water Work Group of FOCUS as provided by the Commission Services (San-

co/13144/2010, version 3, 10 October 2014) as also done by the zRMS in the core assessment.

Risk assessment for groundwater for the pathway surface runoff and drainage into an adjacent ditch with

subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3 stipulating

also risk mitigation measures, if applicable.



5.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1)

Direct Leaching into groundwater

Results of the groundwater modelling in the core assessment show that the active substance ipconazole is

not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the groundwater Scenario

Hamburg relevant for authorisation in Germany in the intended uses of Rancona 450 FS in maize. That

result covers the groundwater risk assessment for the intended uses of Rancona 450 FS in Germany in

maize according to use No.001 to 003.

For the intended uses of Rancona 450 FS in maize, modelling with FOCUS PELMO 5.5.3 resulted in a

groundwater concentration of <0.001 µg/L 1,2,4-triazole. This remains below the groundwater concentra-

tion limit for active substances and relevant metabolites of 0.1 µg/L. 1,2,4-triazole is considered as rele-

vant metabolite according to the definition of the guidance document on the assessment of the relevance

of metabolites in groundwater (2003)2.

1,2,4-triazole is formed as metabolite of several active substances of plant protection products, which are

used in different crops against a wide range of crop deceases. It is therefore possible that several 1,2,4-

triazole forming active substances will be applied onto the same agricultural field in the same year and

season, which may result in a summation of groundwater entries of 1,2,4-triazole from different active

substances. But as the application rate of Rancona 450 FS and the simulated concentrations of 1,2,4-

triazole (<0.001µg/L) are extremely low, a relevant entry of 1,2,4-triazole from Rancona 450 FS in the

groundwater is not expected. This will also apply if the formulation Rancona 450 FS is used with other

1,2,4-triazole forming active substances. In this cases the potential groundwater entries of 1,2,4-triazole

will caused by the intended uses of the other formulations with 1,2,4-triazole forming active substances.

2 According to Guidance Document on the assessment of the relevance of metabolites in groundwater of substances regulated

under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)

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In this special case a groundwater monitoring is therefore not required for the German authorization of

the plant protection product Rancona 450 FS.


None

5.8.3 Groundwater contamination by bank filtration due to surface water

exposure via runoff and drainage

Surface runoff and drainage into an adjacent ditch with subsequent bank filtration into the groundwater

are estimated using the model EXPOSIT 3.

Table 5.8-1: Input parameters related to application of Rancona 450 FS for PECgw and PECsw

calculations with EXPOSIT 3

Use No. 003

Crop maize

Application rate (g as/ha) ipconazole: 3.85

Number of applications/interval (d) 1× /

Crop interception (%) 0

In adapting the risk envelope approach PECgw for use No 001 and 002 is covered by PECgw for use No

003 due to higher application rate of use No. 003.


Table 5.8-2: Input parameters for ipconazole used for PECgw calculations with EXPOSIT 3

Parameter Ipconazole Reference

Molecular weight (g/mol) 333.9 LoEP (2013)

KFoc 2431 arithm. mean (see core assessment)

DT50 soil (d) 352.2 90th percentile lab. data

Solubility in water (mg/L) 11.0 LoEP (2013)

Mobility class 2 Worst case assumption

Reduction by bank filtration 75

The soil metabolite 1,2,4-triazole of ipconazole are formed >10 % in soil. Therefore potential groundwa-

ter contamination due to bank filtration via surface water exposure by runoff and drainage needs to be

assessed.

Table 5.8-3: Input parameter for soil metabolite 1,2,4-triazole of ipconazole for EXPOSIT 3

Parameter Metabolite 1,2,4-triazole Reference

Molecular weight (g/mol) 69.1 LoEP (2013)

Correction factor molecular weight 0.207

Maximum occurrence in soil (%) 100 Worst case assumption

K Foc 89 arithm. mean (see core assessment)

DT50 soil (d) 109.41 90th percentile of DFOP slow phase

DT50 (field data, 20°C, pF2)

Solubility in water (mg/L) 700,000 LoEP (2013)

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Mobility class 3

Reduction by bank filtration 90

PECgw of ipconazole and its metabolites due to bank filtration

Table 5.8-4: PECgw for ipconazole after surface runoff and drainage with subsequent bank fil-

tration (modelled with EXPOSIT 3)

Use No. Application

rate

interception

PECgw due to

Runoff Drainage

Vegetated buffer

strip

(m)

Bank filtrate

(µg/L)

Time of applica-

tion

Bank filtrate

(µg/L)

0 <0.001 spring/summer <0.001

5 <0.001

10 <0.001 autumn/winter/

early spring

0.001

20 <0.001

Required labelling None

Table 5.8-5: PECgw for soil metabolites of ipconazole after surface runoff and drainage with

subsequent bank filtration (modelled with EXPOSIT 3)

Metabolite 1,2,4-triazole

Use No. Application

rate

PECgw due to

Runoff Drainage

Vegetated buffer

strip

(m)

Bank filtrate

(µg/L)

Time of applica-

tion

Bank filtrate

(µg/L)

003 0.6 g/ha 0 <0.001 spring/summer <0.001

5 <0.001

10 <0.001 autumn/winter/

early spring

<0.001

20 <0.001

Required labelling none


active substance ipconazole due to surface runoff and drainage into the adjacent ditch with subsequent

bank filtration can be excluded.

Groundwater contamination at concentrations ≥ 0.1 µg/L by the soil metabolites of ipconazole due to

surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded.


The authorization of the plant protection product Rancona 450 FS is linked with following labelling:

None (regarding runoff and drainage)

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5.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP

9.2.5)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure

of surface water consider the two routes of entry (i) spray drift and volatilization with subsequent deposi-

tion and (ii) runoff, drainage separately. As the product Rancona 450 FS is used as a seed treatment, sur-

face water exposure by spray drift and volatilization with subsequent deposition can be excluded as rele-

vant pathways, whereas predicted off-field exposure concentrations following dust drift deposition are

presented in in the core assessment 5.9.2 and in this document in chapter 5.9.3.

Surface water exposure including effects of risk mitigation via surface runoff and drainage is estimated

using the model EXPOSIT.



5.9.2 PECsw after exposure by spray drift and volatilization with subsequent

deposition


volatilization with subsequent deposition can be excluded as relevant pathways.

5.9.3 PECsw and PECoff-field after exposure by dust drift

The intended use is a seed treatment, therefore exposure of surface water and off-field habitats by the

active substance ipconazole due to dust drift has to be considered as well. The relevant exposure values

for non-target organisms in different off-field structures were calculated according to the draft "Guidance

Document on the Authorization of Plant Protection Products for Seed Treatment” (SANCO/10553/2012,

January 2014). For the calculation of PECoff-field and the PECsw dust please refer to the core assessment

(chapter 5.9.2). The results of the calculation of PECsw total as proposed in the draft "Guidance Document

on the Authorization of Plant Protection Products for Seed Treatment” is presented under chapter 5.9.4.

5.9.4 PECsw after exposure by surface runoff and drainage

The concentration of the active substance ipconazole in adjacent ditch due to surface runoff and drainage

is calculated using the model EXPOSIT 3. The input parameters for Rancona 450 FS related to the appli-

cation used for PECsw calculations with Exposit 3 are summarised in Table 5.8-1.

The substance specific input parameters used for modelling surface water exposure via runoff and drain-

age in an adjacent ditch with EXPOSIT 3 are summarised in chapter 5.8.3 of this document.

As proposed in the draft "Guidance Document on the Authorization of Plant Protection Products for Seed

Treatment”, the calculated values for PECsw dust were added to the PECsw values obtained from Exposit.

The resulting PECsw total are presented in the following table.

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Table 5.6-9: Total PECsw (PECsw drainage/runoff + PECsw dust)

Szenario PECsw dust

[g/L]

PECsw, drainage

[g/L]

Total

PECsw, drainage

[g/L]

PECsw, runoff

[g/L]

Total

PECsw, runoff

[g/L]

Realistic worst case 1)

Spring / summer* 0.500 0.01 0.51 0.01** 0.51**

reference value/certificated seeds 2)

0.175 0.01 0.185 0.01** 0.185**

Product specific 3)

0.026 0.01 0.036 0.01** 0.036**

1) worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of available

data 2) Crop specific reference values are laid down by legal requirements and certified (e.g. legislations on treated maize seed quality

–independent from applied active substances) 3) sufficient and reliable product specific data on seed quality parameter are submitted and considered (see Littlewood, 2013)

* as the application is a seed treatment and the application time was in spring, only the spring / summer-szenario was considered

** without runoff mitigation (=0m Bufferzone)

The aquatic risk assessment, considering the results of the exposure calculation for dust deposition in off-

field areas after the drilling of maize seeds treated with Rancona 450 FS, is outlined in the National ad-

dendum Germany, part B, section 6, chapter 6.5. The ecotoxicological endpoints available for risk as-

sessment are documented there in detail.

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5.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Please refer to chapter 5.9.2.

5.11 Classification and labelling

5.11.1 GHS Classification and labelling

Please refer to the core assessment Part B Section 6.

5.11.2 National labelling and conditions of use

Table 5.11-1 Mandatory conditions of use according to § 36 (1) PflSchG

use group/use No Conditions of use

All uses -

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Appendix 2 Detailed evaluation of the new Annex II studies

No new studies submitted.

REGISTRATION REPORT

Part B

Section 6

Ecotoxicology


Product code: 008398-00/00



Ipconazole 452 g/L

Central Zone


Core Assessment

(authorisation)




MS Finalisation date: 18/09/2019

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Version history

When What

[September

2019]

First Draft RR by UBA

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Table of Contents

6 Ecotoxicology (KCP 10) ............................................................................... 5


6.1.1 Overall conclusions ...................................................................................... 10

6.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than

birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles

and amphibians) (KCP 10.1.3) ..................................................................... 10

6.1.1.2 Effects on aquatic organisms (KCP 10.2) .................................................... 11

6.1.1.3 Effects on bees (KCP 10.3.1) ....................................................................... 11

6.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ................................... 12

6.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on

soil microbial activity (KCP 10.5) ............................................................... 12

6.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ..................................... 13

6.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ........... 13

6.1.2 Grouping of intended uses for risk assessment ............................................ 14

6.1.3 Consideration of metabolites ....................................................................... 14

6.2 Effects on birds (KCP 10.1.1) ...................................................................... 14

6.2.1 Toxicity data ................................................................................................ 14

6.2.1.1 Justification for new endpoints .................................................................... 15

6.2.2 Risk assessment for spray applications ........................................................ 15

6.2.3 Risk assessment for baits, pellets, granules, prills or treated seed ............... 15

6.2.3.1 First-tier assessment (screening/generic focal species) seed treatments ..... 15

6.2.3.2 Higher-tier risk assessment .......................................................................... 16

6.2.3.3 Drinking water exposure .............................................................................. 20

6.2.3.4 Effects of secondary poisoning .................................................................... 20

6.2.3.5 Biomagnification in terrestrial food chains .................................................. 22

6.2.4 Indirect effects via trophic interactions ........................................................ 22


6.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) .................. 25

6.3.1 Toxicity data ................................................................................................ 25


6.3.2 Risk assessment for spray applications ........................................................ 26

6.3.3 Risk assessment for baits, pellets, granules, prills or treated seed ............... 26

6.3.3.1 First-tier assessment (screening/generic focal species) seed treatments ..... 26


6.3.3.3 Drinking water exposure .............................................................................. 28

6.3.3.4 Effects of secondary poisoning .................................................................... 29

6.3.3.5 Biomagnification in terrestrial food chains .................................................. 30


6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

(KCP 10.1.3) ................................................................................................ 31

6.5 Effects on aquatic organisms (KCP 10.2) .................................................... 31

6.5.1 Toxicity data ................................................................................................ 31


6.5.2 Risk assessment ........................................................................................... 33


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6.6 Effects on bees (KCP 10.3.1) ....................................................................... 41

6.7 Effects on arthropods other than bees (KCP 10.3.2) ................................... 42

6.7.1 Toxicity data ................................................................................................ 42

Justification for new endpoints ................................................................................................ 43

6.7.2 Risk assessment ........................................................................................... 44

6.7.2.1 Risk assessment for in-field exposure (seed treatments) ............................. 44

6.7.2.2 Risk assessment for off-field exposure (seed treatments) ............................ 44

6.7.2.3 Additional higher-tier risk assessment ......................................................... 45


6.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) .................... 46

6.8.1 Toxicity data ................................................................................................ 46


6.8.2 Risk assessment ........................................................................................... 47

6.8.2.1 First-tier risk assessment .............................................................................. 47



6.9 Effects on soil microbial activity (KCP 10.5) .............................................. 49

6.9.1 Toxicity data ................................................................................................ 49


6.9.2 Risk assessment ........................................................................................... 49


6.10 Effects on non-target terrestrial plants (KCP 10.6) ..................................... 50

6.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ........... 50

6.12 Monitoring data (KCP 10.8) ........................................................................ 50

6.13 Classification and Labelling ........................................................................ 51

6.13.1 GHS Classification and Labelling ............................................................... 51


Appendix 2 Detailed evaluation of the new studies ..................................................... 53

A 2.1.1 KCP 10.1.2 Effects on terrestrial vertebrates other than birds ................... 53

A 2.1.2 KCP 10.3.2 Effects on non-target arthropods other than bees .................... 55

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6 Ecotoxicology (KCP 10)

This document reviews the eco-toxicological studies for the product Rancona 450 FS (UBI 4336-01) con-

taining the active substance Ipconazole which was included into Regulation (EC) 1107/2009 (EU 571/2014,

26 May 2014). A full risk assessment according to Uniform Principles is provided which demonstrates that

the product is safe for the environment.

National addendum may be prepared for country specific assessments for example, PEC surface water.

Where the assessment is covered by the core assessment cross reference is made under the relevant point.

In these cases this document should be read in conjunction with the relevant addendum.

Where appropriate this document refers to the conclusions of the EU review of the active substance Ipcon-

azole. This will be where:

the active substance data are relied upon in the risk assessment of the Rancona 450 FS; or when

the EU review concluded that additional data/information should be considered at national re-reg-

istration.

Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has

not previously been considered within the EU review process, as part of the Annex I inclusion decision.

New annex II data must only be included if they are considered essential for the evaluation and in this case

a full study summary must be provided.

This product was not the representative formaulation. The product has not been previously evaluated in

Germany according to Uniform Principles.

The EFSA report for Ipconazole (EFSA Journal 2013;11(4):3181) is considered to provide the relevant

review information or a reference to where such information can be found. The following table provides

the EU endpoints to be used in the evaluation.

The Annex I Inclusion Directive for Ipconazole (EU 571/2014) provides specific provisions under Part B

which need to be considered by the applicant in the preparation of their submission and by the MS prior to

granting an authorisation:

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the

active substance Ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 20th March 2014 shall be taken into account. In this

overall assessment:

Member States should/must/may pay particular attention to the:

the protection of workers and operators and ensure that conditions of use prescribe the application

of adequate personal protective equipment where appropriate;

the risk to granivorous birds.

the risk to fish

These concerns have been addressed within the current submission.

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Appendix 1 of this document contains the list of data considered in support of the evaluation.

Appendix 2 of this document contains detailed evaluations of new studies.

Information on the detailed composition of UBI 4336-01 can be found in the confidential dossier of this


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Table 6.1-1: Table of critical GAPs

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Use-

No. *

Member

state(s)

Crop and/or situ-

ation (crop destination

/ purpose of

crop)

F,

Fn, Fpn

G,

Gn, Gpn

or

I **


controlled (additionally: develop-

mental stages of the

pest or pest group)


(days)

Remarks:

e.g. g saf-ener/ syn-

ergist per

ha

Conclusion

Method /

Kind

Timing /

Growth


Max. num-

ber


season

Min. interval

between ap-

plications (days)

kg or L

product/ha


b) max. total


g or kg as/ha


b) max. total


Water L/ha

min/max

Bir

ds

Mam

mal

s

Aq

uat

ic o

rgan

ism

s

Bee

s

No

n-t

arget

art

hro

-

pod

s S

oil

org

anis

ms

No

n-t

arget

pla

nts


001 DE Maize

ZEAMX

F Fusarium spp.

FUSASP

seed treat-

ment before sow-ing

BBCH 00

a.) 1

1

- 1.925 mL/ha

(0.77 mL/seed

unit)

0.875 g a.s

/ha (0.35 g

as/seed unit); (25 mg/kg

seed; 35 kg

seeds/ha)

maximum

application rate 1.925

mL/ha (equivalent

to a maxi-

mum of 2.5 seed

units per

ha; 1 unit includes

50000

grains)

withdrawn

by appli-cant

A A N A N A A

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

002 DE Maize

ZEAMX


RHIZSO

seed treat-ment

before sow-ing

BBCH 00

a.) 1

1

- 1.925 mL/ha (0.77

mL/seed unit)

0.875 g a.s /ha

(0.35 g as/seed unit);

(25 mg/kg

seed; 35 kg seeds/ha)

maximum application

rate 1.925 mL/ha

(equivalent

to a maxi-mum of

2.5 seed

units per ha; 1 unit

includes

50000 grains)

withdrawn by appli-

cant

A A N

N A A

003 DE Maize

ZEAMX


SPHTRE

seed treat-

ment before sow-ing

BBCH 00

a.) 1

1

- 6.3 mL/ha

(2.52

mL/seed unit)

2.85 g a.s./ha

(1.14 g

as/seed unit); (81.36

mg/kg seed;

35 kg seeds/ha)

5 – 70

mL/unit

seed

maximum

application

rate 6.3 mL/ha

(equivalent

to a maxi-mum of

2.5 seed


includes

50000 grains)

A A A A A A A


** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional

and non-professional greenhouse use, I: indoor application

Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use



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N No safe use

Remarks

table:

(1) Numeration necessary to allow references (2) Use official codes/nomenclatures of EU


situation should be described (e.g. fumigation of a structure) (4) F: professional field use, Fn: non-professional field use, Fpn: professional and non-profes-

sional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn:

professional and non-professional greenhouse use, I: indoor application (5) Scientific names and EPPO-Codes of target pests/diseases/ weeds or when relevant the com-

mon names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi,

weeds) and the developmental stages of the pests and pest groups at the moment of applica-tion must be named

(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

(7) Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Black-well, ISBN 3-8263-3152-4), including where relevant, information on season at time of application

(8) The maximum number of application possible under practical conditions of use must be provided

(9) Minimum interval (in days) between applications of the same product. (10) For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty

rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products

(11) The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha).

(12) If water volume range depends on application equipments (e.g. ULVA or LVA) it should be men-

tioned under “application: method/kind”. (13) PHI - minimum pre-harvest interval

(14) Remarks may include: Extent of use/economic importance/restrictions

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6.1.1 Overall conclusions


birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and

amphibians) (KCP 10.1.3)

Birds

Dietary risk assessment

TER values for birds were calculated, taking into account the relevant toxicity data for Ipconazole and

calculated exposure levels for dietary exposure, according to the intended uses of the product Rancona

450 FS as seed treatment for maize. The calculated TER values do not achieve the acceptability criterion

TER ≥ 5 for long-term/reproductive effects on birds, according to Commission Regulation (EU) No

546/2011, Annex, Part I C, point 2.5.2.1. It was, however, demonstrated by a refined modelling approach

(taking into account dissipation of residues on sown treated seeds, focal species and their dietary compo-

sition) that the application of Rancona 450 FS as seed treatment for maize at a rate of 2.85 g a.s./ha is un-

likely to provoke sustaining adverse effects on bird populations under realistic conditions. Thus, it can be

concluded that the risk for birds due to the intended use of Rancona 450 FS as seed treatment for maize

according to the label is acceptable.

It must be evaluated by Member States, whether this refined modelling approach meets the requirements

for the risk assessment with regard to their specific environmental or agricultural circumstances.

Risk assessment for exposure via drinking water

Due to the characteristics of the exposure scenario in connection with the standard assumptions for water

uptake by animals, no specific calculations of exposure and TER were necessary for the intended uses of

the product Rancona 450 FS as seed treatment for maize. Hence, it can be concluded that the risk for birds

due to the intended use of Rancona 450 FS as seed treatment for maize according to the label is accepta-

ble.

Risk assessment for exposure via secondary poisoning


calculated exposure levels for exposure via secondary poisoning, according to the intended uses of the

product Rancona 450 FS as seed treatment for maize. The calculated TER values do achieve the accepta-

bility criterion TER ≥ 5 for long-term/reproductive effects on birds, according to Commission Regulation


risk for birds due to the intended use of Rancona 450 FS as seed treatment for maize according to the la-

bel.

Effects on terrestrial vertebrates other than birds


TER values for mammals were calculated, taking into account the relevant toxicity data for Ipconazole

and calculated exposure levels for dietary exposure, according to the intended uses of the product Ran-

cona 450 FS as seed treatment for maize. Taking into account refined model parameters (dissipation of

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residues on sown treated seeds) and a focal species (wood mouse), the calculated TER values do achieve

the acceptability criteria TER ≥ 10 for acute effects and TER ≥ 5 for long-term/reproductive effects on

mammals, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.1. The

results of the assessment indicate an acceptable risk for mammals due to the intended use of Rancona 450

FS as seed treatment for maize according to the label.




the product Rancona 450 FS as seed treatment for maize. Hence, it can be concluded that the risk for

mammals due to the intended use of Rancona 450 FS as seed treatment for maize according to the label is

acceptable.



and calculated exposure levels for exposure via secondary poisoning, according to the intended uses of

the product Rancona 450 FS as seed treatment for maize. The calculated TER values do achieve the ac-

ceptability criterion TER ≥ 5 for long-term/reproductive effects on mammals, according to Commission

Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.1. The results of the assessment indicate an

acceptable risk for mammals due to the intended use of Rancona 450 FS as seed treatment for maize ac-

cording to the label.

6.1.1.2 Effects on aquatic organisms (KCP 10.2)

Risk ratios of predicted environmental versus regulatory acceptable concentrations (PEC/RAC) for

aquatic organisms were calculated. Calculated exposure concentrations in surface water bodies, according

to the intended uses of the product Rancona 450 FS as seed treatment for maize were considered in the

exposure term. The regulatory acceptable concentration (RAC) is obtained by division of the relevant tox-

icity data for Ipconazole by an assessment factor of 100 for acute effects and 10 for chronic effects on

aquatic organisms. The calculated risk ratios do achieve the acceptability criterion PEC/RAC ≤ 1 for

aquatic organisms exposed to Ipconazole via dust drift, as derived from the prescriptions in Commission

Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.2 and when considering product specific PEC

values. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended


Since the risk assessment is only acceptable if product specific Heubach-values and the resulting PECs

are taken into account. Therefore it must be ensured that the treated seed meets the respective quality. The

amount of abraded dust must not exceed 0.05 g Ipconazole per 100.000 seeds, otherwise unacceptable

risks to the environment are to be expected

6.1.1.3 Effects on bees (KCP 10.3.1)

It is concluded that Rancona 450 FS will not adversely affect bees or bee colonies when used as recom-

mended.

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6.1.1.4 Effects on arthropods other than bees (KCP 10.3.2)

In-field

Risk indicator values for non-target arthropods in treated areas were calculated, taking into account the

relevant toxicity data for Rancona 450 FS and estimated in-field exposure levels, according to the in-

tended uses of the product Rancona 450 FS as seed treatment for maize. The calculated indicator values

of less than 30 % effect level for effects on non-target arthropods, according to agreed EU Guidance in

Document SANCO/10329/2002 rev 2 that overrides the prescriptions of Commission Regulation (EU) No

546/2011, Annex, Part I C, point 2.5.2.4. The results of the assessment indicate an acceptable risk for

non-target arthropods in treated areas due to the intended use of Rancona 450 FS as seed treatment for

maize according to the label.

Off-field

Risk indicator values for non-target arthropods in off-field habitats were calculated, taking into account

the relevant toxicity data for Ipconazole and calculated exposure concentrations in off-field habitats, ac-

cording to the intended uses of the product Rancona 450 FS as seed treatment for maize. The calculated

indicator values do achieve the acceptability criterion TER ≥ 5 for effects on non-target arthropods, ac-

cording to agreed EU Guidance in Document SANCO/10329/2002 rev 2 that overrides the prescriptions

of Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.4, if product specific data are

taken into account. The results of the assessment indicate an acceptable risk for non-target arthropods in

off-field habitats due to the intended use of Rancona 450 FS as seed treatment for maize according to the

label.




risks to the environment are to be expected

6.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil

microbial activity (KCP 10.5)

Earthworms



FS as seed treatment for maize. The calculated TER values do achieve TER ≥ 10 for acute effects / the

acceptability criterion TER ≥ 5 for chronic effects on earthworms, according to Commission Regulation


risk for earthworms due to the intended use of Rancona 450 FS as seed treatment for maize according to

the label.



relevant toxicity data for 1,2,4-triazole and calculated exposure concentrations in soil, according to the




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Effects on soil microbial activity




no exceedance of the acceptability criterion ≤ 25 % effects on soil microorganisms, according to Commis-

sion Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.6. The results of the assessment indicate

an acceptable risk for soil microorganisms due to the intended use of Rancona 450 FS as seed treatment


6.1.1.6 Effects on non-target terrestrial plants (KCP 10.6)





is required.

6.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not relevant

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Not relevant.

6.1.3 Consideration of metabolites

A list of metabolites found in environmental compartments is provided below. The need for conducting a

metabolite-specific risk assessment in the context of the evaluation of Rancona 540 FS is indicated in the

table.

Table 6.1-2 Metabolites of Ipconazol

Metabolite Chemical structure Molar mass Maximum occurrence in

compartments

Risk assessment re-

quired?

1,2,4-triazole

(KNF-317-M-

22)

69.1 Soil:

max. 23.7 % at day 31 (US

study)

Soil photolysis:

max. 10.4 % at day 8

Water/Sediment:

not detected

Aquatic organisms:

No

Soil organisms:

No (lower risk as

compared to parent

confirmed by EU

assessment)

Groundwater:

No,

ecotoxicologically

not relevant (Step

2/Step 3-4)1)

4-chlorobenz-

aldehyde

140.6

Soil photolysis:

max. 6.3 % at day 8

Soil organisms: No

6.2 Effects on birds (KCP 10.1.1)

6.2.1 Toxicity data

Avian toxicity studies have been carried out with Ipconazole. Full details of these studies are provided in

the respective EU DAR and related documents.

Effects on birds of Rancona 450 FS were not evaluated as part of the EU assessment of Ipconazole.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review

process.

NH

N

N

Cl

O

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Table 6.2-1: Endpoints and effect values relevant for the risk assessment for birds

Species Substance Exposure

System

Results Reference

Colinus virginianus Ipconazole Acute LD50 = 962

mg/kg bw

EFSA Journal 2013;

11(4): 3181

Colinus virginianus Ipconazole Short-term LDD50 > 300

mg/kg bw/d

EFSA Journal 2013;

11(4): 3181

Colinus virginianus Ipconazole Dietary

Reproductive toxicity

NOEL = 4.3

mg/kg bw/d

EFSA Journal 2013;

11(4): 3181

Anas platyrhynchos Ipconazole Dietary

Reproductive toxicity

NOEL = 27.1

mg/kg bw/d

EFSA Journal 2013;

11(4): 3181

6.2.1.1 Justification for new endpoints

Not required.

6.2.2 Risk assessment for spray applications

Not relevant.

6.2.3 Risk assessment for baits, pellets, granules, prills or treated seed

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment

for Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as

EFSA/2009/1438).

6.2.3.1 First-tier assessment (screening/generic focal species)

seed treatments

The results of the acute and reproductive first-tier risk assessments are summarized in the following table.

Since Ipconazole is a systemic compound, a scenario with seedlings containing residues due to the trans-

fer of the active substance from the seeds to green plant tissue is included in the assessment. According to

EFSA/2009/1438, a transfer of 100 % from the seeds and a dilution factor of 5 are considered in the cal-

culation of the concentration in seedlings.

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Table 6.2-2: First-tier assessment of the acute and long-term/reproductive risk for birds

due to the use of Rancona 450 FS as a seed treatment for maize (use 003)

Intended use Use 003

Active substance/product Ipconazole

Application rate (kg/ha) 2.85 g a.s./ha (8.136 g a.s./100 kg seed; 35 kg seeds/ha)

Acute toxicity (mg/kg bw) 962

TER criterion 10

Food item Indicator/generic focal species FIR/bw C (mg/kg)

DDD90 (mg/kg bw/d)

TERa

Large seeds Large granivorous bird (GD

default)

0.100 81.000 8.100 118.765

Seedlings Small omnivorous bird (GD

default)

0.500 16.200 8.100 118.765

Reprod. toxicity (mg/kg bw/d) 4.3

TER criterion 5

Food item Indicator/generic focal species FIR/bw C × TWA (mg/kg)

DDDm (mg/kg bw/d)

TERlt

Large seeds Large granivorous bird (GD

default)

0.100 81.000* 8.100 0.531

Seedlings Small omnivorous bird (GD

default)

0.500 8.533 4.267 1.008

TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall

below the relevant trigger.

* No TWA is considered according to DAR Ipconazole- Volume 3, Annex B.9 : Ecotoxicology “There is no generic data on

dissipation and degradation rates of active substances on treated seed. Therefore, in the first tier assessment these processes are not

considered. The appropriate exposure estimate is then the NAR x FIR/bw.”

A TER for long-term/reproductive risk below the acceptability criterion TER ≥ 5 has been calculated for

use 3. A refined risk assessment is thus necessary and documented below.

6.2.3.2 Higher-tier risk assessment

The following parameters of the model for risk estimation were further investigated to support a refined

risk assessment.

Dissipation of residues on sown treated seeds

A study was performed with winter barley seeds that were treated with the product UBI 6932.00 (Ipcona-

zole/Imazalil 20/50 ME) to achieve a nominal loading of 2 g Ipconazole and 5 g Imazalil per 100 kg seed

(Archer, 2009). Seeds were sown on a field in the UK in November according to normal agricultural prac-

tice and subsequently analyzed for their residue content. With regard to Ipconazole dissipation, the study

was assessed in the respective DAR by the RMS UK (Ipconazole- Volume 3, Annex B.9: Ecotoxicology,

2011) and a geometric mean DT50 of 1.36 d was calculated.

The time interval for calculating a time-weighted average (twa) concentration has been proposed by the

applicant as 10 d, thus reflecting the typical period between sowing and germination of the seeds. This is

in line with the approach taken in the Ipconazole DAR. Nevertheless, it should be noted that the reasoning

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for using a twa concentration in the long-term/reproductive risk assessment is not specifically linked to a

limited duration of availability of a food item, but in general to the discrepancy between continuous expo-

sure to the same concentrations in the toxicity test as opposed to declining exposure concentrations in the

field. Therefore, using the twa factor for a 10-d interval (ipconazole: 0.195 for a DT50 of 1.36 d) consti-

tutes a relative worst case.

Selection of focal species

The scenarios used for the tier-1 risk assessment refer to indicator species, which are no real species, but

represent a worst case that is intended to cover all species potentially at risk due to the intended use of a

product. For seed treatments with systemic active substances, these are a ‘large granivorous bird’ with a

bodyweight of 376.0 g and a food intake rate of 0.1 g seeds/g bodyweight and a ‘small omnivorous bird’

with a bodyweight of 28.5 g and a food intake rate of 0.5 g seedlings/g bodyweight.

The applicant has proposed to perform a refined risk assessment using two focal species that are consid-

ered to be more relevant for a scenario with treated maize seeds than the indicator species, namely the

woodpigeon (Columba palumbus) and grey partridge (Perdix perdix), as a representative species for birds

feeding on maize seeds. However, other focal species might also appear at maize fields and feed maize

seeds/seedlings, as is indicated in the literature. Prosser (2001)1 installed bait stations on arable fields in

Great Britain on which different seed types were offered to birds in larger quantities over several days,

while video-camera observations were made of feeding birds at the station (for two days, three weeks af-

ter implementation of the bait station). He recorded red-legged partridges (Alectoris rufa), pheasants

(Phasanius colchius), feral pigeons (Columba livia f. domestica), stock dove (Columba oenas), magpies

(Pica pica), rooks (Corvus frugeligus), carrion crows (Corvus corone) and jackdaws (Corvus monedula)

at the bait station with the smallest bird being the magpie with a body mass of 166 g (according to Buxton

et al., 2007 2). He also recorded some small seed-eating birds (chaffinches, tree and house sparrows), but

none of the birds ingested intact or entire maize seeds. These small birds only participated from fragments

of seeds which had been broken up by larger birds after weathering. This is an artificial exposure situation

attributed to bait stations and it is very unlikely that such a scenario will occur under agricultural practice.

Furthermore, if taking up only fragments of a maize seed, the possible amount of active substance a bird

will ingest from the seed coating will be significantly reduced, compared to a bird which ingests whole

seeds (fragmentation requires previous weathering of the seeds which reduces the loading of the active

substance). From these data it can be assumed that small seed-eating birds will not ingest intact maize

seeds as food items.

For magpies, seeds only make up a small proportion of the diet (< 9%, Glutz von Blotzheim, 20013). On

freshly ploughed and drilled land, magpies preferably prey on insects brought to the surface by agricul-

tural activities (Møller, 19834). The rook is known to build huge swarms of individuals which can damage

cereal (especially maize) fields, especially in winter. They pick up the freshly emerged seedlings in order

1 Prosser, P. (2001): Final milestone report - Potential exposure of birds to treated seed. Project PN0907. Central

Science Laboratory, Sand Hutton, York, Great Britain. 2 Buxton, J.M., Crocker, D.R., Pascual, J.A. (2007): Milestone report - Birds and farming: information for risk as-

sessment. 1998 Update contract PN0919. Central Science Laboratory, Sand Hutton, York, Great Britain. revised

version as part of project PN0919, CSL Project No. M37 3 Glutz von Blotzheim, U. (2001): Handbuch der Vögel Mitteleuropas. CD-ROM Version. Vogelzug Verlag,

Wiebelsheim, Germany. 4 Møller, A.P. (1983): Habitat selection and feeding activity in the magpie Pica pica. Journal für Ornithologie, 124,

pp. 147 - 161

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to reach the remaining seeds (Glutz von Blotzheim, 2001). Because of this feeding behaviour the rook

might be a relevant species which is still not easily detectable by a single field study. But especially dur-

ing the time of the seedlings emergence it can be assumed that the bird will not ingest the whole active

substance load and additionally that other food sources are very attractive for the rooks (Buxton et al.,

2007; Glutz von Blotzheim, 2001).

Additionally to the woodpigeon and the partridge, which were used in the refined risk assessment by the

applicant, the carrion crow shell also be regarded in the risk assessment by zRMS. These three species are

considered to represent focal species in maize sufficiently.

focal species: woodpigeon (Columba palumbus)

bodyweight: 490.0 g2

habitat and diet: Woodpigeons are described as pest in cereal and oilseed rape despite feeding on a

wide range of natural foods (weed seeds, beech mast, berries, etc.) (Buxton et al., 2007; Glutz von Blot-

zheim, 2001). However, as indicated by Prosser (2001) woodpigeons might occur in maize fields and for-

age on maize seeds. Due to the lack of specific and up to date data, zRMS considers the amount of large

seeds that are reported to be consumed in spring/summer to be maize, which accounts to approximately

50 % (Buxton et al., 2007). Therefore, a proportion of 50 % of treated maize seeds will be taken into

account in the diet composition of the focal species Columba palumbus. The remaining 50 % are equally

allocated to non-grass herbs and weed seeds, for which the residues per unit dose (RUD) will be set to 0.

For the active substance Ipconazole, the RUD for treated maize seeds will be set by the user to 81.36 mg

a.i./ kg seeds.

focal species: Grey partridge (Perdix perdix)

bodyweight: 390 g2

habitat and diet: The bird bible describes a largely omnivorous diet with insects being important in

spring and summer for Perdix perdix. Radio-tracking studies showed that it is mostly found near cereal

fields (e.g., winter wheat, winter barley) or oilseed rape (Buxton et al., 2007). Data reported by Dwenger

(19915) indicate the following dietary composition in spring: green matter 50 %, seeds of weeds and other

plants 27 %, grains 17 % and animal matter 6 %; and in summer: green matter 10 %, seeds of weeds and

other plants 41 %, grains 36 % and animal matter 13 %. Due to the opportunistic behavior of the grey par-

tridge, it will consume maize if available. In order to ensure a realistic worst-case, the sum of the seed

content in the summer diet reported by Dwenger (1991) (41% weed seed + 36% grain = 77% seed in to-

tal) was allocated to weed and maize seeds on a 50/50 basis. Therefore, a proportion of 39 % of maize

treated seeds will be taken into account in the diet composition of the focal species Perdix perdix. The

remaining proportion is allocated to 38 % weed seeds, 10 % non-grass weeds, and 13 % animal matter,

for which the residues per unit dose (RUD) will be set to 0. For the active substance Ipconazole, the RUD

for treated maize seeds will be set by the user to 81.36 mg a.i./ kg seeds.

