APP203305 Scorpio Ornamental Fungicide...1 In the updated report the risk to the bystanders is reduced and no buffer zone for boom or aerial application on forestry is needed for tebuconazole

www.epa.govt.nz

SCIENCE MEMO

APP203305 – Scorpio Ornamental Fungicide Substance database No. 48972

December 2017

2

Science memo for application to import or manufacture Scorpio Ornamental Fungicide for release (APP203305)

December 2017

Executive Summary

Scorpio Ornamental Fungicide is a Suspension Concentrate (SC) containing the active ingredients,

tebuconazole and trifloxystrobin, plus other components. It is intended to be used as a fungicide for the

control of myrtle rust and other fungal diseases in ornamentals and plants of the Myrtaceae family. The

applicant seeks to have the substance approved for ground-based as well as aerial use.

The Environmental Protection Authority (EPA) internal database as well as additional data provided by the

applicant were used for the evaluation of the substance. If available and agreed upon, the EPA refers to

summaries provided in the European Union (EU) Draft Assessment Report (DAR) of the respective active

ingredient.

The risks to people and the environment in New Zealand from the use of Scorpio Ornamental Fungicide

have been assessed using the endpoint data available and the standard risk assessment methodologies

used by the EPA. Full details of the risk assessment can be found in Appendix G (human health) and

Appendix H (ecotoxicology).

Tebuconazole was considered the active ingredient with the highest risk profile concerning human health

and therefore the risk assessment focussed on this active ingredient. The risk assessment indicated that the

risk during mixing, loading and application is below the Level Of Concern (LOC) if personal protective

equipment (PPE) consisting of gloves, hood/visor, coveralls and heavy boots is worn.

Predicted exposures to tebuconazole for workers re-entering and working in areas where Scorpio

Ornamental Fungicide has been applied exceed the Acceptable Operator Exposure Level (AOEL) and a

Restricted Entry Interval (REI) of 43 days (without gloves) or 26 days (with gloves) is required. Gloves are

sufficient to protect workers from the residues of trifloxystrobin during re-entry activities.

Estimated bystander exposure to tebuconazole was predicted to be below the LOC if a buffer zone of 2

metres (m) is maintained for boom spray and 6-12 m for aerial application depending on the droplet size, but

no buffer zones were required to protect bystanders in relation to trifloxystrobin1.

Potential risks to the aquatic environment were identified; of these, the risks from boom spray application

could be managed by applying downwind buffer zones (20 m), however, the downwind buffer zones for

aerial application seem unlikely to be practical (400 m). In addition to downwind buffer zones, a runoff buffer

zone of 20 m is required to reduce the risks to the aquatic environment to a negligible level. The risk to

sediment organisms was above the LOC but is likely to be mitigated by the application of the buffer zones.

1 In the updated report the risk to the bystanders is reduced and no buffer zone for boom or aerial application

on forestry is needed for tebuconazole either.

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December 2017

The groundwater assessment identified potential concerns for tebuconazole, its soil metabolite 1, 2, 4-

triazole and the trifloxystrobin soil metabolite CGA321112.

The terrestrial risk assessment considered risks to soil organisms, terrestrial plants, birds, bees and non-

target arthropods. Use of Scorpio Ornamental Fungicide as assessed here was shown to have an

acceptable risk to soil microorganisms, terrestrial plants and bees. The acute risk to earthworms was

acceptable. However, predicted chronic exposures to soil organisms (earthworms) indicated a high risk from

in-field application, a high risk to threatened species off-field from ground application and a high risk to

threatened and non-threatened species from off-field aerial application.

A long term risk to both non-threatened and threatened birds species was identified primarily through

tebuconazole exposure. Several refinement options have been considered in an attempt to mitigate this risk.

At the highest level of refinement possible with the available data, a potential risk remained for threatened

and non-threatened species.

For non-target arthropods, the risk was above the LOC for in-field, and for off-field following aerial

application. The off-field risk was acceptable for ground application.

The EPA staff consider the risks from the substance for the requested use patterns to be high and therefore

these risks should be weighed against the benefits.

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December 2017

Table of Contents

Executive Summary ............................................................................................................................... 2

Table of Contents .................................................................................................................................. 4

1. Introduction/Background ........................................................................................................... 6

2. Hazardous properties ................................................................................................................. 6

3. Risk assessment context ........................................................................................................... 7

4. Human health risk assessment .................................................................................................. 7

5. Environmental risk assessment ................................................................................................ 8

6. Proposed controls ....................................................................................................................... 9

Prescribed controls ........................................................................................................................ 9

Additional and varied controls ....................................................................................................... 9

Application rate ............................................................................................................................ 10

Application method ...................................................................................................................... 10

Buffer zones ................................................................................................................................ 10

Appendix A: Identity of the active ingredients, use pattern and mode of action ......................... 11

Regulatory status......................................................................................................................... 11

Use pattern and mode of action .................................................................................................. 11

Appendix B: Physico-chemical properties of Scorpio Ornamental Fungicide ............................. 13

Appendix C: Mammalian toxicology .................................................................................................. 14

Executive summaries and list of endpoints for Scorpio Ornamental Fungicide .......................... 14

Executive summaries and list of developmental toxicity studies for tebuconazole ..................... 14

General conclusion about mammalian toxicology of active ingredients ...................................... 17

Appendix D: Environmental fate ........................................................................................................ 19

Executive summaries and list of endpoints ................................................................................. 19

Residues relevant to the environment ......................................................................................... 19

Degradation and fate of tebuconazole, trifloxystrobin and their metabolites in aquatic environments 19

Degradation and fate of tebuconazole, trifloxystrobin and their metabolites in soil .................... 21

General conclusion about environmental fate ............................................................................. 22

Appendix E: Ecotoxicity...................................................................................................................... 23

Executive summaries and list of endpoints ................................................................................. 23

Aquatic toxicity ............................................................................................................................. 23

Soil toxicity ................................................................................................................................... 29

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December 2017

Terrestrial vertebrate toxicity ....................................................................................................... 33

Ecotoxicity to bees and other terrestrial invertebrates ................................................................ 34

Appendix F: Hazard classification of Scorpio Ornamental Fungicide ........................................... 35

Appendix G: Human health risk assessment ................................................................................... 38

Quantitative risk assessment ...................................................................................................... 38

Appendix H: Environmental risk assessment .................................................................................. 48

Aquatic risk assessment .............................................................................................................. 48

Combination of tebuconazole and trifloxystrobin in Scorpio Ornamental Fungicide (Environment)51

Groundwater risk assessment ..................................................................................................... 58

Sediment risk assessment .......................................................................................................... 60

Terrestrial risk assessment ......................................................................................................... 61

Non-target plant risk assessment ................................................................................................ 63

Bird risk assessment ................................................................................................................... 65

Pollinator risk assessment ........................................................................................................... 68

Non-target arthropod risk assessment ........................................................................................ 68

Conclusions of the ecological risk assessment ........................................................................... 69

Exposure thresholds .................................................................................................................... 71

Maximum application rate ........................................................................................................... 71

Other ecotoxicity controls ............................................................................................................ 71

Application method ...................................................................................................................... 72

Buffer zones ................................................................................................................................ 72

Label statements ......................................................................................................................... 72

Appendix J: Study summaries ........................................................................................................... 73

Ecotoxicity study summaries ....................................................................................................... 73

Environmental fate studies .......................................................................................................... 96

Appendix K: Standard terms and abbreviations ............................................................................ 108

Appendix L: References.................................................................................................................... 111

Appendix M: Confidential Composition .......................................................................................... 113

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December 2017

1. Introduction/Background

1.1. This application is to import Scorpio Ornamental Fungicide for release.

1.2. Scorpio Ornamental Fungicide is a suspension concentrate containing the active ingredients,

tebuconazole and trifloxystrobin, plus other components. It is intended to be used as a fungicide. The

applicant seeks to have the substance approved for use on azaleas, ornamentals, roses and plants of

the Myrtaceae family.

1.3. The risks to people and the environment of New Zealand have been assessed under the Hazardous

Substances and New Organisms (HSNO) Act 1996. (Eco)toxicological and other data provided by the

applicant have been used, as well as information already available to the EPA.

2. Hazardous properties

2.1. The hazard classifications of Scorpio Ornamental Fungicide determined by the EPA staff are 6.8B,

6.9B and 9.1A (Table 1). The hazard classifications of Scorpio Ornamental Fungicide were determined

based on the information provided by the applicant (including toxicity and ecotoxicity studies),

information on the individual components of Scorpio Ornamental Fungicide, mixture rules and other

available information (EFSA report, DAR etc, Table 4 in Appendix F shows the method used for

classification and indicates the main component that contributes to each hazard classification).

Table 1: Proposed classification for Scorpio Ornamental Fungicide

Hazard endpoint Classification

Reproductive/developmental toxicity 6.8B

Target organ toxicity (oral) 6.9B

Aquatic ecotoxicity 9.1A

2.2. Mammalian toxicity studies with the active ingredients of Scorpio Ornamental Fungicide in a water-

based formulation indicate that the substance is not acutely toxic and should not be classified as a 6.1

substance. The substance is not irritating to the skin or eyes, and is not a contact sensitiser. Based on

mixture rules, Scorpio Ornamental Fungicide should be classified 6.8B (reproductive/developmental

toxicity) and 6.9B (target organ toxicity via the oral route). Based on test data for the formulation,

Scorpio Ornamental Fungicide should be classified 9.1A for aquatic toxicity but does not meet

classification thresholds for the other environmental compartments.

2.3. The applicant proposed the same hazard classifications as those identified by the EPA, with the

exception of proposing a ‘No’ classification for some classification when it was considered that there

was insufficient information available. This was the case for the following classifications: 6.5A

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December 2017

(respiratory sensitisation), 6.6 (mutagenicity), 6.7 (carcinogenicity), 6.8C (reproductive/developmental

toxicity via lactation), 6.9 (target organ systemic toxicity via the dermal and inhalation routes).

3. Risk assessment context

3.1. It is considered that there is potential for significant exposure to people and/or the environment during

the use phase of the lifecycle of Scorpio Ornamental Fungicide. As such, quantitative risk

assessments have been undertaken to understand the likely exposures to the substance under the

use conditions proposed by the applicant, using the endpoint data available and the standard risk

assessment methodologies used by the EPA (EPA 2018).

3.2. During the importation, manufacture, transportation, storage and disposal of this substance, it is

estimated that the proposed controls and other legislative requirements will sufficiently mitigate risks to

a negligible level. This assessment takes into account the existing EPA Notices around packaging,

identification and disposal of hazardous substances. In addition, the Land Transport Rule 45001, Civil

Aviation Act 1990, Maritime Transport Act 1994 and New Zealand’s Health and Safety at Work (HSW)

requirements all have provisions for the safe management of hazardous substances.

4. Human health risk assessment

4.1. The risks on users and operators, re-entry workers and bystanders from the use of tebuconazole and

trifloxystrobin are considered as a proxy for Scorpio Ornamental Fungicide. Full details can be found

in Appendix G. Tebuconazole is the active ingredient with the highest concentration in the Scorpio

Ornamental Fungicide formulation and the lowest AOEL, giving a higher risk profile than trifloxystrobin.

4.2. Predicted operator exposures to tebuconazole were below the AOEL for boom and backpack

applications (applied to ten and one ha/day respectively), provided full PPE (gloves, hood/visor,

coveralls, and heavy boots without a respirator) is worn during mixing, loading, and application.

Therefore, operator exposures are not expected to result in adverse health effects, provided the

appropriate PPE is worn for each application method.

4.3. Predicted exposures to tebuconazole for workers re-entering and working in areas where Scorpio

Ornamental Fungicide has been applied exceed the AOEL for tebuconazole and a REI of 43 days

(without gloves) or 26 days (with gloves) is required. Gloves are sufficient to protect workers from the

residues of trifloxystrobin during re-entry activities.

4.4. Estimated bystander exposure to tebuconazole from spray drift after application by ground boom was

below the AOEL, provided a buffer zone of at least 2 m is maintained. However, the estimated

bystander exposure from spray drift after application by aerial methods was above the AOEL, with a

buffer zone of 12 m (medium coarse droplets) required to reduce this exposure to an acceptable level.

4.5. No impurities of toxicological concern have been identified.

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December 2017

4.6. It is considered that with the above controls applied, the risks to human health are negligible.

5. Environmental risk assessment

5.1. The risks to a range of environmental receptors, including aquatic organisms, bees, soil

microorganisms, soil macro-organisms, terrestrial vertebrates (birds), terrestrial arthropods and

terrestrial plants, from the use of the active ingredients trifloxystrobin and tebuconazole are considered

as proxies for the risks from Scorpio Ornamental Fungicide.

5.2. Risks resulting from predicted exposures were above the LOC, and therefore pose a potential risk to

aquatic organisms based on calculations performed for aquatic invertebrates. To manage these risks it

is proposed to apply controls to reduce spray drift. These include application methods requiring the

substance to be sprayed in wind speeds likely to minimise the risks of spray drift, and downwind buffer

zones of 20 m for ground application and 400 m for aerial application. In addition it is proposed that

application should not be permitted within 20 m of a waterway to protect against the adverse effects

from runoff. With these controls, it is considered that the risks to aquatic invertebrates, which are

considered the most sensitive taxa, are acceptable.

5.3. Risks resulting from predicted exposures to sediment-dwelling organisms were above the LOC;

however any risks are likely to be negligible provided the above buffer zones are implemented.

5.4. Risks resulting from predicted exposures to earthworms and other soil organisms were below the LOC

based on acute exposure. However, long term risks (reproduction) were identified both in-field and off-

field.

5.5. Risks resulting from predicted exposures to non-target plants were above the LOC. It is proposed that

a 4 m downwind buffer zone from sensitive non-target plants is applied when the Scorpio Ornamental

Fungicide is applied aerially. It is acknowledged that application will occur in azalea, ornamental and

rose crops, and that non-target plants will include the target crop. Labelling should make it clear that

these buffer zones are solely recommendations to help applicators protect any sensitive plants which

may be growing close to the application area.

5.6. Assessment of the predicted exposures to birds identified a long term (reproduction) risk to threatened

and non-threatened species. The ecotoxicity endpoint was refined in two steps through considering

the data relating to two species and applying a geometric mean, and refining the No Observed Effect

Concentration (NOEC) for one species to the lowest observed effect level for inclusion in the

geometric mean. The risk could not be mitigated further with the current information and methods of

assessment available.

5.7. Risks resulting from predicted exposures to pollinators were below the LOC.

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December 2017

5.8. Risks resulting from predicted exposures to non-target arthropods were above the LOC in-field and

off-field through aerial application, indicating a risk to these organisms. With ground application,

predicted exposures to non-target arthropods off field were below the LOC.

5.9. Predicted groundwater concentrations were less thabelown the LOC from trifloxystrobin and

contamination of groundwater is not expected for this active ingredient. Predicted groundwater

concentrations were >0.1 µg/L for tebuconazole, the trifloxystrobin soil metabolites and CGA321112.

For NOA413161 insufficient information was available to estimate the concentration but has been

identified as a potential concern by overseas regulators.

5.10. Based on the available information, the toxicity of the metabolites produced in the aquatic environment

and in soil are similar or less toxic than the parent. A separate risk assessment for the metabolites was

not required and it is considered that the assessment of the active ingredients, tebuconazole and

trifloxystrobin, is appropriate to cover any risks posed by these metabolites.

5.11. Tebuconazole and trifloxystrobin are not considered to be bioaccumulative and so there was no need

for a secondary poisoning risk assessment. Tebuconazole is persistent in both the soil and aquatic

environments and the main trifloxystrobin metabolite is persistent in both the soil and aquatic

environments. These properties have been taken into account in the risk assessments.

5.12. No impurities of ecotoxicological concern have been identified.

5.13. It is considered that the risks to the environment are non-negligible. The risks from aerial application

were considered to be high and therefore it is recommended that this use pattern is not approved.

6. Proposed controls

Prescribed controls

6.1. The hazard classifications of Scorpio Ornamental Fungicide determine a set of prescribed controls

specified by the EPA Notices under section 77 of the HSNO Act. There are also requirements in the

HSW (Hazardous Substance) HSW (HS) Regulations under the HSW Act.

6.2. The prescribed controls set the baseline for how the substance should be managed and include

specifications on how the substance is to be packaged, labelled, stored, disposed of, transported,

handled and used.

6.3. In particular, the prescribed controls in the Hazardous Property Controls Notice include records of

application, compliance with the application rate, buffer zones and qualifications required for

applications of class 9 substances.

Additional and varied controls

6.4. It is considered that the prescribed controls will manage some of the risks to humans and the

environment. However, it is recommended that additional controls are added under Section 77 and

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December 2017

Section 77A of the HSNO Act to manage most of the risks to human health and the environment.

However, the following controls are not sufficient to mitigate all identified risks:

6.5. Further information on the controls is provided in Appendix A.

Application rate

6.6. The maximum application rate is 600 g tebuconazole/ha and 300 g trifloxystrobin/ha, with a maximum

of 3 applications/year with a minimum interval between applications of five days.

Application method

6.7. Apply only with ground-based equipment and minimum medium droplets, as defined by the American

Society of Agricultural and Biological Engineers (ASABE) Standard (S572) or the British Crop

Production Council guideline.

Buffer zones

6.8. When applied using ground boom, Scorpio Ornamental Fungicide must not be applied within 2 m of

upwind bystanders.

6.9. When applied using ground boom, Scorpio Ornamental Fungicide must not be applied within 20 m of

any downwind waterbody.

6.10. The EPA staff do not recommend approval of aerial application. If aerial application is approved the

following buffer zones should apply:

12 m of an upwind place where bystanders may be

400 m of any downwind waterbody.

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December 2017

Appendix A: Identity of the active ingredients, use pattern and mode of action

Regulatory status

The regulatory history of tebuconazole and trifloxystrobin is summarised in Table 2 below.

Table 2: Active ingredient regulatory status

Active ingredient

name

Regulatory history in

New Zealand

International regulatory history (Australia,

Canada, Europe, Japan, USA)

Tebuconazole Approved Approved in Australia, Europe, Canada, Japan,

USA

Trifloxystrobin Approved Approved in Australia, Europe, Canada, Japan,

USA

Use pattern and mode of action

The applicant seeks approval for the use of Scorpio Ornamental Fungicide as a fungicide for the control of a

range of pests in azaleas, ornamental, roses and plants of the Myrtaceae family.

The substance is a SC formulation which is diluted in water (1000-2000 litres of water per hectare for

ground-based application and 50-100 litres of water for aerial application).

Application will be at the rate of up to 3 kg of product per hectare which is equivalent to 0.6 kg/ha of

tebuconazole and 0.3 kg/ha of trifloxystrobin, with a maximum frequency of three applications per year a

minimum of five days apart. More details on the intended uses for Scorpio Ornamental Fungicide are given

in Table 3.

Mode of action

Tebuconazole belongs to the triazole group of fungicides that inhibit the 14-alpha-demethylase enzyme

which results in a disruption of the permeability of the fungal cell membrane. The accumulation of lanosterol

and other methylated sterols and a decrease in sterols, especially ergosterols, results in decreased fungal

growth and finally death. Tebuconazole does not prevent spore germination and some species of fungi can

still produce infective structures.

Trifloxystrobin belongs to the oximino-acetate group of fungicides that has a different mode of action. The

site of action of this group is in the mitochondrial respiration pathway (Complex III: cytochrome bc1 and Qo

site). This impacts cell respiration. It is an inhibitor of spore germination and mycelial growth.

Page 12 of 113

Science memo for application to import or manufacture «Short_Name» for release («Application_Number»)

December 2017

Table 3: List of intended uses for Scorpio Ornamental Fungicide

Crop and/or

situation (a)

Use

pattern

(b)

Pests or

group of

pests

controlled

(c)

Mixture Application Application rate per treatment

Remarks

(l) Type (d-

f) Conc of ai(g)

Method

and kind

(h-i)

Growth

stage &

season

(j)

Number

Min max

(k)

Interval

between

applications

– days

(minimum)

kg ai/hL

min max

water

L/ha

min

max

kg ai/ha

max

Azaleas,

ornamentals,

roses, plants

of the

Myrtaceae

family

F, G

Azalea

petal

blight,

botrytis,

downy

mildew,

leaf spots,

rusts,

black

spots etc.

SC

Tebuconazole:

200

Trifloxystrobin:

100

Broadcast NA 1 to 3 5

Tebuconazole: 0.015 – 0.030 kg ai/100L Trifloxystrobin: 0.0075 – 0.015 kg ai/100L

1000-2000

Tebuconazole: 0.15-0.6 Trifloxystrobin: 0.075-0.3

Aerial NA 1 to 3 5

Tebuconazole: 0.15 – 1.2 kg ai/100L Trifloxystrobin: 0.075 – 0.6 kg ai/100L

50-100

Tebuconazole Z: 0.15-0.6 Trifloxystrobin: 0.075-0.3

a Where relevant, the use situation should be described (eg fumigation of soil) b Outdoor or field use (F), glasshouse application (G) or indoor application (I). c eg biting and sucking insects, soil borne insects, foliar fungi, weeds d eg wettable powder (WP), emulsifiable concentrate (EC), granule (GR), suspension concentrate (SC) e CropLife international, 2008. Technical Monograph no 2, 6th edition. Catalogue of pesticide formulation types and international coding system f All abbreviations used must be explained g g/kg or g/l or others h Method, eg high volume spraying, low volume spraying, spreading, dusting, drench, aerial, etc , i Kind, eg overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used must be indicated. If spraying include droplet size spectrum j growth stage at 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 k Indicate the minimum and maximum number of application possible under practical conditions of use l Remarks may include: Extent of use/economic importance/restrictions

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Appendix B: Physico-chemical properties of Scorpio Ornamental Fungicide

The physico-chemical properties of Scorpio Ornamental Fungicide are listed in Table 4.

Table 4: Physical and chemical properties of Scorpio Ornamental Fungicide

Property Reference

Colour White to light beige SDS provided by the applicant

Odour Weak characteristic

Physical state Liquid suspension

Density 1.080 - 1.120 g/cm3 at 20°C

Flash point > 100 °C

pH 6.0 - 8.0 at 100 % (23 °C)

Water Solubility (20°C) Suspension

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December 2017

Appendix C: Mammalian toxicology

Executive summaries and list of endpoints for Scorpio Ornamental Fungicide

Unless otherwise noted, all studies were conducted according to GLP and were fully compliant with the

requirements of the international test guidelines followed. The mammalian toxicology data for Scorpio

Ornamental Fungicide are summarised in Table 5.

Table 5: Summary of mammalian toxicology data for Scorpio Ornamental Fungicide

Endpoint

(Test Guideline)

Klimisch

score Result

HSNO

Classification Reference

Acute oral toxicity

(OECD 423) 1

Combined LD50

>2,000 mg/kg bw No

Schüngel, M., 2003 Study No.: T

2073110

Acute dermal toxicity

(OECD 402) 1

Combined LD50

>4,000 mg/kg bw No

Schüngel, M., 2003 Study No.: T

3073111

Acute inhalation toxicity

(OECD 403) 1

Combined LC50

(nose-only; 4 hour)

>2,430 mg/m3

No Pauluhn, J, 2003

Skin irritation/corrosion

(OECD 404) 1 Not irritating No Renhof, M., 2003.

Eye irritation/corrosion

(OECD 405) 1 Not irritating No Schüngel, M., 2004

Contact sensitisation

(OECD 406) 1 Not sensitising No Vohr, H-W., 2003

Executive summaries and list of developmental toxicity studies for

tebuconazole

Unless otherwise noted, all studies were conducted according to GLP and were fully compliant with the

requirements of the international test guidelines followed. The data for tebuconazole were sourced from

studies provided by the applicant and the Australian Office of Chemical Safety (AOCS), Food and Agriculture

Organization (FAO)/World Health Organisation (WHO), Joint Meeting on Pesticide Residues (JMPR) and

European Commission (EC) DAR unless otherwise stated.

Results of the developmental toxicity studies with tebuconazole are summarised in Table 6.

Table 6: Summary of developmental toxicity studies with tebuconazole

Study type

NOAEL

(mg/kg

bw/day)

LOAEL (mg/kg

bw/day Key effect Reference

Developmental

toxicity: rats

Maternal: 10;

Foetal: 30

Maternal: 30;

Foetal: 100

Maternal: Decreased body weight

gain;

(AOCS 2011) (JMPR

2010)

(EC 2007)

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Study type

NOAEL

(mg/kg

bw/day)

LOAEL (mg/kg


Foetal: Increased resorption,

runts, decreased body weights,

malformations.

Developmental

toxicity: rats

Maternal: 30;

Foetal: 60

Maternal: 60;

Foetal: 120

Maternal: Decreased body weight

gain; liver effects;

Foetal: Increased resorption,

malformations, runts, decreased

number of live foetuses, body

weights.

(EC 2007)

Developmental

toxicity: rabbits

Maternal: 30;

Foetal: 10

Maternal: >30;

Foetal: 30

Maternal: No adverse effects;

Foetal: Increased number of

losses.

(EC 2007)

Developmental

toxicity: rabbits

Maternal: 30;

Foetal: 30

Maternal: 100;

Foetal: 100

Maternal: Decreased feed intake

and body weights;

Foetal: Decreased body weights;

increased external limb

malformations.

(AOCS 2011)

(JMPR 2010)

Developmental

toxicity: rabbits

Maternal: 30;

Foetal: 10

Maternal: 100;

Foetal: 30

Maternal: Decreased feed

consumption and body weight

gain;

Foetal: Increased incidences of

external and skeletal

malformations

Becker, H. and

Biedermann, K., 1995

Developmental

toxicity: mice

Maternal:

100;

Foetal: 10

Maternal: >100;

Foetal: 30

Maternal: No adverse effects;

Foetal: Increased number of runts. (EC 2007)

Developmental

toxicity: mice

Maternal: 3;

Foetal: 10

Maternal: 10;

Foetal: 30

Maternal: Liver enzyme induction

and vacuolisation in the liver;

Foetal: Marginal increase in

frequency of external abnormal

findings; slight retardation of

skeletal development.

Becker, H. and

Biedermann, K., 1995

2-generation

reproductive

toxicity: rats

Maternal: 25;

Foetal: 25

Maternal: 85;

Foetal: 85

Maternal: Reduced litter size;

decreased feed intake;

Foetal: Decreased feed intake;

and, retarded growth.

(EC 2007, AOCS

2011)

Developmental

neurotoxicity,

dietary: rats

22 and 41.3

mg/kg

bw/day

during

gestation

1000 ppm

Maternal: Mortality; reduced body

weight and feed consumption, and

prolonged gestation;

(EC 2007)

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December 2017

Study type

NOAEL

(mg/kg

bw/day)

LOAEL (mg/kg


and lactation

[300 ppm]

Pups: Mortality; reduced pup

weight and body weight gain;

reduced brain weight; delay in

vaginal patency; decreased

cerebellar thickness.

Developmental

neurotoxicity,

perinatal dosing,

gavage, dams and

pups: rats

Maternal: 20;

Pups: 20

Maternal: 60;

Pups: 60

Impaired spatial learning following

perinatal dosing and repeated

dosing after weaning.

(EC 2007)

Two further studies were submitted for tebuconazole that further examined the effects of maternal toxicity on

foetal development in rats and rabbits, and possible mechanisms. The study in pregnant rats (Klaus, A-M.,

Hartmann, E., Schmidt, U., 2001.; Ref: M-136935-01-1; MO-01-013994) noted that specific toxic effects on

the liver were evident as slightly increased absolute and relative liver weights and confirmed by

histopathology (hyperplasia of bile ducts with periportal inflammatory cell infiltration, yellow to brownish

pigment in the liver, increase of hepatocytic glycogen). Histopathology also revealed effects on the adrenal

glands: micro- and occasionally also macrovesicular vacuolation of adrenocortical cells from the zona

fasciculata and zona glomerulosa was observed. Toxicokinetic investigations revealed that HWG 1608 was

neither accumulated nor persisting in female rats and in foetuses. The study in pregnant rabbits (Holzum, B.,

Schmidt, U., Hartmann, E., 1999.; Ref: M-015410-01-2) noted a distinct systemic maternal toxicity at the 100

mg/kg level. Additionally, target effects occurred in the adrenal glands evident by distinct hypertrophy of

cortical cells of the zona fasciculata. This hypertrophy might have resulted in an increased production and

release of glucocorticoids into the blood. The study authors stated that rabbits are known to be very sensitive

to glucocorticoids regarding malformations which are similar to several of those seen in the two previous

developmental toxicity studies.