5 Dwenger R (1991) Das Rebhuhn Perdix perdix, A. Ziemsen Verlag.

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focal species: Carrion crow (Corvus corone; Corvus brachyrhynchos)

bodyweight: 448 g2

habitat and diet: The carrion crow scavenges primarily in pasture/grassland in spring and summer,

arable land is preferred in autumn and winter. Diverse seeds might be consumed in significant amounts in

spring and summer and plant material and insects are indicated as important food sources (Buxton et al.,

2007; Glutz von Blotzheim, 2001). Therefore, the dietary composition is allocated to 25 % grass and cere-

als, 25 % animal matter, and 50 % seeds, whereas the latter was allocated to weed and maize seed on a

50/50 basis. For the active substance Ipconazole, the RUD for treated maize seeds will be set by the user

to 81.36 mg a.i./ kg seeds. For the remaining food sources the residues per unit dose (RUD) will be set to

0.

For the calculation of the FIR/bw for a “crow” the dataset from the EFSA Guidance Document (EFSA,

2009) has been used. Even if Corvus brachyrhynchos is not common in Europe, this species has the low-

est body weight compared to other crows. Therefore this assessment can be considered conservative.

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the

use group A also addresses the risk for birds from all other intended uses in groups B (see 6.1.2). Since

seedlings pose a lower risk to birds than the seeds (see Tables 6.2-2 and 6.2-3), the risk assessment for

birds feeding on seeds covers also the risk of birds feeding on seedlings.

Calculation of TER values

Table 6.2-3: Higher-tier assessment of the long-term/reproductive risk for birds due to the

use of Rancona 450 FS in maize (use 003) – refined parameters (*) are further

described and justified in the text

Intended use 003


Application rate (g/ha) 1 x 2.85 g a.s./ha (8.136 g a.s./100 kg seed; 35 kg seeds/ha)


TER criterion 5

Focal species* Food category,

% in diet*

FIR/bw RUD (mg/kg food)

MAFm ×

TWA*

PT DDDm (mg/kg bw/d)

TERlt

Columba palumbus Maize seeds, 50 % 0.04 81.36 0.195 1 0.708 6.1

Small seeds, 25 % 0.02 0 - 1 - -

non-grass weeds,

25 %

0.02 0 - 1 - -

Perdix perdix Maize seeds, 39 % 0.04 81.36 0.195 1 0.621 6.6

Small seeds, 38 % 0.04 0 - 1 - -

Non-grass weeds, 10

%

0.01 0 - 1 - -

ground-dwelling

invertebrates, 13 %

0.01 0 - 1 - -

Corvus

brachyrhynchos

Maize seeds, 25 % 0.04 81.36 0.195 1 0.643 6.7

Small seeds, 25 % 0.04 0 - 1 - -

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grass and cereals,

25 %

0.04 0 - 1 - -

ground-dwelling

invertebrates, 25 %

0.04 0 - 1 - -

FIR/bw: Food intake rate per body weight; RUD: residue unit dose; MAF: multiple application factor; DDD: daily dietary dose;

TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.

The refined risk assessment indicates that the long-term risk of exposure of birds to the active ingredient

Ipconazole according to the GAP of the formulation Rancona 450 FS achieves the acceptability criteria

TER ≥ 5, according to Regulation (EC) 1107/2009, Annex IV, uniform principles, point 2.5.2.1 for long

term effects.

It must be evaluated by Member States, whether the focal species and diet composition meet the require-

ments for a risk assessment with regard to their specific environmental or agricultural circumstances. It is

noted that the EFSA conclusion identified a long-term risk to small granivorous birds which has not been

resolved jet (see updated Addednum May 2017 - confirmatory data of Ipconazole).

6.2.3.3 Drinking water exposure

When necessary, the assessment of the risk for birds due to uptake of contaminated drinking water is con-

ducted for a small granivorous bird with a body weight of 15.3 g (Carduelis cannabina) and a drinking

water uptake rate of 0.46 L/kg bw/d (cf. Appendix K of EFSA/2009/1438).

Leaf scenario

Since Rancona 450 FS is no product for spray applications, the leaf scenario does not have to be consid-

ered.

Puddle scenario


uptake by animals, no specific calculations of exposure and TER are necessary when the ratio of effective

application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive

substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg).

With a K(f)oc of 2431, Ipconazole belongs to the group of more sorptive substances.

Effective application rate (g/ha) = 2.85

Acute toxicity (mg/kg bw) = 962 quotient = 0.003

Reprod. toxicity (mg/kg bw/d) = 4.3 quotient = 0.663

6.2.3.4 Effects of secondary poisoning

The log Pow of Ipconazole amounts to 4.65 (worst-case value for cis-isomer) and thus exceeds the trigger

value of 3. A risk assessment for effects due to secondary poisoning is required.

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Risk assessment for earthworm-eating birds via secondary poisoning

According to EFSA/2009/1438, the risk for vermivorous birds is assessed for a bird of 100 g body weight

with a daily food consumption of 104.6 g. Bioaccumulation in earthworms is estimated based on predicted

concentrations in soil.

Table 6.2-4: Assessment of the risk for earthworm-eating birds due to exposure to Ipcona-

zole via bioaccumulation in earthworms (secondary poisoning) for the in-

tended use in maize (use 003)

Parameter Ipconazole comments

PECsoil (twa = 21 d) (mg/kg soil) 0.0037 1 x 2.85 g/ha, interception = 0 %, soil layer depth

20 cm, DT50 = 391 d, twa interval = 21 d, with

accumulation

log Pow / Pow 4.65 / 44668

Koc 2431 Mean (n = 6)

foc 0.02 Default

BCFworm 11.042 BCFworm/soil = (PECworm,ww/PECsoil,dw)

= (0.84 + 0.012 × Pow) / foc × Koc

PECworm 0.041 PECworm = PECsoil × BCFworm/soil

Daily dietary dose (mg/kg bw/d) 0.043 DDD = PECworm × 1.05

NOEL (mg/kg bw/d) 4.3 Colinus virginianus

TERlt 100 ≥ 5, acceptable risk

TER values shown in bold fall below the relevant trigger.

Risk assessment for fish-eating birds via secondary poisoning

According to EFSA/2009/1438, the risk for piscivorous birds is assessed for a bird of 1000 g body weight

with a daily food consumption of 159 g. Bioaccumulation in fish is estimated based on predicted concen-

trations in surface water according to FOCUS Step 1.

Table 6.2-5: Assessment of the risk for fish-eating birds due to exposure to Ipconazole via

bioaccumulation in fish (secondary poisoning) for the intended use in maize

(use 003)


PEC-sw, twa (mg/L) - EU

default

0.000539 1 × 2.85 g/ha, FOCUS Step 1,

DT50 = 1000 d, twa interval = 21 d

BCF-fish 1000 whole fish

BMF 1 biomagnification factor (relevant for BCF ≥ 2000)

PEC-fish 0.539 PEC-fish = PEC-sw × BCF-fish × BMF

Daily dietary dose

(mg/kg bw/d/d)

0.086 DDD = PEC-fish × 0.159

NOEL

(mg/kg bw/d)

4.3 Colinus virginianus

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TER-lt 50.2 ≥ 5, acceptable risk


6.2.3.5 Biomagnification in terrestrial food chains

Not relevant.

6.2.4 Indirect effects via trophic interactions

According to Art. 4 (3) of the Commission Regulation (EC) No 1107/2009 the prerequisite for the author-

ization of a PPP is the absence of unacceptable effects on non-target organisms, the biodiversity, and the

ecosystem. The regulation does not foresee a restriction of the assessment to direct effects only but also

includes indirect effects. This view is also confirmed by the current data requirements (Annex to Commis-

sion Regulation (EC) No 283/2013) which state that „the potential impact of the active substance on biodi-

versity and the ecosystem, including potential indirect effects via alteration of the food web, shall be con-

sidered“. The EFSA PPR Panel decision making criteria associate acceptability/unacceptability of effects

with impacts/effects that could occur in the field “including the possibility for indirect effects at the food

chain/community level (birds and other terrestrial vertebrates)” (EFSA PPR panel, 20106). Overall, the

assessment of the impact of effects via alternation of the food web on the abundance and diversity of non-

target organisms and the biodiversity has to be considered as an integral part of the environmental risk

assessment in the light of the current scientific and technical knowledge (see also article 29 (1) (e) and 36

(1) (1) of the Commission Regulation (EC) No 1107/2009). The general principles for the evaluation stated

in the Commission Regulation (EU) No 546/2011) also point out that relevant technical or scientific infor-

mation shall be evaluated by Member States “having regard to current scientific and technical knowledge”

(see Part B 1.1 (b) in connection to Part A 2 (c)). This general requirement for the risk assessment implies

that indirect effects have to be considered in the product authorization even though they are not explicitly

considered in the Specific Principles of Evaluation and Decision Making. In this respect it is acknowledged

that the specific provisions laid down in the Uniform Principles can never form a definitive list of criteria

for evaluation and decision making.

The zRMS considered the potential for a relevant impairment of the function of the in-field NTTP and in-

field NTA in the food web as given if critical effect thresholds on the in-field communities of these groups

have been exceeded due to direct effects of the plant protection product under consideration. For NTAs, we

consider the critical effect thresholds to be exceeded if the harmonized EU risk assessment approach for in-

field communities (see 9.7.2 NTA - Risk assessment for in-field exposure) indicates a high in-field risk

(HQ ≥ 2 at Tier 1 or effects ≥ 50% at Tier 2).

As there exists no guidance on the assessment of the risk for in-field NTTP communities so far the critical

effect threshold to be considered for the NTTP assessment is ≥ 50% effects at the single field rate. The Tier

1 approach of the NTA in-field assessment is not applicable to NTTP as the HQ of 2 resulted from a cali-

bration with NTA field studies and is therefore worthless as a possible acceptability criterion for the risk

assessment for in-field NTTP communities. The focus on the toxicity data of the test species without using

a correction or safety factor for the extrapolation to more sensitive species already acknowledges that spe-

cies of in-field NTTP communities are less diverse.

6 EFSA Panel on Plant Protection Products and their Residues (PPR), 2010. Scientific Opinion on the development

of specific protection goal options for environmental risk assessment of pesticides, in particular in relation to the

revision of the Guidance Documents on Aquatic and Terrestrial Ecotoxicology (SANCO/3268/2001 and

SANCO/10329/2002)

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As pointed out by the EFSA PPR Panel resulting risks for upper levels of the food web due to effects on

lower trophic levels depend on the magnitude of the effects and the time-scale of resulting impairment of

the ecosystem service ´food web support´ in the context of the agricultural landscape. Following the recent

state of scientific knowledge as provided by the above mentioned Scientific Opinion of the EFSA PPR

Panel the zRMS does not see any value in the consideration of field recovery studies, which usually can

only demonstrate recovery rates over a longer time scale than relevant for the protection of the food web

functioning especially when considering that short times of food shortage might have a significant impact

on chick survival for farmland birds.

Step 1: Assessment of the general potential for indirect effects via trophic interaction caused by effects on

the primary producer level (in-field NTTP) and/ or the first (invertebrate) consumer level of the food web

due to the use of Rancona in Maize.

The assessment of the in-field exposure and the risk for negative food web effects at the level of primary

(invertebrate) consumers caused by impairment on the in-field NTA community completely follows the

approach as described by the Terrestrial Guidance Document and used the submitted toxicity data in the

context of the applied formulation in subchapter 9.7.2 (NTA - Risk assessment for in-field exposure). With

respect to the risk for an interruption of the food web at the primary producer level (in-field NTTP) the

zRMS refers to the toxicity data presented in 9.10.2 (NTTP - risk assessment) and the assessment approach

used for the primary consumer level.

Currently, the risk of unacceptable impacts on biodiversity and the ecosystem due to indirect effects via

trophic interactions is only assessed for whole-field treatments in arable crops and vegetable crops, where

the need to regulate and manage these risks is most urgent and sufficient evidence on the relevance of these

effects and the effectiveness of appropriate risk mitigation measures is available. For whole-field treatments

in other crops e.g. in vine and fruit crops, the risk of such food web effects is not assessed for the time

being, as there is currently no sufficient knowledge available yet to consider these effects already in the

authorization practice. For uses in grassland/pasture/meadows/home gardening and in the case of specific

single plant treatment (irrespectively of the crop), an acceptable impact on biodiversity with regard to the

occurrence of food web effects is assumed, taking into account realistic conditions of use.

Table 6.2-6: Assessment of general potential for indirect effects via trophic interaction due

to the use of Rancona in Maize (use 003)

Intended use 003

Active substance/product Rancona 450 FS (452 g/L Ipconazole)

Application rate (g/ha) 3.6 mL/ha (2.85 g a.s./ha)

MAF 1.0

Effects on the primary producer level (in-field NTTP) of the food web

Terrestrial non-target plants are not considered to be at risk from the use of the product Rancona 450 FS as seed

treatment in maize. Although exposure to residues of Ipconazole can occur due to deposition of abraded dust from

maize seeds during sowing, there are no indications that such de-posits with fungicidal a.s. would have significant

adverse effects on terrestrial plants.

Effects on the first (invertebrate) consumer level (in-field NTA) of the food web

Test species

Tier I

LR50 (lab.)

(g/ha)

PERin-field 2)

(g/ha)

HQin-field

criterion: HQ ≤ 2

Pardosa spp. 75.5 2.85

yes

Aleochara bilineata 81.0 yes

1) according to the current guidance mutiple applications are not taken into account 2) PERin-field = Application rate * MAF according to SANCO/10329/2002 rev 2

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3) If an ER50 from a relevant extended laboratory test is available, it should be considered in place of the

rate with ≤ 50 % effect.

The assessment of direct effects on the primary producer level (in-field NTTP) or the primary (invertebrate)

consumer level of the food web due to the use of Rancona 450 FS in Maize (use 003) indicates a low

potential for indirect effects via trophic interaction.

Step 2: If a high potential for indirect effects is concluded at step 1 an assessment of the specific potential

for indirect effects via trophic interaction due to the use of the product Rancona 450 FS in Maize (use 003)

considering specificity of side effects on the primary producer and primary (invertebrate) consumer level

has to be conducted.

A relevant impairment of the food web can be excluded if negative impacts due to effects on in-field NTTP

and/ or in-field NTA are clearly restricted to a marginal part of the communities due to a high specificity

of the expected effects. As the product Rancona 450 FS does not represent a broad-spectrum pesticide a

high risk for food web effects can be excluded without any further considerations.

Step 3: Assessment whether potential for indirect effects via trophic interaction due to the use of Rancona

450 FS in Maize (use 003) can lead to an unacceptable impact on biodiversity and the ecosystem consider-

ing specific ecological and agricultural conditions should be evaluated by the respective MS.

Whether effects on in-field NTTP or in-field NTA communities identified by steps 1 and 2 of the assessment

might lead to an unacceptable impact on biodiversity and the ecosystem due to indirect effects via trophic

interactions clearly depends on the setting of the agricultural landscape. The ecological potential to com-

pensate for an impairment of the ecosystem service ́ food web support´ and the habitat function at landscape

scale will determine whether indirect effects become manifest at population level for farmland species at

risk. Due to the dependence of farmland species on farmland habitats the proportion of untreated farmland

that can serve as alternative habitat beside the treated fields will be one of the key parameters determining

the ecological compensation potential of the landscape. The intensity of agricultural land use and also the

ecological state of agricultural landscapes can be quite different between MS. The assessment at step 3 has

to consider such specific ecological and agricultural conditions. The assessment should therefore be done

at MS level considering the ecological compensation potential of the respective landscapes but also existing

monitoring results on the conservation status of farmland species to be protected.

Conclusion of zRMS:

Based on the results of the assessment in step 1 and 2 the zRMS concludes that the use of the product

Rancona 450 FS has a low potential to cause unacceptable effects on biodiversity and the ecosystem via

trophic interaction.




calculated exposure levels for dietary exposure, according to the intended uses of the product Rancona

450 FS as seed treatment for maize. The calculated TER values do not achieve the acceptability criterion

TER ≥ 5 for long-term/reproductive effects on birds, according to Commission Regulation (EU) No

546/2011, Annex, Part I C, point 2.5.2.1. It was, however, demonstrated by a refined modelling approach

(taking into account dissipation of residues on sown treated seeds, focal species and their dietary compo-

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sition) that the application of Rancona 450 FS as seed treatment for maize at a rate of 2.85 g a.s./ha is un-

likely to provoke sustaining adverse effects on bird populations under realistic conditions. Thus, it can be

concluded that the risk for birds due to the intended use of Rancona 450 FS as seed treatment for maize

according to the label is acceptable.

It must be evaluated by Member States, whether this refined modelling approach meets the requirements

for the risk assessment with regard to their specific environmental or agricultural circumstances.




the product Rancona 450 FS as seed treatment for maize. Hence, it can be concluded that the risk for birds

due to the intended use of Rancona 450 FS as seed treatment for maize according to the label is accepta-

ble.



calculated exposure levels for exposure via secondary poisoning, according to the intended uses of the

product Rancona 450 FS as seed treatment for maize. The calculated TER values do achieve the accepta-

bility criterion TER ≥ 5 for long-term/reproductive effects on birds, according to Commission Regulation


risk for birds due to the intended use of Rancona 450 FS as seed treatment for maize according to the la-

bel.

6.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

6.3.1 Toxicity data

Mammalian toxicity studies have been carried out with Ipconazole. Full details of these studies are provided

in the respective EU DAR and related documents.

Effects on mammals of Rancona 450 FS were not evaluated as part of the EU assessment of Ipconazole.

New data submitted with this application are listed in Appendix 1 and summarised in Section 6 (Mamma-

lian Toxicology) of this report. However, the provision of further data on the formulation Rancona 450

FS is not considered essential, because the risk for mammals arising from maize seeds treated with Ran-

cona 450 FS can adequately be assessed using the available toxicity data for the active substance.


process.

Table 6.3-1: Endpoints and effect values relevant for the risk assessment for mammals


System

Results Reference

mouse ipconazole Acute toxicity LD50 = 468 mg

a.s./kg bw

EFSA Journal 2013;

11(4): 3181

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System

Results Reference

rat Crusoe’* Acute toxicity LD50 > 2000 mg

PPP/kg bw

EFSA Journal 2013;

11(4): 3181

rat Ipconazole 480 FL Acute toxicity LD50 = 3666 mg

PPP/kg bw

xxxxx 2001,

KIIIA1 7.1.1

rat ipconazole Reproductive toxicity

(2-generation test)

NOEL = 8 mg/kg bw

(NOEC = 100 mg/kg

food)

EFSA Journal 2013;

11(4): 3181

* Crusoe’ micro-emulsion seed treatment containing 15 g ipconazole/L


Not required.

6.3.2 Risk assessment for spray applications

Not relevant.

6.3.3 Risk assessment for baits, pellets, granules, prills or treated seed

6.3.3.1 First-tier assessment (screening/generic focal species)

seed treatments

The results of the acute and reproductive first-tier risk assessments are summarized in the following table.

Since Ipconazole is a systemic compound, a scenario with seedlings containing residues due to the trans-

fer of the active substance from the seeds to green plant tissue is included in the assessment. According to

EFSA/2009/1438, a transfer of 100 % from the seeds and a dilution factor of 5 are considered in the cal-

culation of the concentration in seedlings.

Table 6.3-2: First-tier assessment of the acute and long-term/reproductive risk for mam-

mals due to the use of Rancona 450 FS as a seed treatment for maize (use 003)

Intended use 003


Application rate (kg/ha) 1 x 2.85 g a.s./ha (8.136 g a.s./100 kg seed; 35 kg seeds/ha)


TER criterion 10

Food item Indicator/generic focal species FIR/bw C (mg/kg)

DDD90 (mg/kg bw/d)

TERa

Large seeds Small granivorous mammal (GD

default)

0.240 81.000 19.440 24.074

Seedlings Small omnivorous mammal (GD

default)

0.240 16.200 3.888 120.370

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Reprod. toxicity (mg/kg bw/d) 8

TER criterion 5

Food item Indicator/generic focal species FIR/bw C × TWA (mg/kg)

DDDm (mg/kg bw/d)

TERlt

Large seeds Small granivorous mammal (GD

default)

0.240 81.000* 19.440 0.412

Seedlings Small omnivorous mammal (GD

default)

0.240 8.533 2.048 3.906

TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall

below the relevant trigger.

* No TWA is considered according to DAR Ipconazole- Volume 3, Annex B.9 : Ecotoxicology “There is no generic data on

dissipation and degradation rates of active substances on treated seed. Therefore, in the first tier assessment these processes are not

considered. The appropriate exposure estimate is then the NAR x FIR/bw.”

A TER for long-term/reproductive risk below the acceptability criterion TER ≥ 5 has been calculated for

use 003. This refers to granivorous mammals. A refined risk assessment is thus necessary and docu-

mented below.


Dissipation of residues on sown treated seeds

See also chapter 6.2.3.2. Based on experimental data for dissipation of residues on sown treated seeds, a

geometric mean DT50 value of 1.36 d was calculated for Ipconazole. As described above, a twa factor for

a 10-d interval (0.195 for a DT50 of 1.36 d), which constitutes a relative worst case, was applied in the re-

fined risk assessment.

Selection of focal species

The EFSA Guidance Document (1438/2009) proposes the wood mouse (Apodemus sylvaticus) as relevant

focal species in a “bare soil” scenario. Therefore the food intake (FIR) and body weight data as well as the

mixed diet composition of this species will be used for further refinement. According to the Guidance

Document (EFSA, 2009), in a “bare soil” scenario the wood mouse has a mixed diet composed of 50%

ground arthropods and 50% weed seeds (small seeds). However, it is also known that bare soil and/or

prepared seed beds are likely to contain a natural seed bank of weeds (EFSA Guidance Document, 5.2.3),

which might be attractive for wood mouse and lead this omnivorous mammal to consume maize treated

seeds. Therefore, as worst case scenario, a proportion of 25% of maize treated seeds will be taken into

account in the diet composition of the focal species Apodemus sylvaticus. For the 50% ground arthropods

and remaining 25% weed seeds of the mixed diet, the residues per unit dose (RUD) will be set to 0. For the

active substance Ipconazole, the RUD for treated maize seeds will be set by the user to 81.36 mg a.i./ kg

seeds.

Dehusking behaviour

Concerning treated seeds, de-husking behaviour (the peeling of seeds before ingestion) of small mammals

may reduce exposure to pesticides used as treated seeds. The active substance is mainly located on the

husk and therefore de-husking can reduce the amount of active substance ingested. The applicant con-

ducted the refined risk assessment by using a dehusking factor of 0.41 which was chosen after reviewing

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two studies: xxxxx (2011)7 and DEFRA, 20108. According to the Guidance Document (EFSA, 2009),

“[…] dehusking should only be considered in higher-tier assessments with case-specific justifications.

Evidence must be provided that dehusking may actually play a role under field conditions for the relevant

focal species. […]To obtain an estimate on the actual efficiency of dehusking, studies with the relevant

focal species, the relevant seed type and the relevant product are preferable, […]”. Although both studies

cited by the applicant were conducted with wood mice and maize, the studies were not conducted under

field conditions and in both studies maize seeds were not treated with a pesticide, but with pigments only.

Therefore, zRMS considers the dehusking behavior only as supplemental information, even though

dehusking is a natural behaviour of small mammals.

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the

use group A also addresses the risk for mammals from all other intended uses in groups B (see 6.1.2).

Since seedlings pose a lower risk to mammals than the seeds (see Tables 6.3-2 and 6.3-3), the risk assess-

ment for mammals feeding on seeds covers also the risk of mammals feeding on seedlings.

Table 6.3-3: Higher-tier assessment of the long-term/reproductive risk for mammals due to

the use of Rancona 450 FS in maize (use 003) – refined parameters (*) are fur-

ther described and justified in the text

Intended use 003


Application rate (g/ha) 1 x 2.85 g a.s./ha (8.136 g a.s./100 kg seed; 35 kg seeds/ha)


TER criterion 5

Focal species Food category,

% in diet

FIR/bw RUD (mg/kg food)

MAFm ×

TWA

PT DDDm (mg/kg bw/d)

TERlt

Apodemus sylvaticus* Maize seeds, 25 % 0.06 81.36 a) 0.195*

b) 0.093*

1 1.052 7.6

ground arthropods,

50 %

0.13 0 - 1 - -

weed seeds, 25 % 0.06 0 - 1 - -

FIR/bw: Food intake rate per body weight; RUD: residue unit dose; MAF: multiple application factor; DDD: daily dietary dose;

TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.

6.3.3.3 Drinking water exposure

When necessary, the assessment of the risk for mammals due to uptake of contaminated drinking water is

conducted for a small omnivorous mammal with a body weight of 21.7 g (Apodemus sylvaticus) and a

drinking water uptake rate of 0.24 L/kg bw/d (cf. Appendix K of EFSA/2009/1438).

7 xxxxx (2011): Exposure reduction of seed treatments through dehusking behaviour of the wood mouse (Apodemus

sylvaticus). Environmental Science and Pollution Research International, 18, 31-37. 8 DEFRA (2010): Dehusking of seed by small mammals - default values for use in risk assessment. Pp. 1-29, DE-

FRA

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Puddle scenario


uptake by animals, no specific calculations of exposure and TER are necessary when the ratio of effective

application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive

substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg).

With a K(f)oc of 2431, Ipconazole belongs to the group of more sorptive substances. To achieve a concise

risk assessment, the risk envelope approach is applied. Here, the assessment for the use group A also covers

the risk for mammals from all other intended uses in groups B (see 6.1.2).

Effective application rate (g/ha) = 2.85

Acute toxicity (mg/kg bw) = 468 quotient = 0.006

Reprod. toxicity (mg/kg bw/d) = 8 quotient = 0.4

6.3.3.4 Effects of secondary poisoning

The log Pow of Ipconazole amounts to 4.65 (worst-case value for cis-isomer) and thus exceeds the trigger

value of 3. A risk assessment for effects due to secondary poisoning is required.

Risk assessment for earthworm-eating mammals via secondary poisoning

According to EFSA/2009/1438, the risk for vermivorous mammals is assessed for a small mammal of 10 g

body weight with a daily food consumption of 12.8 g. Bioaccumulation in earthworms is estimated based

on predicted concentrations in soil.

Table 6.3-4: Assessment of the risk for earthworm-eating mammals due to exposure to Ip-

conazole via bioaccumulation in earthworms (secondary poisoning) for the in-

tended use in maize (use 003)


PECsoil (twa = 21 d) (mg/kg soil) 0.004 1 × 2.85 g/ha, interception 0%, soil layer depth 5

cm,

DT50 = 391 d, twa interval = 21 d, with

accumulation

log Pow / Pow 44668 log Pow = 4.65

Koc 2431 mean (n = 6)

foc 0.02 default

BCFworm 11.042 BCF-worm/soil = (PEC-worm,ww / PEC-soil,dw)

= (0.84 + 0.012 × Pow) / (foc × Koc)

PECworm 0.041 PEC-worm = PEC-soil × BCF-worm

Daily dietary dose (mg/kg bw/d) 0.052 DDD = PEC-worm × 1.28

NOEL (mg/kg bw/d) 8 Rat, multi-generation

TERlt 153.0 ≥ 5, acceptable risk


Risk assessment for fish-eating mammals via secondary poisoning

According to EFSA/2009/1438, the risk for piscivorous mammals is assessed for a mammal of 3000 g body

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weight with a daily food consumption of 425 g. Bioaccumulation in fish is estimated based on predicted

concentrations in surface water / is based on the regulatory acceptable concentration for aquatic organisms

as a limit value for admissible concentrations of Ipconazole in water.

Table 6.3-5: Assessment of the risk for fish-eating mammals due to exposure to Ipconazole

via bioaccumulation in fish (secondary poisoning) for the intended use in

maize (use 003)


PEC-sw, twa (mg/L) - EU

default

0.000539 1 × 2.85 g/ha, FOCUS Step 1,

DT50 = 1000 d, twa interval = 21 d

BCF-fish 1000 whole fish

BMF 1 biomagnification factor (relevant for BCF ≥ 2000)

PEC-fish 0.539 PEC-fish = PEC-sw × BCF-fish × BMF

Daily dietary dose

(mg/kg bw/d/d)

0.076 DDD = PEC-fish × 0.142

NOEL

(mg/kg bw/d)

8 Rat, multi-generation

TER-lt 104.6 ≥ 5, acceptable risk


6.3.3.5 Biomagnification in terrestrial food chains

Not relevant.




and calculated exposure levels for dietary exposure, according to the intended uses of the product Ran-

cona 450 FS as seed treatment for maize. Taking into account refined model parameters (dissipation of

residues on sown treated seeds) and a focal species (wood mouse), the calculated TER values do achieve

the acceptability criteria TER ≥ 10 for acute effects and TER ≥ 5 for long-term/reproductive effects on

mammals, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.1. The

results of the assessment indicate an acceptable risk for mammals due to the intended use of Rancona 450

FS as seed treatment for maize according to the label.




the product Rancona 450 FS as seed treatment for maize. Hence, it can be concluded that the risk for

mammals due to the intended use of Rancona 450 FS as seed treatment for maize according to the label is

acceptable.

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and calculated exposure levels for exposure via secondary poisoning, according to the intended uses of

the product Rancona 450 FS as seed treatment for maize. The calculated TER values do achieve the ac-

ceptability criterion TER ≥ 5 for long-term/reproductive effects on mammals, according to Commission

Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.1. The results of the assessment indicate an

acceptable risk for mammals due to the intended use of Rancona 450 FS as seed treatment for maize ac-

cording to the label.

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP

10.1.3)

No data submitted, no assessment triggered.

6.5 Effects on aquatic organisms (KCP 10.2)

6.5.1 Toxicity data

Studies on the toxicity to aquatic organisms have been carried out with Ipconazole. Full details of these

studies are provided in the respective EU DAR and related documents.

Effects on aquatic organisms of Rancona 450 FS were not evaluated as part of the EU assessment of Ipcon-

azole. No new data were submitted with this application.


process. The only exception is that exposure following dust drift deposition was not considered in the EU

assessment. As for seed treatments exposure following dust drift deposition is a relevant route of exposure

to surface water and off-field habitats, this pathway should be considered. Therefore, a risk assessment

following dust drift deposition was conducted according to the draft "Guidance Document on the Authori-

zation of Plant Protection Products for Seed Treatment” (SANCO/10553/2012, January 2014).

Table 6.5-1: Endpoints and effect values relevant for the risk assessment for aquatic organ-

isms – Ipconazole and relevant metabolites


System

Results Reference

fish

Oncorhynchus mykiss Ipconazole 96 h, f LC50 = 1.5

mg a.s./L mm

EFSA Journal

2013;11(4):3181

Lepomis macrochirus Ipconazole 96 h, f LC50 = 1.3

mg a.s./L mm

EFSA Journal

2013;11(4):3181

Pimephales promelas Ipconazole 32 d (ELS), f NOEC = 0.00044

mg a.s./L mm

EFSA Journal

2013;11(4):3181

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System

Results Reference

Oncorhynchus mykiss Crusoe’* 96 h, f LC50 = 0.977

mg PPP/L mm

EFSA Journal

2013;11(4):3181

fish 1,2,4-triazole 96 h LC50 = 498 mg/L EFSA Journal

2013;11(4):3181;

PRAPeR expert

meeting 13 (2007)

fish 1,2,4-triazole NOEC = 3.2 mg/L EFSA Journal

2013;11(4):3181;

PRAPeR expert

meeting 13 (2007)

Aquatic invertebrates

Daphnia magna Ipconazole 48 h, f EC50 = 1.7

mg a.s./L mm

EFSA Journal

2013;11(4):3181

Daphnia magna Ipconazole 21 d, s NOEC = 0.0109

mg a.s./L mm1

EFSA Journal

2013;11(4):3181

Daphnia magna Crusoe’ 48 h, s EC50 = 95.7

mg PPP/L mm

(1.33 mg a.s./L)

EFSA Journal

2013;11(4):3181

Aquatic invertebrate 1,2,4-triazole 48 h EC50 > 100 mg/L EFSA Journal

2013;11(4):3181;

PRAPeR expert

meeting 13 (2007)

Sediment dwelling organisms

Chironomus riparius Ipconazole 28 d, spiked water, s NOEC = 3.52

mg a.s./L nom

(heighest dose tested;

emergence

and development

rate)

EFSA Journal

2013;11(4):3181

Algae

Pseudokirchneriella

subcapitata

Ipconazole 72 h, s ErC50 > 2.2

mg a.s./L mm

EbC50 = 0.62

mg a.s./L mm

EFSA Journal

2013;11(4):3181

Pseudokirchneriella

subcapitata

Crusoe’ 72 h, s ErC50 = 185

mg PPP/L mm (2.57

mg a.s./L)

EbC50 = 45.6

mg PPP/L mm (0.634

mg a.s./L)

EFSA Journal

2013;11(4):3181

Algae 1,2,4-triazole EbC50 = 8.2 mg/L

ErC50 = 22.5 mg/L

EFSA Journal

2013;11(4):3181;

PRAPeR expert

meeting 13 (2007)

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System

Results Reference

Higher-tier studies (micro- or mesocosm studies)

No data available - Not required.

s: static; ss: semi-static; f: flow-through; nom: based on nominal concentrations; mm: based on mean measured concentrations;

im: based on initial measured concentrations * Crusoe’ micro-emulsion seed treatment containing 15 g ipconazole/L 1 Based on the arithmetic mean concentration


Not required.

6.5.2 Risk assessment

The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with

the recommendations of the “Guidance document on tiered risk assessment for plant protection products

for aquatic organisms in edge-of-field surface waters in the context of Regulation (EC) No 1107/2009”, as

provided by the Commission Services (SANTE-2015-00080, 15 January 2015).

The relevant global maximum FOCUS Step 1, 2 and 3 PECSW for risk assessments covering the proposed

use pattern and the resulting PEC/RAC ratios are presented in the table below.

The intended use is a seed treatment, therefore exposure of surface water and off-field habitats by the active

substance Ipconazole due to dust drift has to be considered as well. Hence, in addition to the calculation of

PECsw according to FOCUS, estimates for concentrations in surface water bodies following dust drift dep-

osition are presented.

In regard to dust drift it is stated in SANCO/10553/2012, January 2014: “The active substance content (in

% a.s.) in Heubach dust released from treated seeds is deemed to be determined by the active substance

dose applied per seed unit. However, the data base available up to now does not allow for this general

conclusion. A relationship between dose applied and content of a.s. in dust can only be seen when the

dressing technique is rather simple (e.g. for cereals, see Figure A- 5 in Appendix III). However, when the

coating process is rather complex, as for example in maize, the relationship between dose applied and

a.s. content is fogged by other parameters (e.g. seed variety, seed coating and cleaning, use of sticker,

colours etc., subsequent dressing of several products and additives). No relationship is evident between

Heubach values (g dust/ha) and active substance content of the dust (a.s. %). This means that the percent-

age of active substance in the dust does not change as a function of the amount of abraded dust (see Ap-

pendix III). Moreover, when lowest feasible Heubach values for a specific seed crop are approached,

technical limits might lead to high concentration of active substance in the remaining dust.

From the considerations above it must be concluded that no general, constant relationships can be de-

scribed between dust amounts (Heubach values) and the active substance contents (%) in dust from

treated seeds on the one hand and the seed dressing or field application rates on the other hand. This has

further significant implications for the assessment of the risk arising from the sowing of treated seeds,

since the seed quality parameter ‘Heubach value’ (g dust/ha) and ‘active substance content’ (a.s. % in

dust) do drive the deposition rates of active substances in the off-field, and not the application rate in-

field”. Therefore, the risk assessment regarding dust drift is independent of use group/active substance

content in treated maize seeds.

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In the following table, the ratios between predicted environmental concentrations in surface water bodies (PECSW) and regulatory acceptable concentrations (RAC) for

aquatic organisms are given per intended use for each FOCUS scenario and each organism group.