The weight of evidence for tebuconazole indicates that all embryotoxic findings evident in rats, rabbits and

mice correlated with maternal toxicity, so there is no indication of primary developmental toxicity. However,

submitted mechanistic studies suggest that pregnant rabbits and their developing foetuses may be

particularly sensitive to non-specific mechanisms that target the liver and adrenal function.

The dermal absorption studies with tebuconazole and trifloxystrobin are summarised in Table 7.

Table 7: Summary of dermal absorption studies with tebuconazole and trifloxystrobin

Study type Results

Dermal absorption in

human [in vitro]

[14C]-tebuconazole dermal absorption from the tebuconazole + trifloxystrobin SC 300

formulation, Total % potentially absorbable:

200 g/L: 0.61 ± 0.18%;

1 g/L: 26.79 ± 6.03%;

0.4 g/L: 16.64 ± 8.62%.

17


December 2017

The sum of radioactivity is shown in Total % directly absorbed and Total % of dose site

for the intermediate and low doses formulations. In case of the high dose formulation,

this calculation included the percentage recovery in the treated skin and the total

percentage directly absorbed. (Reference: M-539226; Muhamedi, A., 2015).

Dermal absorption in

human [in vitro]

[14C]-trifloxystrobin dermal absorption from the tebuconazole + trifloxystrobin SC 300

formulation, Total % potentially absorbable:

100 g/L: 0.09 ± 0.11%;

0.5 g/L: 3.20 ± 1.83%;

0.2 g/L: 4.18 ± 4.19%.

The sum of radioactivity in sum of radioactivity in Total % directly absorbed and Total %

of dose site for the intermediate and low doses formulations. In case of the high dose

formulation, this calculation included the percentage recovery in the treated skin and the

total percentage directly absorbed. (Reference: M-532937-01-1; Odin, M., 2015)

General conclusion about mammalian toxicology of active ingredients

Acute toxicity, irritation and sensitisation

Tebuconazole is moderately acutely toxic by the oral route and should be classified 6.1D (oral), but is of

relatively low acute toxicity by the dermal and inhalation routes and should not be classified 6.1 (dermal) or

6.1 (inhalation). Tebuconazole is not a skin or eye irritant and should not be classified 6.3 or 6.4.

Tebuconazole was shown not to be a contact sensitiser and should not be classified 6.5B.

Trifloxystrobin is of relatively low acute toxicity by the oral/dermal/inhalation routes and should not be

classified 6.1. Trifloxystrobin is not a skin irritant and should not be classified 6.3, and was shown to be a

moderate eye irritant when unrinsed but not to a severity requiring classification 6.4A. Trifloxystrobin was

shown to be a contact sensitiser in a maximisation test, but not in a Buehler test or modified Local Lymph

Node (LLNA) assay, and should be classified 6.5B.

Mutagenicity

Tebuconazole was shown not to be genotoxic in a variety of in vitro and in vivo test systems, and should not

be classified 6.6.

Trifloxystrobin was shown not to be genotoxic in a variety of in vitro and in vivo test systems, with the

exception of an equivocal positive result at cytotoxic concentrations in an in vitro mammalian forward

mutation assay, and should not be classified 6.6.

Carcinogenicity

Tebuconazole was shown not to be carcinogenic in rats or mice, and should not be classified 6.7.

Trifloxystrobin was shown not to be carcinogenic in rats or mice, and should not be classified 6.7.

18


December 2017

Reproductive and developmental toxicity

Tebuconazole: The EC concluded that the submitted data indicated that developmental toxicity occurred at

doses that were associated with some maternal toxicity in all three of the species tested (rats, rabbits and

mice). The maternal toxicity observed could, however, not in all cases be categorised in severity to a degree

that would influence development of the offspring via non-specific secondary mechanisms to effects such as

malformations. The specialised experts group resolved that there was not sufficient evidence to place

tebuconazole in Category Rep2, but tebuconazole should be regarded as a substance that causes concern

for humans owing to possible developmental toxic effects, and should be allocated to Category Rep3 for

developmental toxicity [Risk phrase R63: Possible risk to the unborn child] (EC 2007).

The ECHA Classification and Labelling database lists a Harmonised classification for tebuconazole of Repr.

2 [H361d: Suspected of damaging the unborn child] with Risk phrase R63 (ECHA 2008).

Category Rep3 for developmental toxicity [Risk phrase R63: Possible risk to the unborn child] is usually

equivalent to 6.8B classification. The Australian National Occupational Health and Safety Commission

(NOHSC) classifies tebuconazole solutions ≥5% as R63 (AOCS 2011).

The weight of evidence indicates that the serious developmental effects (foetal loss and malformations)

caused by tebuconazole in test species is most likely the result of maternal toxicity caused by mechanisms

not specifically developmentally toxic. However, submitted mechanistic studies suggest that pregnant rabbits

and their developing foetuses may be particularly sensitive to these non-specific mechanisms that target the

liver and adrenal function. A 6.8B classification for tebuconazole would be appropriate to highlight this

potential hazard, whereas a 6.9 classification would not specify this particularly susceptible population.

Trifloxystrobin exhibited no specific reproductive and developmental toxicity with wide margins between

parental/maternal toxicity and any foetal/developmental effect, and should not be classified 6.8.

Target organ toxicity

Tebuconazole targets the liver and adrenal glands in all of the species tested (rats, rabbits and dogs), with

dogs exhibiting particular susceptibility in a 90-day oral study. The LOAELs from the 90-day oral studies in

dogs and rats were respectively 37.5 and 40 mg/kg bw/day with toxicologically significant histopathology.

Tebuconazole should be classified 6.9B (oral).

Trifloxystrobin targets the liver in all three of the species tested (rats, mice and dogs). Trifloxystrobin should

be classified 6.9B.

Dermal absorption

An in vitro study using human skin demonstrated 0.61 ± 0.18% absorption at 200 g/L; 26.79 ± 6.03% at 1

g/L; and, 16.64 ± 8.62% at 0.4 g/L for dermal absorption of tebuconazole (Reference: M-539226; Muhamedi,

A., 2015).

An in vitro study using human skin demonstrated 0.09 ± 0.11% absorption at 100 g/L; 3.20 ± 1.8% at 0.5 g/L; and, 4.18 ± 4.19% at 0.2 g/L for dermal absorption of trifloxystrobin [Reference: M-532937-01-1; Odin, M., 2015].

19


December 2017

Appendix D: Environmental fate

Executive summaries and list of endpoints

Unless otherwise noted, all studies were conducted according to Good Laboratory Practice (GLP) and were

fully compliant with all requirements of the standard international test methods used. All relevant test data for

tebuconazole and its metabolites have been provided to the EPA.

Trifloxystrobin was assessed recently by the EPA (APP201862) and environmental toxicity values identified

in that assessment have been applied here for consistency. Those values concur with the values reported in

the HSNO Chemical Classification and Identification Database (CCID). Only the parent compound was

considered with no further analysis of metabolites.

Residues relevant to the environment

For tebuconazole, the metabolite 1,2,4-triazole accounted for up to 32.1% of Applied Radioactivity (AR) in

soil under aerobic conditions. No other information was provided indicating any other soil metabolites was

exceeding 10% of AR. In aqueous systems, 1,2,4-triazole was found at up to 14% AR. Two additional major

water metabolites were identified: HWG 1608-pentanoic acid (maximum 40.2% AR) and HWG 1608-lactone

(maximum 21.0% AR).

The EPA has recently assessed trifloxystrobin in the end use product, Delaro (APP201862, September

2013). In that assessment, only the active ingredient was considered. Additional information has been

provided by the applicant for this assessment. The only major soil metabolite identified was the acid,

CGA321113 (maximum 85-97% at 7-28 days).

Degradation and fate of tebuconazole, trifloxystrobin and their metabolites in

aquatic environments

Information on the degradation and fate of tebuconazole and trifloxystrobin in the aquatic environment is

summarised in Table 8. Information on bioaccumulation potential is listed in Table 9.

Table 8: Degradation and fate in aquatic environments of active ingredients

Test type Active Ingredient Reference

Tebuconazole

Ready biodegradation No EPA internal database

Aqueous photolysis half-life (DT50) 590 d (pH 7, sunlight irradiation for 30 d) EPA internal database

Degradation in aerobic water/sediment (DT50) 38.7 d (whole system) Heimbach, 2003

Water solubility at 20°C [mg/L] 32 mg/L EPA Internal database

Hydrolysis half-life (DT50) Stable at pH 5, 7, 9. EPA internal database

Trifloxystrobin

Aqueous photolysis half-life (DT50) 1.1 and 1.7 days at pH 5 and pH 7,

respectively (natural summer sunlight at

APP201862

20


December 2017

Test type Active Ingredient Reference

geographical latitude of 40°N).

Photolytically unstable.

Degradation in aerobic water/sediment (DT50) 1.2-3.5 d (whole system) APP201862

Water solubility at 20°C [mg/L] 0.61 APP201862

Hydrolysis half-life (DT50) pH 5 at 20°C: 8.6 years

pH 7 at 20°C: 11.4 weeks pH 9 at 20°C :

27.1 hours

APP201862

*In bold values used for the risk assessment

Table 9: Bioaccumulation potential

Test type Active ingredient Reference

Tebuconazole

Partition coefficient octanol/water (Log Kow) 3.7 (pH 7.2, 20oC) EPA internal database

Fish bioconcentration (whole fish) BCF = 78 L/kg EPA internal database

Trifloxystrobin

Partition coefficient octanol/water (Log Kow) log POW at 25°C : 4.5 ± (0.0094).

no pH dependence

APP201862

Fish bioconcentration (whole fish) BCF = 431 L/kg. APP201862

21


December 2017

Degradation and fate of tebuconazole, trifloxystrobin and their metabolites in

soil

Information on the degradation and fate of tebuconazole and its major metabolite in the soil environment is

summarised in Table 10. Information on the degradation and fate of trifloxystrobin and its major metabolite in

the soil environment is summarised in Table 11.

Table 10: Degradation and fate in soil for tebuconazole and its major soil metabolite 1,2,4-triazole

Test type Active ingredient or metabolite Reference

Tebuconazole

Aerobic half-life in soil

(DT50lab)1 > 1 year (770 days) EPA internal database


(DT50field)

57.5 days (upper 80th percentile of 57.5, 28.9, 29.5, 65.3,

25.8 and 48.4 days)

Sommer, 1997

Schramel, 2001

Chapple, 2009

(kinetics analysis)

Sorption to soil (Kd / Koc)1

Kd = 16.39 L/kg; Koc = 910.4 L/kg

Sandy loam, Kansas kd = 12.69 koc = 906 Silt, Höfchen

kd = 16.39 koc = 910 Low-humus sand, Federal Biological

Research Centre for Agriculture and Forestry (BBA) kd =

7.67 koc = 1023 Sandy loam, Monheim kd = 15.89 koc =

1249

Fritz, 1988

1,2,4-triazole


(DT50lab) No study provided.


(DT50field) 92.8 days (upper 80th percentile of slow phase DT50s of

70.7, 59.8, 25.1 and 126 days).

Tahara, 2010

Chapple, 2010

(kinetics analysis)


Koc = 43 L/kg (clay loam); Kd = 0.722 L/kg (silty clay loam)

Silty clay, Kd = 0.833 Koc = 120; Clay loam Kd = 0.748

Koc = 43; Sand Kd = 0.234 Koc = 2.2; Silty clay loam Kd =

0.722 Koc = 104; Sandy loam Kd = 0.719 Koc = 89 L/kg.

Hawkin, 1988

Max % of AR 32.1% Heinemann, 2016

1) Lowest non-sand value

22


December 2017

Table 11: Degradation and fate in soil for trifloxystrobin and its major soil metabolite

CGA321113

Test type Active ingredient or metabolite Reference

Trifloxystrobin


(DT50lab)

0.3-3.6 d (n=10, 19-25oC, 40-75%WHC, r2= 0.98-1.0)

mean first order normalised to 20oC,–10kPa, 0.67 d

(from 11 experiments where n= 5)

APP201862


Koc trifloxystrobin: 1642-3745 (6 soils) mean 2377

Kf trifloxystrobin: 11.2-325 (6 soils)

1/n trifloxystrobin 0.92-1.0 (6 soils) mean 0.96

No pH dependence

APP201862

CGA321113

Aerobic half-life in soil (DT50) 73.9 (upper 80th percentile of 71.6, 55.5, 77.4, 70.1) Study: Ströch and

Weuthen, 2013

Kinetics: Reinken et

al, 2013.

Sorption to soil (Kd / Koc)1 Koc = 84 Schäffer, 1996

1) Lowest non-sand value

General conclusion about environmental fate

Trifloxystrobin is rapidly degraded in water and sediment to the acid (CGA321113). This active ingredient is

not bioaccumulative but still has a relatively high BCF (431 L/kg). In soil, trifloxystrobin is rapidly converted to

the acid (CGA321113). Trifloxystrobin has low mobility in soil. In contrast, the main acid metabolite,

CGA321113, is more persistent (DT50 = 73.9 days) and mobile in soil.

Tebuconazole is persistent in water and sediment. It is not considered bioaccumulative in the environment.

In soil, tebuconazole was persistent in laboratory studies but not under field conditions (representative

DT50field = 57.5 days). It is expected to exhibit medium to high mobility in soil. The only soil metabolite

considered in this assessment was 1,2,4-triazole, formed up to 32.1% AR. No information is available for

persistence of this metabolite in soil in a controlled environment, however the metabolite is considered

slightly degradable in field studies. The metabolite may be considered highly mobile in the soil environment

based on standard soil adsorption/desorption data (Koc = 43 L/kg).

23


December 2017

Appendix E: Ecotoxicity

Executive summaries and list of endpoints

Unless otherwise noted, all studies provided for Scorpio Ornamental Fungicide were conducted according to

GLP and were fully compliant with all requirements of the standard international test methods used. All data

for the substance were sourced from studies provided by the applicant.

The substance is a product containing two active ingredients, trifloxystrobin and tebuconazole. Neither active

ingredient is new to New Zealand. Trifloxystrobin was assessed recently by the EPA (APP201862) and

environmental toxicity values identified in that assessment have been applied here for consistency. Only the

parent compound was considered with no further analysis of metabolites in the most recent EPA assessment

for trifloxystrobin (APP201862).

Aquatic toxicity

Table 12 contains the acute aquatic toxicity test results for the formulated product, Scorpio Ornamental

Fungicide. Table 13 contains the acute and chronic aquatic toxicity test results for the active ingredient

tebuconazole and Table 14 contains the data for its relevant metabolites. Table 15 contains the acute and

chronic aquatic toxicity test results for the active ingredient, trifloxystrobin.

24


December 2017

Table 12: Summary of aquatic toxicity data for Scorpio Ornamental Fungicide (in bold values used for risk assessment)

Test species Test type and

duration Scorpio Ornamental Fungicide Reference

Fish Acute

Rainbow trout. Oncorhynchus mykiss 96 hr LC50 LC50 = 0.286 mg product/L Dorgerloh, 2003

Invertebrates Acute

Daphnia magna 48 hr EC50 EC50 = 0.224 mg product/L Dorgerloh, 2004

Algae and aquatic macrophytes

Green alga, Pseudokirschneriella

subcapitata 72 hr ErC50 ErC50 = 0.99 mg product/L

Dorgerloh, 2004b

25


December 2017

Table 13: Summary of aquatic toxicity data for tebuconazole (in bold values used for risk assessment)


duration Tebuconazole Reference

Fish Acute

Rainbow trout. Oncorhynchus mykiss

96 hr LC50

LC50 = 4.4 mg/L Internal database

Bluegill sunfish, Lepomis macrochirus LC50 = 5.7 mg/L Internal database

Golden orfe (Leuciscus idus) LC50 = 8.7 mg/L Internal database

Sheepshead minnow (Cyprinodon variegatus)

LC50 = 5.9 mg/L Internal database

LC50 >7.82 mg/L Banman et al, 20073

Chronic


83 d ELS NOEC = 0.012 mg/L Internal database

21 d, semi static NOEC = 0.010 mg/L Scheerbaum, 19993

Fathead minnow, Pimephales promelas FSDT1, 122-125 d NOEC = 0.00625 mg/L; NOAEC = 0.0125 mg/L Bomke, 20073

Sheepshead minnow (Cyprinodon variegatus)

36 d ELS NOEC = 0.0219 mg/L Scott Ward, 19913

FFLC2, 203 d NOEC = 0.0436 mg/L Wheat, 19933

Invertebrates Acute

Daphnia magna 48 hr EC50 EC50 = 2.79 mg/L Dorgerloh, 2004b

Mysid shrimp (Mysidopsis bahia) 96 hr LC50 LC50 = 0.46 mg/L Surprenant, 1988a3

Eastern oyster (Crassostrea virginica) 96 hr EC50 EC50 = 3.0 mg/L Surprenant, 1988b3

Chronic

Daphnia magna

21-day flow through NOEC = 0.12 mg/L Internal database

21 d semi static NOEC = 0.010 mg/L Noack, 1999

26


December 2017


duration Tebuconazole Reference

Mysid shrimp (Mysidopsis bahia) 28 d NOEC = 0.035 mg/L (FOLICUR) Sousa, 19913

Chironomus riparius

28 d, spiked water NOEC emergence = 2.33 mg/L Dorgerloh, 2003b

28 d spiked sediment NOEC emergence = 40 mg/kg sediment dw Bruns, 2010


Green alga, Pseudokirschneriella subcapitata 72 hr ErC50 ErC50 = 2.83 mg/L Bowers, 19963

Algae, Desmodesmus subspicatus 72 hr ErC50 ErC50 = 5.30 mg/L Heimbach, 19873

Duckweed, Lemna gibba 14-day ErC50 ErC50 = 0.144 mg/L Bowers, 1997

1) FSDT = Fish Sexual Development Test; 2) FFLC = Fish Full Life Cycle 3) Study has not been summarized, the EPA staff have reviewed and accepts the summary of DAR Tebuconazole

Volume 3, Annex B9 (European Commission, EU review programme 2007)

27


December 2017

Table 14: Summary of aquatic toxicity data for tebuconazole metabolites


duration

Tebuconazole metabolites

Metabolite Value Reference1

Rainbow trout 96 h LC50

HWG 1608-pentanoic acid >10 mg/L Dorgeloh, 2003d

HWG 1608-lactone >10 mg/L Dorgerloh, 2003e

Daphnia magna 48 h EC50

1,2,4-triazole >100 mg/L Bell, 1995

HWG 1608-pentanoic acid >100 mg/L Dorgerloh, 2003f

HWG 1608-lactone >100 mg/L Dorgerloh, 2003g

Green alga, Pseudokirschneriella subcapitata 72 h EC50

1,2,4-triazole >31 mg/L Palmer et al, 2001

HWG 1608-pentanoic acid >100 mg/L Dorgerloh, 2003h

HWG 1608-lactone >100 mg/L Dorgerloh, 2003i

Chironomus riparius 28 d EC15 HWG 1608-lactone 51.2 mg/L Dorgerloh, 2003j

1) Studies have not been summarized the EPA staff have reviewed and accepts the summary of DAR Tebuconazole Volume 3, Annex B9 (European Commission, EU review

programme 2007)

28


December 2017

Table 15: Summary of aquatic toxicity data for Trifloxystrobin (in bold values used for risk assessment)

Test species Test type and duration Trifloxystrobin Reference

Fish Acute


96 hr LC50

LC50 = 0.015 mg/L

Internal database Bluegill sunfish, Lepomis macrochirus LC50 = 0.054 mg/L

Sheepshead minnow (Cyprinodon variegatus) LC50 = 0.078 mg/L

Chronic

Rainbow trout. Oncorhynchus mykiss 95 d ELS NOEC = 0.0077 mg/L Internal database

Invertebrates Acute

Daphnia magna 48 hr EC50 EC50 = 0.011 mg/L Internal database

Eastern oyster (Crassostrea virginica) 96 hr EC50 EC50 = 0.029 mg/L Internal database

Chronic

Daphnia magna 21-day flow through NOEC = 0.0027 mg/L Internal database

Chironomus riparius 28 d, spiked water NOEC = 0.2 mg/L APP201862


Green algae, Pseudokirschneriella subcapitata 120 h EC50 EC50 = 0.037 mg/L Internal database

Algae, Scenedesmus subspicatus 72 h EbC50 EbC50 = 0.0053 mg/L Internal database

29


December 2017

General conclusion about aquatic toxicity

Scorpio Ornamental Fungicide and its active ingredients, tebuconazole and trifloxystrobin trigger 9.1A HSNO

classification based on available data indicating LC50/EC50 results <1 mg/L.

Soil toxicity

Table 16 contains the acute and chronic soil toxicity test results for the formulated product, Scorpio

Ornamental Fungicide. Table 17 contains the acute and chronic soil toxicity results for the active ingredient,

tebuconazole and its major soil metabolite. Table 18 contains the acute and chronic soil toxicity results for

trifloxystrobin.

30


December 2017

Table 16: Summary of soil toxicity data for Scorpio Ornamental Fungicide (in bold values used for risk assessment)

Test species Test type and duration Scorpio Ornamental Fungicide Reference

Soil macro fauna

Earthworm, Eisenia fetida Acute, 14-day LC50 LC50 >1000 mg product/kg soil dw Lechelt-Kunze, 2004a

Reproduction, NOEC (reproduction) = 1710 mL product/ha Lechelt-Kunze, 2004b

Terrestrial plants

Four dicot and 2 monocot crop

species

Vegetative vigour, 21 days

Foliar application to seedling plants

ER50 >1 L product/ha (Tier 1, non GLP study) Nguyen and Gosch, 2004a

Seedling emergence, 21 days

Application to soil surface

ER50 >1 L product/ha (Tier 1, non GLP study) Nguyen and Gosch, 2004b

Soil microbial function

Soil microflora Nitrogen mineralisation, 28 days <25% effects after 28 days at 14.8 mg product/kg soil dw Lechelt-Kunze, 2004c

Carbon mineralisation, 28 days <25% effects after 29 days at 14.8 mg product/kg soil dw Lechelt-Kunze, 2004d

31


December 2017

Table 17: Summary of soil toxicity data for tebuconazole and its major soil metabolite

Test species Test type and duration Test substance Result Reference

Soil macro fauna

Earthworm, Eisenia fetida Acute, 14-day LC50 Tebuconazole LC50 = 1381 mg/kg soil dw Internal database

1,2,4-triazole LC50 >1000 mg/kg soil dw Heimbach, 19861

Reproduction Tebuconazole NOEC = 10 mg/kg soil dw Bätscher, 19991

1,2,4-triazole NOEC = 1.0 mg/kg soil dw Ehlers, 20001

Springtail, Folsomia candida Reproduction 28-day Tebuconazole NOEC = 250 mg/kg soil dw Wilhelmy, 19991

1,2,4-triazole NOEC = 1.8 mg/kg soil dw Lechelt-Kunze, 20021


Soil microflora Nitrogen mineralisation, 28 days

Tebuconazole <25% effects at 8.23 mg/kg

soil dw

Anderson, 2001a1

Carbon mineralisation, 28 days Anderson, 2001b1

1) Study has not been summarised; the EPA staff have reviewed and accepts the summary of DAR Tebuconazole Volume 3, Annex B9 (European Commission, EU review

programme 2007).

32


December 2017

Table 18: Summary of soil toxicity data for trifloxystrobin

Test species Test type and duration Active ingredient

Reference Trifloxystrobin

Soil Macro fauna

Earthworm, Eisenia fetida Acute, 14-day LC50 >1000 mg/kg soil dw APP201862

Chronic, 28 day, NOEC 7 mg/kg soil dw APP203261


Soil microflora Nitrogen mineralisation, 24 days <25% effects at 10000 g/ha APP201862

Carbon mineralisation, 24 days APP201862

33


December 2017

General conclusion about soil toxicity

Neither Scorpio Ornamental Fungicide nor its active ingredients, tebuconazole and trifloxystrobin,

trigger the HSNO thresholds for toxicity to the soil environment based on the data available.

Terrestrial vertebrate toxicity

For effects on terrestrial vertebrates other than birds, refer to the mammalian toxicity section.

Table 19 contains the acute and chronic avian toxicity test results for Scorpio Ornamental Fungicide

and its active ingredients, tebuconazole and trifloxystrobin. Values in bold are those used for the risk

assessment, underlined values are those used to determine the classification.

Table 19: Summary of terrestrial vertebrate toxicity data for Scorpio Ornamental Fungicide (in bold values used for risk assessment)

Test species

Test type

and

duration

Test item Reference

Scorpio Ornamental Fungicide

Bobwhite quail,

Colinus virginianus

Acute oral

LD50 >2291 mg product/kg bw Barfknecht R, 2003

Tebuconazole

Bobwhite quail,

Colinus virginianus

Acute oral

LD50

1555 mg/kg bw internal database

1988 mg/kg bw Internal database

8-day dietary

LC50 >703 mg/kg bw bw/d (>5000 mg/kg diet) Internal database

Reproductive NOEL = 5.8 mg/kg bw/d (73.5 mg/kg diet)

LOEL = 12.4 mg/kg bw/d (156 mg/kg diet)

Toll, 1988b1

Toll, 19901

Mallard duck (Anas

platyrhynchos)

8-day dietary

LC50 >4816 mg/kg diet Stubblefield, 19881

Reproductive

NOEC reproduction 75.8 mg/kg diet

NOEC reproduction 170 mg/kg diet (17.7

mg/kg bw/d)

Toll, 1988c1

Fletcher and

Pedersen, 19901

Trifloxystrobin

Bobwhite quail,

Colinus virginianus

Acute oral

LD50 >2000 mg/kg bw Internal database

8-day dietary

LC50 >5200 mg/kg diet APP201862

Reproductive

NOEC 320 mg/kg diet Internal database

1) Study has not been summarized the EPA staff have reviewed and accepts the summary of DAR Tebuconazole

Volume 3, Annex B9 (European Commission, EU review programme 2007)

34


December 2017

General conclusion about ecotoxicity to terrestrial vertebrates

Neither Scorpio Ornamental Fungicide nor trifloxystrobin trigger the HSNO thresholds for toxicity to

terrestrial vertebrates based on the data available. The LD50 to bobwhite quail for tebuconazole

results in a HSNO classification of 9.3C for that active ingredient.

The bobwhite quail NOEC for tebuconazole was determined based on two studies. In the first study,

statistically significant effects were calculated for mean hatch weight and mean 14-d survivor weight

at the lowest test concentration of 156 mg/kg diet. Despite being statistically significant, the actual

reduction compared to the control was only 4.2 and 6.1% respectively. Due to these effects, a second

study was undertaken at lower rates to establish a NOEC. That study found no effects at the highest

tested rate of 73.5 mg/kg diet.

Ecotoxicity to bees and other terrestrial invertebrates

There are formulation toxicity data available for bees (adult acute) and for several non-target

terrestrial invertebrates. The risk assessment is based on direct exposure to these organisms so will

only be undertaken for the end use product given the availability of test data.

Table 20 contains the toxicity test results for Scorpio Ornamental Fungicide.

Table 20: Summary of terrestrial invertebrate toxicity data for Scorpio Ornamental Fungicide (in bold values used for risk assessment)


duration

Scorpio Ornamental

Fungicide Reference

Honeybee, Apis mellifera

Acute oral LD50 >273.86 µg product/bee Waltersdorfer, 2003a

Acute contact LD50 >298.4 µg product/bee Waltersdorfer, 2003b

Parasitic wasp, Aphidius

rhopalosiphi

LR50, Extended

laboratory study

1091 mL product/ha Moll and Bützler,

2004a

Predatory mite,

Typhlodromus pyri

LR50, Extended

laboratory study >2000 mL product/ha Waltersdorfer, 2004

Predatory bug, Orius

laevigatus

LR50, Extended

laboratory study 321 mL product/ha Barth, 2003a

Single exposure,

different periods of

ageing of residues.