Table 6.5-2: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for Ipconazole for each organism group based on FOCUS Steps 1, 2 and 3

calculations for the use of Rancona 450 FS in maize (use 003); exposed to the active substance via the soil as a result from run off and

drainage or dust drift

Group Fish acute Fish prolonged Inverteb. acute Inverteb. pro-

longed Algae

Sed. dwell. pro-

longed

Test species Lepomis macrochirus Pimephales promelas Daphnia magna Daphnia magna Pseudokirchn. subcapi-

tata Chironomus riparius

Endpoint LC50 NOEC EC50 NOEC EbC50 NOEC

(µg/L) 1300 0.44 1700 10.9 620 3520

AF 100 10 100 10 10 10

RAC (µg/L) 13 0.044 17 1.09 62 352

FOCUS Scenario PEC glb-max

(µg/L)

Step 1

0.5501 0.042 12.502 0.032 0.505 0.009 0.002

Step 2

N-Europe 0.2719 0.021 6.18 0.016 0.249 0.004 0.001

S-Europe 0.2175 0.017 4.943 0.013 0.2 0.004 0.001

Step 3

D1/ditch <0.000001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

D1/stream <0.000001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

D3/ditch <0.000001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

D4/pond <0.000001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

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longed Algae

Sed. dwell. pro-

longed

D4/stream 0.000003 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

D5/pond <0.000001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

D5/stream Failed - - - - - -

R4/stream 0.043 0.003 0.977 0.003 0.039 0.001 <0.001

Dust drift

PECdustdrift (worst-

case*) 0.5 0.038 11.364 0.029 0.459 0.008 0.001

PECdustdrift

(reference

value**)

0.177 0.014 4.023 0.01 0.162 0.003 0.001

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

* worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of available data (see background document of the draft "Guidance Document on

the Authorization of Plant Protection Products for Seed Treat-ment”, Appendix II for list of studies)

** European or national regulation/ requirements are in place that prescribe a quality standard for maize seeds

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drainage and dust drift simultaneously (worst case*)


longed Algae

Sed. dwell. pro-

longed




(µg/L) 1300 0.44 1700 10.9 620 3520

AF 100 10 100 10 10 10

RAC (µg/L) 13 0.044 17 1.09 62 352

FOCUS Scenario PEC glb-max +

dust drift (µg/L)

Step 1

1.0501 0.081 23.866 0.062 0.963 0.017 0.003

Step 2

N-Europe 0.7719 0.059 17.543 0.045 0.708 0.012 0.002

S-Europe 0.7175 0.055 16.307 0.042 0.658 0.012 0.002

Step 3

D1/ditch 0.5 0.038 11.364 0.029 0.459 0.008 0.001

D1/stream 0.5 0.038 11.364 0.029 0.459 0.008 0.001

D3/ditch 0.5 0.038 11.364 0.029 0.459 0.008 0.001

D4/pond 0.5 0.038 11.364 0.029 0.459 0.008 0.001

D4/stream 0.5 0.038 11.364 0.029 0.459 0.008 0.001

D5/pond 0.5 0.038 11.364 0.029 0.459 0.008 0.001

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longed Algae

Sed. dwell. pro-

longed

D5/stream 0.5 0.038 11.364 0.029 0.459 0.008 0.001

R4/stream 0.549 0.042 12.48 0.032 0.504 0.009 0.002


* worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of available data (see background document of the draft "Guidance Document on

the Authorization of Plant Protection Products for Seed Treat-ment”, Appendix II for list of studies)



drainage and dust drift simultaneously (reference value*)


longed Algae

Sed. dwell. pro-

longed




(µg/L) 1300 0.44 1700 10.9 620 3520

AF 100 10 100 10 10 10

RAC (µg/L) 13 0.044 17 1.09 62 352


dust drift (µg/L)

Step 1

0.7271 0.056 16.525 0.043 0.667 0.012 0.002

Step 2

N-Europe 0.4489 0.035 10.202 0.026 0.412 0.007 0.001

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longed Algae

Sed. dwell. pro-

longed

S-Europe 0.3945 0.03 8.966 0.023 0.362 0.006 0.001

Step 3

D1/ditch 0.177 0.014 4.023 0.01 0.162 0.003 0.001

D1/stream 0.177 0.014 4.023 0.01 0.162 0.003 0.001

D3/ditch 0.177 0.014 4.023 0.01 0.162 0.003 0.001

D4/pond 0.177 0.014 4.023 0.01 0.162 0.003 0.001

D4/stream 0.177 0.014 4.023 0.01 0.162 0.003 0.001

D5/pond 0.177 0.014 4.023 0.01 0.162 0.003 0.001

D5/stream 0.177 0.014 4.023 0.01 0.162 0.003 0.001

R4/stream 0.22 0.017 5 0.013 0.202 0.004 0.001


* European or national regulation/ requirements are in place that prescribe a quality standard for maize seeds

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drainage and dust drift simultaneously (Product specific PEC-values*)


longed Algae

Sed. dwell. pro-

longed




(µg/L) 1300 0.44 1700 10.9 620 3520

AF 100 10 100 10 10 10

RAC (µg/L) 13 0.044 17 1.09 62 352


dust drift (µg/L)

Step 1

0.576 0.0443 13.0909 0.0339 0.5284 0.0093 0.0016

Step 2

N-Europe 0.298 0.0229 6.7727 0.0175 0.2734 0.0048 0.0008

S-Europe 0.244 0.0188 5.5455 0.0144 0.2239 0.0039 0.0007

Step 3

D1/ditch 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

D1/stream 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

D3/ditch 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

D4/pond 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

D4/stream 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

D5/pond 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

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longed Algae

Sed. dwell. pro-

longed

D5/stream 0.026 0.0020 0.5909 0.0015 0.0239 0.0004 0.0001

R4/stream 0.075 0.0059 1.7045 0.0044 0.0688 0.0012 0.0002


* for details please refer to table 5.9-8

Table 6.5-6: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for 1,2,4-triazole for each organism group based on FOCUS Steps 1 and 2

calculations for the use of Rancona 450 FS in maize (use 003)

Group Fish acute Fish prolonged Inverteb. acute Algae

Test species Lepomis macrochirus Pimephales promelas Daphnia magna Pseudokirchn. subcapitata

Endpoint LC50 NOEC EC50 EbC50

(µg/L) 498000 3200 100000 8200

AF 100 10 100 10

RAC (µg/L) 4980 320 1000 820

FOCUS Scenario PEC glb-max (µg/L)

Step 1

0.1023 <0.001 <0.001 <0.001 <0.001

Step 2

N-Europe 0.0195 <0.001 <0.001 <0.001 <0.001

S-Europe 0.0391 <0.001 <0.001 <0.001 <0.001


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It is obvious from the tabulated PEC/RAC ratios that at least the nominal risk for aquatic organisms is de-

termined alone by the long-term toxicity of Ipconazole to fish in the ELS test and an exposure via dust

drift. For the intended use 003, calculated PEC/RAC ratios did indicate an acceptable risk for the most

sensitive group of aquatic organisms (chronic risk for fish from Ipconazole as characterized by a NOEC

for Pimephales promelas of 0.44 µg/L in connection with an assessment factor of 10) in FOCUS Step 3

scenarios according to run off. Contrary, the PEC/RAC ratios for dust drift exposure to Ipconazole exceed

1 (11.4 for worst case, 4.0 for reference value).

Product specific PEC values have been calculated. Considering these values the FOCUS step 3 risk assess-

ment shows an acceptable risk for all cases with the exception of R4/stream.

Since the risk assessment is only acceptable if product specific Heubach-values and the resulting PECs are

taken into account. Therefore it must be ensured that the treated seed meets the respective quality. The

amount of abraded dust must not exceed 0.05 g Ipconazole per 100.000 seeds, otherwise unacceptable risks

to the environment are to be expected.


Risk ratios of predicted environmental versus regulatory acceptable concentrations (PEC/RAC) for

aquatic organisms were calculated. Calculated exposure concentrations in surface water bodies, according

to the intended uses of the product Rancona 450 FS as seed treatment for maize were considered in the

exposure term. The regulatory acceptable concentration (RAC) is obtained by division of the relevant tox-

icity data for Ipconazole by an assessment factor of 100 for acute effects and 10 for chronic effects on

aquatic organisms.

The calculated risk ratios do achieve the acceptability criterion PEC/RAC ≤ 1 for aquatic organisms ex-

posed to Ipconazole via dust drift, as derived from the prescriptions in Commission Regulation (EU) No

546/2011, Annex, Part I C, point 2.5.2.2 and when considering product specific PEC values. The results

of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of Rancona

450 FS as seed treatment for maize according to the label.

6.6 Effects on bees (KCP 10.3.1)

Effects on bees of Rancona 450 FS were not evaluated as part of the EU review of ipconazole. Therefore,

all relevant data and assessments are provided here and are considered adequate.

Toxicity

Table 6.6-1 presents the results of laboratory bee toxicity studies with the active substance.

Table 6.6-1: Results of laboratory bee toxicity studies

Test sub-

stance

Exposure

route

LD50 Reference

oral 48 h > 100 µg a.s./bee * Conclusion on the peer review

of the pesticide risk assessment

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ipconazole

tech. contact 48 h > 100 µg a.s./bee *

of the active substance ipcona-

zole; EFSA Journal 2013;

11(4):3181

* EU agreed endpoint

Exposure

The formulation Rancona 450 FS (ipconazole 452 g/L) is a maize seed treatment formulation and applied

to the soil at a rate of up to 0.0063 L product/ha. This maximum single application rate is equivalent to

6.9 g product/ha (2.85 g a.s./ha).

Due to the type of application, direct oral or contact exposure to bees with the formulation can be ex-

cluded. However, bees may be exposed to residues from systemic compounds, present in nectar, pollen or

drift of dust during drilling. But this exposure is considered to be far below a spray application at similar

rates.

Hazard quotients

Due to the type of formulation as a seed treatment, calculation of hazard quotients according to EPPO En-

vironmental Risk Assessment Scheme does not seem to be appropriate.

Risk assessment

Rancona 450 FS is considered to be practically non-toxic to bees, due to results of laboratory tests with

the active substances. In addition, exposure to bees with Rancona 450 FS can widely be excluded due to

the type of formulation as a seed treatment.

Bee brood testing is not required since the test item is not an IGR.

Overall conclusion:

It is concluded that Rancona 450 FS will not adversely affect bees or bee colonies when used as recom-

mended.

6.7 Effects on arthropods other than bees (KCP 10.3.2)

6.7.1 Toxicity data

Studies on the toxicity to non-target arthropods have been carried out with representative formulations of

Ipconazole. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on non-target arthropods organisms of Rancona 450 FS were not evaluated as part of the EU as-

sessment of Ipconazole. New data submitted with this application are listed in Appendix 1 and summa-

rized in Appendix 2.

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Table 6.7-1: Endpoints and effect values relevant for the risk assessment for non-target ar-

thropods


System

Results Reference

Typhlodromus pyri

‘CA11F317L’

SL formulation with

9.21% w/w

ipconazole

Laboratory test

glass plates (2D) LR50 = 17.4 g/ha

ER50 > 16 g/ha

(31 % eff.)

EFSA Journal 2013;

11(4): 3181

Aphidius

rhopalosiphi

(adults)

‘CA11F317L’

SL formulation with

9.21% w/w

ipconazole

Laboratory test

glass plates (2D) LR50 = 35.1 g/ha

ER50 = 15.3 g/ha

EFSA Journal 2013;

11(4): 3181

Pardosa spp.1

(adults)

Crusoe’ treated wheat

seed (micro-emulsion

seed treatment

containing 15 g

ipconazole/L)

Sowing rate of 30

seeds/64 cm2

(equivalent to 3500

kg seed/ha); 1.81 g

a.s./100 kg seed

Compared to

unseeded control:

Mortality: 11.5%

Mean prey

consumption: 1%

reduction

EFSA Journal 2013;

11(4): 3181

Aleochara

bilineata

Crusoe’ treated wheat

seed (micro-emulsion

seed treatment

containing 15 g

ipconazole/L)

Sowing rate of 90

seeds/176 cm2

(equivalent to 3500

kg seed/ha) 1.81 g

a.s./100 kg seed

Compared to the

seeded control

Reduction in

reproduction: 11%

EFSA Journal 2013;

11(4): 3181

Pardosa spp. 1 UBI 4336:0

(=Rancona 450 FS)

treated maize seed

Sowing rate of 1 or

2 seeds/64 cm²

(equivalent to 500,

and 1000 kg

seed/ha; 37.75 and

75.5 g a.s./ha)

No effect at 500 kg

seeds/ha;

At 1000 kg seeds/ha:

Mortality: 19.4%

Mean prey

consumption: 0.47%

reduction (compared

to unseeded control)

Gray, J. (2009)

KIIIA1 10.5.2/01

Aleochara bilineata Rancona 450 FS

treated maize seed Sowing rate of 1, 3

or 6 seeds/176 cm²

(equivalent to 180,

540 and 1080 kg

seed/ha; 13.5, 40.5

and 81 g a.s./ha )

No reduction in mean

number of 2nd

genertaion adults

compared to control

at any concentration

Gray, J. (2010)

KIIIA1 10.5.2/02

Apis mellifera Ipconazole Contact LD50 > 100 µg

a.s./bee

EFSA Journal 2013;

11(4): 3181

Apis mellifera Ipconazole Oral LD50 > 100 µg

a.s./bee

EFSA Journal 2013;

11(4): 3181 1 Validity criterion for control mortality was not met

Justification for new endpoints

Not required.

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The evaluation of the risk for non-target arthropods was performed in accordance with the recommenda-

tions of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services

(SANCO/10329/2002 rev.2 (final), October 17, 2002), and in consideration of the recommendations of the

guidance document ESCORT 2. However, no specific guidance for assessing the impact of seed treatments

on non-target arthropods is provided in those documents, but reference is made to earlier guidance: “For

the time being the recommendations of ESCORT 1 should be followed, i.e. seed coatings, pellets, and baits

should be tested on two appropriate species, e.g. spiders and ground dwelling beetles.”

6.7.2.1 Risk assessment for in-field exposure (seed treatments)

As mentioned in the ESCORT 2 report, calculation of HQ values or similar risk indicators is not appropri-

ate in an in-field risk assessment for seed treatments. Instead, nominal application rates of the product

Rancona 450 FS are directly compared to results from tests with Pardosa spp. and Aleochara bilineata,

where exposure was realized by sowing treated maize seeds in the soil of the test boxes.

Table 6.7-2: First- and higher-tier assessment of the off-field risk for non-target arthro-

pods due to the use of Rancona 450 FS as seed treatment in maize (use 003)

Intended use 003

Active substance/product Rancona 450 FS (452 g/L Ipconazole)

Application rate (g/ha) 3.6 mL/ha (2.85 g a.s./ha)

MAF 1

Test species

Tier I

Rate with ≤ 30 % effect*

(g/ha)

PERin-field

(g/ha)

PERin-field below rate with

≤ 30 % effect?

Pardosa spp. 75.5 2.85 yes

Aleochara bilineata 81.0 2.85 yes

MAF: Multiple application factor; PER: Predicted environmental rate. Criteria values shown in bold breach the relevant trigger.

* 30-% effect criterion for acceptability according to ESCORT 1, still referred to in Uniform Principles, Commission

Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.4

6.7.2.2 Risk assessment for off-field exposure (seed treatments)

Arthropods in field border structures can be exposed to residues of Ipconazole due to deposition of

abraded dust from maize seeds during sowing. Incidents after sowing of seeds treated with insecticides

have shown that this exposure pathway cannot be neglected in a risk assessment. A respective assessment

is performed based on estimates for dust drift deposition in off-field areas according to the “Draft Guid-

ance Document on Authorisation of Plant Protection Products for Seed Treatment” (SANCO/10553/2012,

January 2014). However, since the current data requirements for seed treatments primarily aim at soil-

dwelling arthropods in the in-field area, only limited data to support an off-field assessment are available

for Ipconazole, which is approved as active substances for seed treatment uses. To obtain an approximate

estimate of the potential for adverse effects coming from dust drift deposits of Ipconazole, the available

information is thus interpreted and used as follows. The endpoints for foliar dwelling arthropods (Typh-

lodromus pyri and Aphidius rhopalosiphi) were used for calculation of the TER3D dust as described in

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SANCO/10553/2012, January 2014. Since the soil-dwelling arthropods Pardosa spp. and Aleochara bi-

lineata were tested additionally with Ipconazole treated seeds, the TER trigger value is reduced from 10

to 5.

It is assumed in the empirically-derived approach of SANCO/10553/2012, January 2014 that the amount

of abraded and deposited active substance per sown seed unit is not dependent on the active-substance

concentration on treated seeds, but takes a certain constant value for each seed type.

Experimental data have shown that dust drift particles abraded from treated seeds during sowing are ef-

fectively filtered out by 3-dimensional plant structures in the vicinity of a field; hence a factor for residue

accumulation in such 3-dimensional plant structures is applied, as defined in SANCO/10553/2012, Janu-

ary 2014. For further information please refer to dRR PartB Section 5.

The TER3D dust was calculated as follows (SANCO/10553/2012, January 2014):

�� = � �� !� �. #. ℎ�⁄ &

'�(�� )*�� !� �. #. ℎ�⁄ &

where

TER = Toxicity to Exposure Ratio


PEC 3D dust deposition = Predicted Environmental Concentration after deposition of

abraded dust in adjacent 3-dimensional structures

Table 6.7-3: First -tier assessment of the off-field risk for non-target arthropods due to the

use of Rancona 450 FS as seed treatment in maize (extrapolation factor = 13;

according to SANCO/10553/2012, January 2014)

Test species

Tier I

LR50 (g/ha) PEC 3D TER trigger TER

Typhlodromus pyri 17.4 Worst case:

19.5 5

0.89

Aphidius rhopalosiphi 35.1 1.80

Typhlodromus pyri 17.4 Reference

value:

6.89

5 2.53


Typhlodromus pyri 17.4 Product

specific:

1.02

5

17.06


PEC 3D: Predicted Environmental Concentration after deposition of abraded dust in adjacent 3-dimensional structures; TER

values shown in bold fall below the relevant trigger.

6.7.2.3 Additional higher-tier risk assessment

Not required.

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In-field

Risk indicator values for non-target arthropods in treated areas were calculated, taking into account the

relevant toxicity data for Rancona 450 FS and estimated in-field exposure levels, according to the in-

tended uses of the product Rancona 450 FS as seed treatment for maize. The calculated indicator values

of less than 30 % effect level for effects on non-target arthropods, according to agreed EU Guidance in

Document SANCO/10329/2002 rev 2 that overrides the prescriptions of Commission Regulation (EU) No

546/2011, Annex, Part I C, point 2.5.2.4. The results of the assessment indicate an acceptable risk for

non-target arthropods in treated areas due to the intended use of Rancona 450 FS as seed treatment for

maize according to the label.

Off-field

Risk indicator values for non-target arthropods in off-field habitats were calculated, taking into account

the relevant toxicity data for Ipconazole and calculated exposure concentrations in off-field habitats, ac-

cording to the intended uses of the product Rancona 450 FS as seed treatment for maize. The calculated

indicator values do achieve the acceptability criterion TER ≥ 5 for effects on non-target arthropods, ac-

cording to agreed EU Guidance in Document SANCO/10329/2002 rev 2 that overrides the prescriptions

of Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.4, if product specific data are

taken into account. The results of the assessment indicate an acceptable risk for non-target arthropods in

off-field habitats due to the intended use of Rancona 450 FS as seed treatment for maize according to the

label.




risks to the environment are to be expected.

6.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

6.8.1 Toxicity data

Studies on the toxicity to earthworms and other non-target soil organisms (meso- and macrofauna) have

been carried out with Ipconazole and its relevant metabolites. Full details of these studies are provided in

the respective EU DAR and related documents.

Effects on earthworms and other non-target soil organisms (meso- and macrofauna) of Rancona 450 FS

were not evaluated as part of the EU assessment of Ipconazole. The applicant did not submit further data

on the formulation, because the EU risk assessments for Ipconazole resulted in acceptable risks with a

sufficient margin of safety. The selection of studies and endpoints for the risk assessment is thus intended

to be in line with the results of the EU review process.

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Table 6.8-1: Endpoints and effect values relevant for the risk assessment for earthworms

and other non-target soil organisms (meso- and macrofauna)


System

Results Reference

Eisenia fetida Ipconazole Mixed into substrate

14 d, acute

10 % peat content

LC50 = 597 mg/kg dw

LC50,corr = 298.5

mg/kg dw*

EFSA Journal 2013;

11(4): 3181

Eisenia fetida Ipconazole Mixed into substrate

56 d

10 % peat content

NOEC = 0.78

mg/kg dw

NOECcorr = 0.39

mg/kg dw*

EFSA Journal 2013;

11(4): 3181

Eisenia fetida 1,2,4-triazole acute LC50 > 1000

mg/kg dw

EFSA Journal 2013;

11(4): 3181

Eisenia fetida 1,2,4-triazole chronic NOEC = 1.0

mg/kg dw

EFSA Journal 2013;

11(4): 3181

Folsomia candida 1,2,4-triazole chronic NOEC = 0.18

mg/kg dw

EFSA Journal 2013;

11(4): 3181

* Corrected value derived by dividing the endpoint by a factor of 2 in accordance with the EPPO earthworm scheme 2002.


Not required.


The evaluation of the risk for earthworms and other non-target soil organisms (meso- and macrofauna) was

performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicol-

ogy”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

6.8.2.1 First-tier risk assessment

The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section 5 (En-

vironmental Fate), Chapter 5.7.2, Table 5.7-3. According to the assessment of environmental-fate data,

multi-annual accumulation in soil is considered for Ipconazole.

Table 6.8-2: First-tier assessment of the acute and chronic risk for earthworms and other

non-target soil organisms (meso- and macrofauna) due to the use of Rancona

450 FS in maize (use 003)

Intended use 003

Acute effects on earthworms

Product/active substance LC50

(mg/kg dw)

PECsoil

(mg/kg dw)**

TERa

(criterion TER ≥ 10)

Ipconazole 298.5* 0.0048 62188

1,2,4-triazole > 1000 0.0009 >1111111

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Chronic effects on earthworms

Product/active substance NOEC

(mg/kg dw)

PECsoil

(mg/kg dw) **

TERlt


Ipconazole 0.39* 0.0048 81.3

1,2,4-triazole 1.0 0.0009 1111.1

Chronic effects on other soil macro- and mesofauna


(mg/kg dw)

PECsoil

(mg/kg dw) **

TERlt


1,2,4-triazole 0.18 0.0009 200



** taking into account accumulation in soil


Not relevant.


Earthworms



FS as seed treatment for maize. The calculated TER values do achieve TER ≥ 10 for acute effects / the

acceptability criterion TER ≥ 5 for chronic effects on earthworms, according to Commission Regulation


risk for earthworms due to the intended use of Rancona 450 FS as seed treatment for maize according to

the label.



relevant toxicity data for 1,2,4-triazole and calculated exposure concentrations in soil, according to the







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6.9 Effects on soil microbial activity (KCP 10.5)

6.9.1 Toxicity data

Studies on effects soil microorganisms have been carried out with Ipconazole and its relevant metabolites.

Full details of these studies are provided in the respective EU DAR and related documents as well as in

Appendix 2 of this document (new studies).

Effects on soil microorganisms of Rancona 450 FS were not evaluated as part of the EU assessment of

ipconazole or imazalil. The applicant did not submit further data on the formulation, because a study with

ipconazole applied at rates of up to 2160 g a.s./ha had no effect on nitrogen and carbon transformation in

soil. This application rate is about 750 times higher than the nominal application rate of 2.85 g a.s/ha Ip-

conazole on treated wheat seeds. The applicant thus proposes that proposed Ipconazole has a low risk on

soil microbial activity when the product Rancona 450 FS is applied as seed treatment for maize according

to the label. The zRMS can agree that the non-submission of studies on the toxicity to soil microorgan-

isms of the product Rancona 450 FS is thus acceptable.

The selection of studies and endpoints for the risk assessment is thus in line with the results of the EU re-

view process.

Table 6.9-1: Endpoints and effect values relevant for the risk assessment for soil microor-

ganisms

Endpoint Substance Exposure

System

Results Reference

N-mineralisation Ipconazole 28 d, aerobic Nitrate formation

2.88 mg/kg soil dw

-17.08 %

EFSA Journal 2013;

11(4): 3181

C-mineralisation Ipconazole 28 d, aerobic CO2 formation

2.88 mg/kg soil dw

+16.3 %

EFSA Journal 2013;

11(4): 3181


Not required.


The evaluation of the risk for soil microorganisms was performed in accordance with the recommendations

of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services

(SANCO/10329/2002 rev 2 (final), October 17, 2002).


vironmental Fate), Chapter 5.7.2, Table 5.7-3 and were already used in the risk assessment for earthworms

and other non-target soil organisms (meso- and macrofauna) (see 6.8).

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Table 6.9-2: Assessment of the risk for effects on soil micro-organisms due to the use of

Rancona 450 FS in maize (use 003)

Intended use 003

N-mineralisation

Product/active substance Max. conc. with effects

≤ 25 % (mg/kg dw)

PECsoil

(mg/kg dw)

Risk acceptable?

Ipconazole 2.88 (at 28 d) 0.0048 yes

C-mineralisation

Product/active substance Max. conc. with effects

≤ 25 % (mg/kg dw)

PECsoil

(mg/kg dw)

Risk acceptable?

Ipconazole 2.88 (at 28 d) 0.0048 yes





no exceedance of the acceptability criterion ≤ 25 % effects on soil microorganisms, according to Commis-

sion Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.6. The results of the assessment indicate

an acceptable risk for soil microorganisms due to the intended use of Rancona 450 FS as seed treatment


6.10 Effects on non-target terrestrial plants (KCP 10.6)





is required.

6.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not relevant.

6.12 Monitoring data (KCP 10.8)

Not relevant.

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6.13 Classification and Labelling

6.13.1 GHS Classification and Labelling

Table 6.13-1 Classification and labelling of Rancona 450 FS

Relevant toxicity The classification of ipconazole is based on chronic toxicity data for fish

Pimephales promelas NOEC = 0.00044 mg a.s./L

Classification and labelling according to Regulation 1272/2008

Hazard symbol GHS09

Signal word Warning

Hazard statement H410 - Very toxic to aquatic life with long lasting effects.

Precautionary Statements: P273 - Avoid release to the environment.

P391 - Collect Spillage

P501 - Dispose of contents/ container to an approved waste disposal plant.

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Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Owner

KCP

10.1.2.1

KIIIA1

7.1.1

xxxxx 2001 Acute Oral Toxicity Study in Rats – Defined LD50

Report No: 10223

Product Safety Labs

ICS 92068

GLP

Unpublished

Y Gustafson

LLC

KIIIA1

10.5.2/01

Gray, J.

2009 Evaluation of the effect of a seed treatment formulation (UBI 4336.0) on wolf spiders Pardosa spp. in an

extended laboratory study

Docuemtn No: FDD 0031

Huntingdon Life Sciences

ICS 92066

GLP

Unpublished

N Chemtura

Europe

Limited

KIIIA1

10.5.2/02

Gray, J 2010 Evaluation of the effect of a seed treatment formulation (Rancona 450 FS) on the rove beetle Aleochara

bilineata in an extended laboratory study

Docuemtn No: FDD 0038

Huntingdon Life Sciences

ICS 92067

GLP

Unpublished

N Chemtura

Europe

Limited

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Appendix 2 Detailed evaluation of the new studies

A 2.1.1 KCP 10.1.2 Effects on terrestrial vertebrates other than birds

A 2.1.1.1 KCP 10.1.2.1 Acute oral toxicity to mammals

A 2.1.1.1.1 KIIIA1 7.1.1. Acute oral toxicity

Comments of zRMS: Study is acceptable

LD50 = 3666 mg PPP/kg bw

Reference: KIIIA1 7.1.1

Report Acute Oral Toxicity Study in Rats – Defined LD50, xxxxx, 2001, Report No:

10223, M-285723-02-1, ICS 92068

Guideline(s): OPPTS 870.1100 (1998) and OECD No. 401 (2001)

Deviations: No

GLP: OPPTS 870.1100 (1998) and OECD No. 401 (2001)

Acceptability: Yes

Duplication


No


After acclimation to the laboratory, 30 healthy rats were selected for test. Dose levels of 2,000, 4,000, 5,000

and 7,000 mg/kg were selected for testing. Five males and five females were selected for the 2,000 and

4,000 mg/kg dose levels. For the 5,000 mg/kg level, only five females were tested and for the 7,000 mg/kg

level, only five males were used.

In each test group, the animals were administered the test substance, then observed for mortality, signs of

gross toxicity, and behavioral changes at least once daily for 14 days. Bodyweights were recorded prior to

administration and again on Days 7 and 14 or after death. Necropsies were performed on all animals.


Under the conditions of this study, the acute oral defined LD50 of the test substance is 5,284 mg/kg of

bodyweight in male rats and 3,666 mg/kg of bodyweight in female rats.

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Conclusion

Uner the conditions of this study, the acute oral defined LD50 of Ipconazole 480 FL calculated by Probit

Analysis was 5284 mg formulation/kg bw in male rats with 95% Confidence Limits of 6570 mg/kg (upper)

and 4515 mg/kg (lower). Calculated separately, by the Moving Angle Average Method, the LD50 for the

female rates was 3666 mg /kg with 95% Confidence Limits of 4514 mg/kg (upper) and 3065 mg/kg (lower).

The data does not permit calculation of an LD50 for the sexes combined.

A 2.1.2 KCP 10.3.1 Effects on bees

Hazard quotients for bees (IIIA 10.4.1)

Due to the type of formulation as a seed treatment, calculation of hazard quotients according to EPPO

Environmental Risk Assessment Scheme does not seem to be appropriate.

Oral exposure QHO (IIIA 10.4.1.1)

Refer to IIIA 10.4.1.

Contact exposure QHC (IIIA 10.4.1.2)


Acute toxicity of the formulation to bees (IIIA 10.4.2)

No acute toxicity studies were generated in accordance with OECD 213/214, EPPO 170 or other appropriate

test guidelines and GLP requirements were presented.

Oral (IIIA 10.4.2.1)


Contact (IIIA 10.4.2.2)


Effects on bees of residues on crops (IIIA 10.4.3)

Not required.

Cage tests (IIIA 10.4.4)

Not required.

Field tests (IIIA 10.4.5)

Not required.

Investigation into special effects (IIIA 10.4.6)

Not required.

Larval toxicity (IIIA 10.4.6.1)

Not required since the test item is not an IGR.

Long residual effects (IIIA 10.4.6.2)

Not required.

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Disorienting effects on bees (IIIA 10.4.6.3)

Not required.

Tunnel tests (IIIA 10.4.7)

Not required.

A 2.1.3 KCP 10.3.2 Effects on non-target arthropods other than bees

A 2.1.3.1 KCP 10.3.2.1 Standard laboratory testing for non-target arthropods

A 2.1.3.2 KCP 10.3.2.2 Extended laboratory testing, aged residue studies with

non-target arthropods

A 2.1.3.2.1 KIIIA1 10.5.2 Effects on non-target terrestrial arthropods in extended la-

boratory tests

Comments of zRMS: It is noted that the toxic reference (dimethoate) was sprayed at 900 g a.s./ha. As

the exposure regime was different to that tested (i.e. treated seed) the RMS does

not consider that the toxic reference was suitable to demonstrate that the study

design was entirely suitable.

The calculation of x field rates regards a field drilling rate of 20 kg seed/ha.

However, the field drilling rate requested in this application is 35 kg seeds/ha.

Furthermore, the seeds were treated with 7.55 g ipconazole/100 kg seed, re-

quested in this application is a treatment of 8.136 g Ipconazole/ha. Therefore,

equivalents of x-field rates are not correct. Regarding the requested application

the concentrations of 1 or 2 seeds/64 cm² correspond to 13.2 and 26.5 times the

maximum proposed field rate, respectively.

However, the study is acceptable and can be considered as suitable for risk as-

sessment purposes.

No effects on mortality at 500kg seeds/ha (13.2 x field rate)

At 1000 kg seeds/ha (26.5 times the field rate) 19.4% corrected mortality was

recorded, with no effect on behaviour or predation rate of surviving spiders.

Reference: KIIIA1 10.5.2/01

Report Evaluation of the effect of a seed treatment formulation (UBI 4336.0) on wolf

spiders Pardosa spp. in an extended laboratory study, Gray, J., 2009,

FDD0031, ICS 92066

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Guideline(s): Heimbach et. al. (2000), A method for testing effects of plant protection prod-

ucts on spiders of the genus Pardosa (Araneae Lycosidae) Guidelines to eval-

uate side-effects of plant protection products to non-target arthropods’,

IOBC, BART and EPPO Joint Initiative

SETAC-Europe, ESCORT 1 (1994)


Deviations: 1. The temperature and humidity were not monitored for the first

seven days of the 17 day pre-treatment phase.

2. The humidity dropped to below 60% during the pre-treatment

phase and during the study period with a minimum reading of 33%.

3. The temperature rose above 15ºC during the pre-treatment phase,

reaching a maximum of 18.5ºC.

4. During the pre-treatment phase the light level ranged between 440

– 550 lux, the minimum daily level being below the 500 lux stated in

the protocol.

5. On one occasion during the pre-treatment phase the spiders were

not fed for four days.

6. The temperature fell below 18ºC and rose above 22ºC in the 7-day

period prior to application, reaching a minimum of 17.9ºC and a max-

imum of 23.6ºC.

7. The temperature fell below 18ºC and rose above 22ºC during the

exposure phase, reaching a minimum of 17.6ºC and a maximum of

26.6ºC.

8. Mortality in the control exceeded the acceptable limit of 6.7%,

reaching 10% by day 14.

9. Additional assessments of mortality were carried out on days 8 and

11 to allow a continuous determination of mortality.

These deviations were not considered by the Study Director to have

had any adverse effect on the outcome of the study.

GLP: Yes

Acceptability: Yes

Executive summary

The test substance Rancona 450 FS was applied as a seed dressing on maize seed with the seed being

sown at a density equivalent to 9, 27 and 54 times the maximum proposed field rate. The maximum an-

ticipated field drilling rate is 20 kg seed/ha (i.e. 2 g seed/m2, approximately 6-7 seeds/m2). The maximum

application rate to treated seed is 8 g ipconazole/100 kg seed, equivalent to 0.00016 g ipconazole/m2.

A test was conducted which comprised five treatments: water control (one untreated maize seed per repli-

cate), Rancona 450 FS one, three and six treated seeds per replicate and a toxic reference group treated

with Decis at a rate of 50 g a.s./ha (one untreated maize seed). For all treatments the seeds were sown

into LUFA 2.1 soil to a depth of approximately 1.0 cm. The water control and Decis were applied using a

laboratory track sprayer calibrated to deliver spray at a volume rate of 400 L/ha. A total of four replicates

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each containing 10 mated pairs of beetles, were set up for each treatment rate. Emergence of second gen-

eration adults was assessed.

Under the conditions of this extended laboratory study Rancona® 450 FS treated seeds at up to 54 times

the recommended field rate have no effect on the reproductive capacity of adult rove beetles, compared to

the control.

The study was considered valid as the mean number of 2nd generation beetles was above 400 in the control

and the toxic reference Decis (applied at 50 g a.s./ha) resulted in a reduction in reproduction of 99.96%

compared to the control treatment.


Test material

Plant protection product: UBI 4336

Lot/batch no. (seed): SI 10676

Seed loading: Maize seed treated with (UBI 4336.00) with a loading of 7.66 g ip-

conazole/100 kg seed

Description (seed): Pink coloured maize seed

Vehicle control: Not applicable

Positive control: 400 g dimethoate/L

Test animals

Species: Pardosa spp. (including P. pullata)

Source: Commercial

Acclimatisation period: 13 days

Food: Drosophlila spp.

Housing: Clear polystyrene containers, approximately 9 x 4.5cm deep. Each

container was filled with 140g LUFA 2.1 soil maintained at 50% of

its water holding capacity).

Environmental conditions (exposure)

Temperature: 17.6–26.6ºC

Humidity: 33-75%

Air changes: Not specified

Photoperiod: 16 hours light : 8 hours dark

Light intensity: 702-1310 lux

Preparation of treatment solutions

Maize seed treated with UBI 4336.0 to give

7.55 g ipconazole/100 kg seed,

was used as supplied. Seeds were sown to give application rates at 25 and 50 times the field rate respec-

tively was used as supplied.

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The toxic reference was prepared by adding 5.625 mL of dimethoate (400 g/L) to a final volume of 1000

mL of reverse osmosis water to give a concentration of 2.25 g a.s./L (equivalent to 900 g a.s./ha in 400

L/ha).

Treatment

Four treatments were employed in the study. These consisted of:

Water control (one untreated seed).

UBI 4336:0 (76.6 mg/kg ipconazole) 25 x field rate (one treated seed).

UBI 4336:0 (76.6 mg/kg ipconazole) 50 x field rate (two treated seeds).

Dimethoate 900 g a.s./ha (one untreated seed).

The density of seeds was based on the surface area of the test chamber of 63.626 cm2.

A total of 40 replicates, each containing one spider, 20 male and 20 female, were used for each treatment.

Reverse osmosis (RO) water was used for the control and as the diluent for the toxic

The seed treatments were sown in the order of seeded control, followed by the UBI 4336.0 treated seed at

25 the field rate and 50 times field rate. The spiders were introduced into the test units once the seed sowing

was completed. The cypermethrin and water control treatments were applied using a Potter laboratory pre-

cision spray tower calibrated to deliver spray at a volume rate of 400 L/ha. Spiders were present in the test

chambers for the water control and toxic reference treatments at the time of application. Immediately af-

ter sowing five live fruit flies were introduced as food.

Observations

The condition of the spiders was assessed after one hour and 20 minutes then 1, 2, 4, 7, 10 and 14 days after

treatment application. The results were recorded as:

Alive: apparently unaffected/moving as normal

Affected: showing signs of irritability and/or uncoordinated movement

Moribund: twitching but unable to move

Dead: not moving

Observations on moulting and behaviour were also made

Five live fruit flies (Drosophila spp.) were introduced as food immediately after treatment application and

on days 1, 2, 3, 7 and 10. The number of Drososphila consumed was assessed on days 1, 2, 3, 4, 8 and 11,

old food was removed at each assessment.

Validity criteria

Although mortality in the seeded and unseeded (water) controls exceeded the validity criteria

of 6.7% this was considered to be the result of natural mortality.

The toxic reference treatment reached 65 ± 35% mortality after one day.

Taxonomic identification of a sub-sample of spiders indicated that the majority were P. pullata.

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All samples identified were Pardosa spp.

Statistics

There were four treatment groups in this study with 20 spiders per treatment per sex. The groups were a

seeded control, UBI 4336:0 treatment at 1 and 2 seeds and dimethoate at 900 g a.s./ha. Statistical analysis

was conducted for mortality 1 hour 20 minutes and 1, 2, 3, 4, 7,10 and 14 days after treatment, the number

of Drosophilia fruit flies consumed on days 1, 2, 3, 4, 8 and 11 and the bodyweight, which was measured

before exposure and at the end of the study.

For times when at least one spider had died in each group, mortality was analysed by generalised linear

model with binomial errors, logit link and factors for group and sex. Wald tests were used to compare the

UBI 4336:0 and dimethoate treated groups to seeded control.

For feeding, pairwise Cochran-Mantel-Haenszel tests for nonzero correlation, stratified for sex, were used

to compare the UBI 4336:0 and dimethoate treated groups to seeded control. The final weights of the

spiders were analysed by one-way analysis of covariance of logtransformed data, using log(initial weight)

as a covariate. UBI 4336:0 treated groups were compared to seeded control using Williams’ test (Williams

1971, 1972).

Data were received as Excel files and analysed using SAS version 9.1 (SAS Institute, 2002). The general-

ised linear model used PROC GENMOD. The Cochran-Mantel-Haenszel tests used PROC FREQ.


Mortality

Corrected mortality in the UBI 4336:0 seed treatment groups reached 0 and 19.4% at rates of one and two

seeds/replicate respectively. Corrected mortality in the toxic reference, dimethoate applied at 900 g a.s./ha,

reached 97.2% after 14 days of exposure.

At 3, 4, 7, 10 and 14 days there was a significant increase in mortality in the UBI 4336:0, 2 seed group

compared to the seeded control group (p=0.032, p=0.032, p=0.032, p=0.023 and p=0.047 respectively).

There was a significant increase in mortality in the dimethoate group compared to the seeded control group

after 1, 2, 3, 4, 7, 10 and 14 days (p<0.001) (Table 2). No abnormal behaviour was observed in either the

control group or UBI 4336:0 treated groups.

No moulting was observed in any of the test groups throughout the study.

A summary of results is given in Table Table 10.5.2.1-1

Table 10.5.2.1-1: Spider mortality at each assessment occasion

Treatment Seeds/

replicate

Percent spider mortality at each assessment occasion (day) Corrected

mortality

Day 14

(%)

1 hr

20

min

1 2 3 4 7 10 14

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Control 1 0 5 5 5 5 5 7.5 10 -

UBI 4336.0

seed treat-

ment

1 0 0 5 5 5 5 10 10 0

2 0 15 20 22.5 22.5 22.5 27.5 27.5 19.4

Dimethoate 900 g

a.s/ha* 0 97.5 97.5 97.5 97.5 97.5 97.5 97.5 97.2

- Not applicable

* One untreated seed per replicate

A value for corrected mortality was derived using Abbott’s formula:

M = [(Mt-Mc)/(100-Mc)] x 100

where:

Mt = % mortality of treated spiders

Mc = % mortality of control spiders

M = corrected mortality (%)

Food consumption

Mean prey consumption is presented in Table 10.5.2.1-2

Overall mean prey consumption was 23.50 and 24.87 Drosophila per spider for one and two seeds of

UBI4336:0 respectively, compared to 25.15 Drosophila per spider in the dimethoate treatment (one spider

only after Day 1) and 23.61 in the control.

The dimethoate group consumed significantly fewer Drosophilia than the seeded control group on day 1

and overall (p<0.001 and p=0.001 respectively).

Table 10.5.2.1-2: Mean prey consumption

Treatment Seeds/ replicate Total mean prey

consumed1

Proportional dif-

ference

Percent reduc-

tion

Control 1 23.61 - -

UBI 4336.0 seed

treatment

1 23.50 0.9953 0.47

2 24.87 1.0534 0a

Dimethoate 900 g a.s./hab 25.15 1.0652 0a 1 = Totals from assessments on days 1, 2, 3, 4, 8 and 11

- Not applicable a Increase in prey consumption recorded b one untreated seed per replicate

The overall mean total prey consumed per spider was the sum of the mean prey consumption on each

assessment occasion for each treatment. The difference between the control and treated groups was then

determined.

A value for the effect on consumption is derived using the following formula:

R = Rt/Rc

Where:

R = proportional difference in prey consumption.

Rt = mean prey consumption in the treated group

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Rc = mean prey consumption in the control group.

If the R value was < 1.0 the percent reduction in consumption was calculated as follows;

Percent reduction in consumption = (1-Rt/Rc) x 100

Conclusion

Under the conditions of this extended laboratory study UBI 4336:0 seed treatments sown at 25 times the

field rate no significant effect on the survival, behaviour and predation rate of wolf spiders, via residual

contact on soil. At 50 times the field rate 19.4% corrected mortality was recorded, with no effect on be-

haviour or predation rate of surviving spiders.

Comments of zRMS: It is noted that the toxic reference (decis) was sprayed at 50 g a.s./ha. As the

exposure regime was different to that tested (i.e. treated seed) the RMS does not

consider that the toxic reference was suitable to demonstrate that the study de-

sign was entirely suitable.

The calculation of x field rates regards a field drilling rate of 20 kg seed/ha.

However, the field drilling rate requested in this application is 35 kg seeds/ha.

Furthermore, the seeds were treated with 7.5 g ipconazole/100 kg seed, re-

quested in this application is a treatment of 8.136 g Ipconazole/ha. Therefore,

equivalents of x-field rates are not correct. Regarding the requested application

the concentrations of 1, 3 or 6 seeds/176 cm² correspond to 4.7, 14.2, and 28.4

times the maximum proposed field rate, respectively.

Furthermore, the mean number of 2 nd generation adults increased with increas-

ing test concentrations (68.23 in the control; 93.20 at 1080 kg seeds/ha).

However, the study is acceptable and can be considered as suitable for risk as-

sessment purposes.

Reference: KIIIA1 10.5.2/02

Report Evaluation of the effect of a seed treatment formulation Rancona 450 FS) on

the rove beetle Aleochara bilineata in an extended laboratory study , Gray, J.,

2010, Document No.: FDD 0038, ICS 92067

Guideline(s): Grimm et al (2000), A test for evaluating the chronic effects of plant protec-

tion products on the rove beetle Aleochara bilineata Gyll. (Coleoptera: Staph-

ylinidae) under laboratory and extended conditions in: Candolfi et. al. (2000)

‘Guidelines to evaluate side effects of plant protection products to non-target

arthropods’, IOBC, BART and EPPO Joint Initiative



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Deviations: 1. The temperature dropped to below 18ºC and rose above 22ºC dur-

ing the prestudy period, with a range of 17.9 - 23.3ºC. The tempera-

ture rose to above 22ºC during the study period with a maximum

reading of 22.8ºC.

2. The humidity dropped to below 60% during the pre treatment

phase to 43% and in the study period with a minimum reading of

41%.

3. The source of the test species is not reported to maintain supplier

confidentiality.

These deviations were not considered by the Study Director to have

had any adverse effect on the outcome of the study.

GLP: Yes

Acceptability: Yes/No/Supplementary

Executive summary

The test substance Rancona 450 FS was applied as a seed dressing on maize seed with the seed being

sown at a density equivalent to 9, 27 and 54 times the maximum proposed field rate. The maximum an-

ticipated field drilling rate is 20 kg seed/ha (i.e. 2 g seed/m2, approximately 6-7 seeds/m2). The maximum

application rate to treated seed is 8 g ipconazole/100 kg seed, equivalent to 0.00016 g ipconazole/m2.

A test was conducted which comprised five treatments: water control (one untreated maize seed per repli-

cate), Rancona 450 FS one, three and six treated seeds per replicate and a toxic reference group treated

with Decis at a rate of 50 g a.s./ha (one untreated maize seed). For all treatments the seeds were sown

into LUFA 2.1 soil to a depth of approximately 1.0 cm. The water control and Decis were applied using a

laboratory track sprayer calibrated to deliver spray at a volume rate of 400 L/ha. A total of four replicates

each containing 10 mated pairs of beetles, were set up for each treatment rate. Emergence of second gen-

eration adults was assessed.

Under the conditions of this extended laboratory study Rancona® 450 FS treated seeds at up to 54 times

the recommended field rate have no effect on the reproductive capacity of adult rove beetles, compared to

the control.

The study was considered valid as the mean number of 2nd generation beetles was above 400 in the control

and the toxic reference Decis (applied at 50 g a.s./ha) resulted in a reduction in reproduction of 99.96%

compared to the control treatment.


A. MATERIALS

Test material Plant protection product: UBI 4336

Lot/batch no. (seed): SI 10676

Seed loading: Maize seed treated with (UBI 4336.00) with a loading of

7.5 g ipconazole/100 kg seed

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Description (seed): Pink coloured maize seed

Vehicle control: Not applicable

Positive control: Decis® (50 g deltamethrin/ha)

Test animals Species: Rove beetle

Strain: Aleochara bilineata (Gyll.) (Coleoptera: Staphylinidae)

Source: Laboratory cultured

Acclimatisation period: Not specified

Age at start of dosing: Up to 7 days old

Food: Musca domestica pupae

Housing: Plastic containers, approximately 16 x 11 x 7 cm deep filled to a

depth of approximately 4 cm with LUFA 2.1 soil maintained at 35%

of its water holding capacity

Environmental conditions (exposure) Temperature: 19.4–22.8ºC

Humidity: 41-86%

Air changes: Not specified

Photoperiod: 16 hours light : 8 hours dark

Light intensity: 725-1290 lux

B. STUDY DESIGN AND METHODS

Preparation of treatments and application rates

Five treatments were employed in the study. These consisted of:

i. Water control (1 untreated seed).

ii. Rancona 450 FS (75.0 mg/kg ipconazole) 9 x field rate (1 treated seed).

iii. Rancona 450 FS (75.0 mg/kg ipconazole) 27 x field rate (3 treated seeds)

iv. Rancona 450 FS (75.0 mg/kg ipconazole) 54 x field rate (6 treated seeds)

v. Decis 50 g a.s./ha (1 untreated seed).

Reverse osmosis (RO) water was used for the control and as the diluent for the toxic reference substance.

The density of seeds sown was based on the surface area of the test chamber of 176 cm2. The seeds were

evenly spaced at a depth of 1 cm beneath the soil surface. Untreated seed was sown in the control and

toxic reference chambers prior to spraying. Replicates were infested with 20 beetles (10 males and 10

females) after the seeds had been sown for UBI 4336.0 treatments and after the spraying of the water con-

trol and toxic reference. Food (20 Musca domestica pupae per replicate was provided immediately after

addition of the beetles.

A total of four replicates, each containing ten males and ten females, were used for each treatment. The

exposure chambers consisted of white one litre containers 16 x 11 cm x 7 cm deep. Each container was

filled with 4 cm depth of LUFA 2.1 soil, at 35% of its water holding capacity. This moisture level was

maintained throughout the exposure period by addition of reverse osmosis water three times a week.

LUFA 2.1 soil used during the study was standard test soil from LUFA Speyer, batch number SP 3308. A

ventilated lid was placed on each chamber after infestation and treatment. The germinating maize was

trimmed to just above soil level to avoid contact with the chamber lid. The Musca domestica pupae were

replenished three times a week.

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Approximately 500 Delia antiqua pupae were added to each replicate 7, 14 and 21 days after the intro-

duction of the adult beetles and mixed to ensure an even distribution throughout the soil. The 1st genera-

tion adults were removed on Day 28 and the D. antiqua fly pupae removed one week later and placed in

emergence pots.

Observations

Once the 2nd generation adults had begun to emerge, they were counted and removed until emergence in

the control group fell below a rate of two beetles per replicate per day.

Validity criteria

The study was considered valid as the mean number of 2nd generation adults emerged in the control ex-

ceeded 400 and the reduction in the reproductive capacity in the toxic reference treatment relative to the

control exceeded 50%.

Statistics

Results were expressed as mean number of second-generation adults produced per female.

A value for the effect on reproduction was derived using:

R = Rt/Rc

where:

R = proportional difference in reproduction

Rt = mean number of second generation adults produced per female in the treated group

Rc = mean number of second generation adults produced per female in the control group

Where an R value of less than 1.0 was calculated, the percentage reduction in reproduction was calculated as:

Percentage reduction in reproduction = (1 - Rt/Rc) x 100

Statistical analysis was carried out using the Safestat programme.


Fecundity The numbers of 2nd generation adults produced per replicate and per original female beetles are shown in

Table 10.5.2.2-1. The proportional difference in reproduction and percent reduction in reproduction are

shown in Table 10.5.2.2-2.

The mean number of 2nd generation adults produced per original female beetle was 82.53, 81.70 and

93.20 in the Rancona 450 FS seed treatment groups at 9, 27 and 54 x the field rate respectively. This

compared to a mean of 68.23 in the control. A mean of 0.03 2nd generation beetles were produced in the

toxic reference treatment.

Table 10.5.2.2-1: Mean number of 2nd generation beetles produced per original female following

28 days exposure to ipconazole treated seed

Treatment Rate of ap-

plication

Total number of 2nd generation bee-

tles emerged in each replicate

Mean number

of 2nd genera-

tion adult bee-

tles/

Mean number

of 2nd genera-

tion adult bee-

tles/female Rep 1 Rep 2 Rep 3 Rep 4

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replicate (n=10)

Control - 616 661 668 784 682.25 68.23

UBI 4336

9 x field rate 832 856 806 807 825.25 82.53

27 x field

rate 851 807 803 807 817.00 81.70

54 x field

rate 954 925 871 978 932.00 93.20

Decis 50 g a.s./ha 1 0 0 0 0.25 0.03 - Not applicable

There was no reduction in reproduction in any treatment group when compared to the seeded control (Table

10.5.2.2-2). These effects were not statistically significant. The reduction in reproduction for the toxic

reference treatment, Decis® was 100%.

Table 10.5.2.2-2: Mean number of second generation adults produced per original female, pro-

portional difference in reproduction and percent reduction in reproduction

after exposure to UBI 4336 treated seed

Treatment Rate of applica-

tion

Mean number

of second gener-

ation beetles per

original female

Proportional

difference in

reproduction

(R)

Reduction in

reproduction

(%)

Seeded control - 68.23 - 0

UBI 4336 treated seed

9 x field rate 82.53 1.2096 0

27 x field rate 81.70 1.1974 0

54 x field rate 93.20 1.3660 0

Decis® 50 g a.s/ha 0.03 0.0004 99.96

Conclusion

Under the conditions of this extended laboratory study UBI 4336 treated seeds sown at 9, 27 and 54 x the

field rate have no effect on the reproduction of the 2nd generation adults compared to the control.

The study was considered valid as the mean number of 2nd generation beetles was above 400 in each

replicate in the control and the toxic reference Decis (applied at 50 g a.s./ha) resulted in a reduction in

reproduction of 99.96% compared to the control treatment.

REGISTRATION REPORT

Part B

Section 6

Ecotoxicology





Ipconazole 452 g/L

Central Zone


National Addendum

Germany

(authorisation)




MS Finalisation date: 18/09/2019

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Part B – Section 9 - National Addendum

Germany

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Version history

When What

[September

2019]

First Draft RR by UBA

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Table of Contents

6 Ecotoxicology (KCP 10) ............................................................................... 5


6.1.1 Overall conclusions ........................................................................................ 8


birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles

and amphibians) (KCP 10.1.3) ....................................................................... 8

6.1.1.2 Effects on aquatic organisms (KCP 10.2) ...................................................... 8

6.1.1.3 Effects on bees (KCP 10.3.1) ......................................................................... 8

6.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ..................................... 9

6.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on

soil microbial activity (KCP 10.5) ................................................................. 9

6.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ....................................... 9

6.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ............. 9

6.1.2 Grouping of intended uses for risk assessment ............................................ 10

6.1.3 Consideration of metabolites ....................................................................... 10

6.2 Effects on birds (KCP 10.1.1) ...................................................................... 10

6.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) .................. 10

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

(KCP 10.1.3) ................................................................................................ 10

6.5 Effects on aquatic organisms (KCP 10.2) .................................................... 11

6.5.1 Toxicity data ................................................................................................ 11

6.5.2 Risk assessment ........................................................................................... 11

6.5.3 Overall conclusions (DE national addendum) ............................................. 13

6.6 Effects on bees (KCP 10.3.1) ....................................................................... 14

6.7 Effects on arthropods other than bees (KCP 10.3.2) ................................... 14


6.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) .................... 14

6.8.1 Toxicity data ................................................................................................ 14

6.8.2 Risk assessment ........................................................................................... 14

6.8.2.1 First-tier risk assessment .............................................................................. 15



6.9 Effects on soil microbial activity (KCP 10.5) .............................................. 16

6.10 Effects on non-target terrestrial plants (KCP 10.6) ..................................... 16

6.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ........... 16

6.12 Monitoring data (KCP 10.8) ........................................................................ 16

6.13 Classification and Labelling ........................................................................ 16

6.13.1 GHS Classification and Labelling ............................................................... 16

6.13.2 National Labelling ....................................................................................... 17

6.13.3 Conditions of Use ........................................................................................ 17


Appendix 2 Detailed evaluation of the new studies ..................................................... 18

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6 Ecotoxicology (KCP 10)

This national addendum has been produced to support a national decision on a possible authorisation of

the product Rancona 450 FS in Germany for the uses listed below. It reflects the impact of specific Ger-

man environmental or agricultural circumstances on the risk assessment for Rancona 450 FS. It must be

evaluated by Member States, whether the approaches and conclusions in this national addendum meet the

requirements for a risk assessment with regard to their specific environmental or agricultural circum-

stances.

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Table 6.1-1: Table of critical GAPs

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Use-

No. *

Member

state(s)

Crop and/or situ-

ation (crop destination

/ purpose of

crop)

F,

Fn, Fpn

G,

Gn, Gpn

or

I **


controlled (additionally: develop-

mental stages of the

pest or pest group)


(days)

Remarks:

e.g. g saf-ener/ syn-

ergist per

ha

Conclusion

Method /

Kind

Timing /

Growth


Max. num-

ber


season

Min. interval

between ap-

plications (days)

kg or L

product/ha


b) max. total


g or kg as/ha


b) max. total


Water L/ha

min/max

Bir

ds

Mam

mal

s

Aq

uat

ic o

rgan

ism

s

Bee

s

No

n-t

arget

art

hro

-

pod

s S

oil

org

anis

ms

No

n-t

arget

pla

nts


001 DE Maize

ZEAMX

F Fusarium spp.

FUSASP

seed treat-

ment before sow-ing

BBCH 00

a.) 1

1

- 1.925 mL/ha

(0.77 mL/seed

unit)

0.875 g a.s

/ha (0.35 g

as/seed unit); (25 mg/kg

seed; 35 kg

seeds/ha)

withdrawn

by appli-cant

A A N

Ple

ase

refe

r to

outc

om

e by

JK

I N A A

002 DE Maize

ZEAMX


RHIZSO

seed treat-

ment before sow-ing

BBCH 00

a.) 1

1

- 1.925 mL/ha

(0.77 mL/seed

unit)

0.875 g a.s

/ha (0.35 g

as/seed unit);

(25 mg/kg seed; 35 kg

seeds/ha)

withdrawn

by appli-cant

A A N

Ple

ase

refe

r to

outc

om

e by

JK

I N A A

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

003 DE Maize

ZEAMX


SPHTRE

seed treat-ment

before sow-ing

BBCH 00

a.) 1

1

- 6.3 mL/ha (2.52

mL/seed unit)

2.85 g a.s./ha (1.14 g

as/seed unit); (81.36

mg/kg seed;

35 kg seeds/ha)

maximum application

rate 6.3 mL/ha

(equivalent

to a maxi-mum of

2.5 seed


includes

50000 grains)

A A A

Ple

ase

refe

r to

outc

om

e by

JK

I

A A A


** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional

and non-professional greenhouse use, I: indoor application

Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use



N No safe use

Remarks

table:

(1) Numeration necessary to allow references (2) Use official codes/nomenclatures of EU


situation should be described (e.g. fumigation of a structure) (4) F: professional field use, Fn: non-professional field use, Fpn: professional and non-profes-

sional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn:

professional and non-professional greenhouse use, I: indoor application (5) Scientific names and EPPO-Codes of target pests/diseases/ weeds or when relevant the com-

mon names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi,

weeds) and the developmental stages of the pests and pest groups at the moment of applica-tion must be named

(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

(7) Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Black-well, ISBN 3-8263-3152-4), including where relevant, information on season at time of application

(8) The maximum number of application possible under practical conditions of use must be provided

(9) Minimum interval (in days) between applications of the same product. (10) For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty

rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products

(11) The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha).

(12) If water volume range depends on application equipments (e.g. ULVA or LVA) it should be men-

tioned under “application: method/kind”. (13) PHI - minimum pre-harvest interval

(14) Remarks may include: Extent of use/economic importance/restrictions

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birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and

amphibians) (KCP 10.1.3)

The results of the core assessment indicate an acceptable risk for birds and mammals due to the intended



None

6.1.1.2 Effects on aquatic organisms (KCP 10.2)


TER values for aquatic organisms were calculated, taking into account the relevant toxicity data for Ip-

conazole and calculated exposure levels, according to the intended uses of the product Rancona 450 FS as

seed treatment for maize. The calculated TER values do achieve the acceptability criterion TER ≥ 10 for

chronic effects on aquatic organisms, according to Commission Regulation (EU) No 546/2011, Annex,

Part I C, point 2.5.2.2. The results of the assessment indicate an acceptable risk for aquatic organisms due

to the intended use of Rancona 450 FS as seed treatment for maize according to the label.




seed treatment for maize. The calculated TER values do not achieve the acceptability criterion TER ≥ 10

for chronic effects on aquatic organisms, according to Commission Regulation (EU) No 546/2011, An-

nex, Part I C, point 2.5.2.2. The results of the assessment indicate an unacceptable risk for aquatic organ-

isms due to the intended use of Rancona 450 FS as seed treatment for maize (due to dust drift) according

to the label.


No authorisation is possible for the intended uses of the product Rancona 450 FS as seed treatment for

maize.

6.1.1.3 Effects on bees (KCP 10.3.1)

The chapter is provided by the JKI.

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6.1.1.4 Effects on arthropods other than bees (KCP 10.3.2)

The results of the core assessment indicate an acceptable risk for non-target arthropods in off-field habi-

tats due to the dust drift of intended use of Rancona 450 FS as seed treatment for maize according to the

label.


None.

6.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil

microbial activity (KCP 10.5)

Earthworms










relevant toxicity data for Ipconazole and calculated exposure concentrations in soil, according to the in-

tended uses of the product Rancona 450 FS as seed treatment for maize. The calculated TER values do







None

6.1.1.6 Effects on non-target terrestrial plants (KCP 10.6)

As clarified in the core assessment, no quantitative risk assessment is required.


None

6.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not relevant.

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6.1.3 Consideration of metabolites


6.2 Effects on birds (KCP 10.1.1)



None

6.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)


6.3.1 Indirect effects via trophic interactions

Based on the results of the risk assessment (CA chapter 9.2.4 indirect effects via trophic interactions),

zRMS concluded that the use of Rancona 450 FS has a high potential to cause unacceptable effects on

biodiversity and the ecosystem via the disruption of trophic interactions in the food web.


None

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP

10.1.3)



None

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6.5 Effects on aquatic organisms (KCP 10.2)

6.5.1 Toxicity data



The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with

the recommendations of the “Guidance document on tiered risk assessment for plant protection products

for aquatic organisms in edge-of-field surface waters in the context of Regulation (EC) No 1107/2009”, as

provided by the Commission Services (SANTE-2015-00080, 15 January 2015).

For authorisation in Germany, three entry routes are considered separately in the exposure assessment for

surface water: (i) spray drift together with volatilisation and subsequent deposition (where relevant), (ii)

run-off, and (iii) drainage. Consequently, specific risk mitigation measures are defined and can be im-

posed separately for each entry route. Thus, the risk assessment from the core assessment is replaced by a

specific national assessment for Germany, which is described below.

As the product Rancona 450 FS is used as a seed treatment, surface water exposure by spray drift and vo-

latilization with subsequent deposition can be excluded as relevant pathways, whereas predicted off-field

exposure concentrations following dust drift deposition were considered.

Exposure of surface water bodies via dust drift with subsequent deposition

Exposure assessment

Concentrations of Ipconazole in surface water due dust drift with subsequent deposition are calculated ac-

cording to the draft "Guidance Document on the Authorization of Plant Protection Products for Seed Treat-

ment” (SANCO/10553/2012, January 2014). As proposed in SANCO/10553/2012, January 2014, the cal-

culated values for PECsw dust were added to the PECsw values obtained from Exposit.

Exposure of surface water bodies via run-off or drainage

Exposure assessment

The concentrations of the active substance Ipconazole in an adjacent ditch due to surface run-off or drain-

age as well as dust drift are calculated using the model EXPOSIT 3.01. The relevant input parameters for

exposure modelling are provided in the Environmental Fate section.

Selection of relevant toxicity endpoint

The long-term toxicity of Ipconazole to fish in the ELS test giving a NOEC of 0.00044 mg a.s./L is rele-

vant for risk assessment.

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Table 6.5-1: Assessment of the risk for aquatic organisms due to the use of Rancona 450 FS

as seed treatment for maize (use 003) – exposure to entries of Ipconazole via

run-off or drainage considering risk mitigation measures or dust drift

Active substance: Ipconazole

Intended use 003

Application parameters: 2.85 g a.s./ha, 0 % interception

Endpoint (µg/L): NOEC = 0.44 µg a.s./L (Pimephales promelas, ELS)

TER acceptability criterion: 10

Run-off

Buffer zone (m) PEC (µg/L) TER

0 0.01 48.07

5 0.01 55.46

10 0.01 64.71

20 0.00 92.44

Drainage

Time of application PEC (µg/L) TER

Spring/summer 0.01 49.70

Autumn/winter 0.03 16.15

Dust drift

Realistic worse case1 0.500 0.88

Reference value / certified seeds2 0.177 2.49

Product specific 0.026 16.9

Risk mitigation measures: Run-off: none; Drainage: none

PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger 1 worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of available

data 2 Crop specific reference values are laid down by legal requirements and certified (e.g. legislations on treated maize seed quality –

independent from applied active substances) 3 sufficient and reliable product specific data on seed quality parameter are submitted and considered (see Littlewood, 2013), see

Tab. 5.6-9

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Table 6.5-2: Assessment of the risk for aquatic organisms due to the use of Rancona 450 FS

as seed treatment for maize (use 003) – exposure to entries of Ipconazole via

run-off or drainage and dust drift

Active substance: Ipconazole

Intended use 003

Application parameters: 2.85 g a.s./ha, 0 % interception

Endpoint (µg/L): NOEC = 0.44 µg a.s./L (Pimephales promelas, ELS)

TER acceptability criterion: 10

Run off / drainage*; Product specific3


0, Spring / summer* 0.036 12.2

Run off / drainage*; Product specific3


0, Spring / summer* 0.036 12.2

Risk mitigation measures: none

PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger;

*PEC values for run-off and drainage are equal, therefore, the presented calculations account for both scenarios 1 worst case if no legal requirements apply and/or no quality data available or certified values calculated on the basis of available

data 2 Crop specific reference values are laid down by legal requirements and certified (e.g. legislations on treated maize seed quality

–independent from applied active substances) 3 sufficient and reliable product specific data on seed quality parameter are submitted and considered (see Littlewood, 2013), see

Tab. 5.6-9

* as the application is a seed treatment and the application time was in spring, only the spring / summer-szenario was considered

6.5.3 Overall conclusions (DE national addendum)







to the intended use of Rancona 450 FS as seed treatment for maize according to the label.







to the intended use of Rancona 450 FS as seed treatment for maize (due to dust drift) according to the la-

bel.

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none

6.6 Effects on bees (KCP 10.3.1)

Please refer to outcome provided by JKI.

6.7 Effects on arthropods other than bees (KCP 10.3.2)



The results of the core assessment indicate an acceptable risk for non-target arthropods in off-field habi-

tats due to the dust drift of intended use of Rancona 450 FS as seed treatment for maize according to the

label.


None.

6.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

6.8.1 Toxicity data



The evaluation of the risk for earthworms and other non-target soil organisms (meso- and macrofauna)

was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Eco-

toxicology”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17,

2002).

Exposure assessment

In the German exposure assessment, the considered soil layer depth is based on experimental data.1 Gen-

erally, a soil layer depth of 2.5 cm is applied in the calculation for active substances with a Kf,oc <500,

whereas a soil layer depth of 1 cm is applied for active substances with a Kf,oc >500. A soil bulk density of

1.5 g/cm³ is assumed as in the core assessment.

1 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in

den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin

1999

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6.8.2.1 First-tier risk assessment


vironmental Fate), Chapter 5.7.2, Table 5.7-3. According to the assessment of environmental-fate data,

multi-annual accumulation in soil is considered for Ipconazole.

Table 6.8-1: First-tier assessment of the acute and chronic risk for earthworms and other

non-target soil organisms (meso- and macrofauna) due to the use of Rancona

450 FS as seed treatment for maize (use 003)

Intended use 003

Acute effects on earthworms

Product/active substance LC50

(mg/kg dw)

PECsoil

(mg/kg dw)**

TERa


Ipconazole 298.5* 0.0200 14925

1,2,4-triazole > 1000 0.0193 51813

Chronic effects on earthworms


(mg/kg dw)

PECsoil

(mg/kg dw) **

TERlt


Ipconazole 0.39* 0.0200 19.5

1,2,4-triazole 1.0 0.0193 51.8

Chronic effects on other soil macro- and mesofauna


(mg/kg dw)

PECsoil

(mg/kg dw) **

TERlt


1,2,4-triazole 0.18 0.0193 9.3



** taking into account accumulation in soil


Not relevant.


Earthworms








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relevant toxicity data for Ipconazole and calculated exposure concentrations in soil, according to the in-

tended uses of the product Rancona 450 FS as seed treatment for maize. The calculated TER values do







None

6.9 Effects on soil microbial activity (KCP 10.5)



None

6.10 Effects on non-target terrestrial plants (KCP 10.6)



None

6.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)


6.12 Monitoring data (KCP 10.8)


6.13 Classification and Labelling

6.13.1 GHS Classification and Labelling


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6.13.2 National Labelling

NW 262 Ipconazole:

Pseudokirchneriella subcapitata NOEC = 0.22 mg a.s./L

NW 264 Ipconazole:

Lepomis macrochirus LC50 = 1.3 mg a.s./L

Daphnia magna EC50 = 1.7 mg a.s./L

6.13.3 Conditions of Use

NW 467 The product and its remains, empty containers and packaging and rinsing fluids must not be

dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and

to rain-water and sewage canals.

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Appendix 2 Detailed evaluation of the new studies


Part B – Section 7 National Assessment – Germany

Rancona 450 FS (UBI 4336.01) Registration Report –Central Zone

Page 1 of 172

Applicant (Arysta LifeScience) Evaluator Applicant Document ID (insert company doc ID) Date Applicant Author (Arysta LifeScience)

REGISTRATION REPORT

Part B

Section 7: Efficacy Data and Information

Concise summary

Product code: Rancona 450 FS (UBI 4336.01)

Active Substance: ipconazole 452 g/L

Central Zone

Member State: Germany

CORE ASSESSMENT

Applicant: Arysta LifeScience GB Limited

Date: 09/03/2019

MS Finalisation date: 14.07.2020 Formatiert: Schriftart: 16 Pt.

Formatiert: Standard, Zentriert

Formatiert: Schriftart: 16 Pt., Muster: Transparent (Akzent

Formatiert: Schriftart: 16 Pt., Muster: Transparent (Akzent

Formatiert: Englisch (Vereinigtes Königreich)



Page 1 of 172


Version history

When What

04/2015 dRR Applicant

07/2016 DE evaluation of dRR

03/2019 update dRR by applicant

09/2019 DE evaluation of dRR with additional information, green boxes have been

added at the end of each chapter, additional information has been considered

in the green boxes, highlighting of additional information in dRR has been

removed

04/2019 Response to DE evaluation with new summary tables provided to enable

review of submitted efficacy data.

07/2020 Final RR of DE, additional information received from applicant and cMSs concerning the DE evaluation have been considered and the green boxes have been amended accordingly. Highlighting of additional information in dRR has been removed.

Formatiert: Schriftart: (Standard) Arial



Page 2 of 172


Table of Contents

IIIA1 6 Efficacy Data and Information (including Value Data) on the Plant Protection

Product ........................................................................................................................... 109

IIIA1 6.1.1 Preliminary range-finding tests ............................................................................. 161513

IIIA1 6.1.2 Minimum effective dose tests ................................................................................. 191815

IIIA1 6.1.3 Efficacy tests ............................................................................................................ 302821

IIIA1 6.1.3.1 Procedures for cleaning application equipment ................................................... 393726

IIIA1 6.1.4 Effects on yield and quality .................................................................................... 393726

IIIA1 6.1.4.1 Impact on the quality of plants and plant products ............................................. 393726

IIIA1 6.1.4.2 Effects on the processing procedure. ..................................................................... 393726

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products .................................... 393726

IIIA1 6.2 Adverse effects ......................................................................................................... 484627

IIIA1 6.2.1 Phytotoxicity to host crop ....................................................................................... 484627

IIIA1 6.2.2 Adverse effects on health of host animals ............................................................. 605729

IIIA1 6.2.3 Adverse effects on site of application ..................................................................... 605729

IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) .................................. 605729

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ....................... 625931

IIIA1 6.2.6 Impact on succeeding crops .................................................................................... 636032

IIIA1 6.2.7 Impact on other plants including adjacent crops ................................................. 636032

IIIA1 6.2.8 Possible development of resistance or cross-resistance ........................................ 636032

IIIA1 6.3 Economics ................................................................................................................ 706733

IIIA1 6.4 Benefits ..................................................................................................................... 706734

IIIA1 6.5 Other/special studies ............................................................................................... 706734

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ........................ 716834

APPENDIX 1: LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ......... 716835

APPENDIX 2: GAP TABLE ...................................................................................................... 170167134



Page 3 of 172


The following data and information was mainly provided by the applicant and was submitted

as dRR and BAD.

Additional comments and the final evaluation by the zRMS in this Registration Report are

marked by green boxes.

Typographical errors have been corrected. Not all appendices mentioned by the applicant are

shown. In these cases, the references to the appendices have been deleted.

Introduction Rancona 450 FS is a new product applied as seed treatment containing the active substance ipconazole (452 g/L). The containing active substance is authorised for two uses in Germany (HORVX/USTINH; TRZAX /TILLCA) as seed treatment and in a wide range of other European countries. The requested dose rate is 8.1 g active substance per 100 kg seed. Information about the active substances and the according mode of action is provided. DE acts as zRMS.

Information about the disease in Europe is given. The applicant stated that the disease is occurring only sporadically. A potential of rapidly increasing infection level is given only under favourable climatic conditions. The applicant added a small paragraph to describe the need of an effective control against Sphacelotheca reiliana in maize. To the opinion of the zRMS, the need of an obligatory approval of a PPP against headsmut in maize remains questionalble.No information about the relevance of the disease in Germany is provided.

No information about the reference product is given in the dRR.

The applicant stated that the trials have been conducted according to CEB and EPPO Standards but no information about the required EPPO Standard is given in the dRR. The applicant refers to the BAD.

Preliminary tests:

In the revised version, the applicant added some explanations concerning the justification. Still, only 2 trials were provided The applicant conducted 2 trials to demonstrate the need of ipconazole. The trials were carried out in France in 2001. Three different formulations at rates of 1, 2 and 4 g active substance per 100 kg seed were included in the Preliminary tests. The requested dose rate of 8.1 g active substance per 100 kg seed was not tested. The experimental design of the preliminary tests was non-orthogonal, not all rates were tested for all formulations. A reliable evaluation of the results is therefore difficult to conduct.

The results of these preliminary tests show clear differences in the efficacy of the formulations. The formulation UBI 6726 shows an efficacy of 89.5%, while the formulation UBI 6774 shows an efficacy of 45.7%, both with 4 g a.s.

Formatiert: Schriftart: (Standard) Arial

Formatiert: Abstand Nach: 0 Pt., Keine Absatzkontrolle,Tabstopps: Nicht an 1,27 cm



Page 4 of 172


The highest level of control was achieved at 4 g a.s. (89.5%). The efficacy level of the reference product was 97.4%. It remains unclear and questionable why the applicant conclude that disease control of the product and the reference product is comparable.

The two trials presented by the applicant do not show that the different formulations are comparable and could be used for later efficacy trials.

It can be concluded not to accept the data provided by the applicant for the preliminary range finding test.

Minimum effective dose rate tests (Dose justification)

The version revised by the applicant now shows 11 MED trials with the requested formulation. New summary tables have been provided, which include only data generated with formulations UBI 4336-00 and UBI 4336-01. These new tables demonstrate the efficacy of formulation UBI 4336-01 (and equivalent formulation UBI 4336-00) at a range of rates. All trials were conducted in the field.

A total 19 trials were conducted to test the MED, 3 trials in the maritime EPPO zone and 14 in the Mediterranean EPPO zone and 2 in the South East EPPO zone The version revised by the applicant now shows 11 MED trials with the requested formulation.

. No information is given about the conditions. Were the trials conducted under controlled conditions or in the field? This information has to be added in the dRR.

In the new data table of the applicant one trial from the maritime EPPO zone with the application rate from 2.5 – 10.4 g a.s. per 100 kg seed was tested. The efficacy between the different application rates do not differ significantly.