>55% mortality with 28 d

aged residues at 1 L/ha;

Mortality of 33.3% with

exposure to 42 d aged

residues at 1 L/ha; no

impact on reproduction.

Barth, 2004

Ladybird, (Coccinella

septempunctata)

LR50, Extended

laboratory study 3093 mL product/ha Röhlig, 2004

35


December 2017

Table 21: Summary of bee toxicity data for tebuconazole and trifloxystrobin

Test species Test type and duration Scorpio Ornamental

Fungicide Reference

Tebuconazole

Honeybee, Apis mellifera

Acute oral LD50 >83.05 µg/bee

Kling, 20011

Acute contact LD50 >100 µg/bee

Trifloxystrobin

Honeybee, Apis mellifera LD50 (exposure route not

specified) >200 µg/bee

EPA internal

database

1) Study has not been summarized the EPA staff have reviewed and accepts the summary of DAR Tebuconazole

Volume 3, Annex B9 (European Commission, EU review programme 2007) (EC 2007)

General conclusion about ecotoxicity to bees and terrestrial invertebrate toxicity

Scorpio Ornamental Fungicide does not trigger the HSNO thresholds for toxicity to terrestrial

invertebrates based on the data available.

Appendix F: Hazard classification of Scorpio Ornamental Fungicide

The hazard classifications of Scorpio Ornamental Fungicide are listed in Table 22 below.

Table 22: Applicant and EPA Staff classifications of Scorpio Ornamental Fungicide2

Hazard Class/Subclass

Mixture classification

by:

Method of

classification

Remarks

Applicant EPA Staff

Mix

ture

da

ta

Rea

d a

cro

ss

Mix

ture

ru

les

Class 1 Explosiveness No

Class 2, 3 & 4 Flammability No Flashpoint: > 100°C SDS

Class 5 Oxidisers/Organic

Peroxides ND

Subclass 8.1 Metallic

corrosiveness No pH 6.0 – 8.0

Subclass 6.1 Acute toxicity

(oral) No No


(dermal) No No

2 Use of mixture rules may not adequately take into account interactions between different components in some circumstances and must be considered of lower reliability than substance (formulation) data.

36


December 2017



by:

Method of

classification

Remarks

Applicant EPA Staff

Mix

ture

da

ta

Re

ad

ac

ros

s

Mix

ture

ru

les


(inhalation) No No

Subclass 6.1 Aspiration hazard No ND

Although there are no

data, the concentrated

substance is ~55% water,

therefore this hazard is

unlikely

Subclass 6.3/8.2 Skin

irritancy/corrosion No No

Subclass 6.4/8.3 Eye

irritancy/corrosion No No

Subclass 6.5A Respiratory

sensitisation No ND

No data on several

components

Subclass 6.5B Contact

sensitisation No No

Subclass 6.6 Mutagenicity No ND No data on several

components

Subclass 6.7 Carcinogenicity No ND No data on several

components

Subclass 6.8 Reproductive/

developmental toxicity 6.8B 6.8B

Tebuconazole [6.8B]

≥0.1%

Subclass 6.8 Reproductive/

developmental toxicity (via

lactation)

No ND No data on several

components

Subclass 6.9 Target organ

systemic toxicity (oral) No 6.9B

Tebuconazole and

trifloxystrobin [6.9B] ≥1%


systemic toxicity (dermal) No ND

No data on several

components


systemic toxicity (inhalation) No ND

No data on several

components

Subclass 9.1 Aquatic

ecotoxicity 9.1A 9.1A

Fish 9.1A LC50 = 0.286 mg/L

Daphnia 9.1A EC50 = 0.224 mg/L

37


December 2017



by:

Method of

classification

Remarks

Applicant EPA Staff

Mix

ture

da

ta

Re

ad

ac

ros

s

Mix

ture

ru

les

Algae 9.1A ErC50 = 0.99 mg/L

Subclass 9.2 Soil ecotoxicity - No LC50 > 1000 mg/kg soil

Subclass 9.3 Terrestrial

vertebrate ecotoxicity - No LD50 > 2291 mg/kg bw

Subclass 9.4 Terrestrial

invertebrate ecotoxicity - No

LC50 (oral and contact) >

273.86 µg/bee

NA: Not Applicable. For instance testing for a specific endpoint may be omitted if it is technically not possible to

conduct the study as a consequence of the properties of the substance: eg very volatile, highly reactive or

unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion

or the radio-labelling of the substance required in certain studies may not be possible.

ND: Not determined

No: Not classified based on actual relevant data available for the substance or all of its components. The data are

conclusive and indicate the threshold for classification is not triggered.

38


December 2017

Appendix G: Human health risk assessment

Quantitative risk assessment

The operator exposure assessment is based on a modification of the approach used by European

regulators, taking into account New Zealand specific factors. The model is based on the results of

actual measurements carried out in the field and has an established history of providing reliable and

reproducible results.

The re-entry worker exposure assessment is based on a modification of the approach used by

European regulators and the US EPA. The parameters for the modelling are based on empirical data

relating to measurements of dermal exposure of workers from contact with residues on foliage for

various activities and the amount of foliar residues that are dislodgeable.

The bystander exposure assessment is based on a modification of the approaches used by European

regulators and the US EPA. Spray drift deposition from ground-based application is estimated using

the AgDrift model using the curves produced by the Australian Pesticides and Veterinary Medicines

Authority (APVMA 2010), parameters are based on empirical data. Spray drift deposition from aerial

application is estimated using the AGDISP model along with appropriate New Zealand input

parameters.

To assess risks the predicted systemic exposures to the active ingredients are compared with an

AOEL for the active ingredient and a Risk Quotient (RQ) is calculated. RQ values greater than one

indicate that predicted exposures are greater than the AOEL and potentially of concern. RQ values

below one indicate that predicted exposures are less than the AOEL and are not expected to result in

adverse effects.

Combination of tebuconazole and trifloxystrobin in Scorpio Ornamental Fungicide

(Human Health)

The EPA has not reviewed any studies explicitly examining any possible interaction between the

toxicology of tebuconazole and trifloxystrobin that may alter the toxicological profile of the tank mix.

Tebuconazole Trifloxystrobin

The two active ingredients, tebuconazole and trifloxystrobin have different chemical structures that

metabolise down to different metabolic profiles. Tebuconazole is a triazole compound that acts as a

demethylation inhibitor of fungal sterol biosynthesis. Trifloxystrobin is a strobilurin compound that acts

39


December 2017

on the mitochondrial pathway [inhibits electron transfer from cytochrome b to cytrochrome c1 in the

mitochondrial membrane] to inhibit fungal respiration.

Available acute toxicity data for tebuconazole, trifloxystrobin and Scorpio Ornamental Fungicide are

not suitable for revealing any possible interaction between active ingredients (Table 23).

Table 23: Acute toxicity values for individual and formulated active ingredients

Acute toxicity values for:

Tebuconazole Trifloxystrobin Scorpio Ornamental Fungicide

Oral LD50 M/F: >5000/3950 mg/kg bw

M/F: 4000/1700 mg/kg bw >5000 mg/kg bw >2000 mg/kg bw

Dermal LD50 >5000 mg/kg bw

>2000 mg/kg bw >2000 mg/kg bw >4000 mg/kg bw

Inhalation LC50 Aerosol: >371-818 mg/m3

Dust: >3093 mg/m3 >4650 mg/m3 >2430 mg/m3

The Joint FAO/WHO Meeting on Pesticide Residues (JMPR 1994, JMPR 2010) on tebuconazole

noted that the liver and adrenals were the main targets of repeat exposure toxicity in rats, mice, and

dogs. The liver effects in rodents included enzyme induction and centrilobular fine vacuolisation (male

mice). Canine adrenals revealed a distinct hypertrophy of the cortical cells of the zona fasciculata.

The Joint FAO/WHO Meeting on Pesticide Residues (JMPR 2004) on trifloxystrobin noted that the

liver was also the main target of repeat exposure toxicity in rats, mice and dogs. The histopathology of

the liver was noted as hepatocellular hypertrophy, single-cell or focal necrosis, fatty change and

inflammatory cell infiltration [mice].

The limited available information suggests that the toxicity of tebuconazole and trifloxystrobin is likely

to occur by different mechanisms, based on the chemical differences and distinctions in liver

histopathology. However, there is insufficient information to rule in, or rule out possible interactions

between the two active ingredients.

Input values for the human health risk assessment

Reference doses for tebuconazole and trifloxystrobin established by internationally reputable

regulatory authorities are summarised in Table 24.

For tebuconazole, the EC DAR considered the No Observed Effect Level (NOAEL) of 3 mg/kg bw/day

from 1-year dietary study in dogs most suitable with uncertainty factors of 100, because the dog was

the most sensitive species, supported by a NOAEL of 10 mg/kg bw/day from a developmental toxicity

study in mice with uncertainty factors of 300, due to the severity of the adverse effects (EC 2007).

Because tebuconazole was classified as a developmental toxicant in the EC, an Acute Reference

Dose (ARfD) was established, based on a NOAEL of 10 mg/kg bw/day from a developmental toxicity

study in mice with a combined uncertainty factor of 100 (EC 2007).

40


December 2017

The AOCS noted that the lowest long-term oral NOAEL for tebuconazole was 1.5 mg/kg bw/day [40

ppm] from a 1-year dietary study in dogs based on lenticular effects and adrenal toxicity at 200 ppm,

but a second, later 1-year dietary study in dogs established a NOAEL of 3 mg/kg bw/day [100 ppm],

with only adrenal effects seen at 4.5 mg/kg bw/day [150 ppm]. The AOCS considered that the higher

NOAEL of 3 mg/kg bw/day was most appropriate for a conservative risk assessment for home garden

uses, where estimated exposure is compared against the ADI (AOCS 2011).

The EPA concurred that the NOAEL of 3 mg/kg bw/day from 1-year dietary study in dogs was most

suitable basis for the AOEL for tebuconazole, because the dog was the most sensitive species, and

would be protective for all anticipated toxicological effects.

For trifloxystrobin, EC considered the NOAEL of 9.8 mg/kg bw/day from 2-year dietary study in rats

most suitable with a combined uncertainty factor of 100, and adjusted for 60% oral absorption (EC

2003). The lowest NOAEL from 90-day oral studies was 6.4 mg/kg bw/day for rats, and given the

dose selection in the relevant studies, the 2-year dietary study in rats gave the most robust NOAEL.

The AOCS noted that the lowest long-term oral NOAEL for trifloxystrobin was 5 mg/kg bw/day from a

1-year dietary study in dogs, but a 2-generation reproductive toxicity study in rats gave a NOAEL of

2.2 mg/kg bw/day. The AOCS considered that the NOAEL from the 2-generation reproductive toxicity

study would be protective for all toxicological effects, for a conservative risk assessment for home

garden uses, where estimated exposure is compared against the Acceptable Daily Intake (ADI)

(AOCS 2011).

Table 24: Reference doses established by overseas regulators

Available

international

Reference

doses

Key systemic

Effect

NOAEL

(LOAEL)

mg/kg

bw/day

Uncertainty

factors

mg/kg

bw/day Remarks

Tebuconazole

EC DAR, 2007

Hypertrophy of

adrenal zone

fasciculate cells at

4.5 mg/kg bw/day

3.0 100 AOEL = 0.03

1-year dietary

toxicity study in

dogs

Tebuconazole

AOCS, 2011

Hypertrophy of

adrenal zone

fasciculate cells at 4.5

mg/kg bw/day

3.0 100 ADI = 0.03

1-year dietary

toxicity study in

dogs

Tebuconazole

JMPR, 2010

Hypertrophy of

adrenal zone

fasciculate cells at 4.5

mg/kg bw/day

3.0 100 ADI = 0.03

1-year dietary

toxicity study in

dogs

Tebuconazole

EC DAR, 2007

Enzyme induction

and vacuolisation of

the livers. External

anormalies

10 100 ARfD = 0.1 Embryotoxicty

study in mice

Trifloxystrobin Decreased

bodyweight, feed 9.8 100 AOEL = 0.06

[adjusted

2-year dietary

combined

41


December 2017

Available

international

Reference

doses

Key systemic

Effect

NOAEL

(LOAEL)

mg/kg

bw/day

Uncertainty

factors

mg/kg

bw/day Remarks

SANCO, 2003 consumption;

increased liver

weight,

hepatocellular

hypertrophy, liver

fatty change

and necrosis;

increased kidney

weight.

for 60% oral

absorption]

carcinogenicity/

chronic toxicity

study in rats

Trifloxystrobin

SANCO, 2003

Decreased

bodyweight, feed

consumption;

increased liver

weight, hepatocellular

hypertrophy, liver

fatty change and

necrosis; increased

kidney weight.

9.8 100 ADI = 0.1

2-year dietary

combined

carcinogenicity/ch

ronic toxicity study

in rats

Trifloxystrobin

AOCS, 2011

Reduced feed

consumption and

body weight gain at

33 mg/kg bw/day

2.2 100 ADI = 0.02

2-generation

reproductive

toxicity study in

rats

Trifloxystrobin

JMPR, 2004

Reduced body

weight, feed

consumption;

histopathology in liver

and kidneys

3.8 100 ADI = 0.04

2-generation

reproductive

toxicity study in

rats

Input values for the exposure assessment are summarised in Table 25.

Dermal absorption data were available to the EPA for tebuconazole and trifloxystrobin; these data are

reviewed and summarised in Table 7.

Table 25: Input values for human exposure modelling

Active

ingredient

Physical

form

Concentration

of each active

ingredient

(%)

Maximum

application rate

(for each active

ingredient, for

each method of

application)

g ai/ha

Dermal absorption (%) AOEL

mg/kg

bw/day

Concentrate Spray

Tebuconazole Liquid 19.1 [20] 600 0.79 25.2 0.03

42


December 2017

Active

ingredient

Physical

form

Concentration

of each active

ingredient

(%)

Maximum

application rate

(for each active

ingredient, for

each method of

application)

g ai/ha

Dermal absorption (%) AOEL

mg/kg

bw/day

Concentrate Spray

Trifloxystrobin 9.5 [10] 300 0.2 8.4 0.06

Operator exposure assessment

The results of the operator exposure assessment are shown in Table 26. Tebuconazole is the active

ingredient with the highest concentration in the formulation and the lowest AOEL, giving a higher risk

profile than trifloxystrobin.