In the 3 trials of the maritime zone application rate from 2.5 – 10.9 g a.s. per 100 kg seed was tested. Five different formulation were included in the trials. In two out of three trials infection level of untreated control was 1.6 and 2.6%, which is too low. Those trials cannot be accepted.

In the Mediterranean mediterranean zone application rates from 2.55 – 20.112.2 g a.s. per 100 kg seed were tested in 14 8 trials. Infection level of the untreated control was 6.8 – 42.5%. The efficacy between the application rates 5.8-6.1 g a.s./100kg and the applied rate of 8.1 g a.s./100 kg does not differ significantly (72.17% and 74.64%).

Five different formulation were included in the trials. No information about the different formulation is given.

In the sSouthe East EPPO zone, 2 trails were carried out. Application rates ranged from 4.1 – 12.2 g a.s. per 100 kg seed. The iInfection level of the untreated control was 12.7 – 21.1%. The dose reduction from 8.1g a.s . per 100 kg seeds to 6.1 g per 100 kg seeds caused a decrease of disease control by 12.6%.

It can be concluded to accept the data provided by the applicant to demonstrate the minimum effective dose for the control of Sphacelotheca reiliana in maize. Efficacy

Formatiert: Abstand Nach: 6 Pt.

Formatiert: Links, Einzug: Links: 0,04 cm, Rechts: 0,4 cm,Abstand Vor: 0 Pt.

Formatiert: Links, Einzug: Links: 0 cm

Formatiert: Links

Formatiert: Links, Einzug: Links: 0,04 cm

Formatiert: Links

Formatiert: Textkörper;style5, Rechts: 0,4 cm, Abstand Vor: 0,1 Pt.

Formatiert: Links




Page 5 of 172


In the first version twenty-five Twenty-five field trials were carried out between 2005 and 2017 within 3 different climate zones (maritime, mediterranean and southeast). Five different formulations have been tested at rates of 2.55 – 20.1 g a.s. /100 kg seed. The version revised by the applicant now shows 11 efficacy trials with the requested formulation.

It is not reasonable why the applicant applied different dose rates and different formulations to approve the dose rate of 8.1 g a.s /100 kg seed for the formulation UBI 4336.1. According to EPPO Standard PP 1/214 (Principles of acceptable efficacy), the product should show results significantly superior to the untreated control and not be less effective than the reference product.

One trial from the maritime EPPO zone was conducted with the applied conditions such as the formulation UBI 4336 with 8.1 g a.s. /100 kg seed. The efficacy was 99.1%.

In the mediterranean EPPO zone, 8 trials with the applied conditions were conducted with an efficacy on average of 74.6%.

In the southeast EPPO zone, 2 trials with the applied conditions were conducted with an efficacy on average of 89.3%.

Summarizing the results of the efficacy trials (11 trials) from all 3 zones, the efficacy is satisfactory (79.5%).

It is not clear, which parameter of disease control is presented (disease severity, incidence, emergence). A reliable evaluation of the results is therefore difficult to conduct.

The applicant should add the missing information and present the results as it is

recommended in the EPPO Standard PP 1/181 (Conduct and reporting of efficacy evaluation

trials including good experimental practice).

It can be concluded not to accept the data provided by the applicant to demonstrate the effectiveness against Sphacelotheca reiliana in maize. Effects on yield and quality

Five out of 25 efficacy trials and 6 seven7 selectivity trials were harvested. The applicant presented some quality parameters, grain yield and silage yield results.

The presented data correspond with the requirements of the EPPO Standards PP 1/181 (Conduct and reporting of efficacy evaluation trials, including Ggood eExperim.ental Practice), PP 1/214 (Principles of acceptable efficacy) and PP 1/223 (Introduction to the efficacy evaluation of plant protection products). No negative effect was observed by applying this fungicide.

Even though the applicant could not present data from all efficacy trials it can be concluded to accept the data provided by the applicant to demonstrate the effectiveness of the plant protection product against Sphacelotheca reiliana in maize.The applicant mentioned, that quality parameters have been tested on some of these trials, but no details have been presented. Furthermore, yield results were mentioned and discussed. Data is accepted by the zRMS.

Formatiert: Links, Abstand Nach: 6 Pt.

Formatiert: Abstand Nach: 0 Pt., Zeilenabstand: Genau 14Pt.


Formatiert: Links

Formatiert: Schriftart: Fett



Page 6 of 172


Phytotoxicity

The presented data correspond with the requirements of the EPPO Standard PP 1/135

(Phytotoxicity assessment). The applicant assessed phytotoxicity across 14 maize cultivars in

37 efficacy and crop selectivity trials. In three trials (1 efficacy and 2 crop selectivity) minor

symptoms have been recorded. Furthermore, he assessed specific crop safety trials for seed

treatments and germination test after treatment and after storage (e.g. 12 month) were

conducted. No negative impact in these tests were reported by the applicant.

No information is given if phytotoxicity is assessed according to the EPPO Standard PP 1/135

(Phytotoxicity assessment).

No information is given if phytotoxicity trials were conducted in the field or under controlled

conditions.

No information is given about the reference product (mode of action, time and application)

No information is given about germination tests after treatment and after storage (e.g. 12

month) were conducted.

Based on this submitted data and expert knowledge about ipconazole it can be concluded to

accept the data provided by the applicant. The applicant should add the missing information

as required in the EPPO Standard PP 1/135.

Risk of resistance


(Resistance risk analysis). The applicant addresses all points of the EPPO -Standard to

evaluate the possible actual resistance risk of ipconazole. Based on FRAC assessment

the applicant stated the risk of resistance due to the mode of action for DMI fungicides

(SBI-class I; Triazole) that it will be assessed as low to medium depends on the pathogen

(combined resistance risk = 2-4).

Based on this submitted data and expert knowledge about ipconazole it can be concluded to accept the data provided by the applicant.

The presented data don´t correspond with the requirements of the EPPO Standard PP 1/213

(Resistance risk analysis). The applicant did not addresses any points of the Standard to

evaluate the possible actual resistance risk of ipconazole. The applicant stated that the

resistance risk of the active substance could be described as low risk.

According to FRAC code list 2018, the resistance risk of ipcoanzole is assessed to be

medium.

The applicant should add the missing information according to EPPO Standard PP 1/213:

Information about:

- pathogens and the intended use

- mode of action (including FRAC target site and code)





Formatiert: Links




Page 7 of 172


- risk management and strategy Adverse effects

The applicant did not present any data especially for this annex point. NHe expected no

negative effects of the product on parts of plant used for propagating purposes will be

expected.

Based on long-term experience in the practical field use with ipconazole and on expert

knowledge it can be concluded to accept the information provided by the applicant.




The applicant has not conducted an assessment according to EPPO Standard PP 1/207

(Effects on succeeding crops), however the submitted explanation and results of a confined

rotational crop study attempts to demonstrate the absence of effects and therefore the levels

of active substance in the soil are not important.




The applicant has not conducted an assessment to EPPO Standard PP 1/256 (Effects on

adjacent crops). He referred to a Heubach dust-study in section IIIA1 6.5.1. The section IIIA1

6.5.1 does not exist in this dRR. The study under section IIIA1 6.5. “Dust” may give a clue

that the applied plant protection product does not have a negative impact to adjacent crops.




Formatiert: Schriftart: Nicht Fett




Page 8 of 172


Reg.-No. 008398-00/00 GAP rev.1, date: 2019-07-30

PPP (product name/code):

Rancona 450 FS Formulation type: FS (a, b)

Active substance 1: Ipconazole Conc. of as 1: 452.00 g/L (c)

Applicant: Arysta LifeScience Great Britain Limited Professional use: Yes Zone(s): interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungizid

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Use-No. (e)

Member state(s)

Crop and/ or situation (crop destination / purpose of crop)

F, Fn, Fpn G, Gn, Gpn or I

Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group)


Remarks: e.g. g safener/synergist per ha (f)

Conclusion (efficacy)

Method / Kind


Max. number a) per use b) per crop/ season

Min. interval between applications (days)

kg or L product / ha a) max. rate per appl. b) max. total rate per crop/season

g or kg as/ha a) max. rate per appl. b) max. total rate per crop/season


003 DE maize (ZEAMX)

F head smut of maize (Sphacelotheca reiliana) (SPHTRE)

seed treatment

Before sowing

a) 1 b)

a) 2.52 mL per unit seeds b) 6.30 mL/ha

a) 1.13904 kg/ha b) 0.00285 kg/ha

5 - 70 mL per unit seeds

- Notes on dose rate: maximum application rate 6.3 mL /ha (equivalent to a maximum of 2.5 seed units per ha;1 unit includes 50 000 grains)

RN

Remarks table heading:

(a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(d) Select relevant

(b) Catalogue of pesticide formulation types and international coding system Crop Life International Technical Monograph n°2, 6th Edition Revised May 2008

(e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1

(c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

Formatierte Tabelle



Page 9 of 172


Remarks columns:

1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use must be provided.

2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be

used; when relevant, the use situation should be described (e.g. fumigation of a structure)

10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products.

4 F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha).

5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named.

12

13 14

If water volume range depends on application equipment (e.g. ULVA or LVA) it should be mentioned under “application: method/kind”. PHI - minimum pre-harvest interval Remarks may include: Extent of use/economic importance/restrictions

6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated.

15 A: Acceptable R: Acceptable with further restriction C: To be confirmed by cMS N: Not acceptable / evaluation not possible n.r.: Not relevant for section 3

7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application



Page 10 of 172


IIIA1 6 EFFICACY DATA AND INFORMATION (INCLUDING VALUE

DATA) ON THE PLANT PROTECTION PRODUCT

Introduction

This document summarises the information related to the efficacy of the plant protection product Rancona 450

FS (UBI 4336.01) containing the active substance ipconazole which was approved in accordance with

Regulation (EC) No 1107/2009 (EU 571/2014). The SANCO report for ipconazole (SANCO/11788/2013-

draft) is considered to provide the relevant review information or a reference to where such information can

be found.

The Commission Regulation EU No. 540/2011 implementing Regulation (EC) No. 1107/2009 of the European

Parliament and the Council as regards the list of approved active substances; provides specific provisions

under Part B which need to be considered by the applicant in the preparation of their submission and by the

MS prior to granting an authorisation:

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No.

1107/2009, the conclusions of the review report on ipconazole, and in particular Appendices I and II thereof,

as finalised in the Standing Committee on the Food Chain and Animal Health on 20/03/2014 shall be taken

into account. In this overall assessment, no concerns relevant to the efficacy of the active substance have been

raised.


evaluation.

Appendix 2 of this document is the table of intended uses for Rancona 450 FS (UBI 4336.01).

Information on the detailed composition of UBI 4336.01 can be found in the confidential dossier of this


Rancona 450 FS (UBI 4336.01) is a new product formulated as a Flowable Suspension concentrate (FS)

containing 452 g/L ipconazole for use as a fungicidal seed treatment on Maize. The product controls Maize

Head Smut (Sphacelotheca reiliana). It is designed to be a very low use rate product for mixture with other

fungicides, insecticides and nutrients.

The objective of this draft Registration Report is for the authorisation of UBI 4336.01 seed treatment in

Germany for the control of Head smut (Spacelotheca reiliana).

A summary of all authorisations in Europe and worldwide for seed treatments containing ipconazole is shown in



Page 11 of 172


Table 1Table 1.

Since the date of the original submission, Rancona 450 FS (UBI 4336-01) has been registered in France (2180865), Czech Republic (5747-0) and Greece (60863).

Rancona® is a registered trademark of Arysta LifeScience.



Page 12 of 172


Table 1: Summary of authorisations for seed treatments containing ipconazole worldwide

Formulation Country Local Name Registration Number Date Granted

ipconazole 15 ME

Austria Rancona 15 ME 3286 2/12/2013

Belarus Rancona 15 ME 900 12/30/2009

Belarus Rancona 15 ME 03-0104 12/30/2009

Bulgaria Rancona 15 ME 01119-PPP 2/1/2011

Czech Republic Rancona 15 ME 4689-0 5/13/2011

France Rancona 15 ME AMM 2100051 5/21/2010

Hungary Rancona 15 ME 02.5/1135/1/2010 3/29/2010

Italy Rancona 15 ME 14816 9/26/2011

Kazakhstan Provax 1.5% ME III-140 1/29/2007

Moldova Rancona 15 ME 04-2-0563 9/23/2009

Poland Rancona 015 ME 46/2012 3/5/2012

Romania Rancona 15 ME 2791 8/14/2008

Russian Federation Rancona ME 1948-10-107-169-0-1-0-0 6/18/2010

Russian Federation Rancona ME Hygienic 77.99.30.244.A.001506.03.09 3/18/2009

Slovakia Rancona 15 ME 14-01-1411 27/01/2014

Ukraine Rancona 15 ME 5827 11/11/2011

United Kingdom Rancona 15 ME MAPP 16136 3/24/2008

ipconazole 20 ME

Argentina Crusoe 20 ME 34062 06/03/2006

Bolivia Crusoe 20 ME 1686 26/02/2010

Uruguay Crusoe 20 ME 3000 09/09/2009

ipconazole/imazalil 20/50 ME

Czech Republic Rancona i-Mix 4848-0 10/29/2012

Hungary Rancona i-MIX 04.2/980-1/32014 20/02/2014

Russian Federation Rancona I-Mix 2560-13-107-169-0-1-0-0 3/18/2013

United Kingdom Rancona i-Mix MAPP 15574 12/19/2011

ipconazole 452 FS

Argentina Rancona 45 FS Semillero 36372 03/08/2010

Canada Rancona 3.8 FS 29175 6/4/2009

Mexico Rancona 450 FS RSCO-FUNG-0303C-301-064 21/09/2011

Romania Rancona 450 FS 2869 17/12/2013

USA Rancona 3.8 FS 400-544 3/2/2007

ipconazole/metalaxyl 25/20 ME

Argentina Dimension 34972 21/12/2006

China Rancona Dimension 45 ME PD20120231 23/03/2010

USA Rancona CTS 400-592 12/09/2012

ipconazole/cypermethrin 20/4 ME Australia Rancona C 63309 10/05/2010

ipconazole 4.62 MD Canada Rancona Apex 29176 06/04/2009

USA Rancona Apex 400-546 12/11/2008

ipconazole/metalaxyl/imidacloprid 4.61/6.15/154 FS

USA Rancona Crest 400-574 12/11/2009

ipconazole/metalaxyl/imidacloprid 4.61/6.15/31 FS

USA Rancona Crest WR 400-573 12/11/2009

ipconazole/metalaxyl 4.62/6.5 MD Canada Rancona Pinnacle 30769 08/02/2013

USA Rancona Pinnacle 400-566 13/01/2009

ipconazole/carboxin 9.38/87.5 FS Canada Rancona RS 30217 24/01/2012

USA Rancona RS 400-581 05/01/2011

ipconazole/metalaxyl 9.6/15.4 MD USA Rancona Summit 400-570 06/07/2009

ipconazole/metalaxyl 11/17.6 MD USA Rancona Xxtra 400-571 06/07/2009

ipconazole/carboxin USA Rancona V100 Pro FS 400-596 19/09/2013

ipconazole/carboxin/metalaxyl USA Rancona V RTU FS 400-595 28/10/2013



Page 13 of 172


The detailed assessment of individual trial and study data is located in the Biological Assessment Dossier for UBI 4336.01. The objective of this draft Registration report is to summarise data to support the use of UBI 4336.01 as a seed treatment for use on maize, the claims proposed are:

“UBI 4336.01 controls Maize Head Smut (Sphacelotheca reiliana).”

Proposed Label Text:

Crop Target No. of

applications Application

timing (BBCH) Dose g a.i./100

kg seed

Maize (Zea

mays) Head smut (Sphacelotheca

reiliana) 1 00 8.1

Description of the plant protection product

Information on the detailed composition of UBI 4336.01 can be found in the confidential dossier of this submission (Registration Report- Part C)

UBI 4336.01 is a flowable Suspension Concentrate (FS) containing 452 grams per litre (g/l) ipconazole for use on maize. Further details are given in Table 2Table 2.

Table 2: Details of the Active substance

Active Substance Ipconazole

g/l 20

Chemical group triazole

Mode of action interferes with ergosterol biosynthesis

Biological action Pre-planting seed treatment

For further physical-chemical properties, reference should be made to Registration Report Part B Section 1: Identity and Physical and Chemical properties.

The data presented in the Biological Assessment Dossier and summarised in this dRR fully support the label claims for UBI 4336.01 for the control of Maize Head Smut (Sphacelotheca reiliana).

Proposed uses for this product are supplied in Appendix 2.

The detailed assessment of the individual trial and study data is located in the following report IIIA1 6.0 Biological Assessment Dossier for UBI 4336.01 (Rancona 450 FS).

In the south west of France where the disease is common, Maize head smut can cause localised heavy yield losses of 30-50% but is usually of lower impact. Maize head smut is present throughout Europe but occurs sporadically. Whilst it is difficult to determine the potential economic losses due to this disease, the indicated 100kg/ha loss of yield per 1% increase in infection, cited by Pacheco and Dittrich, 19991 is an indicator of the potential for loss of production. In addition, the potential for teliospores to remain viable in the soil for years means there is potential to see a rapid increase in infection levels given favourable climatic conditions for disease development.

Sphacelotheca reiliana occurs sporadically throughout Europe. However, climate change, particularly

increasing temperatures in the spring combined with changing rainfall patterns could increase the likelihood

of optimal conditions for the development of the pathogen. The recent approval of the seed treatment product

1 Pacheco, A.C. and Dittrich, R.C. (1999). Resistance of commercial maize hybrids to head smut. Agropecuria-Catarinense 12:2, 44-45; 6 ref.



Page 14 of 172


Vibrance 500 S (Sedaxane) in Germany (reg. no 008230-00) demonstrates that growers require products to be

available to control this target pathogen.

In addition to the requirement for controlling head smut in Germany the seed trade within Europe should be

considered. Maize seed exports globally are worth approximately $3 billion per annum, the greatest seed

exporter is France with 21% of the market (worth $631 million in 20172), Germany has a 2.8% share of this

lucrative market (worth $48.2 million in 2017)2 with exports primarily to the Netherlands (24%), France

(22%), Denmark (10%), United Kingdom (9.2%) and Switzerland (5.6%). When exporting to areas affected

by head smut, the ability to apply seed treatment against this pathogen is an advantage.

Substantial crop yield losses may occur as a result of head smut infection, and once infected, sites are likely

to experience recurring infections due to soil borne teliospores infecting subsequent crops (spores can remain

viable in the soil for 7-8 years)3. The susceptibility of breeding lines used in Europe is also an important factor.

This disease is not included on the list of major/minor uses for Germany (21 May 2019)4 and is therefore

concluded to be a minor pest at this time.

Mode of Action

The active ingredient ipconazole (chemical group of triazoles) inhibits ergosterol biosynthesis in the metabolism of plant-damaging fungi. Ergosterol is the crucial component of the cell membrane of fungal pathogens. Ipconazole is assigned to the DMI fungicides (SBI: Class 1(sterol biosynthesis inhibitor)); )). The FRAC classification is G1: Inhibition of C14-demethylase in sterol biosynthesis (ERG11 / CYP51) in membranes. In agriculture, the active ingredient is used in wheat against leaf rust (Puccinia triticina) and in barley against seed- and soil-borne diseases. Ipconazole is used in many other crops, such as root and leaf vegetables, cabbage and pumpkin species. Other crops which are treated with ipconazole are cotton, sunflower, oilseed rape, ornamental plants, conifers and turf grass (seed treatment). The mode of action of ipconazole is based on the inhibition of the 14-C demethylation of ergosterol biosynthesis in the fungal pests. The target site is the enzyme cytochrome P-450 (CYP51), which catalyzes the 14-C-demethylation step in the pathway. This mechanism leads to a change in the membrane structure and function, and to failures in the distribution and development of fungal cells. The biosynthesis of ergosterol arising from lanosterol is blocked at the C-14 demethylation by inhibiting one or more enzymes in the microsomes, so that there is concentration of certain precursors, i.e. from C-14 and C-4 methylsterolen. According to FRAC (Fungicide Resistance Action Committee) the resistance risk of the active ingredient is classified as medium (FRAC code 3). Currently resistances in different fungal species are known. These are mutations in the CYP51 destination (ERG 11) gene, e.g. V136A, Y137F, A379G, I381V. Thus, differences exist in the activity spectra of DMI fungicides.

2 https://oec.world/en/profile/hs92/100510/ Accessed 03/04/2020 3 CEB 160 Efficacy trials method for fungicide products intended to control head smut of maize, Sphacelotheca reiliana

(Kuhn) Clinton 4 https://lueckenindikationen.julius-kuehn.de/liste-minor-/-major-uses.html Feldfunktion geändert



Page 15 of 172


DMI fungicides are sterol biosynthesis inhibitors (SBI), but show no cross-resistance to other classes SBI (G2, G3 or G4). FRAC SBI guidelines must be observed for resistance management. The active ingredient is absorbed by the roots and leaves and translocated acropetally predominantly in young, growing plant tissue. There, it inhibits the formation of ergosterol as an important component of the cell membrane of fungal pathogens.



Page 16 of 172


Efficacy data

This dRR summarises data from the Biological Assessment Dossier, data within the dossier has been presented in the most appropriate way for the data available.

Data against Head smut (Sphacelotheca reiliana) has been generated across both Maritime and Mediterranean climatic regions of France and in Italy and Romania. All data have been summarized by climatic zone.

Trials within the BAD have been carried out by Arysta LifeScience, contractor companies and Official Research Institutes, all of which follow CEB or EPPO standards and are officially recognized as competent authorities to carry out field registration trials in accordance with the principles of Good Experimental Practice (GEP).

Trials generally followed the requirements of the general EPPO standards:

- PP 1/152(4) “Design and analysis of efficacy evaluation trials”;

- PP 1/181(3/4) “Conduct and reporting of efficacy evaluation trials including good experimental practice”;

- PP 1/135(3/4) “Phytotoxicity assessment”;

- PP 1/225(1/2) “Minimum effective dose”;

The trials also followed the specific CEB efficacy guideline, as no EPPO standard is currently available for

this target:

- CEB guideline N°160 ‘Efficacy trials method for fungicide products intended to control head smut of maize’;

Trials undertaken by Arvalis in 2008/2009 did not specify the EPPO guidelines followed and trial plots were

smaller than recommended by the CEB guidance (2 rows of 6m rather than 2 rows of 10m); however, these

trials included 6 replicates rather than the minimum of 4.

UBI 4336.01 is a seed treatment for application to maize and is shown to be efficacious across a wide range

of climatic conditions. The target disease, maize head smut (Sphacelotheca reiliana) is sporadic in nature and

development of the disease depends upon many factors including the presence of soil borne infection, a

susceptible variety, warm soil temperatures with low to moderate soil moisture and for optimal conditions

nitrogen deficiency. Due to these factors this disease is particularly difficult to trial and many trials failed to

develop disease. All the formulations tested in the trials were applied as seed treatments, previous experience

with ipconazole seed treatments with multiple formulations indicated that formulation type would not impact

efficacy. Therefore, data generated with all formulations are summarised in this dossier and the performance

checked against the standards.

The formulation to be registered is UBI 4336-01, the change from UBI 4336-00 to UBI 4336-01 concerns an antifoaming agent and is not considered to be biologically significant. This is confirmed by EPPO PP1/307(1), where “Changes in co-formulants added to preserve the formulation in the container or in the tank (e.g. preservatives, anti-freeze and anti-foaming agents)” are cited in the list of biologically non-significant changes in chemical composition.



Page 17 of 172


Reference products

A list of reference products used in the trials to demonstrate the efficacy and crop selectivity of Rancona 450 FS (UBI 4336-00/4336-01) is shown below. All reference products were seed treatment applications with the exception of Atout 10 (flutriafol), which is a soil incorporated microgranule.

Table 2a List of reference products included in trials with UBI 4336-00 and UBI 4336-01

Product Active Substance AI Content g a.i./l Formulation Formulation

type Registration no. Manufacturer

Alios triticonazole 300g/l 300g/l SC 9400008 BASF

Stylor T anthraquinone + flutriafol + thiram 210 + 15 + 320 g/l 545 g/l SC 9000563 SOPRA

Atout 10 flutriafol 5 g/kg 5g/kg MG 9200038 Cheminova

Celest XL fludioxonil + mefenoxam 25 + 10 g/l 35g/l FS 9800344 Syngenta

Maxim XL fludioxonil + mefenoxam 25 + 10 g/l 35 g/l SC 15946/2003 Syngenta

Vitavax 2000 carboxin + thiram 200 + 200 g/l 400 g/' FS 16377/2003 Chemtura

Vitavax Flo NF carboxin + thiram 200 + 200 g/l 400 g/' FS 007106 Chemtura

Influx XL fludioxonil + mefenoxam 25 + 10 g/l 35 g/l SC 9800344 Syngenta

Feuver prothioconazole 300 g/l 300 g/l FS 2100175 Bayer

IIIA1 6.1.1 Preliminary range-finding tests

Preliminary range finding studies have been carried out against head smut Sphacelotheca reiliana. A number of different ipconazole formulations have been utilised throughout the preliminary studies.

Head smut

Two preliminary range finding tests were carried out in Southern France (Beccas and Lalonquette) in 2001. Three ipconazole formulations were included in these trials, UBI 6726 a 20g/l FS, UBI 6735 a 20g/l ME and UBI 6774 a 20g/l LS formulation.

The trials were conducted in France by AGPM services. One trial was carried out on a site known to be infected with head smut for the purpose of establishing the efficacy of ipconazole formulations against the disease. A second trial was carried out on a clean field to determine any phytotoxic effects upon the crop in the absence of infection. The trials were carried out according to CEB method 160 ‘Charbon des inflorescences du mais’ as no EPPO guideline exists for this target.

Both trials were conducted as a randomised complete block design with four replicates, plots were 8m2. Plants were considered to be affected by the disease when Head smut developed on the cob and / or panicle and data were subjected to Analysis of variance

A summary of the mean % control achieved by three ipconazole formulations at rates of between 1 and 4 g a.i./100 kg seed are included in Table 3Table 3.



Page 18 of 172


Table 3: Mean % control of Head Smut (Sphacelotheca reiliana) by ipconazole formulations in preliminary range

finding test (2001)

g a.i./100kg seed Ipconazole 20 FS Ipconazole 20 ME Ipconazole 20 LS

UBI 6726 UBI 6735 UBI 6774

1 13.7 - 8.5

2 45.1 18.3 9.8

4 89.5 - 45.7

Standard Alios 40ml/50000 seeds 97.4

The highest rate of ipconazole 20 FS (UBI 6726) tested 4 g a.i./100kg seed control not significantly different to that of the CEB reference product Alios. The LS formulation (UBI 6774) tested in the preliminary range finding did not achieve the same level of control as the FS formulation and no further testing with the LS formulation has been carried out. The preliminary range finding indicated that ipconazole applied at rates of below 4 g a.i./100kg seed were insufficient to achieve effective control of head smut. The rate of 4 g a.i./ 100 kg seed gave statistically equivalent to control to that of the reference Alios however a higher rate may give superior results.

Plant counts were carried out in both trials, there were no symptoms of seedling diseases identified in these trials. Application of ipconazole at rates of between 1 and 4 g a.i./100kg seed had no significant effect upon the number of established plants in either study. The results were comparable with those of the reference products included in the trials. Ipconazole applied at rates of up to 4 g a.i. /100kg seed in two preliminary trials caused no phytotoxic symptoms.

Conclusion

Ipconazole at rates below 4 g a.i/100kg seed was not effective to control Maize head smut. A rate of 4g a.i/100kg seed achieved good control of Maize head smut. Ipconazole at 1-4g a.i/100kg seed caused no phytotoxicity to maize.

NOTE: The efficacy data were generated in compliance with the Uniform Principles (Council

Directive 97/57/EC)



Page 19 of 172


The preliminary evaluation of ipconazole for use on maize was conducted in 2 trials, 2001_OTS 00168 and 2001_OTS 00172.

Trial 2001_OTS 00168 was conducted on a contaminated site and trial 2001_OTS 00172 on a site without a history of head smut infection. The efficacy evaluation for trial 2001_OTS 00168 is shown below. Data generated in trial 2001_OTS 00172 was used to demonstrate the selectivity of ipconazole formulations.

The trial indicated that Ipconazole (FS formulation UBI 6726) applied at the highest rate tested, (4g a.s./100kg) seed gave comparable efficacy to the reference product Alios (applied at the rate of 40ml/50,000 seeds). The tested LS formulation (UBI 6774) did not show comparable levels of efficacy to the reference product Alios or the FS formulation. The ME formulation was tested at only a single rate (2 g a.s./100 kg seed) at this rate it did not show comparable efficacy to the reference product Alios.

The data generated with UBI 6726 indicated a minimum of 4 g a.s./100 kg seed is considered necessary to achieve control equivalent to the reference product.

This data indicates a minimum rate required when applying Ipconazole in an FS formulation for the control of SPHTRE.

Trial ID Year Country Assessment

Type

Plant

part

eval

Raw data

in

untreated

plot

Alios Atout 10 Stylor T

320 UBI 6774 (LS)

UBI

6735

(ME)

UBI 6726 (FS)

triticonazole flutriafol flutriafol Ipconazole

40ml/50000

seeds 10kg/ha

0.5l/100

kg

1 g

a.s./100

kg

2 g

a.s./100

kg

4 g

a.s./100

kg

2 g

a.s./100

kg

1 g

a.s./100

kg

2 g

a.s./100

kg

4 g

a.s./100

kg

Seed Treatment application BBCH 00

2001_OTS 00168 2010 FR %PESINC

Head 15.3 a 0.40 b 0.80 b 7.10 a 14.0 a 13.8 a 8.3 a 12.50 a 13.20 a 8.40 a 1.60 b

%Efficacy 0 97.40 94.80 53.60 8.5 9.8 45.7 18.30 13.70 45.10 89.50



Page 20 of 172


Conclusion to Preliminary tests:

In the revised version, the applicant added some explanations concerning the justification. Still, onlyThe applicant conducted 2 trials were provided to demonstrate the need of ipconazole. The trials were carried out in France in 2001.Three different formulations at rates of 1, 2 and 4 g active substance per 100 kg seed were included in the Preliminary tests. The requested dose rate of 8.1 g active substance per 100 kg seed was not tested. The experimental design of the preliminary tests was non-orthogonal, not all rates were tested for all formulations. A reliable evaluation of the results is therefore difficult to conduct.

The results of these preliminary tests show clear differences in the efficacy of the formulations. The formulation UBI 6726 shows an efficacy of 89.5%, while the formulation UBI 6774 shows an efficacy of 45.7 %, both with 4 g a.s.

The highest level of control was achieved at 4 g a.s. (89.5%). The efficacy level of the reference product was 97.4%. It remains unclear and questionable why the applicant conclude that disease control of the product and the reference product is comparable.

The two trials presented by the applicant do not show that the different formulations are comparable and could be used for later efficacy trials.

It can be concluded not to accept the data provided by the applicant for the preliminary range

finding test.

IIIA1 6.1.2 Minimum effective dose tests

There is one target for control by UBI 4336.01 on maize, Head smut (Sphacelotheca reiliana). Data is presented from efficacy trials which include ipconazole formulations at rates of between 2.55 and 20.1g a.i./100kg seed against head smut.

Head smut

Maritime Data has been generated on the control of Head smut with ipconazole formulation (4336.01) in 3 trials. Application rates ranged from 2.5 to 10.9 g a.i./100kg seed and infection levels from 1.6 to 11.3%. Due to the low infection levels in two of the trials results must be treated with caution. Trials with low infection levels (1.6 % infection in one trial and 2.6% in a second trial) highlight the importance of varietal sensitivity in the development of this disease. Data have been generated in the Northern part of France within the Maritime climatic zone. The mean combined % control of maize head smut by ipconazole formulations applied at rates of between 2.5 and 10.9 g a.i./100kg seed is shown in Fehler! Verweisquelle konnte nicht gefunden werden.Figure 1, the box plot indicates low levels of control as a result of the low infection trials where variable efficacy was seen. In one trial where infection reached 11.3% in the untreated control efficacy was excellent across all rates tested (95.5-100%). Data from the three trials in the Maritime climatic zone which included UBI 4336 indicates an application rate of 8.1g a.i./100 kg seed is the minimum effective dose for the control of Head smut in maize. However, from this data it is not possible to determine the minimum effective dose. Data generated in the Mediteranean



Page 21 of 172


climatic zone are considered to be relevant to the Maritime climatic zone for this target disease due to the specific nature of the conditions required for disease development already discussed. Data generated in the Mediterranean climatic zone provides a greater test of the product with higher infection levels and more susceptible varieties and therefore the minimum effective dose for the product UBI 4336.01 is determined from trials in the Mediterranean climatic zone.

Figure 1: Dose justification of ipconazole formulation UBI 4336 applied at 2.5 – 10.9 g a.i./100kg seed against

Maize Head Smut (Sphacelotheca reiliana) in the Maritime climatic zone

2.5 4.1 6.1 8.1 10

Count 3 3 3 2 3

Mean 41.06 46.16 33.04 53.41 42.30

SD 49.19 50.44 57.23 64.64 51.75

Min 0.00 0.00 0.00 7.70 0.00

Q1 13.80 19.24 0.00 30.56 13.45

Median 27.60 38.47 0.00 53.41 26.90

Q3 61.59 69.24 49.56 76.27 63.45

Max 95.58 100.00 99.12 99.12 100.00

Mediterranean

Data has been generated on the control of Head smut by ipconazole formulations (UBI’s 6969, 6919, 6983,

6894 and 4336) from 14 trials. Application rates ranged from 2.55 to 20.1 g a.i./100kg seed and infection

levels from 6.8-42.5%. Data have been generated in the South-West of France and Italy within the

Mediterranean climatic zone. A box plot chart indicates the mean % control of maize head smut by ipconazole formulations applied at rates of between 2.55 and 20.1 g a.i./100kg seed (Figure 2Figure 2). The data demonstrates that an application rate of 8.1g a.i./100 kg seed is the minimum effective dose for the control of Head smut in maize. Rates of 5.0 –



Page 22 of 172


6.1 g a.i./100 kg seed showed a lower mean % control (62.41%) and greater variability of control than the rate of 8.1g a.i./100 kg seed (78.36%). Application at rates above 8.1g a.i./100 kg seed further reduced variability of control however the mean % control of head smut decreased (77.02%).

Figure 2 Dose justification of ipconazole formulations (UBI’s 6969, 6919, 6983, 6894 and 4336) applied at 2.5 –

12.2 g a.i./100kg seed against Maize Head Smut (Sphacelotheca reiliana) in the Mediterranean climatic zone

A further box plot indicates the efficacy of only UBI 4336 at a range of rate between 5.8 and 12.2 g a.i./100kg seed (Figure 3Figure 3). Once again the rate of 8.1 g a.i./100 kg seed resulted in less variability in control than the lower rates tested. Mean control of maize head smut at 8.1g a.i./100 kg (74.58%) was also higher than for the lower rate tested (72.16%). Increasing the dose rate further to between 10.4 and 12.2 g a.i./100kg seed increased mean control to 78.93% but did not result in less variability than the rate of 8.1g a.i./100 kg seed, with the exception of one outlier.

2.55-4.4 5 - 6.1 8.1 10.0 - 12.2

Count 6 14 10 12

Mean 39.77 62.41 78.36 77.02

SD 36.50 31.71 22.65 16.45

Min 3.50 0.00 35.10 55.40

Q1 19.98 40.83 69.54 62.58

Median 23.95 63.20 83.30 76.15

Q3 57.40 94.96 97.20 91.66

Max 100.00 100.00 100.00 100.00



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Overall the rate of 8.1g a.i./100 kg seed demonstrates good levels of control of maize head smut across a range of trials with moderate to high infection levels. Lower rates show inconsistency of control and, though the higher rate at times demonstrates greater efficacy, the overall reliability of the 8.1 g a.i./100kg seed rate indicates it is the minimum effective dose against this target.

Figure 3: Dose justification of ipconazole formulation (UBI 4336) applied at 5.8 – 12.2 g a.i./100kg seed against

Maize Head Smut (Sphacelotheca reiliana) in the Mediterranean climatic zone

5.8 8.1 10.4-12.2

Count 8 8 8

Mean 72.16 74.58 78.93

SD 28.75 23.86 18.49

Min 32.35 35.10 55.71

Q1 44.38 62.52 62.58

Median 81.30 76.90 80.19

Q3 97.16 95.74 94.32

Max 100.00 100.00 100.00



Page 24 of 172


Southeast

Two trials in the Southeast climatic zone generated data on the control of Head smut by ipconazole

(formulation UBI 4336.01). Both trials were carried out in Romania in 2014 with Maize cultivar PO412.

Application rates of ipconazole in these trials ranged from 4.1 to 12.2g a.i./100kg seed all rates were included

in both trials, infection levels in the untreated control ranged from 12.71-21.09%. The mean combined %

control of maize head smut by ipconazole formulation UBI 4336.01 applied at rates of between 4.1 and 12.2

g a.i./100kg seed is shown in Figure 4. The error bars indicate the range of control shown at each dose and the

red dotted line indicates the mean % control achieved by the reference product Alios applied at 37ml/u.

The data shows that ipconazole applied at 8.1g a.i./100kg seed achieves comparable or greater control than

the reference product Alios applied at 37ml/u seed. The higher rate of ipconazole demonstrated the highest

level of control of Head smut (mean 98.05%) however this was not significantly higher than the control

demonstrated by 8.1g a.i./100kg seed rate. The lower rates of ipconazole tested, did not achieve sufficient

control of head smut in these trials. The data indicates that the proposed rate of 8.1g a.i./100kg seed is the

minimum effective dose for the control of Head smut.

Figure 4: Dose justification, mean % efficacy of ipconazole formulation (UBI 4336) applied at 4.1 – 12.2 g

a.i./100kg seed against Maize Head Smut (Sphacelotheca reiliana) in the Southeast climatic zone (Romania)

Conclusions

At the proposed application rate of UBI 4336.01 (8.1g a.i./100kg seed), ipconazole formulations demonstrated

good control of maize head smut, lower rates tested showed generally lower control with greater variability.

Higher rates tested did increase the control levels in some trials but the higher rates did not greatly reduce the

variability further. The data supports the proposed rate of 8.1g a.i./100kg seed for the control of maize head

smut.

All trials were conducted in the field as confirmed in Appendix 3 of the BAD.

0

10

20

30

40

50

60

70

80

90

100

4.1 g a.i./100kg 6.1 g a.i./100kg 8.1 g a.i./100kg 12.2 g a.i./100kg

% C

on

tro

l

Ipconazole (UBI 4336) g a.i./100kg seed



Page 25 of 172


New data tables have been added in order to allow the comparison of rates in individual trials. The new tables included below include only data generated with formulations UBI 4336-00 and UBI 4336-01. The change from UBI 4336-00 to UBI 4336-01 concerns an antifoaming agent and is not considered to be biologically significant. This is confirmed by EPPO PP1/307(1), where “Changes in co-formulants added to preserve the formulation in the container or in the tank (e.g. preservatives, anti-freeze and anti-foaming agents)” are cited in the list of biologically non-significant changes in chemical composition.

Summary tables are presented for those trials where infection levels were considered to be high enough for reliable evaluation of efficacy (5% incidence). All data presented are for % pest incidence and data are presented by climatic zone: Mediterranean zone (Table 4Table 1), Maritime zone (

Table 5Table 2) and South-East zone (Table 6Table 3).



Page 26 of 172


Table 41: Summary of Minimum effective dose (% Pest incidence) in trials conducted in the Mediterranean climatic zone (infection levels >5%) (formulations UBI 4336-

00/01)


Type Days after

sowing

Crop Stage at

Asst (BBCH)

Plant part assessed

Raw data in untreated plot

UBI 4336-00 / UBI 4336-011

ipconazole

2.5 g a.s./100 kg

4.1 g a.s./100 kg

5.8 - 6.1 g a.s./100 kg

8.1 g a.s./100 kg

10 - 10.4 g a.s./100 kg

12.2 g a.s./100 kg

47 TS NR 2008 176 (ANJOU 285)

2008 FR %PESINC

178 DAS - Head 7 - 3.80 3.70 3.10

%Efficacy 45.71 47.14 55.71

47 TS NR 2008 176 (ANJOU 249)

2008 FR %PESINC

178 DAS - Head 6.8 - 4.60 2.20 2.10

%Efficacy 32.35 67.65 69.12

47 TS NR 2009 184 2009 FR %PESINC

157 DAS - Head 9.7 a 0.00 c 0.20 c 0.00 c

%Efficacy 100.00 97.94 100.00

47 TS SPACE NR 2010 203 (ANJOU LG 3271)

2010 FR %PESINC

141 DAS - Head 21.1 - 0.80 0.00 0.30

%Efficacy 96.21 100.00 98.58

48 TS SPACE NR 2010 203 (ANJOU 249)

2010 FR %PESINC

141 DAS - Head 8 - 0.00 0.40 0.70

%Efficacy 100.00 95.00 91.25

ESG14-168 2014 IT %PESINC

118 DAS 89 Head 7 a 2.30 b 2.00 b 1.50 b 2.8 b

%Efficacy 67.90 71.40 78.60 60.70


99 DAS 89 Head 14.3 a 11.5 ab 8.5 ab 9.30 ab 5.3 b

%Efficacy 19.30 40.40 35.10 63.20

AE16-022 2016 FR %PESINC

178 DAS 83 Head 11.5 a 0.8 b 0.00 b 1.00 b 2.80 b 0.80 b

%Efficacy 93.04 100.00 91.30 75.65 93.04

8 data Average SPHTRE - %PESINC - Head – Final efficacy assessment 10.68 72.17 74.64



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Mediterranean %Efficacy

zone Min 6.80 32.35 35.10

Max 14.30 100.00 97.94

5 Average SPHTRE - %PESINC - Head – Final efficacy assessment 10.52 74.86 81.55 82.93


zone Min 6.80 32.35 47.14 55.71

Max 21.10 100.00 100.00 100.00

2 data Average SPHTRE - %PESINC - Head – Final efficacy assessment 10.65 43.60 55.90 56.85 61.95


Min 7.00 19.30 40.40 35.10 60.70

Max 14.30 67.90 71.40 78.60 63.20

1Statistical analysis in trials 47 TS NR 2008 176 and 48 TS SPACE NR 2010 203 was conducted across both tested varieties and is therefore not indicated in the summary table above.

Table 52: Summary of Minimum effective dose (% Pest incidence) in trials conducted in the Maritime climatic zone (infection level >5%)(formulations UBI 4336-00/01)


Type

Days after

sowing

Crop Stage at

Asst (BBCH)

Plant part

eval

Raw data in

untreated plot

UBI 4336-00 / UBI 4336-01

ipconazole

2.5 g

a.s./100 kg

4.1 g a.s./100

kg

5.8 - 6.1 g

a.s./100 kg

8.1 g

a.s./100 kg

10 - 10.4 g

a.s./100 kg


109 83 Head 11.2 a 0.50 b 0 b 0.10 b 0.10 b 0.00 b

%Efficacy 0 95.54 100.00 99.11 99.11 100.00



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Table 63: Summary of Minimum effective dose (% Pest incidence) in trials conducted in the South-East climatic zone (infection level >5%)(formulations UBI 4336-00/01)


Type

Days

after

sowing

Crop

Stage at

Asst

(BBCH)

Plant

part

eval

Raw data in

untreated plot

UBI 4336-00 / UBI 4336-01

Ipconazole

4.1 g a.s./100 kg 6.1 g a.s./100 kg 8.1 g a.s./100 kg 12.2 g a.s./100 kg


ESG14-164 2014 Romania %PESINC

113 - Head 12.71 a 6.15 b 4.09 b 2.11 bc 0.36 c

%Efficacy 0 51.60 67.80 83.40 97.20


114 - Head 21.09 a 6.46 b 3.06 bc 1.02 cd 0.24 d

%Efficacy 0 69.40 85.50 95.10 98.90

2 data

South-East

zone

Average SPHTRE - %PESINC - Head – Final efficacy assessment 16.90 6.31 3.58 1.57 0.30

%Efficacy 0.00 60.50 76.65 89.25 98.05

Min 12.71 51.60 67.80 83.40 97.20

Max 21.09 69.40 85.50 95.10 98.90



Page 29 of 172


Conclusion to minimum effective dose tests (Dose justification):

A total of 19 trials were conducted to test the MED, 3 trials in the maritime EPPO zone, 14 in the mediterranean EPPO zone and 2 in the southeast EPPO zone. The version revised by the applicant now shows 11 MED trials with the requested formulation. New summary tables have been provided, which include only data generated with formulations UBI 4336-00 and UBI 4336-01. These new tables demonstrate the efficacy of formulation UBI 4336-01 (and equivalent formulation UBI 4336-00) at a range of rates. All trials were conducted in the field. No information is given about the conditions (controlled conditions or field trials).

In the new data table of the applicant one trial from the maritime EPPO zone the application rate from 2.5 – 10.4 g a.s. per 100 kg seed was tested. The efficacy between the different application rates do not differ significantly.In the 3 trials from the maritime EPPO zone the application rate from 2.5 – 10.9 g a.s. per 100 kg seed was tested. Five different formulation were included in the trials. In two out of three trials, the infection level of untreated control was 1.6 and 2.6%, which is too low for a reliable result. Those trials cannot be accepted.

In the mediterranean EPPO zone the application rates from 2.55 – 12.2 20.1 g a.s. per 100 kg seed were tested in 14 8 trials. Infection level of the untreated control was 6.8 – 42.5%. The efficacy between the application rates 5.8-6.1 g a.s./100 kg and the applied rate of 8.1 g a.s./100kg does not differ significantly (72.17% and 74.64%).Infection level of the untreated control was 6.8 – 42.5%. Five different formulation were included in the trials. No information about the different formulation is given.

In the southeast EPPO zone 2 trails were carried out. Application rates ranged from 4.1 – 12.2 g a.s. per 100 kg seed. The infection level of the untreated control was 12.7 – 21.1%. The dose reduction from 8.1g a.s . per 100kg seeds to 6.1 g per 100 kg seeds caused a decrease of disease control by 12.6%.

Summarising the results of MED trials the justification of the proposed application rate of 8.1g a.s. per 100kg seeds will not be accepted.The presentation of the results is inadequate and incomplete. The tables are confusing and important information is missing. For instance, infection level of untreated control of the according trials. Furthermore, the different formulations were not included in the table. In addition, low rates were clustered together in tables and in the figure. It is not possible to draw a coherent conclusion from this way of result presentation. The dose rate has to be specified as well as the amount of according trials. No information is given which parameter of disease control has been considered and presented (disease severity, incidence, emergence). No information is given about the year of conduction (all of them in 2014?)

It can be concluded to accept the data provided by the applicant to demonstrate the

minimum effective dose for the control of Sphacelotheca reiliana in maize.

Formatiert: Textkörper;style5, Rechts: 0,4 cm, Abstand Vor: 0,1 Pt.

Formatiert: Nicht Hervorheben






Page 30 of 172




Page 31 of 172


IIIA1 6.1.3 Efficacy tests

A total of 25 field trials carried out between 2005 and 2017 generated data to evaluate the efficacy of ipconazole formulations against Maize head smut Sphacelotheca reiliana.

Data to support the registration of UBI 4336.01 in Germany has been generated from across three climatic

zones (Maritime, Mediterranean and Southeast). As UBI 4336.01 is a seed treatment it is less susceptible to

climatic differences than foliar or soil applied chemicals. Maize planting dates across the central and western

EU are fairly consistently between mid-April and mid-May. Maize head smut develops when soil moisture is

low to moderate and the soil temperature is generally between 21-28°C or where a nitrogen deficiency exits.

These factors determine the development of this disease, and the conditions may appear in any season across

the maize growing areas in the central and western EU. If we look more precisely where the trials were placed,

we can notice as follows:

The trials were performed in France (north and south), in areas climatically favorable to grow maize with not

a real Mediterranean climate with quite a lot of rainfall and humidity. We can say the same regarding the trials

performed in Italy and Romania. They were placed in the north under very favorable and comparable

conditions than the French trials. As a result, we can say that these trials were placed under comparable climate

conditions to the mean Maritime EPPO zone conditions.

Infection and expression of the disease requires a combination of a site infected with Sphacelotheca reiliana,

a susceptible variety of maize and favourable climatic conditions for the development of the disease. As a

result, the disease is sporadic and it is not easy to gather data. Therefore, all data generated in the Maritime,

Mediterranean and Southeast climatic zones are considered as relevant to support the registration of UBI

4336.01 in Germany.

In addition to these trials, data are presented from two field trials against maize head smut in Mexico.

Control of Head smut (Sphacelotheca reiliana)

Trials to generate data on the control of Head smut by UBI 4336.01 have been carried out using a number of formulations. Ipconazole formulations UBI 6983, UBI 6969, UBI 6919, UBI 6894 and UBI 4336 have been included in these trials at rates of between 2.55 and 20.1g a.i./100kg seed, all formulations are considered to be comparable when applied at equivalent rates. The proposed label rate for UBI 4336.01 against Head smut based on the minimum effective dose is 8.1g a.i./100kg seed

Maritime

Four trials in the Maritime climatic zone generated data on the control of Head smut by ipconazole formulations UBI 6983 and UBI 4336.01, all formulations are considered to be comparable when applied at equivalent rates of active substance. The trials were carried out in 2006 and 2017, some on a highly susceptible cultivar (cv. Banguy).

The infection level of head smut in the 2006 trial was high (32.5%). Ipconazole formulation UBI 6983 was used in this trial at rates of 2.55, 5.0 and 10.0g a.i./100kg seed. The proposed label rate for UBI 4336.01 against Head smut based on the minimum effective dose is 8.1g a.i./100kg seed.

At the rate of 5g a.i./100kg seed UBI 6983 achieved 50.8% control of Head smut, the level of control increased to 68.5% at the higher rate of 10g a.i./100kg seed. The proposed label rate of 8.1g a.i./100kg seed was not tested in this early development trial. When compared with the reference product Alios (37ml/u), UBI 6983 applied at all rates (2.55 – 10g a.i./100kg) showed numerically greater control of Head smut, though this difference was not significant (

Table 7Table 4).



Page 32 of 172


Trials conducted in 2017 included ipconazole applied per unit seed (50,000 seeds), when converted to a rate per 100kg seed this equates to 8.8 g a.i./100kg seed. The data are summarised with the 8.1 g a.i./100 kg seed data. The infection levels of head smut across the trials conducted in 2016 and 2017 ranged from 1.6% to 11.3%. Data are presented in Table 8Table 5 from all trials were ipconazole formulations have been included at the proposed rate of 8.1g a.i/100kg seed. Where the infection levels in the trials was below the threshold of 5% in the untreated control the data are shown in grey text in the summary table, summary data that includes both valid trials (above 5% infection) and low infection trials is also shown in grey text. Data from trials with low infection levels are included as they demonstrate the effect of varietal sensitivity in the development of head smut.

At the rate of 8.1g a.i./100kg seeds UBI 4336.01 achieved 49.5% control of head smut across the three trials, which was statistically equivalent to the tested reference Alios in all trials. Where infection exceeded 5% in one trial control of head smut reached 99.12% with UBI 4336.01 and 93.88% with the reference product Alios.

A summary of the mean % efficacy of ipconazole formulations against maize head smut in trials carried out in the Maritime climatic zone is included in

Table 7Table 4 and Table 8Table 5.

The data generated in these trials is supportive of the label claim for the control of Head smut (Sphacelotheca

reiliana) by UBI 4336.01 applied at 8.1g a.i./100kg seed (0.18L product/t seed) in maize.

Table 74: Summary of mean % efficacy of Ipconazole formulation 6983 against Head smut (Sphacelotheca

reiliana) on maize in the Maritime climatic zone

Treatment Formulations (UBI) Application Rate Number of

Trials

Efficacy

g a.i./100kg Mean % control

Ipconazole 6983

2.55 1 49.20

5.0 1 50.80

10.0 1 68.50

Alios n/a 37ml/u 1 47.70

Untreated n/a n/a 1 0.00

Table 85: Summary of mean % efficacy of Ipconazole formulation 4336.01 against Head smut (Sphacelotheca

reiliana) on maize in the Maritime climatic zone

SPHTRE-Maize-Maritime

Number of trials

Mean infestation of the untreated control (%)

(min & max)

Mean % control (min & max) No of trials

where Rancona 450 FS is

UBI 4336 8.1 g a.i/100 kg Alios 37-40

ml/50,000 seeds

>, <, = compared to

standard

Average of all trials with ipconazole formulations

3 5.15 49.5 57.13

3 trials = (1.56-11.3) (7.7-99.12) (23.1-93.8)

1 11.3 99.12 93.8

1 trial = - - -

Text shown in grey indicates data included from trials where infection l evels were below the threshold of 5%

Mediterranean

Thirteen trial series generated data on the control of Head smut by ipconazole formulations (UBI 6983, UBI 6969, UBI 6919, UBI 6894 and UBI 4336) in the Mediterranean climatic zone. The trials were carried out between 2005, 2014, 2016 and 2017 in France and Italy. Of these trial series four included two trials and one included three trials, giving a total of 19 independent trials.



Page 33 of 172


The infection levels of head smut across the trials ranged from 1.4% to 42.5%. Data are presented here from all trials were ipconazole formulations have been included at the proposed rate of 8.1g a.i/100kg seed. Where the infection levels in the trials was below the threshold of 5% in the untreated control the data are shown in grey text in the summary table, summary data that includes both valid trials (above 5% infection) and low infection trials is also shown in grey text. Data from trials with low infection levels are included as they form part of a trial series which demonstrates the effect of varietal sensitivity in the development of head smut.

Fifteen trials included ipconazole formulations (UBI 6969, UBI 6919 and UBI 4336) at the proposed rate of 8.1 g a.i./100kg seed. Data from these trials are presented in Table 9Table 6. Trials conducted in 2016 and 2017 included ipconazole applied per unit seed (50,000 seeds), when converted to a rate per 100kg seed this equates to between 7.6 and 8.9 g a.i./100kg seed. The data are summarised with the 8.1 g a.i./100 kg seed data.

At the proposed label rate of 8.1g a.i./100kg seed ipconazole formulations UBI 6969, UBI 6919 and UBI 4336 gave mean control of Head smut of 73.75% (range 27.3 – 100%) across all 15 trials where this rate was included. When only trials with above 5% infection are considered formulations UBI 6919 and UBI 4336 gave mean control of Head smut of 78.36% (range 35.1 – 100%). At this rate ipconazole formulations gave statistically equivalent levels of control to that of the reference product Alios applied at 37-40ml/u in all trials.

Whilst no bridging studies are available. All the formulations were applied as seed treatments; and showed consistently comparable levels of efficacy to the reference product Alios. Data generated with all formulations are considered supportive of the formulation UBI 4336. The data generated in these trials is supportive of the label claim for the control of Head smut (Sphacelotheca reiliana) by UBI 4336.01 applied at 8.1g a.i./100kg seed (0.18L product/t seed) in maize.

Table 96: Summary of mean % efficacy of Ipconazole formulations against Head smut (Sphacelotheca reiliana)

on maize in the Mediterranean climatic zone

Orthogonal comparison between test and reference products Number

of trials

Mean infestation of the untreated control (%)

(min & max)

Mean % control (min & max) No of trials

where Rancona 450 FS is

SPHTRE-Maize-Mediterranean

UBI 6969 8.1 g

a.i/100 kg

UBI 6919 8.1 g

a.i/100 kg

UBI 4336 8.1 g

a.i/100 kg

Alios 37-40 ml/50,000

seeds

>, <, = compared to standard

Average of all trials with ipconazole formulations

15 9.11 73.75

(27.3-100) 69.24

(22.7-100) -

(1.4-28.1)

10 12.48

(6.8-28.1) 78.36

(35.1-100) 65.84

(39.81-97.8) -

Orthogonal comparison, with reference products

1 1.4 53.3

- - 92.5

1 trial = (-) (-) (-)

2 19.7

- 93.5

- 92.55

2 trials = (11.3-28.1) (88-99) (87.3-97.8)

1 2.8

- 100

- 75

1 trial = (-) (-) (-)

8 10.68

- - 74.58 59.16

8 trials = (6.8-21.1) (35.1-100) (39.81-97.3)

3 2.56

- - 63.26 70.9

3 trials = (1.5-4) (27.3-82.5) (22.7-100)

Text shown in grey indicates data included from trials where infection levels were below the threshold of 5%

Southeast

Two trials in the Southeast climatic zone generated data on the control of Head smut by ipconazole formulation UBI 4336.01 (452g/l FS). The trials were carried out in Romania in 2014 using two cultivars (cv. PO412 and Losc).



Page 34 of 172


The infection levels of head smut in the trials were moderate to high (12.71 – 21.09%). Ipconazole formulation UBI 4336.01 was included in this trial at rates of between 4.1 and 12.2g a.i./100kg seed. The proposed label rate for UBI 4336.01 against Head smut based on the minimum effective dose is 8.1g a.i./100kg seed.

At the rate of 8.1g a.i./100kg seed UBI 4336.01 achieved 89.25% control of maize head smut (range 83.4-95.1%). UBI 4336.01 applied at the proposed rate of 8.1g a.i./100kg gave control of Head smut that was comparable with that of the reference product Alios applied at the rate of 37ml/u.

A summary of the mean % efficacy of UBI 4336.01 against maize head smut in trials carried out in the Southeast climatic zone is included in

Table 10Table 7.

The data generated in these trials is supportive of the label claim for the control of Head smut (Sphacelotheca

reiliana) by UBI 4336.01 applied at 8.1g a.i./100kg seed (0.18L product/t seed) in maize.

Table 107: Summary of mean % efficacy of Ipconazole formulations against Head smut (Sphacelotheca reiliana)

on maize in the Southeast climatic zone

SPHTRE-Maize-Southeast

Number of trials Mean infestation of

the untreated control (%) (min & max)

Mean % control (min & max) No of trials where Rancona 450 FS is

UBI 4336 8.1 g a.i/100 kg

Alios 37-40 ml/50,000 seeds

>, <, = compared to standard

Average of all trials with ipconazole

formulations 2

16.9 89.25 84.05 2 trials =

(12.71-21.09) (83.4-95.1) (80.9-87.2)

Mexico

Two trials were carried out in Mexico (Puebla region) at Jamay and Acambaro, to determine the efficacy of UBI 4336.01 against Head smut. The trials were both carried out in 2009 and include rates of between 7.5 and 12.5 g a.i./100kg seed and the commercial reference Baytan 150 FS (triadimenol). Infection rates reached a maximum of 9.19% in the untreated control at the site in Acambaro and 21.66% in the untreated control at the site in Jamay.

Efficacy against head smut was evaluated 5 times during both trials. Rancona 450 FS applied at 7.5 g a.i./100kg seed gave mean control of head smut that was comparable with or superior to that of the reference product Baytan 150 FS at all assessment timings. At the trial in Acambaro mean efficacy against head smut at the rate of 7.5g a.i./100kg seed ranged from 87.46% to 100% and at the site in Jamay efficacy ranged from 86.39% to 92.4%. A summary of the mean efficacy of UBI 4336.01 against head smut in Mexico is included in Table 11Table 8.

There were no significant differences in efficacy between the rates applied in either trial.

Table 118: Summary of mean % efficacy of Ipconazole formulation UBI 4336.01 against Head smut

(Sphacelotheca reiliana) on maize in Mexico

Crop Pest Country Formulation No. of Trials Iponazole 7.5g a.i./100kg seed

Mean % Control Limits

Maize SPHTRE Mexico UBI 4336.01 2 91.49 90.58 - 92.4

Conclusions

When included in trials at the proposed label rate of 8.1g a.i./100kg seed, Ipconazole formulations achieved good control of head smut. The data generated in these trials is supportive of the label claim for the control of Head smut (Sphacelotheca reiliana) by UBI 4336.01 applied at 8.1g a.i./100kg seed.



Page 35 of 172


This finding is consistent with studies in Mexico, which showed ipconazole to be very effective in controlling the disease at a similar application rate.

New tables have been added below in response to the comments above. The tables summarise % pest incidence for all trials where the infection levels in the untreated plots exceeded 5%. Only trials where UBI 4336-00 or the equivalent formulation UBI 4336-01 have been tested are included in the summary tables, which are presented for each climatic zone: Mediterranean zone (Table 12Table 4), Maritime zone (Table 13Table 5) and South-East zone (Table 14Table 6).

In the Mediterranean zone, control levels following application of UBI 4336-00/4336-01 at 8.1 g a.s./ha, were numerically superior than the reference product Alios in 6 of the 8 trials where the products were directly compared. No statistically significant differences in efficacy were reported between UBI 4336-00/4336-01 and Alios in any of the 8 trials. Mean efficacy across 8 trials was 74.64% for UBI 4336-00/01 and 58.53% for Alios.

In one trial in the Maritime climatic zone, efficacy with UBI 4336-00/4336-01 was 99.11%, numerically superior to that of the reference product Alios (93.75%). The difference was not statistically significant in this trial.

In the South East climatic zone in 2 trials, the efficacy of UBI 4336-00/4336-01 was numerically superior to that of the reference product Alios in both trials. Again, the difference was not statistically significant in these trials. Mean efficacy across the 2 trials was 89.25 % for UBI 4336-00/01 and 84.05% for Alios.

In conclusion, across 11 trials in the Mediterranean (8), Maritime (1) and South-East (2) climatic zones, the efficacy of UBI 4336-00/4336-01 has been demonstrated to be numerically superior to that of the reference product Alios in 9 of the 11 trials where they were directly compared. Alios demonstrated numerically superior efficacy than that of UBI 4336-00/4336-01 in 2 of the 11 trials. There were no statistically significant differences between UBI 4336-00/4336-01 and the reference product Alios in any of the 11 trials where they were directly compared.



Page 36 of 172


Table 124: Summary of Efficacy (% Pest incidence) in trials conducted in the Mediterranean climatic zone (infection level >5%)

Trial ID Year Countr

y Assessmen

t Type

Days after

sowing

Crop Stage at Asst (BBCH)

Plant part eval

Raw data in untreated

plot

Alios Feuver Tebuvax Vitavax Flo NF UBI 4336-00 / UBI

4336-01

triticonazole prothioconazole tebuconazole carboxin + thiram ipconazole

37-40ml/50000 seeds

(0.24g a.s./100 kg)

0.09 g a.s./100 kg 15 g a.s./100 kg 160 g a.s./100 kg 8.1 g a.s./100 kg


47 TS NR 2008 176 (ANJOU 285)

2008 FR %PESINC 178

DAS - Head

7 - 4.20 3.70

%Efficacy 40.00 47.14

47 TS NR 2008 176 (ANJOU 249)

2008 FR %PESINC 178

DAS - Head

6.8 - 3.00 2.20

%Efficacy 55.88 67.65

47 TS NR 2009 184 2009 FR %PESINC 157

DAS - Head

9.7 a 1.40 c 0.20 c

%Efficacy 85.57 97.94

47 TS SPACE NR 2010 203 (ANJOU LG 3271)

2010 FR %PESINC 141

DAS - Head

21.1 12.70 0.00

%Efficacy 39.81 100.00

48 TS SPACE NR 2010 203 (ANJOU 249)

2010 FR %PESINC 141

DAS - Head

8 4.10 0.40

%Efficacy 48.75 95.00

ESG14-168 2014 IT %PESINC 118

DAS 89 Head

7 a 3.80 b 3.30 b 1.50 b

%Efficacy 46.40 53.60 78.60


99 DAS 89 Head 14.3 a 6.50 b 5.80 b 9.30 ab

%Efficacy 54.40 59.60 35.10

AE16-022 2016 FR %PESINC 178

DAS 83 Head

11.5 a 0.30 b 0.30 b 0.30 b 2.80 b

%Efficacy 97.39 97.39 97.39 75.65

8 data Average SPHTRE - %PESINC - Head – Final efficacy assessment 10.68 4.50

2.51



Page 37 of 172


Mediterranean %Efficacy 0.00 58.53 74.64

zone Min 6.80 39.81 35.10

Max 14.30 97.39 97.94

5 Average SPHTRE - %PESINC - Head – Final efficacy assessment 10.52 5.08 1.30

Mediterranean %Efficacy 0.00 54.00 81.55

zone Min 6.80 39.81 47.14

Max 21.10 85.57 100.00

2 data Average SPHTRE - %PESINC - Head – Final efficacy assessment 10.65 5.15 4.55 5.40

Mediterranean %Efficacy 0.00 50.40 55.60 56.85

Min 7.00 46.40 53.60 35.10

Max 14.30 54.40 59.60 78.60

Table 135: Summary of Efficacy (% Pest incidence) in trials conducted in the Maritime climatic zone (infection level >5%)


Type

Days

after

sowing

Crop

Stage at

Asst

(BBCH)

Plant

part

eval

Raw data in

untreated plot

Alios Feuver Tebuvax UBI 4336-00 / UBI

4336-01

triticonazole prothioconazole tebuconazole ipconazole

37-40ml/50000

seeds

0.09 g a.s./100 kg 15 g a.s./100 kg 8.1 g a.s./100 kg



109 83 Head 11.2 a 0.70 b 0.00 b 0.10 b 0.10 b

%Efficacy 0 93.75 100.00 99.11 99.11



Page 38 of 172


Table 146: Summary of Efficacy (% Pest incidence) in trials conducted in the South-East climatic zone (infection level >5%)


Type

Days after

sowing

Crop Stage

at Asst

(BBCH)

Plant part

eval Raw data in untreated plot

Alios UBI 4336-00 / UBI 4336-01

triticonazole ipconazole

37ml/50000 seeds 8.1 g a.s./100 kg



113 - Head 12.71 a 2.42 bc 2.11 bc

%Efficacy 0 80.90 83.40


114 - Head 21.09 a 2.70 bc 1.02 cd

%Efficacy 0 87.20 95.10

2 data

South-East

zone

Average SPHTRE - %PESINC - Head – Final efficacy assessment 16.90 2.56 1.57

%Efficacy 0.00 84.05 89.25

Min 12.71 80.90 83.40

Max 21.09 87.20 95.10


Rancona 450 FS (UBI 4336.01) Registration Report – Central Zone

Page 39 of 172


Conclusion to the efficacy: In the first version twenty-five Twenty-five field trials were carried out between 2005 and 2017 within 3 different climate zones (maritime, mediterranean and southeast). Five different formulations have been tested at rates of 2.55 – 20.1 g a.s /100 kg seed. The version revised by the applicant now shows 11 efficacy trials with the requested formulation.

It is not reasonable why the applicant applied different dose rates and different formulations to approve the dose rate of 8.1 g a.s /100 kg seed for the formulation UBI 4336.1. According to EPPO Standard PP 1/214 (Principles of acceptable efficacy), the product should show results significantly superior to the untreated control and not be less effective than the reference product.

One trial from the maritime EPPO zone was conducted with the applied conditions such as the formulation UBI 4336 with 8.1 g a.s. /100 kg seed. The efficacy was 99.1%.

In the mediterranean EPPO zone 8 trials with the applied conditions were conducted with an efficacy on average of 74.6%.

In the southeast EPPO zone 2 trials with the applied conditions were conducted with an efficacy on average of 89.3%.

Summarizing the results of the efficacy trials (11 trials) from all 3 zones, the efficacy is satisfactory (79.5%).

It is not clear, which parameter of disease control is presented (disease severity, incidence, emergence). A reliable evaluation of the results is therefore difficult to conduct.

The applicant should add the missing information and present the results as it is

recommended in the EPPO Standard PP 1/181 (Conduct and reporting of efficacy evaluation

trials including good experimental practice).

It can be concluded not to accept the data provided by the applicant to demonstrate the

effectiveness against Sphacelotheca reiliana in maize.



Page 40 of 172


IIIA1 6.1.3.1 Procedures for cleaning application equipment

Seed treating equipment, which has been used for the application of UBI 4336.01, should be cleaned by physical removal i.e. scraping of any seed, dust and chemical deposits followed by washing with cold water. Wash water should be disposed of according to local recommendations. Solid waste should be collected by vacuuming where possible. Chemical pumps, and chemical lines should be flushed with clean water after treating and before application of any other product. UBI 4336.01 applies a very small quantity of active substance, and this has proved to leave very few chemical deposits in the application equipment when measured after small scale and some limited commercial scale applications.

Tests on another formulation UBI 6932 (ipconazole + imazalil), Rancona® i-MIX, for use as a seed treatment in cereals showed a double rinse procedure was effective in removing at least 99.98% of the active substance ipconazole from the seed treatment unit used.

The following wording is proposed for the product label:

“After applying, clean the application equipment with water. Ensure the rinse water is kept away from any

water source and disposed of in accordance with National Guidelines”.

IIIA1 6.1.4 Effects on yield and quality

Yield and quality parameters have been assessed in six selectivity trials and five efficacy trials.

IIIA1 6.1.4.1 Impact on the quality of plants and plant products

Quality parameters have been assessed on five crop selectivity trials three in the Maritime climatic zone. Four of the trials were harvested for grain, Hectolitre weight and thousand grain weight have been determined in three of these trials; in one trial grain quality parameters of protein, fat, starch ash and cellulose have been determined. In one trial the maize was harvested for silage, quality assessments are for Protein content, Digestibility, Ash and Fibre content.

Crop quality data has been generated in five crop selectivity trials in the maritime climatic zone. UBI 4336.01 has been included in trials at rates of between 2.5 and 12.2g a.i./100 kg seed. Application of UBI 4336.01 at rates of up to 12.2g a.i./100kg seed does not have any negative effect upon crop quality.

NOTE: The efficacy data were generated in compliance with the Uniform Principles (Council Directive

97/57/EC)

IIIA1 6.1.4.2 Effects on the processing procedure.

The proposed maximum label rate of ipconazole as UBI 4336.01 is just 8.1g a.i/100kg seed. At the maximum expected seed rate of 20kg/ ha this equates to 1.62g ipconazole per hectare. Residue levels in harvested grain from 8 field residue trials in France showed levels at <0.01mg/ kg seed and in many cases below the limit of detection.

As residue levels are below 0.01mg/kg in harvested maize grain transformation tests are not required for UBI 4336.01.

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products

Yield data has been generated in six crop selectivity trials and five efficacy trials across three climatic zones. UBI 4336.01 has been included in trials at rates of between 1.5 and 12.2g a.i./100 kg seed. No negative effects on yield have been recorded in any of the trials however in two trials significant yield increases were recorded following application of UBI 4336.01 at the rate of 8.1g a.i./100kg seed.

Application of UBI 4336.01 at rates of up to 12.2g a.i./100kg seed does not have any negative effect upon crop yield



Page 41 of 172


Quality parameters have been assessed at the proposed application rate of 8.1 g a.s./100 kg seed in three crop selectivity trials, in the Maritime climatic zone. Hectolitre weight and thousand grain weight have been determined in one trial (Table 15Table 7). Grain quality parameters of protein, fat, starch ash and cellulose have been determined in another trial (Table 16Table 8). In a further trial, maize was harvested for silage and quality assessments carried out included protein content, digestibility, ash and fibre content (Table 17Table 9). No significant differences in any of the assessed quality parameters were recorded for any of the treatments. It can be concluded that application of UBI 4336.01 at rates of up to 12.2g a.s./100kg seed does not have any negative effect upon crop quality.

Crop yield data for both efficacy trials (5) and selectivity trials (7) are presented in the summary tables below, by zone and assessment type.

Data from the efficacy trials are summarized as follows: Grain yield data from the Mediterranean climatic zone are presented in Table 18Table 10, silage yield data from the Maritime zone in Table 19Table 11 and grain yield from the South-East zone in Table 20Table 12.

Application of Rancona 450 FS at the rate of 8.1 g a.s./100kg seed did not have any negative impact upon crop yield in any of the 5 efficacy trials where yield was assessed. In 2 trials in the Mediterranean climatic zone, grain yields were not significantly different from either the untreated control or the reference Alios (triticonazole 37ml/50000 seeds), though a numerical improvement in yield was evident for both Rancona 450 FS and Alios treatments.

In the Maritime climatic zone, silage yield was recorded in a single trial. There was no significant difference in crop yield between the untreated control and Rancona 450 FS and Alios treatments. However, a small numerical improvement in yield was seen when Rancona 450 FS was applied at 8.1 g a.s./100kg seed.

In two trials in the South-East climatic zone, Rancona 450 FS (8.1 g a.s./100 kg) significantly increased grain yields; this increase was comparable with (1 trial) or greater than (1 trial) that of the reference product Alios (37ml/50000 seeds).

Crop yield has been assessed in 7 crop selectivity trials in the Maritime (3), Mediterranean (2) and South-East (2) climatic zones. In the two South-East zone trials, the application rates at a maximum rate of 3.7 g a.s./100 kg seed were lower than the proposed application rate for Rancona 450 FS to control head smut (8.1 g a.s./100kg seed). These data are included as some symptoms of phytotoxicity (yellowing) were recorded in one of these trials.

In 2 trials in the Mediterranean climatic zone, Rancona 450 FS applied at rates of up to 12.2 g a.s./100 kg seed had no effect upon grain yield (Table 21Table 13). In the Maritime climatic zone, grain yields were recorded in 2 trials (Table 22Table 14) and silage yield in a further trial (Table 23Table 15). No significant differences in yield were recorded between the untreated and any of the tested rates of Rancona 450 FS (up to 12.2 g a.s./100kg seed) or any of the reference products tested in these trials (Celest/Maxim XL and Alios). There were also no significant differences on yield between reference products and test product at any of the tested rates.



Page 42 of 172


In the South-East climatic zone, 2 trials generated yield data (Table 24Table 16). As stated above, the rates tested in these trials with the maximum tested rate being 3.7 g a.s./100 kg seed were lower than the requested rate for the control of head smut in maize (8.1 g a.s./100kg seed). In one of these trials (ESG13-36), some symptoms of phytotoxicity (yellowing) were reported, but this had no effect upon crop yield; all treatments included in this trial numerically (though not significantly) increased grain yield when compared to the untreated control.

Therefore, it can be concluded as above that application of UBI 4336.01 at rates of up to 12.2g a.s./100kg seed does not have any negative effect upon crop yield.