For the aerial application scenario, the boom application is considered similar enough to assess the

risks from mixing and loading exposures, while exposure during application for an aerial applicator is

not considered relevant.

Table 26: Output of operator mixing, loading and application exposure assessment for tebuconazole

Exposure Scenario

Estimated operator

exposure (mg/kg

bw/day)

Risk Quotient (RQ)

Boom

No personal protective equipment (PPE)3 during mixing,

loading and application 0.0458 1.53

Gloves only during mixing and loading 0.0444 1.48

Gloves only during application 0.0384 1.28

Full PPE during mixing, loading and application (excluding

respirator) 0.0029 0.10

Full PPE during mixing, loading and application (including FP1,

P1 and similar respirator achieving 75% inhalation exposure

reduction)

0.0028 0.09


P2 and similar respirator achieving 90% inhalation exposure

reduction)

0.0028 0.09

Backpack - High Level Target

No PPE during mixing, loading and application 0.1041 3.47

3 ‘Full PPE’ includes: gloves, hood/visor, coveralls, and heavy boots during application and gloves during mixing and loading.

43


December 2017






P1 and similar respirator achieving 75 % inhalation exposure

reduction)

0.007542 0.25


P2 and similar respirator achieving 90 % inhalation exposure

reduction)

0.007092 0.24

Predicted operator exposures during mixing, loading and application of Scorpio Ornamental Fungicide

by boom over ten ha are below the AOEL for tebuconazole, provided full PPE (gloves, hood/visor,

coveralls, and heavy boots without a respirator) is worn during mixing, loading, and application.


by backpack sprayer over one hectare are below the AOEL for tebuconazole, provided full PPE

(gloves, hood/visor, coveralls, and heavy boots without a respirator) is worn during mixing, loading,

and application.

For aerial applications, the boom exposure estimates indicate that full PPE (gloves, hood/visor,

coveralls, and heavy boots without a respirator) is required during mixing and loading, but no

exposure during aerial application is expected to occur.

Table 27: Output of operator mixing, loading and application exposure assessment for trifloxystrobin

Exposure Scenario Estimated operator exposure

(mg/kg bw/day) RQ

Boom

No personal protective equipment (PPE)4 during mixing,

loading and application 0.0076 0.13





Full PPE during mixing, loading and application (including

FP1, P1 and similar respirator achieving 75 % inhalation

exposure reduction)

0.0005 0.01

4 ‘Full PPE’ includes: gloves, hood/visor, coveralls, and heavy boots during application and gloves during mixing and loading.

44


December 2017



exposure reduction)

0.0005 0.01

Backpack - High Level Target

No PPE during mixing, loading and application 0.0178 0.30







exposure reduction)

0.0015 0.02



exposure reduction)

0.0012 0.02

Predicted operator exposures to trifloxystrobin are below the AOEL, but the risks to the operator

during mixing, loading and application are driven by the exposure to tebuconazole.

Re-entry worker exposure assessment

The results of the re-entry worker exposure assessment are summarised in Table 28.

Table 28: Output of the re-entry worker exposure assessment for tebuconazole and trifloxystrobin

Active

ingredient Crop/activity

Internal (absorbed)

dose available for

systemic

distribution

(mg/kg bw/8 hours)

AOEL

(mg/kg

bw/day)

RQ

immediately

after

application

REI

(days)

Tebuconazole

Ornamentals –

Cut/sort/bundle/carry

0.572 (without

gloves)

0.03

19.1 (without

gloves)

43 (without

gloves)

0.16 (with gloves) 5.3 (with gloves) 24 (with

gloves)

Trifloxystrobin

0.01 (without gloves)

0.06

1.59 (without

gloves)

7 (without

gloves)

0.03 (with gloves) 0.44 (with

gloves) 0


Ornamental Fungicide has been applied are above the AOEL, and a REI of 43 days is required

without gloves. Even if gloves are worn the REI of 24 days is required based on the transfer

coefficient for the modelled activity. The likelihood of this re-entry activity (ornamentals –

45


December 2017

cut/sort/bundle/carry) after application of Scorpio Ornamental Fungicide is uncertain and may

overestimate the re-entry risk.

Predicted exposures to trifloxystrobin for workers re-entering and working in areas where Scorpio

Ornamental Fungicide has been applied are below the AOEL provided gloves are worn, but risk

mitigations associated with tebuconazole already mitigate this risk.

Quantitative bystander risk assessment

It is considered that the main potential source of exposure to the general public for substances of this

type (other than via food residues which will be considered as part of the registration of this substance

under the ACVM Act 1997) is via spray drift. In terms of bystander exposure, toddlers are regarded as

the most sensitive sub-population and are regarded as having the greatest exposures. For these

reasons, the risk of bystander exposure is assessed in this sub-population. The AOEL calculated for

the operator and re-entry worker exposure assessments was used for the bystander assessment, as

the use of an oral chronic reference dose (CRfD) is usually likely to be over precautionary.

The results of the bystander exposure assessment are summarised in Table 29.

Table 29: Output of the bystander exposure assessment for tebuconazole

Exposure Scenario

Estimated exposure of 15 kg toddler

exposed through contact to surfaces

8 m from an application area

(µg/kg bw/day)

RQ

Buffer zone needed to

reduce toddler

exposure to the AOEL

(metres)

Boom

High boom, fine droplets 6.89 0.2296 2

High boom, coarse droplets 1.09 0.0364 2

Low boom, fine droplets 2.32 0.0775 2

Low boom, coarse droplets 0.55 0.0184 2

Aerial (forestry)

Swath width 7.5 m,

medium-coarse droplet size

40.96 1.3652 12

Swath width 7.5 m, coarse-

very coarse droplets

35.87 1.1957 12

Swath width 7.5 m,

extremely coarse droplets

32.07 1.0691 6

Estimated bystander exposures to tebuconazole after boom application is below the AOEL, but those

from aerial application are above the AOEL. The appropriate buffer zones are listed in Table 29.

46


December 2017

Table 30: Output of the bystander exposure assessment for trifloxystrobin

Exposure Scenario

Estimated exposure of 15 kg toddler

exposed through contact to surfaces

8 m from an application area

(µg/kg bw/day)

RQ

Buffer zone needed to

reduce toddler

exposure to the AOEL

Boom

High boom, fine droplets 1.57 0.0261 0

High boom, coarse droplets 0.25 0.0041 0

Low boom, fine droplets 0.53 0.0088 0

Low boom, coarse droplets 0.13 0.0021 0

Aerial – forestry

Swath width 7.5 m,

medium-coarse droplet size

9.31 0.1552 0

Swath width 7.5 m, coarse-

very coarse droplets

8.16 0.1359 0

Swath width 7.5 m,

extremely coarse droplets

7.29 0.1215 0

Estimated bystander exposures to trifloxystrobin after boom and aerial application are below the

AOEL, but the risks to bystanders are driven by the exposure to tebuconazole.

Conclusions of the human health risk assessment

Tebuconazole is the active ingredient with the highest concentration in the Scorpio Ornamental

Fungicide formulation and the lowest AOEL, giving a higher risk profile than trifloxystrobin.

Recommended controls, such as PPE, REI and buffer zones, to protect against unacceptably high

exposures to tebuconazole will also provide adequate mitigation against trifloxystrobin exposures.


by boom over 10 hectares are below the AOEL for tebuconazole, provided full PPE (gloves,

hood/visor, coveralls, and heavy boots without a respirator) is worn during mixing, loading, and

application.


by backpack sprayer over 1 hectare are below the AOEL for tebuconazole, provided full PPE (gloves,

hood/visor, coveralls, and heavy boots without a respirator) is worn during mixing, loading, and

application.


Ornamental Fungicide has been applied exceed the AOEL and a REI of 43 days (without gloves) or

26 days (with gloves) is required. While gloves are sufficient to protect workers from the residues of

trifloxystrobin, the restrictions from tebuconazole remain.

Estimated bystander exposure to tebuconazole after boom application is below the AOEL, provided a

buffer zone of at least 2 m is maintained. However, the estimated bystander exposure from spray drift

47


December 2017

after application by aerial methods is above the AOEL, with a buffer zone of 12 m required to protect

bystanders from tebuconazole, when medium droplet size nozzles are used for application.

Estimated bystander exposures to trifloxystrobin are below the AOEL, but the risks to bystanders are

driven by the exposure to tebuconazole.

48


December 2017

Appendix H: Environmental risk assessment

Aquatic risk assessment

The basis for the aquatic risk assessment is a comparison of the Estimated Environmental

Concentrations (EEC) with toxicity endpoints to which safety factors have been applied. The EEC is

divided by the toxicity endpoint to calculate a RQ value.

Calculation of expected environmental concentrations

The parameters used in GENEEC2 modelling are listed in Table 31.

Table 31: Input parameters for GENEEC2 analysis

Tebuconazole Trifloxystrobin

Crop(s) Azaleas, ornamentals, roses, plants of the Myrtaceae family.

Application rate (g/ha) 600 300

Application frequency 3 3

Application interval (days) 5 5

Kd/Koc Koc = 910.4 Koc = 1642

Aerobic soil DT50 (days) 57.5 0.67

Pesticide wetted in? No No

Methods of application Ground based, high boom, fine droplets

Aerial, fine to medium droplets

‘No spray’ zone 0 0

Water solubility (ppm) 32 0.61

Hydrolysis (DT50 in days)

Aerobic aquatic DT50 whole

system(days) 38.7

3.5

Aqueous photolysis DT50

(days) 590

1.7

Output from the GENEEC2 model

GROUND APPLICATION

RUN No. 1 FOR Tebuconazole ON Ornamental * INPUT VALUES *

RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

ONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)

--------------------------------------------------------------------

.535( 1.513) 3 5 910.4 32.0 GRHIFI( 1.2) .0 .0

49


December 2017

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

--------------------------------------------------------------------

METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

--------------------------------------------------------------------

57.50 2 N/A ******_******** 38.70 38.69

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

--------------------------------------------------------------------

PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

--------------------------------------------------------------------

38.72 38.06 34.33 27.50 23.51

The maximum EEC for tebuconazole when used in Scorpio Ornamental Fungicide as estimated by

GENEEC2 is 38.72 μg/L for ground application.

AERIAL APPLICATION

RUN No. 1 FOR Tebuconazole ON Ornamental * INPUT VALUES *


ONE(MULT) INTERVAL Kd (PPM ) (%DRIFT) ZONE(FT) (IN)

--------------------------------------------------------------------

.535( 1.513) 3 5 910.4 32.0 AERL_B( 13.0) .0 .0


--------------------------------------------------------------------



--------------------------------------------------------------------

57.50 2 N/A ******_******** 38.70 38.69


--------------------------------------------------------------------



--------------------------------------------------------------------

42.53 41.84 37.78 30.30 25.92

50


December 2017

The maximum EEC for tebuconazole when used in Scorpio Ornamental Fungicide as estimated by

GENEEC2 is 42.53 μg/L for aerial application.

GROUND APPLICATION

RUN No. 1 FOR Trifloxystrobin ON Ornamental * INPUT VALUES *

--------------------------------------------------------------------


ONE(MULT) INTERVAL Koc (PPB ) (%DRIFT) (FT) (IN)

--------------------------------------------------------------------

.268( .270) 3 5 1642.0 610.0 GRHIFI( 6.6) .0 .0


--------------------------------------------------------------------



--------------------------------------------------------------------

.67 2 N/A ******_******* 3.50 3.50


--------------------------------------------------------------------



--------------------------------------------------------------------

1.53 1.38 .66 .26 .17

The maximum EEC for trifloxystrobin when used in Scorpio Ornamental Fungicide as estimated by

GENEEC2 is 1.53 μg/L for ground application.

AERIAL APPLICATION

RUN No. 1 FOR Trifloxystrobin ON Ornamental * INPUT VALUES *

--------------------------------------------------------------------


ONE(MULT) INTERVAL Koc (PPB ) (%DRIFT) (FT) (IN)

--------------------------------------------------------------------

.268( .270) 3 5 1642.0 610.0 AERL_B( 13.0) .0 .0


--------------------------------------------------------------------


51


December 2017


--------------------------------------------------------------------

.67 2 N/A ******_****** 3.50 3.50


--------------------------------------------------------------------



--------------------------------------------------------------------

2.53 2.31 1.11 .43 .29

The maximum EEC for trifloxystrobin when used in Scorpio Ornamental Fungicide as estimated by

GENEEC2 is 2.53 μg/L for aerial application.

Combination of tebuconazole and trifloxystrobin in Scorpio Ornamental

Fungicide (Environment)

GENEEC2 determines active ingredient specific predictions of receiving water concentrations based

on the unique properties of the active ingredients. As such, the output cannot be directly compared to

toxicity data for a combination product such as Scorpio Ornamental Fungicide. To inform the

assessment, a determination of the driver of toxicity for each trophic level has been determined. For

practical application, if a single active ingredient can be shown to contribute ≥90% towards the

toxicity, the risk assessment will be performed for that active ingredient (EFSA 2013). According to

EFSA (2013), the relative contribution of each active ingredient may be determined according to the

following equation:

%𝑟𝑒𝑙𝑎𝑡𝑖𝑣𝑒_𝑒𝑐𝑜𝑡𝑜𝑥𝑖𝑐𝑖𝑡𝑦_𝑐𝑜𝑛𝑡𝑟𝑖𝑏𝑢𝑡𝑖𝑜𝑛 =

𝑝𝑖𝐸𝐶𝑥𝑖

∑𝑝𝑖𝐸𝐶𝑥𝑖

𝑛𝑖=1

× 100

with n denoting the number of mixture components, Pi being the relative fraction of chemical i in the

mixture, and x is a common effect level, which is provoked by an exposure to a single substance or

mixture concentration. These calculations will be performed for rainbow trout, Daphnia magna and the

green algae, Pseudokirschneriella subcapitata initially as there are common toxicity results for the two

active ingredients, and end-use product toxicity results to allow a comparison.