Page 43 of 172


Table 157: Summary of HLW and TKW in Maritime zone, crop selectivity trials


Type

Days

after

sowing

Crop Stage at

Asst

(BBCH)

Raw data in

untreated

plot

Royalkare

Red Maxim XL Celest XL UBI 4336-00 / UBI 4336-01

colour

fludioxonil

+

metalaxyl-

M

fludioxonil

+

mefenoxzm

ipconazole

20ml/100 kg

seed 12.5

ml/50000

seed

100

ml/100kg

seed

2.5 g a.s./100

kg

3.7-4.1 g

a.s./100 kg

8.1 g a.s./100

kg

12.2 g

a.s./100 kg


ESG13-61 2013 DE TKW (g)

195 99 85.1 a 85.89 a 85.06 a 86.67 a 85.41 a 86.62 a 86.45 a 86.77 a

HLW (kg) 65.9 a 65.76 a 65.88 a 66.01 a 64.86 a 65.76 a 66.09 a 65.06 a

Table 168: Summary of maize grain quality analysis in Maritime zone, crop selectivity trials


Type

Days after

application

Crop

Stage at

Asst

(BBCH)

Raw data in

untreated plot

Alios Alios UBI 4336-00 / UBI 4336-01

triticonazole triticonazole ipconazole

81 g a.s./100 kg 120 g a.s./100kg 8.1 g a.s./100 kg 12.2 g a.s./100 kg


11 GRM F CH TS 003 2011 FR (N)

Cellulose %

254 89

1.1 a 1.3 a 1.18 a 1.15 a 1.23

Starch % 59 a 59.06 a 58.79 a 58.89 a 58.13

Fat % 4 a 4.1 a 3.85 a 3.89 a 3.82

Ash % 1.4 a 1.45 a 1.42 a 1.45 a 1.35

Protein% 7.96 a 7.93 a 7.84 a 7.89 a 7.74



Page 44 of 172


Table 179: Summary of silage quality parameters in Maritime zone, crop selectivity trials


Type

Days after

sowing

Crop

Stage at Asst

(BBCH)

Raw data

in untreated

plot

Royalkare


colour

fludioxonil

+ metalaxyl-

M

fludioxonil +

mefenoxzm ipconazole

20ml/100 kg

seed 12.5

ml/50000

seed

100

ml/100kg

seed

2.5 g

a.s./100 kg

3.7-4.1 g

a.s./100 kg

8.1 g a.s./100

kg

12.2 g

a.s./100 kg


ESG13-62 2013 DE

% Dry matter

188 99

27.18 a 27.3 a 27.65 a 28.03 a 28.1 a 24.58 a 27.05 a 25.45 a

% protein content 3.8 a 3.9 a 3.3 a 2.78 a 3.78 a 2.9 a 2.93 a 2.95 a

Digestibility % 62.7 a 62.98 a 62.65 a 62.8 a 62.63 a 62.8 a 62.75 a 62.75 a

Ash content % 7.38 a 7.05 a 7.33 a 7.13 a 7.25 a 7.23 a 7.35 a 7.73 a

Fibre content % 32 a 30.53 a 31.5 a 32.18 a 31.18 a 31.53 a 31.6 a 31.6 a

Table 1810: Summary of Grain Yield (q/ha) in Mediterranean zone, efficacy trials


Type

Days after

sowing

Crop

Stage at

Asst

(BBCH)

Raw data

in

untreated

plot

Alios Feuver Tebuvax UBI 4336-00 / UBI 4336-01


0.24 g

a.s./100 kg

0.09 g

a.s./100kg

15g

a.s./100kg 2.5 g

a.s./100

kg

4.1 g

a.s./100

kg

5.8 - 6.1

g a.s./100

kg

8.1 g

a.s./100

kg

10 - 10.4

g a.s./100

kg 37-

40ml/50000

seeds

15ml/50000

seeds

3.1ml/50000

seeds



Page 45 of 172



AE16-019 2016 FR Yield Q/ha 201 89 64.08 a 70.68 a 63.76 a 63.23 a 71.94 a 63.93 a 65.20 a 66.68 a 73.06 a

AE16-022 2016 FR Yield Q/ha - 89 66.67 a 66.77 a 66.52 a 72.79 a 72.15 a 71.98 a 64.42 a 73.02 a 70.17 a

2 data Mediterranean

zone

Average Yield - Q MET/ha (grain) 65.38 68.73 65.14 68.01 72.05 67.96 64.81 69.85 71.62

Min 64.08 66.77 63.76 63.23 71.94 63.93 64.42 66.68 70.17

Max 66.67 70.68 66.52 72.79 72.15 71.98 65.20 73.02 73.06

Table 1911: Summary of Silage yield (t/ha) in Maritime zone, efficacy trials


Type

Days

after

sowing

Crop

Stage at Asst

(BBCH)

Raw data

in untreated

plot

Alios Feuver Tebuvax UBI 4336-00 / UBI 4336-01


0.24 g

a.s./100 kg

0.09 g

a.s./100kg

15g

a.s/100kg 2.5 g

a.s./100

kg

4.1 g

a.s./100

kg

5.8 - 6.1 g

a.s./100 kg

8.1 g

a.s./100 kg

10 - 10.4 g

a.s./100 kg 37-

40ml/50000

seeds

15ml/50000

seeds

3.1ml/50000

seeds


AE16-024 2016 FR Yield t/ha 130 87 22.46 a 22.62 a 23.52 a 19.22 a 21.61 a 22.75 a 21.97 a 23.42 a 21.37 a

Table 2012: Summary of Grain yield (t/ha) in South-East zone, efficacy trials


Type

Days

after

sowing

Crop Stage at

Asst

(BBCH)

Raw data in

untreated plot

Alios UBI 4336-00 / UBI 4336-01

triticonazole ipconazole

6.1 g a.s./100 kg 8.1 g a.s./100 kg



Page 46 of 172


37ml/50000 seeds 4.1 g a.s./100

kg

12.2 g a.s./100

kg


ESG14-164 2014 RO Yield t/ha 136 99 7.03 c 7.70 a 7.40 b 7.51 b 7.77 a 7.84 a

ESG14-165 2014 RO Yield t/ha 134 99 6.37 d 7.10 ab 6.7 c 6.86 bc 7.18 a 7.33 a

2 data

South-East

zone

Average Yield t/ha - Grain 6.70 7.40 7.05 7.19 7.48 7.59

Min 6.37 7.10 6.70 6.86 7.18 7.33

Max 7.03 7.70 7.40 7.51 7.77 7.84

Table 2113: Summary of Grain yield (q/ha) in Mediterranean zone, crop selectivity trials


Type

Days

after

sowing

Crop Stage at

Asst

(BBCH)

Raw data in

untreated plot

Influx XL Celest XL UBI 4336-00 / UBI 4336-01

fludioxonil +

mefenoxzm

fludioxonil +

mefenoxzm ipconazole

100 ml/100kg

seed

100 ml/100kg

seed

2.5 g a.s./100

kg

4.1 g a.s./100

kg

8.1 g a.s./100

kg

12.2 g a.s./100

kg


ESG13-38 2013 FR Yield Q/ha 179 89 59.21 a 58.75 a 56.59 a 54.96 a 61.58 a 61.34 a 56.59 a

ESG13-39 2013 FR Yield Q/ha 192 89 108.22 a 113.53 a 111.87 a 117.88 a 109.17 a 107.88 a 114.44 a

2 data Mediterranean

zone

Average Yield - Q MET/ha (grain) 83.72 86.14 84.23 86.42 85.38 84.61 85.52

Min 59.21 58.75 56.59 54.96 61.58 61.34 56.59

Max 108.22 113.53 111.87 117.88 109.17 107.88 114.44



Page 47 of 172


Table 2214: Summary of Grain yield (q/ha or t/ha) in Maritime zone, crop selectivity trials

Trial ID Yea

r

Countr

y

Assessme

nt Type

Days

after sowin

g

Crop Stage

at Asst

(BBC

H)

Raw data

in untreated

plot

Royalkar

e Red Alios Alios

Maxim

XL Celest XL UBI 4336-00 / UBI 4336-01

colour triticonazol

e

triticonazol

e

fludioxoni

l +

metalaxyl-

M

fludioxonil

+

mefenoxz

m

ipconazole

20ml/100

kg seed

81 g a.s./100

kg

120 g

a.s./100kg 12.5

ml/50000

seed

100

ml/100kg

seed

2.5 g

a.s./100

kg

3.7-4.1

g

a.s./100

kg

8.1 g

a.s./100

kg

12.2 g

a.s./100

kg


11 GRM F CH TS 003

2011 FR (N)

Yield Q/ha 169 89 79.31 a 82.65 a 74.32 a

74.25 a

79.63 a

ESG13-61 2013 DE Yield t/ha 195 89 8.45 a 8.8 a 8.97 a 9.04 a 8.2 a

9.15 a 9.09 a 8.9 a

Rancona 450 FS in trial ESG 13-61 applied in combination with 20ml/100kg Royalkare Red

Table 2315: Summary of Silage yield (Whole plant and cob) in Maritime zone, crop selectivity trials


Type

Days

after

sowing

Crop Stage at

Asst

(BBCH)

Raw data in

untreated

plot

Royalkare


colour

fludioxonil

+ metalaxyl-

M

fludioxonil

+

mefenoxzm

ipconazole

20ml/100 kg

seed 12.5

ml/50000

seed

100

ml/100kg

seed

2.5 g

a.s./100 kg

3.7-4.1 g

a.s./100 kg

8.1 g a.s./100

kg

12.2 g

a.s./100 kg


ESG13-62 2013 DE Plant Yield t/ha 120 85 20.5 a 24.56 a 23.45 a 21.35 a 20.74 a 17.91 a 22.19 a 24.67 a



Page 48 of 172


Cob Yield t/ha 18.64 a 20.82 a 20.52 a 18.9 a 17.81 a 15.12 a 19.2 a 20.59 a

Table 2416: Summary of Grain yield (q/ha) in South-East zone, crop selectivity trials


Type

Days after

sowing

Crop

Stage at

Asst

(BBCH)

Raw data in

untreated plot

Maxim XL Vitavax 2000 UBI 4336-00 / UBI 4336-01

fludioxonil +

metalaxyl-M

carboxin +

thiram ipconazole

100ml/100kg 250ml/100kg 2.5 g a.s./100 kg 3.7 g a.s./100 kg


ESG13-36 2013 HU Yield Q/ha 205 89 105.5 a 112.3 a 124.3 a 119.7 a 124.5 a

ESG13-37 2013 HU Yield Q/ha 155 97 78.8 a 76.7 a 79.1 a 80.4 a 75.7 a

2 data South-East zone

Average Yield - Q MET/ha (grain) 92.15 94.50 101.70 100.05 100.10

Min 78.80 76.70 79.10 80.40 75.70

Max 105.50 112.30 124.30 119.70 124.50



Page 49 of 172


Yield and quality:

Five out of 25 efficacy trials and 6 seven 7selectivity trials were harvested. The applicant

presented some quality parameters, grain yield and silage yield results.

The presented data correspond with the requirements of the EPPO Standards PP 1/181

(Conduct and reporting of efficacy evaluation trials, including gGood eExperim.ental

pPractice), PP 1/214 (Principles of acceptable efficacy) and PP 1/223 (Introduction to the

efficacy evaluation of plant protection products). No negative effect was observed by applying

this fungicide.

Even though the applicant could not present data from all efficacy trials it can be concluded to

accept the data provided by the applicant to demonstrate the effectiveness of the plant

protection product against Sphacelotheca reiliana in maize.The applicant mentioned, that

quality parameters have been tested on some of these trials, but no details have been

presented. Furthermore, yield results were mentioned and discussed, but here too the yield

data are missing.

IIIA1 6.2 Adverse effects

IIIA1 6.2.5 Phytotoxicity to host crop

Phytotoxicity

Phytotoxicity has been assessed across 14 maize cultivars in 37 efficacy and crop selectivity trials carried out in the Maritime, Mediterranean and Southeast climatic zones. Minor symptoms of Phytotoxicity have been recorded in a small number of trials (1 efficacy and 2 crop selectivity). The symptoms recorded have been minor and generally transitory in nature. No other symptoms of phytotoxicity have been observed in the remaining crop selectivity and efficacy trials after application of UBI 4336.01 or equivalent formulations at rates of up to 12.2g a.i./100 kg seed. The trials have been carried out over a wide area (three climatic zones) with 14 cultivars of maize. It is therefore reasonable to conclude that UBI 4336.01 applied at the label rates of 8.1g a.i./100kg seed is crop safe on maize.

Emergence

In the absence of disease, application of UBI 4336.01 at rates of up to 12.2g a.i./100kg seed had no effect upon emergence in maize in 5 trials. It is therefore reasonable to conclude that UBI 4336.01 applied at the label rates of 8.1g a.i./100kg seed is crop safe on maize.

Vigour

Application of UBI 4336.01 had no negative effects on crop vigour, significant improvement in crop vigour was recorded in one trial and increases were generally comparable with that of the reference products included in the trials.

Varietal interaction

A field trial to study the selectivity of UBI 4336.01 applied together with other commercial seed treatment fungicides (influx, Gustafson 42S, Alios) on four cultivars of maize (LG30.211, Anjou 277, Nutreca, Adevey)


Formatiert: Schriftart: Kursiv



Page 50 of 172


was assessed for germination, vigour and phytotoxicity effects in differing climates. This study showed that UBI 4336.01 applied as a seed treatment to maize did not present any significant safety issues in the field during one year of trials at three sites in France.

NOTE: The efficacy data were generated in compliance with the Uniform Principles (Council Directive

97/57/EC)

Phytotoxicity was assessed according to EPPO PP1/135 in the majority of trials. Table 27Table 17 below summarises all trials where Rancona 450 FS (UBI 4336-00 or UBI 4336-01) has been applied. Efficacy trials conducted in France between 2008 and 2010 were not conducted according to EPPO; however, no symptoms of phytotoxicity were reported in any of these trials.

A range of doses of UBI 4336-00/01 have been tested, between 2.5 and 12.2 g a.s./100kg seed, with 8 efficacy and 5 selectivity trials including the dose of 1.5N (12.2g a.s./100 kg seed). The reference products included in the trials were Alios (300 g/L triticonazole, FRAC Group 3 DMI fungicide) or Celest XL/Maxim XL/Influx XL (all equivalent formulations) containing fludioxonil (25g/l) + mefenoxam (10g/l). Fludioxonil is a phenylpyrrole and mefenoxam a phenylamide fungicide. This product is registered widely across the EU for broad spectrum control in maize. Both Alios and Celest XL/Maxim XL/Influx XL are seed treatments applied prior to planting similarly to Rancona 450 FS. Full details of treatments applied in each trial are available in the Biological Assessment Dossier in sections IIIA 6.1.3.1.5 and IIIA 6.2.1.1.5 and within the individual trial reports.

Where symptoms of phytotoxicity have been recorded, they are summarized in Table 27Table 17 below.

In one efficacy trial (ESG14-193), some deformation (<4%) was assessed at early assessment timings, but this was transient with no symptoms at the final assessment.

Thinning was recorded in one selectivity trial (ESG13-62), across all treatments and the untreated control. The symptoms reduced between assessments at 8 and 20 days after planting and were not visible at later assessments.

Discoloration (yellowing) was observed in one selectivity trial ESG13-36, but the effects were not dose related and were transient with no symptoms recorded after the second assessment.

In summary, all symptoms were transient and equivalent to those of the reference products tested in the trials. All trials listed in Table 18 have been conducted in the field.

Seed Safety before and after storage

Two studies have been conducted and are presented separately. The report for ESG16-54 is not yet final, however, an interim report and results summary are available.

ES09/30A

A laboratory study carried out in 2010 (ES09/30A) has determined the effect of an application of UBI 4336-

00 on germination and vigour of treated maize seeds after 12 months in storage, compared to the untreated

seeds. The study was conducted by a facility that was officially recognized as competent to carry out testing

according to European Directive 93/71/EEC (ORETO certificate no 230), following EPPO guidelines

PP1/152(3) and PP1/181(3) in accordance with GEP and ISTA seed testing guidelines.



Page 51 of 172


UBI 4336-00 is the same as UBI 4336-01; it is a flowable formulation containing ipconazole 450 g/L as an

active ingredient for seed treatment. The only difference between the 2 formulations is in the antifoaming

agent used.

Maize seed cultivars Algans and Bowling were treated with UBI 4336-00 at the rates of 5.9, 8.1, 10.3 and

16.2 g a.s./100 kg seed and placed in environmental conditions presenting different challenges: standard

germination conditions (25°C for 7 days), cold, wet planting conditions (10°C for 7 days, 25°C for 5 days),

accelerated ageing of the seeds (42°C for 96 hours, 25°C for 7 days). There were 4 replicates per treatment.

After the incubation periods, the germination rate of 50 seeds on paper towel was assessed.

The results of the germination tests are presented in Fehler! Verweisquelle konnte nicht gefunden

werden.Table 17.

Table 2517: Germination rate or vigour of maize seeds treated with various rates and under standard conditions

after storage

Environmental conditions

for germination UBI 4336-00

Rate (g a.i./100 kg seeds)

Mean germination data (%)

Algans Bowling

Standard - 7 days at 25°C

Untreated 86.6 85.0

5.9 84.0 80.6

8.1 86.6 86.0

10.3 82.0 80.6

16.2 82.6 83.6

Accelerated ageing - 42°C for 96 hours, 25°C for 7 days

Untreated - 10.6

5.9 - 79.0

8.1 - 77.6

10.3 - 71.0

16.2 - 75.0

12 month storage period followed by 25°C for 7 days

Untreated 78.0 83.0

5.9 81.0 90.0

8.1 81.6 91.6

10.3 80.6 92.0

16.2 89.0 90.6

Mean vigour (%)

Simulation of cold, wet conditions - 10°C for 7 days, 25°C for 5 days

Untreated 33.0 33.0

5.9 33.6 38.0



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8.1 34.6 36.6

10.3 31.0 36.6

16.2 35.6 37.0

The treated seeds retained viability of at least 80.6% under standard conditions of germination at T0, and also after 12 months of storage, with no dose effects of treatment, as illustrated in Table 25Table 17. It can be concluded that UBI 4336-00 treatment causes no adverse effects on the germination of maize seeds after a storage period of 12 months.

UBI 4336-00 treatment provided a considerably greater level of germination following a period in conditions

designed to simulate accelerated ageing, compared to the untreated.

UBI 4336-00 had no adverse effects on the germination of maize seeds exposed to cold conditions, compared

to the untreated.

Trial ESG16-54

This trial was set up to evaluate the seed safety of Rancona 450 FS at a range of rates on maize both before and after storage. Rates of between 2.53 and 33.9 g a.s./100 kg seed have been tested on three commercial cultivars (Ambition, Yukon and Figaro).

The paper towel test was carried out to evaluate any effects associated with Rancona 450 FS on the germination of maize in comparison with seed treated with the standard product Vitavax 200FF (UBI 1196-06) containing 200 g/L of carboxin and 200 g/L of thiram.

The testing was conducted by Arysta LifeScience (Chemtura Europe Ltd) which is officially recognised as competent to carry out testing in accordance with European Commission Directive 1107/2009 (Certificate number ORETO 315). The conduct of this study is commensurate with UK Good Experimental Practice.

The seed testing method was in accordance with International Seed Testing Association (ISTA) seed testing guidelines. Germination testing has been conducted at three timings T0 (immediately after product application), T6 (6 months after product application) and T12 (12 months after product application).

Four replicates with 50 seeds per replicate were tested, the results, presented in Table 18 below, summarise the mean % germination per treatment. Results are presented only for the 7-day assessment timing for all three timings (T0, T6, T12) in Table 18.

Results T0

No significant differences in germination were observed following treatment with Rancona 450 FS at 0.056 – 0.75 mL/kg seed when compared to the untreated at the 7-day assessment timing.

Results T6



Page 53 of 172



Results T12


The results demonstrate that when applied at the rates stated in this study (0.056 – 0.75ml/kg), Rancona 450 FS (UBI 4336-01) had no detrimental effect on germination of maize cultivars Ambition, Figaro and Yukon following application or after 12 months storage.

No phytotoxic symptoms were observed during the trial.

Table 2618 Mean % Germination of three maize cultivars after 7 days (T0, T6 & T12 months following

application)

Environmental

conditions for

germination

Formulation

tested

Rate (g a.i./100 kg

seeds)

Mean % germination

Ambition Yukon Figaro

Standard - 7 days at 25°C

Untreated 0 96.6 94 96

UBI 4336-01

2.53 96 96 99

12.66 96.6 96.6 100

25.31 98 97 97.6

33.9 96 97 99

UBI 1196-06 100 99 95.6 97.6

6-month storage period followed by

25°C for 7 days

Untreated 0 84.6 84 92

UBI 4336-01

2.53 90 91 93.6

12.66 91 77.6 91

25.31 94 83.6 88

33.9 92.6 89 91.6

UBI 1196-06 100 93 91.6 98.6

12-month storage period followed by

25°C for 7 days

Untreated 0 91.6 89 96.6

UBI 4336-01

2.53 92 89.6 99.6

12.66 92 85 97

25.31 90.6 87.6 98.6



Page 54 of 172


33.9 93 88.6 96

UBI 1196-06 100 91 91 97.6



Page 55 of 172


Table 2719: Summary of phytotoxicity symptoms in efficacy and crop selectivity trials with Rancona 450 FS (UBI 4336-00 and UBI 4336-01)

Trial type

Study ID Country Crop code

Cultivar Reference product

tested

EPPO

PP1/135

Soil texture Date of

application Date of drilling

Seed rate seeds/ha

Appl. Soil moisture

Maximum rate of

application of UBI

4336-00/01 (g

a.i./100kg)

Phytotoxicity UBI 4336-00/01 Y/N

Similar effects

for standard Y/N

Significant adverse impact on yield Y/N

Comments on observed phytotoxicit

y

Efficacy 47 TS NR

2008 176 France

ZEAMX

Anjou 285 Alios N not recorded not

recorded 25/06/200

8 92000

not recorded

10.4 N Y -

Trials not EPPO, trial reports do not identify

any phytotoxic

symptoms for either UBI

4336-00/01 or the

reference Alios

Efficacy 47 TS NR

2008 176 France

ZEAMX


recorded 25/06/200

8 92000

not recorded

10.4 N Y -

Efficacy 47 TS NR

2009 184 France

ZEAMX

LG 3271 Alios N not recorded not

recorded 12/05/200

9 not

recorded not

recorded 10.4 N Y -

Efficacy 47 TS NR

2009 184 France

ZEAMX


recorded 12/05/200

9 not

recorded not

recorded 10.4 N Y -

Efficacy

47 TS SPHACE

NR 2010 203

France ZEAM

X LG 3271 Alios N not recorded

not recorded

25/05/2010

not recorded

not recorded

10.4 N Y -

Efficacy

47 TS SPHACE

NR 2010 203

France ZEAM

X Anjou 249 Alios N not recorded

not recorded

25/05/2010

not recorded

not recorded

10.4 N Y -

Efficacy AE16-019 France ZEAM

X Portile Alios Y SCL 03/05/2016

08/06/2016

63000 not

recorded 9.4 N Y N


X X Alios Y C 19/04/2016

29/04/2016

110000 not

recorded 10 N Y N


X - Alios Y S 19/04/2016

21/05/2016

110000 good 10 N Y N


X SI

PRESTIGIO Alios Y LS 27/04/2017

27/04/2017

86000 normal 10.9 N Y -



Page 56 of 172


Trial type



tested

EPPO

PP1/135



Seed rate seeds/ha

Appl. Soil moisture

Maximum rate of

application of UBI

4336-00/01 (g

a.i./100kg)


Similar effects

for standard Y/N



y


X SI

PRESTIGIO Alios Y Peat 25/04/2017

27/04/2017

100000 dry 10.9 N Y -


X SI

PRESTIGIO Alios Y

Calcareous Clay

25/04/2017 11/05/201

7 105000 normal 10.9 N Y -

Efficacy ESG14-164 Romania ZEAM

X PO412 Alios Y SCL 21/05/2014

21/05/2014

78571 not

recorded 12.2 N Y N

Efficacy ESG14-165 Romania ZEAM

X PO412 Alios Y SCL 20/05/2014

22/05/2014

78571 not

recorded 12.2 N Y N

Efficacy ESG14-167 France ZEAM

X Splitter Alios Y S 24/04/2014

03/06/2014

78000 dry 12.2 N Y -

Efficacy ESG14-168 Italy ZEAM

X Splitter Alios Y Loam 28/04/2014

22/05/2014

70000 dry 12.2 N Y -


X Splitter Alios Y Loam 28/04/2014

26/05/2014

70000 dry 12.2 N Y -


X Oxxygen Alios Y Silty Sand 12/05/2014

21/05/2014

59000 not

recorded 12.2 Y Y -

Minor deformation

(<4%) at assessment 35 DAS, not

dose rate related and

equivalent to or less

severe than for the

reference Alios. No

Phytotoxicity symptoms

were recorded at

the final assessment

134 DAS



Page 57 of 172


Trial type



tested

EPPO

PP1/135



Seed rate seeds/ha

Appl. Soil moisture

Maximum rate of

application of UBI

4336-00/01 (g

a.i./100kg)


Similar effects

for standard Y/N



y


X Splitter Alios Y Silty clay 24/04/2014

12/06/2014

78000 not

recorded 12.2 N Y -


X Oxxygen Alios Y Silt Loam 12/05/2014

27/05/2014

74074 not

recorded 12.2 N Y -

Selectivity

11 GRM F

CH TS 003 France

ZEAMX

B Alios Y Loamy clay 29/03/2011 21/04/201

1 100000 fine 12.2 N Y N

Selectivity

ESG13-38 France ZEAM

X Olympic

Celest XL / Influx XL

Y Loam 19/04/2013 06/05/201

3 83000 dry 12.2 N Y N

Selectivity

ESG13-39 France ZEAM

X Olympic

Celest XL / Influx XL

Y Silty Loam 19/04/2013 07/05/201

3 87000 normal 12.2 N Y N

Selectivity

ESG13-62 German

y ZEAM

X P8488

Celest XL / Maxim

XL Y Clay Loam 25/04/2013

06/06/2013

90000 not

recorded 12.2 Y Y N

Symptoms of phytotoxicity

(thinning) were

recorded for all treatments

and the untreated at assessments

8 and 20 DAS.

Symptoms were greatest

in plots treated with

the colourant Royalkare

red alone at 20ml/100kg

at both assessments (28% 8 DAS,

19.25% 20DAS).

Symptoms were less



Page 58 of 172


Trial type



tested

EPPO

PP1/135



Seed rate seeds/ha

Appl. Soil moisture

Maximum rate of

application of UBI

4336-00/01 (g

a.i./100kg)


Similar effects

for standard Y/N



y

severe at the later

assessment for all

treatments and the

untreated. There were

no statistically significant

differences in thinning

symptoms between

treatments and the

untreated control at

either assessment

timing.No symptoms at

final assessment

Selectivity

ESG13-61 German

y ZEAM

X P8488

Celest XL / Maxim

XL Y Loamy sand 29/04/2013

30/04/2013

90000 not

recorded 12.2 N Y N

Selectivity

ESG13-36 Hungary ZEAM

X Cisko Maxim XL Y Calcareous 19/04/2013

25/04/2013

81000 not

recorded 3.7 N Y N

Some discolouration (yellowing)

for all treatments at

the early assessments

which was not dose rate

related. Symptoms

did not



Page 59 of 172


Trial type



tested

EPPO

PP1/135



Seed rate seeds/ha

Appl. Soil moisture

Maximum rate of

application of UBI

4336-00/01 (g

a.i./100kg)


Similar effects

for standard Y/N



y

exceed 10% and were

transient, no symptoms of phytotoxicity

were recorded after the second

assessment.

Selectivity

ESG13-37 Hungary ZEAM

X Cisko Maxim XL Y Clay Loam 19/04/2013

24/04/2013

67000 normal 3.7 N Y N



Page 60 of 172


Conclusion to phytotoxicity:


(Phytotoxicity assessment). The applicant assessed phytotoxicity across 14 maize

cultivars in 37 efficacy and crop selectivity trials. In three trials (1 efficacy and 2 crop

selectivity) minor symptoms have been recorded. Furthermore, specific crop safety trials

for seed treatments and germination test after treatment and after storage (e.g.12 month)

were conducted. No negative impact in these tests were reported by the applicant.

Based on this submitted data and expert knowledge about ipconazole it can be concluded

to accept the data provided by the applicant.

No information is given if phytotoxicity is assessed according to the EPPO Standard

PP 1/135 (Phytotoxicity assessment).

No information is given if phytotoxicity trials were conducted in the field or under controlled

conditions.

No information is given about the reference product (mode of action, time and application)

According to EPPO Standard PP 1/213 (Phytotoxicity assessment), specific crop safty

trials are required for seed treatments, such as selectivity trials with N rate and 1.5 N dose

rate. Furthermore, germination test after treatment and after storage (e.g.12 month) are

required.

No information is given about germination tests after treatment and after storage (e.g. 12

month) were conducted.

The applicant should add the missing information as required in the EPPO Standard PP

1/213 (Phytotoxicity assessment).






Page 61 of 172


IIIA1 6.2.6 Adverse effects on health of host animals

This section is not relevant for UBI 4336.01 as the product is a fungicide applied directly to maize seed for

the control of seed and soil borne diseases.

IIIA1 6.2.7 Adverse effects on site of application

No observations of adverse effects upon the site of application have been reported.

IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees)

The effects of ipconazole as UBI 4336.00 on beneficial organisms was examined in two extended laboratory studies at up to 54 x maximum field rate using methodology adapted from the guidelines laid down by the SETAC-Europe report from the ESCORT 2 workshop “Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products with Non-Target Arthropods” (Candolfi et al. 2001) and Annexes II and III of the Council Directive 91/414/EEC, concerning the placing of plant protection products on the market, as amended by EC Directive 96/12/EC. The method follows those outlined by Grimm et al. in the IOBC, BART and EPPO Joint Initiative, Candolfi et al. (2000).

There are no adverse effects of UBI 4336.00 at 8.1g a.i/100kg seed or up to 25x that rate on beneficial arthropods. Results show no adverse effects of UBI 4336.00 at up to 25x field rate (=40.5g a.i/ha) on survival, weight, behaviour and predation rate of adult Wolf spiders (Grey, 2009). Results show no adverse effect of UBI 4336.00 at up to 54x field rate (=87.5g a.i/ha) on the reproductive capacity of adult Rove beetles (Grey, 2010).

NOTE: The data were generated in compliance with the Uniform Principles (Council Directive

97/57/EC)

The fungicide Rancona 450 FS (= UBI 4336-01, 452 g/L ipconazole, FS) has been proposed for application in maize at a total maximum application rate of 6.3 mL/ha (equivalent to a maximum of 2.5 seed units per ha) and season. This corresponds to 2.85 g active substance/ha and year. As Rancona 450 FS will be used as seed dressing product, there will be direct exposure of soil-dwelling or ground active arthropods.

Throughout the field trials on effectiveness and selectivity there have been no reports or observations to suggest a detrimental impact of Rancona 450 FS on beneficial or non-target organisms.

Appropriate studies on the potential adverse effects of the test product and comparable formulations on beneficial arthropods are available from Registration Report Part B, Section 6, Annex Point IIIA 10.5 (Effects on Arthropods Other Than Bees), Core Assessment (February 2015).

The toxicity of the test product and comparable formulations has been investigated by carrying out:

- laboratory tests on the standard test organism Typhlodromus pyri,

- extended laboratory tests on Aleochara bilineata and Pardosa spp.

When laboratory tests and higher tier tests were available for the same species, only the results from the higher tier test are being used for the assessment. These results are presented in Table 6.2.4-1.



Page 62 of 172


Table 6.2.4-1: Effects of CA11F317L* (92.1 g/L ipconazole, SL) and UBI 4336-01 (452 g/L ipconazole, FS) on beneficial arthropods in laboratory tests on artificial substrates and extended laboratory tests on natural substrates.

Species

(Exposed Stage)

Substrate Rate

[g a.i./ha]

Corrected Mortality

[%]

Sublethal Effect

[%]

Reference

Typhlodromus Glass 2.56* 4.0 -1.1 IP-106-E

pyri 6.4* 10.0 -7.1 (Taylor, 2006)

(protonymphs) 16.0* 43.0 31.0

40.0* 100.0

100.0* 100.0

Aleochara bilineata (larvae)

Treated maize seeds in

LUFA 2.1

14.4 -21.0 (Re) FDD0038

(Gray, 2010) 43.2 -19.8 (Re)

86.4 -36.6 (Re)

Pardosa spp. (adults)

Treated maize seeds in

LUFA 2.1

40.0 0 0.5 (F)# FDD0031

(Gray, 2009) 80.0 19.4 -5.3 (F) #

Re = reproduction, F = food consumption

# The Study was not valid, as the mortality in the control was >6.7%.

On the basis of the presented results no effects ≥25 % are expected for populations of the rove beetle Aleochara bilineata and when Rancona 450 FS is applied according to the recommended use pattern.

Since the study with the species Pardosa was not valid, the standard test organism Typhlodromus pyri was used for the assessment of predatory mites and spiders. The results for this species indicate that the test product should not cause effects ≥25% on populations of relevant predatory mites and spiders.

Classification scheme of the effects:

Laboratory tests on artificial substrates (glass, quartz sand)

< 30 % = not harmful

30 – 80 % = slightly harmful



Page 63 of 172


> 80 % = harmful

Extended laboratory tests on natural substrates, semi-field and field tests

< 25 % = not harmful

25 – 50 % = slightly harmful

> 50 % = harmful

Proposal for classification:

Rancona 450 FS is classified as:

- not harmful for the rove beetle Aleochara bilineata,

- not harmful for populations of relevant predatory mites and spiders.

Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 6 Ecotoxicological Studies in the Registration Report.

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes

No data is presented to support the lack of adverse effects on plant parts used for propagation purposes. Testing has been carried with direct application of UBI 4336.01 to the seed at exaggerated application rates, and no negative growth effects have been seen. It can therefore be assumed especially bearing in mind the very low product applications rate, that the risk of any negative impact occurring on the harvested seed at maturity is negligible. Residue testing has found no evidence of the active substance in the young plant, so there would be no source to cause adverse effects. UBI 4336.01 may theoretically be used on the parent lines to produce the F1 seed grown for forage or grain production, but this grain would never normally be used to grow subsequent crops.

Conclusion to adverse effects on parts of plant used for propagating purposes:

The applicant did not present any data especially for this annex point. He expected no

negative effects of the product on parts of plant used for propagating purposes.

Based on long-term experience in the practical field use with ipconazole and on expert

knowledge it can be concluded to accept the information provided by the applicant.





Page 64 of 172


IIIA1 6.2.6 Impact on succeeding crops

UBI 4336.01 would be applied at a maximum rate of just 8.1g ipconazole/100kg maize seed. At the maximum seed rate of 20kg/ha this would equate to a field rate of 1.62g ipconazole/ ha as a seed treatment.

Very low levels of ipconazole will reach the soil from the treated seed and, therefore, residues may be available for uptake into succeeding rotational crops.

A confined rotational crop study with ipconazole has been conducted with crops grown in soil treated with radio-labelled ipconazole at a rate of 216 g active substance per hectare (133 times the maximum field use rate as a seed treatment). Uptake of residues, measured as ‘mg ipconazole equivalents’ at plant-back times of 30 – 365, days ranged between 0.007 - 0.055 mg/kg for carrot, 0.002 - 0.027 mg/kg for lettuce and < 0.002 - 0.428 mg/kg for wheat. The rate of 216 g/ha in this study is approximately 133 times the maximum proposed application rate for seed treatment. Taking this into account, the residue levels in rotational crops will be below 0.01 mg/kg.

There is no effect of ipconazole on growth of rotational crops and residue levels would be below 0.01mg/kg from seed treatment in the previous crop. There would be no restriction on following crops.

Conclusion to impact on succeeding crops:

The applicant has not conducted an assessment according to EPPO Standard PP 1/207

(Effects on succeeding crops), however the submitted explanation and results of a confined

rotational crop study attempts to demonstrate the absence of effects and therefore the levels

of active substance in the soil are not important.


IIIA1 6.2.7 Impact on other plants including adjacent crops

UBI 4336.01 is designed for use as a fungicidal seed treatment for the control of seed and soil borne diseases of maize. The product is a fungicide and has no herbicidal activity. UBI 4336.01 is applied to the seed pre-drilling and there will therefore be no impact on other plants including adjacent crops. A study to determine the amount of free dust has been carried out and is summarized in Section IIIA1 6.5.1. Free dust levels were substantially below the guideline thresholds.


The applicant has not conducted an assessment to EPPO Standard PP 1/256 (Effects on

adjacent crops). He referred to a Heubach dust-study in section IIIA1 6.5.1. The section IIIA1

6.5.1 does not exist in this dRR. The study under section IIIA1 6.5. “Dust” may give a clue that

the applied plant protection product does not have a negative impact to adjacent crops.


IIIA1 6.2.8 Possible development of resistance or cross-resistance




Page 65 of 172


In the case of UBI 4336.01, the following resistance management strategy should ensure there is no adverse shift in the sensitivity of pathogen populations to the product:

A single application (seed treatment) per crop

Maintaining the recommended dose

Application to be made prior to disease development (i.e. as a seed treatment)

Good agronomy including use of resistant varieties where possible, adequate nitrogen fertilizer and good crop rotation

The following proposed label statement is therefore fully endorsed;

Resistance Management:

At the time of printing, there are no cases of resistance to UBI 4336.01 known to Arysta LifeScience. The

possible development of diseases resistant to UBI 4336.01 cannot be excluded or predicted. UBI 4336.01

contains ipconazole which belongs to the DMI-fungicide group (SBI: Class I). Disease control may be

reduced accordingly if strains of fungi resistant to ipconazole develop.