52


December 2017

Table 32: Acute toxicity contribution active ingredients

Tebuconazole (200 g/L) Trifloxystrobin (100 g/L)

Fish

96 h LC50 4.4 mg/L 0.015 mg/L

% contribution to toxic units 0.7 99.3

Crustaceans

48 h EC50 2.79 mg/L 0.011 mg/L


Algae

72 h EC50 2.83 mg/L 0.037 mg/L


Calculation of risk quotients

This analysis indicates that for the acute assessment, trifloxystrobin will drive toxicity to fish, aquatic

invertebrates and algae. The peak EEC values determined from GENEEC2 for trifloxystrobin will

therefore be assessed for end use product toxicity values for fish, Daphnia magna and algae. The

peak EEC value for tebuconazole will be compared to the tebuconazole Lemna gibba EC50 as there is

no product toxicity data for Scorpio Ornamental Fungicide.

The calculated acute RQs for each trophic level considering the above EEC and lowest relevant

toxicity figures are presented in Table 33 for ground and Table 34 for air. The acute toxicity of the

mixture expressed in ai/mL is higher compared to tests with the individual active ingredients, therefore

the acute risks are determined based on the formulation data with the exception of Lemna gibba for

which no toxicity test was performed with the product. The calculated chronic RQs are presented in

Table 35 for trifloxystrobin and Table 36 for tebuconazole.

53


December 2017

Table 33: Acute risk quotients derived from the GENEEC2 model (ground) and toxicity data

Species

Peak EEC

from

GENEEC2

(mg/L)

LC50 or EC50

(mg/L) Acute RQ Conclusion

Fish , Oncorhynchus

mykiss 0.001531

0.286 mg

prod/L

(0.029 mg

trifloxystrobin/L)

0.05 Below LOC for non-threatened

species.

Above LOC for threatened

species.

Crustacea, Daphnia

magna 0.001531

0.224 mg

prod/L

(0.022 mg

trifloxystrobin/L)

0.07

Below LOC for non-threatened

species.


species.

Algae,

Pseudokirschneriella

subcapitata

0.001531

0.99 mg prod/L

(0.099 mg

trifloxystrobin/L)

0.015


species. No threatened species

have been identified.

Aquatic plants Lemna

gibba 0.0392

0.144 mg

tebuconazole/L 0.27


and non-threatened species

1 Trifloxystrobin peak EEC; 2 Tebuconazole peak EEC

Table 34: Acute risk quotients derived from the GENEEC2 model (air) and toxicity data

Species

Peak EEC

from

GENEEC2

(mg/L)

LC50 or EC50

(mg/L) Acute RQ Conclusion

Fish , Oncorhynchus

mykiss 0.002531

0.286 mg

prod/L

(0.029 mg

trifloxystrobin/L

0.09 Below LOC for non-threatened

species.


species.

Crustacea, Daphnia

magna 0.002531

0.224 mg

prod/L

(0.022 mg

trifloxystrobin/L)

0.11

Above LOC for non-

threatened species.


species.

Algae,

Pseudokirschneriella

subcapitata

0.002531

0.99 mg prod/L

(0.099 mg

trifloxystrobin/L)

0.026


species. No threatened species

have been identified.

Aquatic plants Lemna

gibba 0.0432

0.144 mg

tebuconazole/L 0.30

Above LOC for non-

threatened species.


species.

1 Trifloxystrobin peak EEC; 2 Tebuconazole peak EEC

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December 2017

Table 35: Chronic risk quotients derived from the GENEEC2 model and toxicity data for trifloxystrobin

Species

Relevant EEC

from GENEEC2

(mg /L)*

NOEC

(mg/L)

Chronic

RQ Conclusion

Ground application

Fish, Oncorhynchus

mykiss 0.00017 (90 day) 0.0077 0.02

Below LOC for threatened/non-

threatened species

Crustacea, Daphnia

magna 0.00066 (21 day) 0.0027 0.24


species

Above LOC for threatened/non-

threatened species

Aerial application

Fish, Oncorhynchus

mykiss 0.00029 (90 day) 0.0077 0.04

Below LOC for threatened species

Crustacea, Daphnia

magna 0.0011 (21 day) 0.0027 0.41


species


species

* EEC selected must be as close as possible from the exposure duration of the study selected for risk assessment purpose.

Table 36: Chronic risk quotients derived from the GENEEC2 model and toxicity data for

tebuconazole

Species

Relevant EEC

from GENEEC2

(mg /L)*

NOEC

(mg/L)

Chronic

RQ Conclusion

Ground application

Fish, Onchorynchus

mykiss 0.024 (90 day) 0.012 2.0


threatened species

Crustacea, Daphnia

magna 0.034 (21 day) 0.010 3.4


threatened species

Aerial application

Fish, Onchorynchus

mykiss 0.026 (90 day) 0.012 2.17


threatened species

Crustacea, Daphnia

magna 0.038 (21 day) 0.010 3.8


threatened species

* EEC selected must be as close as possible from the exposure duration of the study selected for risk assessment purpose.

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December 2017

Refinement of the aquatic risk assessment

Acute RQs were above the LOC for threatened species (aquatic invertebrates) for trifloxystrobin, and

above the LOC for threatened and non-threatened species (aquatic plants) for tebuconazole. Chronic

RQs were above the LOC for threatened (aquatic invertebrates) for trifloxystrobin for both use

scenarios. The risks for both non-threatened and threatened fish and aquatic invertebrates for both

use scenarios were above the LOC for tebuconazole.

The scenario modelled is a worst-case scenario, using the maximum application rate at the shortest

interval and maximum frequency of application. Because risks were identified further modelling was

performed to consider whether buffer zones may be able to mitigate risks from spray drift and runoff.

Spray drift

Spray drift assessed direct exposure to water bodies.

There are several relevant water column metabolites for tebuconazole. However, the basic aquatic

toxicity data provided in Table 14 show these to be considerably less toxic than the parent substance

so no further assessment of tebuconazole metabolites from spray drift is required.

For ground application, the Agdrift model was used to calculate the required downwind buffer zone to

protect the aquatic environment from adverse effects of the substance due to spray drift (see Table

37). The ecotoxicity endpoint applied is the lowest for each substance based on consideration of

acute and chronic endpoints, and applying the threatened species LOC. For both trifloxystrobin and

tebuconazole, the chronic endpoints will result in a lower ecotoxicity endpoint and will be applied in

the spray drift assessment. The receiving water concentrations are calculated applying the EPA’s

spray drift spreadsheet and considers factors reducing actual concentrations due to degradation and

partitioning both to sediment and suspended solids.

Table 37: Input parameters and calculation of spray drift buffer zone for the refined risk assessment

Input parameters Trifloxystrobin Tebuconazole

Application rate (kg ai/ha) 300 600

Number of applications 3 3

Application interval 5 5

Application method Broadcast (boom)

Air

Broadcast (boom)

Air

Droplet size Medium Medium

Boom height High High

DT50 soil 0.67 57.5

DT50 water 3.5 38.7

Koc 1642 (koc) 910.4 (Koc)

Toxicity endpoint 0.011 mg/L (acute)1 0.144 mg/L (acute)2

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December 2017

0.0027 mg/L (chronic) 0.010 mg/L (chronic)

Assessment factor (threatened species) 20 (acute), 10 (chronic) 20 (acute), 10 (chronic)

1 It was demonstrated above that acute toxicity of the formulation to fish, aquatic invertebrates and algae was driven by

trifloxystrobin. 2 There is no product toxicity data to the aquatic macrophyte, Lemna gibba, so tebuconazole is assessed

separately for that trophic level.

For aerial application, input parameters for the NZ fixed wing fungicide AgDisp settings are applied

except the fraction of actives for trifloxystrobin and tebuconazole are set at 0.015 and 0.03

respectively. A medium droplet size is modelled. For both active ingredients, the fraction of non-

volatiles is 0.018 (sum of active ingredients in the product is 300 g/L; 3 L/ha (900 g total active), 50

L/ha spray volume). While aerial application is likely to be limited to helicopter spot spraying, there is

no standard agriculture fungicide AgDisp scenario available. The fixed wing scenario is applied in the

first instance.

The following table summarises the downwind buffer zones:

Table 38: Downwind buffer zones (m) to protect against spray drift exposure – threatened species; medium droplet size

Ground application Aerial application

Active ingredient Acute Chronic Acute Chronic

Trifloxystrobin 18 2 376 74

Tebuconazole 2 32 44 490

Buffer zones based on threatened species levels of concern are large, particularly for aerial

application. It is likely aerial application will be by helicopter, and possibly only in a targeted fashion.

Further information should be provided by the applicant if they wish to pursue use through aerial

methods, otherwise, application should be restricted to ground methods since required buffer zones

are not feasible.

The buffer zones based on chronic exposure are considerably larger for tebuconazole than for

trifloxystrobin. The tebuconazole endpoint applied in the assessment is from the 21 day Daphnia

magna study. There is evidence that under more realistic exposure conditions, toxicity to this

organism is reduced (Kern and Lam, 2005). The change to the chronic tebuconazole endpoint,

however, will not change significantly as results for fish will need to be adopted. There are several

longer term fish endpoints based on early life cycle testing and full fish life cycle testing (see Table

13). An evaluation of these different studies, with the intention of confirming an appropriate chronic

fish endpoint, was provided (Grau and Breur, 2007), and it was concluded that the overall population

relevant No Observed Adverse Effect Concentration (NOAEC) for chronic risk assessments of fish of

12 µg ai/L is considered to be justified. The EPA staff agree with this conclusion.

That endpoint is from an 83 day early life stage test with rainbow trout. Applying this endpoint and an

83 day exposure period in the EPA’s spreadsheet allows a reduction in chronic buffer zones from

tebuconazole application to 6 m (medium droplets, ground application) and 196 m (medium droplets,

57


December 2017

aerial application). However, the identified buffer zone based on acute exposure to trifloxystrobin

through aerial application remains large at 376 metres and 18 meters for ground based application.

Runoff

The REXTOX model was used to calculate the required buffer zone to protect the aquatic

environment from adverse effects of the substance due to runoff (see Table 39). For this assessment,

the default 30 mm rainfall value has been used. The scenario with the highest runoff potential (bare,

moist soils) has been modelled. A crop interception value of 50% has been applied and a 5% slope

has been adopted in the first instance. It is assumed the runoff event occurs three days after the final

application.

Table 39: Input parameters and calculation of runoff buffer zone for the refined risk assessment

Input parameters Trifloxystrobin Tebuconazole

Application rate (kg ai/ha) 0.3 0.6


Time between applications 5 5

DT50 soil 0.67 57.5

Multiple application factor (MAF) 1.0 2.831

Koc/Kd Kd = 11.2 (lowest non-sand) Kd = 16.39 (lowest non-sand)

Slope 5% 5%

Toxicity endpoint 0.0027 mg/L 0.010 mg/L

Assessment factor 10 10

Buffer zone (m) 0 metres 17 metres

1 The MAF is a function of half-life. The very short half-life of trifloxystrobin in soil essentially results in little to no predicted

carryover between applications, hence the low MAF compared to tebuconazole with a much longer soil half-life.

The greater persistence of tebuconazole along with its higher application rate results in greater

predicted edge of field concentrations. A buffer zone of 17 m is calculated to allow a reduction in the

edge of field concentrations to an acceptable level.

The major soil metabolites for the two active ingredients have also been modelled with REXTOX. For

tebuconazole, the only major soil metabolite is 1,2,4-triazole formed at a maximum of 32.1% of

parent. Applying a Kd = 0.722 L/kg and soil DT50 = 92.8 the peak edge of field concentration is

predicted to be approximately 3.5 µg/L with a 17 m buffer zone. This is highly conservative as it

assumes the runoff event occurs after peak formation of the metabolite with no change in the sorption

pattern over time. Available toxicity data for this metabolite (see Table 14) show it to be significantly

less toxic than the parent compound and the resulting aquatic risk from runoff exposure to this

metabolite can be considered acceptable.

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December 2017

For trifloxystrobin, the acid (CGA321113) is assumed to be formed through complete conversion of

the parent so the total application rate will equate to 0.9 kg/ha (three applications of 0.3 kg/ha). The

Koc is 84 L/kg and the aerobic half-life in soil is 73.9 days. The predicted concentration in runoff water

assuming full conversion has occurred is predicted to be 114 µg/L. The EPA has not been provided

with toxicity data for this metabolite to aquatic organisms so no further assessment can be

undertaken.

Conclusions of the aquatic risk assessment

Use of tebuconazole and trifloxystrobin, applied as the formulated product Scorpio Ornamental

Fungicide, results in predicted aquatic exposures above the LOC for the aquatic environment.

The following controls are proposed to reduce exposures below the LOC:

1. Do not apply by aerial application;

2. Downwind buffer zone for ground application of 20 m (based on trifloxystrobin; protection of

threatened species; acute toxicity endpoint) applying with a medium droplet size;

3. If aerial application is approved a downwind buffer zone for aerial application of 400 m (based

on trifloxystrobin; protection of threatened species; acute toxicity end-point) applying with a

medium droplet size. Based on this large and impractical buffer zone, the EPA staff suggest

not to approve aerial application (unless the benefits outweigh the risks).

4. Downslope buffer zone of 20 m for mitigation from runoff (based on tebuconazole; protection

of threatened species; chronic toxicity end-point).

Buffer zones are rounded up towards so it is easier for end user to visualise and remember the buffer

zone.

The applicant provided higher tier studies for trifloxystrobin including a mesocosm study and expert

assessments regarding aquatic risk for this active ingredient. While the EPA considered these studies

and assessments, they are not taken into account further in the risk assessment as they do not

address the issues raised for the aquatic risk assessment with this application given the concerns are

based on the tebuconazole active ingredient, not trifloxystrobin.

Groundwater risk assessment

The predicted concentration of tebuconazole and its soil metabolite, 1,2,4-triazole; and the predicted

concentration of trifloxystrobin and its soil metabolite, CGA321113 in ground water, calculated using

the Sci-Grow model, is shown in Table 40. The concentration is initially compared to the EU limit for

the maximum permissible concentration of pesticide active ingredients and their relevant metabolites

of 0.1 µg/L.