The use of UBI 4336.01 should conform to resistance management strategies. Such strategies should include subsequent foliar applications being made with products containing an active substance with a

different mode of action. Arysta LifeScience recommends responsible product stewardship to ensure

effective long term control of the fungal diseases on this label.

Maximum number of treatments: 1 per year.

Ipconazole as UBI 4336.01 used a seed treatment presents a low risk of resistance development in providing protection against Sphacelotheca reiliana in maize when used as directed.

Rancona 450 FS (UBI 4336-01) is a Flowable concentrate for Seed treatment (FS) formulation containing

452 g/L ipconazole and is intended for professional use as a seed treatment giving control of Sphacelotheca

reiliana (Maize head smut) in maize. The intended uses for Rancona 450 FS are included in the GAP table

in Appendix 2.

Mode of Action

The active substance ipconazole is a broad-spectrum systemic and contact fungicide for the control of soil-

borne and seed-borne plant diseases. It belongs to the triazole chemical family and is classified as part of

the FRAC Group 3, G1: Class I Sterol Biosynthesis Inhibitor category of DeMethylation Inhibitors (DMI

fungicides) by the Fungicide Resistance Action Committee (FRAC).

The mode of action of Group G1 herbicides, such as ipconazole, primarily occurs through the inhibition of

ergosterol biosynthesis due to a specific interaction with the fungal enzyme sterol-1-4-α-demethylase that

converts lanosterol to ergosterol, a phospholipid that plays a critical role in the cell membrane of all fungi.

As a result of this inhibitory activity, toxic sterols are produced resulting in disruptive changes to cell

membrane structure and function that arrests fungal development.

Mechanism of resistance

Ipconazole is classified as being at medium risk of resistance arising among target fungal pathogen

populations by FRAC3.



Page 66 of 172


Practical resistance to DMI’s developed during the 1980’s in several pathogens (Powdery mildews,

Venturia inaequalis and Mycosphaerella fijiensis var. difformis). However, it developed relatively slowly

with fluctuating severity, which is considered to be characteristic of polygenic resistance5. Resistance to DMIs is known in various fungal species. Several resistance mechanisms are known, including target site mutations in the cyp51/erg 11 gene, e.g. V136A, Y137F, A379G, I381V; cyp51 promotor; ABC transporters and others.

Efficacy therefore declines over several years of intensive use rather than a rapid loss of control, referred

to as continuous selection, quantitative selection or shifting. The accumulation of several mutations is

therefore needed to lower the sensitivity of pathogens to DMIs. This has the effect of quantitative resistance

among a naturally occurring population of a particular fungus, with sensitivity ranging from very high to

moderate or low within the same field population. In general, a decrease in sensitivity is observed which

typically has fitness costs and a complete loss of activity is unlikely. Furthermore, following reduced

selection pressure, a partial recovery in sensitivity is often observed (www.FRAC.info.com, 2013).

Evidence of Resistance

A list of documented cases of resistance to DMI fungicides is shown in

Table 28Table 21 below. There is a single case of resistance documented to DMI active substances in maize,

for the pathogen Ustilago maydis (Blister smut) documented in a laboratory study by Walsh & Sisler (1981).

There are no documented cases of resistance among populations of Sphacelotheca reiliana causing maize

head smut.

Overall there are no cases of field resistance to DMIs in maize, and no known resistance to

ipconazole since its introduction for use as a seed treatment in 1994.

Cross resistance

All DMIs inhibit fungi by interacting with the same target site, C14-demethylase (erg11/cyp51), and are

therefore considered to be cross-resistant with each other; however they show no cross resistance with other

SBI classes including amines, hydroxyanilides, amino-pyrolinones, thiocarbamates and allylamines6.

Table 2823: List of published cases of field and laboratory generated resistance of fungal plant pathogens to

Group G1 DMI fungicides (https://www.frac.info Accessed March 2020)

Pathogen Crop Reference Remarks

Scientific name Common name

Aspergillus nidulans - - De Waard & van Nistelrooy 1979

genetic study

Blumeriella jaapii Leaf spot Cherry Proffer et al. 2006 field

Botryosphaeria dothidea - - Fan Kun et al. 2013 Labortory

Botrytis cinerea Grey mold Vegetables

Various

Elad 1992

Stehmann & De Waard 1996

field

laboratory investigation of lack of intrinsic activity

Calonectria pauciramosa - Nurseries Guarnaccia et al. 2014 Field

Calonectria polizzii - Nurseries Guarnaccia et al. 2014 Field

5 Brent, KJ & Hollomon, DW Fungicide resistance in crop pathogens, how can it be managed. FRAC Monograph -1 Available from https://www.frac.info/fungicide-resistance-management/background

6 https://www.frac.info/frac-teams/working-groups/sbi-fungicides

Formatiert: OECD-BASIS-TEXT



Page 67 of 172




Cercospora beticola Leaf spot Sugar beet Henry & Trivellas 1989

Karaoglanidis et al.

2000

Budakov et al. 2014

Laboratory mutants

Field isolates

Field

Cladosporium caryigenum Scab Pecan Reynolds et al. 1997 cross resistance, laboratory

Colletotrichum

gloeosporioides

Anthracnose Mango Gutierrez-Alonso et al. 2003

postharvest / laboratory

Erysiphe graminis f .sp. hordei Powdery mildew Barley Fletcher & Wolfe 1981

field

Erysiphe graminis f .sp. tritici Powdery mildew Wheat De Waard et al. 1986 field

Fusarium asiaticum

Fusarium graminearum

Fusarium head blight

Wheat Yin et al. 2009 Lab study on isolates from China

Fusarium graminearum Head blight Wheat Spolti et al. 2014 Field (tebuconazole)

Fusarium fujikuroi - - Zhao Zhi-hua et al. 2007

Laboratory mutation (prochloraz)

Fusarium monilifore Bakanae Rice Yanh HongFu et al.

2013 Field (prochloraz)

Fusarium solani. See Nectria

haematococca var. cucurbiae

Cucurbits Foot rot Kalamarakis et al. 1991

genetic study

Fusarium verticillioides Fusarium Corn Fan et al. 2014 Laboratory

Microdochium (Fusarium)

nivale

- - Cristani & Gambogi 1993

Laboratory

Monilinia fructicola Twig blight, brown rot

Stone fruit Nuninger-Ney et al.

1989

Elmer et al. 1992

Chen et al. 2013

Laboratory

Field

Field

Mycosphaerella fijiensis Sigatoka Banana Anonymous 1992

Mycosphaerella graminicola Leaf spot Wheat Metcalfe et al. 2000

Mavroedi & Shaw 2005

HGCA 2005

Cools et al. 2005

field experiments

field experiments

field

laboratory

Mycovellosiella nattrassii Leaf mold Eggplant Yamaguchi et al. 2000 field

Nectria haematococca var. cucurbiae

Cucurbits Foot rot Kalamarakis et al. 1991

laboratory genetics

Penicillium digitatum

Citrus Green mold Eckert 1987

Wang Jinlong et al.

2014

Laboratory selection

Storage

Penicillium italicum - Blue mold De Waard et al. 1982 laboratory

Phakopsora pachyrhizi Rust Soybeans Schmitz et al. 2014 Field



Page 68 of 172




Pseudocercosporella

herpotrichoides Lente or R type

Eyespot Wheat Leroux & Marchegay 1991

field

Puccinia horiana White rust Chrysanthemum Cevat 1992

Cook 2001

field

field

Puccinia striiformis Yellow / stripe rust

Wheat Bayles et al. 2000

Napier et al. 2000

sensitivity shift laboratory

Pyrenopeziza brassicae Light leaf spot Oilseed Rape Carter et al.2014 Field

Pyrenophora teres Net blotch Barley Sheridan et al. 1985 field

Pyrenophora tritici-repentis Tan spot Wheat Reimann & Deising 2005

field

Rhizoctonia solani Rhizoctonia leafspot

Rice Manish Agrawal et al.

2013 Field

Rhynchosporium secalis Leaf blotch, scald Barley Hunter et al. 1986

Kendall & Hollomon 1990

Kendall et al. 1993

Cooke et al. 2004

Glasshouse

field

Field isolates

field

Sclerotinia homoeocarpa -

Dollar spot

-

Turfgrass

Vargas et al. 1992

Ma & Tredway 2013

Laboratory

Field

Septoria tritici

- - - See Mycosphaerella

graminicola

Sphaerotheca fuligenea Powdery mildew Cucumber Schepers 1983, 1985a, 1985b

field

Sphaerotheca mors-uvae Powdery mildew Blackcurrant Goszczynski et al.

1988 field

Sphaerotheca pannosa Powdery mildew Nectarine Reuveni 2001 field

Trichoderma koningii - - Figueras-Roca et al. 1996

Laboratory

Uncinula necator Powdery mildew Grapevine Steva et al. 1990

Reidi & Steinkellner 1996

Miller & Gubler 2003

field

field

field

Ustilago avenae Loose smut Oats Hippe & Koller 1986 laboratory

Ustilago maydis Smut / blister smut

Maize Walsh & Sisler 1981 laboratory

Venturia inaequalis Scab Apple Stanis & Jones 1985; Köller et al. 1991

field

laboratory

Venturia nashicola Japanese pear scab

Pear Tomita & Ishii 1998 field



Page 69 of 172


Sensitivity data

No sensitivity data have been generated.

The performance of SBIs against fungal disease pathogens in the field is continuously monitored across

many countries in the EU by the FRAC SBI Working Group and a report summarizing the gathered data is

published on an annual basis. The most recent report follows a meeting on January 24th 20207.

Sphacelotheca reiliana is not included in the monitoring program; however, field performance of DMIs

was generally reported to be stable across a range of crop diseases.

Use pattern

Rancona 450 FS (UBI 4336-01), a Flowable concentrate for Seed treatment (FS) formulation containing

452 g/L ipconazole, is intended for professional use as a seed treatment giving systemic and contact control

of Sphacelotheca reiliana (maize head smut) in maize.

The GAP, shown in Appendix 2, gives details of the intended use.

Treatment with Rancona 450 FS (UBI 4336-01) is carried out by seed treatment at 18ml product/100 kg

seeds, which is equivalent to 2.85g ipconazole per hectare at a maximum seed rate of 35 kg/ha.

Resistance risk assessment of unrestricted use pattern

Inherent risk – active substance

According to FRAC, ipconazole is considered to be at medium risk for the development of resistance

among plant pathogenic fungi.

Agronomic risk

The intended use for Rancona 450 FS (UBI 4336-01) is as a seed treatment in maize.

In areas where disease pressure is very high and intensive treatment programmes are required, there is

generally a higher risk of resistance developing. Agronomic factors that affect the pathogenicity of target

organism SPHTRE include crop rotation, varietal resistance, nitrogen deficiency, climate and soil

characteristics.

Based on the likelihood of Good Agricultural Practice, and on the assumption that growers will follow all

label recommendations and implement best practices for the control of target disease pathogen inoculums,

it is estimated that there is a low to medium risk associated with agronomic factors in this case.

Inherent risk – target pathogens

The FRAC Pathogen Risk list does not list Sphacelotheca reiliana; however, seed and soil borne pathogens

are generally considered to be low risk, and the target is therefore considered to be at low risk of developing

resistance to fungicides.

Overall risk of resistance

The combined risk of resistance arising to Rancona 450 FS (UBI 4336-01) from an unrestricted use pattern

against the target pathogen Sphacelotheca reiliana is 1-4, according to FRAC guidance, and therefore

considered to be low-medium overall depending on the agronomic risk.

Acceptability of the resistance risk

The overall risk of resistance is low to medium (1-4), and therefore acceptable.

5https://www.frac.info/frac-teams/working-groups/sbi-fungicides/recommendations-for-sbi Accessed 23/03/2020.



Page 70 of 172


Management strategy

The SBI working group has provided the following recommendations for use in order to maintain the

effectiveness of this class of fungicides, which includes DMIs, although some of these are not wholly

relevant to seed treatment:

Repeated application of SBI fungicides alone should not be used on the same crop in one season

against a high-risk pathogen in areas of high disease pressure for that particular pathogen.

For crop/pathogen situations where repeated spray applications (e.g. orchard crops/powdery

mildew) are made during the season, alternation (block sprays or in sequence) or mixtures with an

effective non cross-resistant fungicide are recommended (see FRAC Code List).

Where alternation or the use of mixtures is not feasible because of a lack of effective or compatible

non cross-resistant partner fungicides, then input of SBI's should be reserved for critical parts of

the season or crop growth stage.

If the performance of SBIs should decline and sensitivity testing has confirmed the presence of

less sensitive isolates, SBIs should only be used in mixture or alternation with effective non cross-

resistant partner fungicides.

The introduction of new classes of chemistry offers opportunities for more effective resistance

management. The use of different modes of action should be maximized for the most effective

resistance management strategies.

Users must adhere to the manufacturers’ recommendations. In many cases, reports of “resistance"

have, on investigation, been attributed to cutting recommended use rates, or to poorly timed

applications.

Fungicide input is only one aspect of crop management. Fungicide use does not replace the need

for resistant crop varieties, good agronomic practice, plant hygiene/sanitation, etc.

Implementation of the management strategy

Statements relating to resistance risks and best practice management strategies will be included on the

proposed label for Rancona 450 FS (UBI 4336-01).

Monitoring, reporting and reaction to changes in performance

The Applicant is committed to responding to any reports of changes in performance levels following the

use of Rancona 450 FS (UBI 4336-01) in the field. In the event that the Applicant is made aware of a

reduction in performance, samples will be collected from the treated area and tested for sensitivity using

published methodology.

If resistance is confirmed, the Applicant will respond appropriately by informing the relevant authorities

and communicating with growers, following the advice of the relevant national authorities and FRAC in

cases of confirmed fungicide resistance, continuing to monitor performance and amending the resistance

management strategy if necessary.

Conclusion to possible development of resistance or cross-resistance:


(Resistance risk analysis). The applicant addresses all points of the EPPO -Standard to

evaluate the possible actual resistance risk of ipconazole. Based on FRAC assessment the



Page 71 of 172


applicant stated the risk of resistance due to the mode of action for DMI fungicides (SBI-class

I; Triazole) that it will be assessed as low to medium depends on the pathogen (combined

resistance risk = 2-4).

Based on this submitted data and expert knowledge about ipconazole it can be concluded to

accept the data provided by the applicant.The presented data don´t correspond with the

requirements of the EPPO Standard PP 1/213 (Resistance risk analysis). The applicant did

not addresses any points of the Standard to evaluate the possible actual resistance risk of

ipconazole. The applicant stated that the resistance risk of the active substance could be

described as low risk.

According to FRAC code list 2018, the resistance risk of ipcoanzole is assessed to be

medium.

The applicant should add the missing information according to EPPO Standard PP 1/213:

Information about:

- pathogens and the intended use

- mode of action (including FRAC target site and code)

- risk management and strategy

IIIA1 6.3 Economics


IIIA1 6.4 Benefits


IIIA1 6.5 Other/special studies

Dust

A study has been carried out to determine the level of free dust obtained from maize seed following an application of UBI 4336.01.

UBI 4336.01 applied at the rates of 2.5 g and 8.1 g a.i./100 kg seed were pre-diluted with water to a total volume of 5 ml/kg seed and were applied to 500 g batches of the maize cultivar, Algans. The Heubach Dustmeter Type II was used to measure the free dust levels from both the treated seed and the untreated seed. The results showed that the mean measurement of free dust obtained from the untreated maize seed was 0.2997 g/100 kg seed. Following applications of UBI 4336.01 at 2.5 g and 8.1 g a.i./100 kg seed the levels of free dust were 0.1998 and 0.3996 g/100 kg seed respectively.

In conclusion, the free dust levels produced from maize seed following applications of UBI 4336-01 at 2.5 g and 8.1 g a.i./100 kg seed were extremely low.

Bulk chemical loading

A study was carried out to determine the level of active substance (ipconazole) retrieved from the surface of maize seed following an application of UBI 4336.01 before and after an adhesion test and to determine



Page 72 of 172


the uniformity of distribution of ipconazole across the seeds before and after storage of the treated seed for six, twelve and eighteen months.

The uniformity of distribution showed that levels of active substance (ipconazole) were consistent across the storage period and the “Relative Standard Deviation” (RSD’s) were substantially less than the CRD guideline of 25% RDS.

Drill flow

A study was conducted to determine the effect of an application of UBI 4336.00 on maize seed on the flow of seed through a seed drill mechanism. The seed flow metering test was conducted on the test item, maize seed treated with UBI 4336.00 and an untreated sample of the same maize seed lot. The seed flow results show that an application of UBI 4336.00 will reduce the flow rate of maize seed through a seed drill mechanism, compared to the untreated seed. However, the associated RSD values show that the variability of the flow was similar for the untreated seed and seed treated with UBI 4336.00 (3.09% and 3.18% respectively). Therefore, with appropriate calibration of the seed drill mechanism, it will be possible to drill seed treated with UBI 4336.00 at a chosen rate and achieve a distribution at least as even as that achieved by drilling the same seed in its untreated state.

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5

Proposed uses for UBI 4336.01 (Rancona 450 FS) are supplied in appendix 2.

IIIA1 6.7 List of test facilities including the corresponding certificates

All certificates are included in Section IIIA1 6.7 of the Biological Assessment Dossier included in this submission.

APPENDIX 1: LIST OF DATA SUBMITTED IN SUPPORT OF THE

EVALUATION

OECD data point number - reference

number

Author(s) Year Title, Source (where different from company) Report Number, GLP or GEP,

Published or not

Data Protection Claimed

Y/N

Owner

IIIA1 6.0 Arysta

LifeScience 2019

Biological Assessment Dossier – UBI 4336.01 (Rancona 450 FS), Arysta LifeScience, Unpublished

Y Arysta

LifeScience



Page 73 of 172


Appendix 1: Lists of data considered in support of the evaluation List of data submitted by the applicant and relied on

Data Point Author(s)

Year Title

Report-No.

Source

GLP/GEP

Published

Authority registration No./JKI-No.

Vertebrate study

(J=Yes

O=Open

N=No)

Data protection claimed

(J=Yes

O=Open

N=No)

Justification if data protection is claimed

Owner

Document C

Anonymous 2015 Proposed label text Rancona 450 FS

Chemtura

N/N

N

2838052/433827

N N Chemtura

KIIIA1 6 Anonymous 2015 UBI 4336-01 (450 FS) BAD DE FINAL

Chemtura

N/N

N

2838089/433836

N J Chemtura



Page 74 of 172


KIIIA1 6.1.1

Naibo B., Barjone, R.

2001 Lutte contre le Charbon des Inflorescences avec Les fongicides en soil contamine

2001_OTS 00168

Chemtura

N/N

N

2838090/433837

N J Chemtura

KIIIA1 6.1.1

Naibo B., Barjone, R.

2001 Lutte contre le Charbon des Inflorescences avec Les fongicides en soil sain

2001_OTS 00172

Chemtura

N/N

N

2838091/433838

N J Chemtura



Page 75 of 172


KIIIA1 6.1.2

Ferro, G. 2010 Efficacy and Selectivity Evaluation on Maize against seedling diseases North of Italy (Veneto Region) - Year 2010

SREP10CH03TR1

Chemtura

N/J

N

2838098/433845

N J Chemtura

KIIIA1 6.1.2


SREP10CH03TR4

Chemtura

N/J

N

2838099/433846

N J Chemtura

KIIIA1 6.1.2

Coudrain, H. 2013 Seedling Disease Complex of Maize - France 2013

ESG13-40

Chemtura

N/J

N

2838100/433847

N J Chemtura



Page 76 of 172


KIIIA1 6.1.2


ESG13-41

Chemtura

N/J

N

2838101/433848

N J Chemtura

KIIIA1 6.1.2

Coudrain, H. 2013 Seedling Disease Complex of Maize - Hungary 2013

ESG13-43

Chemtura

N/J

N

2838102/433849

N J Chemtura

KIIIA1 6.1.2

Coudrain, H. 2013 Seedling Disease Complex of Maize - Germany 2013

ESG13-44

Chemtura

N/J

N

2838103/433850

N J Chemtura



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KIIIA1 6.1.2


ESG13-45

Chemtura

N/J

N

2838104/433851

N J Chemtura

KIIIA1 6.1.2


ESG13-46

Chemtura

N/J

N

2838105/433852

N J Chemtura

KIIIA1 6.1.2

Robin, N. 2007 Etude de l'efficacite de traitements de semences vis-a-vis du Charbon des Inflorescences

47 TS NR 2007 078

Chemtura

N/J

N

2838107/433854

N J Chemtura



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KIIIA1 6.1.2


47 TS NR 2008 176

Chemtura

N/J

N

2838108/433855

N J Chemtura

KIIIA1 6.1.2


47 TS NR 2009 184

Chemtura

N/J

N

2838109/433856

N J Chemtura



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KIIIA1 6.1.2


47 TS SPHACE NR 2010 203

Chemtura

N/J

N

2838110/433857

N J Chemtura

KIIIA1 6.1.2

Moulonguet, G.

2007 Fungicide efficacy on Maize Head Smut (Sphacelotheca reiliana)

07 F MG CR 01

Chemtura

N/J

N

2838111/433858

N J Chemtura

KIIIA1 6.1.2

Moulonguet, G.

2007 Fungicide efficacy on Maize Blister Smut (Ustilago maydis)

07 F MG CR 02

Chemtura

N/J

N

2838112/433859

N J Chemtura



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KIIIA1 6.1.2

Nassoy, G. 2005 Fungicide efficacy on Maize Head Smut (Sphacelotheca reiliana)

05 F MG CR 04

Chemtura

N/J

N

2838113/433860

N J Chemtura

KIIIA1 6.1.2


06 F MG CR 01 02 03

Chemtura

N/J

N

2838114/433861

N J Chemtura

KIIIA1 6.1.2


06 F MG CR 01 02 03

Chemtura

N/J

N

2838115/433862

N J Chemtura



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KIIIA1 6.1.2


47 PATH NR 2006 128

Chemtura

N/J

N

2838116/433863

N J Chemtura

KIIIA1 6.1.2

Packwood, J. 2014 Determination of Efficacy of Rancona 450 UBI 4336-01 against Head smut (Sphacelotheca reiliana) of Maize in Romania 2014

ESG14-164

Chemtura

N/J

N

2838119/433866

N J Chemtura



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KIIIA1 6.1.2


ESG14-165

Chemtura

N/J

N

2838120/433867

N J Chemtura

KIIIA1 6.1.2

Thomas, M. 2014 Evaluate product efficacy of Rancona 450 against Head smut on Maize in Italy in 2014

ESG14-168

Chemtura

N/J

N

2838121/433868

N J Chemtura



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KIIIA1 6.1.2


ESG14-169

Chemtura

N/J

N

2838122/433869

N J Chemtura

KIIIA1 6.1.2

Thomas, M. 2014 Evaluate efficacy of Royalflo 480 FS (UBI 6898-00) against damping off in maize

ESG14-96

Chemtura

N/J

N

2838123/433870

N J Chemtura



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KIIIA1 6.1.2


ESG14-98

Chemtura

N/J

N

2838124/433871

N J Chemtura

KIIIA1 6.1.2


ESG14-99

Chemtura

N/J

N

2838125/433872

N J Chemtura



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KIIIA1 6.1.2


ESG14-100

Chemtura

N/J

N

2838126/433873

N J Chemtura

KIIIA1 6.1.2


ESG14-101

Chemtura

N/J

N

2838127/433874

N J Chemtura



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KIIIA1 6.1.3


SREP10CH03TR1

Chemtura

N/J

N

2838136/433883

N J Chemtura

KIIIA1 6.1.3


SREP10CH03TR4

Chemtura

N/J

N

2838137/433884

N J Chemtura

KIIIA1 6.1.3


ESG13-40

Chemtura

N/J

N

2838138/433885

N J Chemtura



Page 87 of 172


KIIIA1 6.1.3


ESG13-41

Chemtura

N/J

N

2838139/433886

N J Chemtura

KIIIA1 6.1.3


ESG13-43

Chemtura

N/J

N

2838140/433887

N J Chemtura

KIIIA1 6.1.3


ESG13-44

Chemtura

N/J

N

2838141/433888

N J Chemtura



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KIIIA1 6.1.3


ESG13-45

Chemtura

N/J

N

2838142/433889

N J Chemtura

KIIIA1 6.1.3


ESG13-46

Chemtura

N/J

N

2838143/433890

N J Chemtura

KIIIA1 6.1.3


47 TS NR 2007 078

Chemtura

N/J

N

2838145/433892

N J Chemtura



Page 89 of 172


KIIIA1 6.1.3


47 TS NR 2008 176

Chemtura

N/J

N

2838146/433893

N J Chemtura

KIIIA1 6.1.3


47 TS NR 2009 184

Chemtura

N/J

N

2838147/433894

N J Chemtura



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KIIIA1 6.1.3



Chemtura

N/J

N

2838148/433895

N J Chemtura

KIIIA1 6.1.3

Packwood, J. 2014 Determination of Efficacy of Royalflo UBI 6898-00 against Fusarium spp. of maize in Romania 2014

ESG14-94

Chemtura

N/J

N

2838150/433897

N J Chemtura



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KIIIA1 6.1.3


ESG14-164

Chemtura

N/J

N

2838151/433898

N J Chemtura

KIIIA1 6.1.3


ESG14-165

Chemtura

N/J

N

2838152/433899

N J Chemtura



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KIIIA1 6.1.3


ESG14-168

Chemtura

N/J

N

2838153/433900

N J Chemtura

KIIIA1 6.1.3


ESG14-169

Chemtura

N/J

N

2838154/433901

N J Chemtura



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KIIIA1 6.1.3


ESG14-96

Chemtura

N/J

N

2838155/433902

N J Chemtura

KIIIA1 6.1.3


ESG14-98

Chemtura

N/J

N

2838156/433903

N J Chemtura



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KIIIA1 6.1.3


ESG14-99

Chemtura

N/J

N

2838157/433904

N J Chemtura

KIIIA1 6.1.3


ESG14-100

Chemtura

N/J

N

2838158/433905

N J Chemtura



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KIIIA1 6.1.3


ESG14-101

Chemtura

N/J

N

2838159/433906

N J Chemtura

KIIIA1 6.1.3

Sanchez, M.C.H.

2009 Estudio de evaluacion de la efectividad biologicadel producto ipconazole 450 FS para el control del carbon de las espiga (S. reiliana) en el cultivo de maiz en el municipio de Jamay, Jalisco

Chemtura

N/J

N

2838162/433909

N J Chemtura



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KIIIA1 6.1.3

Ferro, G. 2013 A study to determine the minimum effective dose of Rancona 450FS (UBI 4336.01) for control of seedling diseases in maize

ESG13-24

Chemtura

N/J

N

2838163/433910

N J Chemtura

KIIIA1 6.1.3


ESG13-25

Chemtura

N/J

N

2838164/433911

N J Chemtura



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KIIIA1 6.1.3


ESG13-26

Chemtura

N/J

N

2838165/433912

N J Chemtura

KIIIA1 6.1.3


ESG13-27

Chemtura

N/J

N

2838166/433913

N J Chemtura



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KIIIA1 6.1.3

Sanchez, M.C.H.

2009 Estudio de evaluacion de la efectividad biologica del producto ipconazole 450 FS para el control del carbon de las espiga (S. reiliana) en el cultivo de maiz en el municipio de Acambaro Jalisco

Chemtura

N/J

N

2838167/433914

N J Chemtura

KIIIA1 6.1.3

Varga, A. 2011 Evaluate Rancona 450FS for control of seedling diseases in maize

F-74-1-2011

Chemtura

J/N

N

2838168/433915

N J Chemtura



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KIIIA1 6.1.3

Miklos, V. 2011 Report on fungicide Trial 2011

F-74-3-2011

Chemtura

N/J

N

2838169/433916

N J Chemtura

KIIIA1 6.1.3

Abdai, E. 2011 Report onfungicide trial2011

F-74-2-2011

Chemtura

J/N

N

2838170/433917

N J Chemtura

KIIIA1 6.1.3

Ferro, G. 2012 Evaluate Rancona 450FS for control of seedling diseases in maize

SREP12CHE001TR1

Chemtura

N/J

N

2838171/433918

N J Chemtura



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KIIIA1 6.1.3


SREP12CHE001TR2

Chemtura

N/J

N

2838172/433919

N J Chemtura

KIIIA1 6.1.3


SREP12CHE001TR3

Chemtura

N/J

N

2838173/433920

N J Chemtura

KIIIA1 6.1.3


ESG13-23

Chemtura

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Ferro, G. 2014 A study to determine the Minimum effective dose of Royalflo (UBI 6898-00) when applied as a seed treatment against Rhizoctonia sp. of maize

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Zollner, H. 2014 Evaluation of the Efficacy of Rancona 450 (ipconazole 452g/L FS) in seed Treatment against headsmut (Spacelotheca reiliana) in maize

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Grey, J. 2010 Evaluation of the effect of a seed Treatment formulation (Rancona® 450 FS) on the Rove beetle Aleochara bilineata in an Extended laboratory study

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MIIIA1 Sec 6

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Sanchez, M. C. H.

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Grey, J. 2009 Evaluation of the effects of a seed treatment formulation (UBI 4336.00) on Wolf Spiders Pardosa spp. in an extended laboratory study

FDD0031

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KIIIA1 6.2 Thomas, M. 2014 Evaluate product efficacy of Rancona 450 against Head smut on Maize in France in 2014

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ESG14-189

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KIIIA1 6.2 Thomas, M. 2014 Evaluate product efficacy of Rancona 450 against Head smut on Maize in France in 2014

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KIIIA1 6.2 Zollner, H. 2014 Evaluation of the Efficacy of Rancona 450 (ipconazole 452g/L FS) in seed treatment against headsmut (Spacelotheca reiliana) in maize

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KIIIA1 6.2 Zollner, H. 2019 Evaluation of the Efficacy of Rancona 450 (ipconazole 452g/L FS) in seed treatment against headsmut (Spacelotheca reiliana) in maize

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N

3790146/587612




Page 155 of 172



2011 A Seed Laboratory study to evaluate the seed safety of two samples of Rancona 450 FS, prepared by Evesham Formulation Group, when applied to maize seed

ES11 24

N/J

N

3790148/587613



2011 A Seed Laboratory study to evaluate the profile of Rancona® 450FS, UBI 4336.00, in terms of seed safety, growth under stress and dust measurements, when applied as a seed Treatment to maize seed

ES11 37

O/J

N

3790149/587614

N J Crompton (Uniroyal Chemical)



Page 156 of 172


KIIIA1 6.1.2

Littlewood, KM

2009 A study to determine the effect on maize seed treated with UBI4336.00 through a seed drill

ESP09 03

J/N

N

3790150/587615



2013 A study to determine the physical characteristics of Rancona 450 FS, UBI4336.00 on maize seed before and after storage

ESP11 04

J/N

N

3790151/587616




Page 157 of 172



2013 A study to determine the application quality of Rancona 450 FS UBI 4336.01, when applied to maize seed, in terms of free dust measurements using the Heubach Dustmeter Type II

ESP13-03

J/O

N

3790152/587617


KIIIA1 6 Clinton 2010 EFFICACY TRIALS METHOD FOR FUNGICIDE PRODUCTS INTENDED TO CONTROL HEAD SMUT OF MAIZE, Sphacelotheca reiliana

M160

O/O

N

3790153/587618




Page 158 of 172


KIIIA1 6 Anonymous 2019 Rancona 450 FS BAD - Section 7: Efficacy Data and Information Detailed summary

O/O

N

3790154/587619


MIIIA1 Sec 7

Arysta 2019 dRR - B7 - core - DE - 008398-00/00 Rancona 450 FS (word)

N/N

N

3790155/587620


KIIIA1 6.1.2


47 TS NR 2007 078

O/J

N

3790156/587621




Page 159 of 172


KIIIA1 6.1.2


47 TS NR 2008 176

O/J

N

3790157/587622


KIIIA1 6.1.2


47 TS NR 2009 184

O/J

N

3790158/587623




Page 160 of 172


KIIIA1 6.1.2


O/J

N

3790159/587624


KIIIA1 6.1.2

Nassoy, G. 2005 Fungicide efficacy on Maize Head Smut (Sphacelotheca reiliana), Promo-vert

05 F MG CR 04

O/J

N

3790160/587625




Page 161 of 172


KIIIA1 6.1.2

Nassoy, G. 2005 Fungicide efficacy on Maize Head Smut (Sphacelotheca reiliana), Promo-vert

06 F MG CR 02

O/J

N

3790161/587626


KIIIA1 6.1.2

Nassoy, G. 2005 Fungicide efficacy on Maize Head Smut (Sphacelotheca reiliana), Promo-vert,

06 F MG CR 03

O/J

N

3790162/587627




Page 162 of 172


KIIIA1 6.1.2


47 PATH NR 2006 128

O/J

N

3790163/587628


KIIIA1 6.1.2


ESG14-164

O/J

N

3790164/587629




Page 163 of 172


KIIIA1 6.1.2


ESG14-165

O/J

N

3790165/587630


KIIIA1 6.1.2


ESG14-168

O/J

N

3790166/587631




Page 164 of 172


KIIIA1 6.1.2


ESG14-169

O/J

N

3790167/587632


KIIIA1 6.1.2


AE16-024

O/J

N

3790168/587633




Page 165 of 172


KIIIA1 6.1.2

Lecat, H. 2017 Evaluate efficacy of product rancona 450 (ipconazole_UBI 4336-01) at different dose rate against headsmut in seed treatment in maize FRANCE in 2017

AE17-236

O/J

N

3790169/587634


KIIIA1 6.1.2

Ranuzzi, A. 2017 Evaluation of efficacy of formulations with ipconazole, prothioconazole and tebuconazole against Head-smut (SPHTRE) on Maize

AE16-019

O/J

N

3790170/587635




Page 166 of 172


KIIIA1 6.1.2


AE16-022

O/J

N

3790171/587636


KIIIA1 6.1.2

Lecat, H. 2017 Evaluate efficacy of product rancona 450 (ipconazole_UBI 4336-01) at different dose rate against headsmut in seed treatment in maize France in 2017.

AE17-200

O/J

N

3790172/587637




Page 167 of 172


KIIIA1 6.1.3

Sanchez, M.C.H.

2009 Estudio de evaluacion de la efectividad biologica del producto ipconazole 450 FS para el control del carbon de las espiga (S. reiliana) en el cultivo de maiz en el municipio de Acambaro Jalisco, Benemerita Uiversidad Autonoma de Puebla

O/J

N

3790173/587638


MIIIA1 Sec 7

Arysta 2019 dRR - B7 - core - DE - 008398-00/00 Rancona 450 FS (pdf)

N/N

N

3790470/587639




Page 168 of 172


MIIIA1 Sec 6

Arysta 2018 dRR - B6 - core - DE - 008398-00/00 Rancona 450 FS (pdf)

N/N

N

3790474/587640


Part A Arysta 2018 dRR - A - DE - 008398-00/00 Rancona 450 FS (pdf)

N/N

N

3790475/587641





Page 169 of 172


Data Point

Author(s)

Year Title

Report-No.

Source

GLP/GEP

Published


Vertebrate study

(J=Yes

O=Open

N=No)


(J=Yes

O=Open

N=No)


Owner


Data Point

Author(s)

Year Title

Report-No.

Source

GLP/GEP

Published


Vertebrate study

(J=Yes

O=Open

N=No)


(J=Yes

O=Open

N=No)


Owner

List of data relied on and not submitted by the applicant but necessary for evaluation



Page 170 of 172


Data Point

Author(s)

Year Title

Report-No.

Source

GLP/GEP

Published


Vertebrate study

(J=Yes

O=Open

N=No)


(J=Yes

O=Open

N=No)


Owner



Page 171 of 172


APPENDIX 2: GAP TABLE

GAP rev. 1.0, date: 2014-01-30

PPP (product name/code) Rancona 450 FS (UBI 4336)

active substance 1 ipconazole

safener None

synergist None


Conc. of as 1: 452 g/L

Conc. of safener: zero

Conc. of synergist: zero

Applicant: CHEMTURA Europe Ltd

Zone(s): Central/Southern/Northern

professional use Yes

non professional use No

Verified by MS: northern/central/southern

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally: developmental stages of the pest or pest group)


Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures

Method / Kind


Max. number (min. interval between applications) a) per use b) per crop/ season

kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season

g, kg as/ha a) max. rate per appl. b) max. total rate per crop/season


1 2 3 4 5 6 7 8 10 11 12 13 14

DE Maize ZEAMX

F Head smut Ustilago reiliana f. sp. Zeae

Sphacelotheca reiliana

SPHTRE

Seed treatment

Seed before planting BBCH 00

(a) 1 (b) 1

0.18 L /tonne seed

0.18 L product/tonne seed = 81.36 g ipconazole per tonne seed

At a maximum seed rate of 35 kg/ha, the application rate is 2.85 g ipconazole per hectare

0.36 - 5 L per tonne seed

Not applicable



Page 172 of 173