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December 2017

Table 40: Input parameters for Sci-Grow analysis and resulting PEC values for trifloxystrobin and its metabolite

Input parameters Trifloxystrobin CGA321113

Application rate (kg ai/ha) 0.30 0.30 (fraction formation = 1)

Application rate (lb ai/acre)1 0.268 0.268


Koc2 1642 84

Aerobic soil DT50 (days) 0.67 73.9

PECgw (µg/L) 6.25 x 10-5 0.92

1 The application rate is conversion from kg ai/ha to lb/acre (the units required to be entered into the model) by multiplying it by 0.892

2 Lowest Koc from a non-sandy soil (normalised values for the OC, temp and pH)

EC (2003) does not discuss the trifloxystrobin metabolite NOA413161 in terms of its formation fraction

in soil from either laboratory or field studies, and as such, this metabolite has not been assessed

further in this assessment.

Table 41: Input parameters for Sci-Grow analysis and resulting PEC values for tebuconazole and its metabolite

Input parameters Tebuconazole 1,2,4-triazole

Application rate (kg ai/ha) 0.60 0.193 (fraction formation = 0.321)

Application rate (lb ai/acre)1 0.535 0.172


Koc2 910.4 43

Aerobic soil DT50 (days) 57.5 (field) 92.8

PECgw (µg/L) 0.113 1.66

1 The application rate is conversion from kg ai/ha to lb/acre (the units required to be entered into the model) by multiplying it by 0.892

2 Lowest Koc from a non-sandy soil (normalised values for the OC, temp and pH)

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December 2017

Conclusions of the groundwater risk assessment

The groundwater assessment for trifloxystrobin indicates this active ingredient will not be found in

groundwater at relevant concentrations. This is expected given its very short field half-life and

relatively strong sorption. However, the more persistent and mobile metabolite may approach a

groundwater concentration above 0.1 µg/L in vulnerable soils, and there is documented concern that

a second trifloxystrobin metabolite, NOA413161, may leach to groundwater at levels exceeding 1

µg/L.

The groundwater assessment for tebuconazole indicates it may be found at levels >0.01 µg/L,

particularly when the higher laboratory DT50 value is applied (predicted level = 0.11 µg/L). Further, the

major soil metabolite, which can form at levels exceeding 30% of parent and is more mobile, is

predicted to have a groundwater concentration >1.0 µg/L (predicted 1.66 µg/L).

Sediment risk assessment

The effects of trifloxystrobin on sediment-dwelling arthropods were studied in a spiked water test so

the risk assessment was done as for the aquatic organisms (see above). No tests were available with

spiked sediments, so a sediment risk assessment was not performed. Therefore, risks could not be

directly evaluated. In an outdoor mesocosm study (Heimbach et al, 2002), the fate of trifloxystrobin

after application to water was followed over time. Mesocosms were dosed at 3.7, 6.7, 12, 21.6 and 39

µg ai/L and recovery rates of 71.8-145% AR were found in the water column immediately after

treatment. Over a period of 77 days, there was no movement to the sediment (Limit of Quantification

(LOQ) = 1 µg/kg dw) with the exception of the highest dose rate where trifloxystrobin was found at

concentrations up to 3 µg/kg over the 14-35 day period. The lack of significant movement to sediment

indicates the assessment to sediment organisms from exposure through the water column is sufficient

to conclude an acceptable risk to these organisms.

The input parameters used in the risk assessment are summarised in Table 42.

Table 42: Input values and calculations for sediment risk assessment

Input parameters Tebuconazole

PEC local water 0.03872 mg/L (21 d average

ground based)

0.04253 mg/L (21 d average

aerial)

Koc 910.4 910.4

Toxicity value 40 mg/kg sediment (NOEC) 40 mg/kg sediment (NOEC)

Assessment factor 100 100

PEC local sediment 0.7966 mg/kg sediment 0.875 mg/kg sediment

RQ 1.99 2.19

The RQ for tebuconazole is above the LOC (LOC ≥1) indicating a potential risk to sediment

organisms.

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December 2017

The risk assessment above is based on a single long-term test to the standard sediment organisms,

Chironomus riparius with exposure through spiked sediment. In this study, the dose-response was

very steep with no statistical difference in emergence at 40 mg/kg sediment and no emergence at all

at the next (and highest) treatment group of 80 mg/kg sediment.

An additional long term study to the same organism was undertaken with exposure through spiked

water. A similar pattern was observed with no statistically significant reduction in the number of

emerged midges at 3.2 mg/L (initial measured concentration = 2.33 mg/L) and no emergence at the

next highest treatment level of 5.6 mg/L (initial measured concentration = 4.08 mg/L. It is unfortunate

in this study that sediment concentrations were not measured. However, applying the same

assessment factor of 100 given there is only one species tested, the PNECwater is 23.3 µg/L and the

GENEEC 21 day average water concentration is 34 µg/L. The resulting RQ = 1.5, which still indicates

a potential risk to sediment organisms.

Provided the downslope buffer zone is applied, and the downwind spray drift buffer zones are

observed, the overall exposure to organisms through sediment is expected to result in an acceptable

risk.

Terrestrial risk assessment

The terrestrial risk assessment considers the risks to soil organisms, terrestrial plants, birds, bees and

non-target arthropods.

The soil organism exposure assessment is based on the methods described in FOCUS (1997). At

that time, it was recognised that interception of sprayed pesticide by the crop canopy is an important

factor, but insufficient information was available to guide model assumptions. Such information has

been published in more recent years. EFSA (2014) provides a range of crop interception factors, and

while ornamentals are not specifically addressed, it appears a value of 50% interception would

provide a suitably conservative estimate, based on leafy vegetables with an intermediate canopy

cover. This will be applied in determining soil PEC values.

Soil organisms risk assessment

The soil organism risk assessment is based on a comparison of the PEC with toxicity values for the

substance. The toxicity value is divided by the PEC to give a Toxicity Exposure Ratio (TER). There

are acute and chronic earthworm toxicity data available for the formulated product. Accordingly, these

values will be used in the assessment. The end use product has a density of 1.08-1.12 g/cm3.

Applying a mean value of 1.10 g/cm3, a single application rate of 3 L product/ha equates to 3300 g

product/ha. The risk assessment is based on a single application.

Endpoints for the product are used to determine the risks since the toxicity of the product is higher

than the effects obtained from tests with the single active ingredients.

The results of the acute risk assessment for soil organisms are summarised in Table 43. Results of

the chronic risk assessment are summarised in Table 44.

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December 2017

Table 43: Acute TER values for soil organisms

Species

LC50

(mg/kg

soil)

Drift (%)

PEC

(mg/kg

soil)

TER

acute Conclusion

Scenario – 3000 mL product/ha – “in-field”

Ground and air >1000 mg

prod/kg NA 2.21 >455

Low risk (above LOC for threatened

species).

Scenario – 3000 mL product/ha – “off-field” – not calculated due to acceptable in-field risk.

1 Single application of end use product at 3 L product/ha (3300 g product/ha), 50% interception. No loss between

applications assumed.

Table 44: Chronic TER values for soil organisms

Species

NOEC

(mg/kg

soil)

Drift (%)

PEC

(mg/kg

soil)

TER

acute Conclusion

Scenario – 3000 mL product/ha – “in-field”

Ground and air 1710 mL

product/ha NA

1500 mL

product/ha1 1.14


threatened species

Scenario – 3000 mL product/ha – “off-field”

Ground

1710 mL

product/ha 8.022

120 mL

product/ha 14

Below the LOC for non-threatened

species.


species

Air 503 750 g

product/ha 2.28


threatened species

1 The toxicity value was determined based on an application rate of the product to the soil surface. The PEC is based on the

maximum product rate with a foliar interception value of 50% (single application)

2 Drift factor at 3 m off crop, BBA high boom.

3 Drift factor at 1 m off crop, AgDISP, medium droplet size.

The TERs above for the chronic risk assessment are based on a single application rate and assumes

50% interception for both in- and off-field assessments. The product can be applied several times with

a relatively short interval between applications. However, multiple application factors (MAF) for the

end use product itself cannot be derived as the active ingredients in the product behave differently.

There are individual active ingredient toxicity data for tebuconazole (56 d NOEC = 10 mg ai/kg soil),

and for trifloxystrobin (28 d NOEC = 7 mg ai/kg soil dw).

Using the same conversion, the product NOEC of 1710 mL product/ha (1880 g/ha) equates to a soil

concentration of 2.5 mg product/kg, which indicates it is much more toxic than either of the individual

active ingredients. An application rate of 1710 mL/ha (1880 g/ha) of Scorpio Ornamental Fungicide

will result in a theoretical concentration of 0.25 mg trifloxystrobin/kg soil, and 0.50 mg

63


December 2017

tebuconazole/kg soil, both of which are below their respective NOECs when tested as pure active

ingredients.

Of further note are the results of the end use product chronic toxicity testing (Lechelt-Kunze, 2004b).

While mortality and weights of adults were not impacted at up to 17.8 L/ha, there were significant

effects on reproduction at 1.8 L/ha. At only 0.09 L/ha less than this, there were no effects on

reproduction. From 1.8 L/ha to the highest tested rate of 17.8 L/ha there was a clear dose/response

on reproduction and it can only be concluded that either the active ingredients are acting in a greater

than additive way towards earthworms, or there is some other component of the formulation that is

exerting toxicity towards earthworms.

In order for the TER to be at an acceptable level (TER = 50), exposure cannot exceed 34 mL

product/ha (calculated as 50 divided by 1710 mL). Assuming 50% interception by plants off-field, this

equates to a fraction of deposition of 0.023 (34 mL / (3000 mL * 50%)). This fraction of deposition is

expected to occur 10 m downwind for ground application [based on the drift curves from the

BBA(EFSA 2014)]. For aerial application (medium droplets), this fraction of deposition occurs at 82 m

downwind using the specific AgDisp® drift curve.

Conclusions of the soil organism risk assessment

Predicted acute exposures to soil organisms (earthworms) are below the LOC. However, predicted

chronic exposures to soil organisms (earthworms) indicate a risk above the LOC from in-field

application, a risk above the LOC to threatened species off-field from ground application and a high

risk to threatened and non-threatened species from off-field aerial application.

For an acceptable risk to threatened species to be concluded, the TER has to be ≥50, which equates

to a deposition of 34 mL product/ha. Allowing for off crop interception of 50%, the allowable fraction of

deposition was calculated to be 0.023, which is predicted to occur at 5-10 m downwind (ground-based

application) or 84 m downwind (aerial; medium droplet).

Further, the adverse impacts assessed for the chronic exposure relate to reproduction. Effects on

adult earthworms already existing at the time of application are not expected either in terms of adult

mortality or decreased health (body weight).

Non-target plant risk assessment

The non-target plant risk assessment is based on a comparison of the PEC with toxicity values for the

substance. Depending on the type of data provided, for non-threatened plants a TER or an RQ is

calculated (a TER is used when an EC50 is available, an RQ is used when an EC25 is available). For

threatened non-target plants a RQ is calculated by comparing the PEC with a NOEC.

There are screening (Tier 1) test data available for the end use product, Scorpio Ornamental

Fungicide where a single application of 1 L product/ha was applied in both vegetative vigour and

seedling emergence tests. In both tests, the effects were less than 25% on all test species. The most

sensitive species in the vegetative vigour study was sunflower (19% inhibition in dry weight) and the

most sensitive species in the seedling emergence test was cucumber (32% inhibition in dry weight).

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December 2017

These were not statistically significant and there was no adverse effect noted with respect to mortality

and phytotoxicity. A 27% inhibition in germination was recorded for soybean in the seedling

emergence study, but again was not statistically significant.

For the purpose of this assessment, an application rate of 1 L product/ha is taken to approximate an

ER25. This is a fraction of deposition of 0.33 based on the maximum single application rate of 3 L

product/ha.

RQ/TER values for non-threatened non-target plants are shown in Table 45. TER values for

threatened non-target plants are shown in Table 46.

Table 45: RQ/TER value for non-target plant

Scenarios Exposure (L

product/ha)

EC25

(g ai/ha)

Downwind

distance for

drift factor =

0.33

Conclusion

Ground 3.0 1000 1 Below LOC for non-threatened

species at 1 m downwind

Air 3.0 1000 2 Below LOC for non-threatened

species at 4 m downwind

No dose response data is available for either the end use product or the individual active ingredients,

so no NOEC or EC05 can be calculated to assess the risk to threatened plants.

Table 46: TER value for threatened non-target plant

Scenarios

Exposure (g

ai/ha)

* drift factor

NOEC

(g ai/ha) TER Conclusion

Ground and air 3000 - - No assessment possible.

With respect to the target crops, Scorpio Ornamental Fungicide is registered in Australia for use on

certain ornamental species including roses, azaleas, chrysanthemums, begonia, pelargoniums and

geraniums. Efficacy data have demonstrated the product is not phytotoxic to these. Further efficacy

data have been provided to the EPA demonstrating there were no phytotoxic effects on plants from

the Myrtaceae family evaluated in several Australian trials.

Conclusion for non-target plant risk assessment

Predicted non-target plant exposures to Scorpio Ornamental Fungicide when applied to azaleas,

ornamentals and roses were below the LOC for non-threatened species at downwind distances of 1 m

for ground application and 4 m for aerial application.

There are insufficient data to assess the potential risk to threatened plant species, however, when

applying a weight of evidence approach, an effect is unlikely.

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December 2017

Bird risk assessment

The bird risk assessment is based on a comparison of the PEC with toxicity values for the substance.

The toxicity value is divided by the PEC to give a TER.

Screening assessment

Predicted exposure to Scorpio Ornamental Fungicide and its active ingredients, trifloxystrobin and

tebuconazole, under the bird acute dietary and reproduction screening assessments is shown in

Table 47.

Table 47: Exposure of birds for acute and reproduction screening assessments

Screening

type1

Indicator

species2

Application

rate

(kg/ha)

Short-

cut

value3

Time

Weighted

Average

(TWA)4

MAF5 No of

applications TER

Ornamentals, 3 applications, 5 day spray interval

Scorpio Ornamental Fungicide

Acute

Small

insectivorous

bird

3 46.8 1.0 1.8 3 >9.1

Trifloxystrobin

Acute Small

insectivorous

bird

0.30 46.8 1.0 1.8 3 >79

Reproduction 0.30 18.2 0.53 2.2 3 5.0

Tebuconazole

Acute Small

insectivorous

bird

0.60 46.8 1.0 1.8 3 >30.8

Reproduction 0.60 18.2 0.53 2.2 3 0.46

1 EFSA, (EFSA 2009), Table 5 p27 2 EFSA, (EFSA 2009), Table 6 p28 3 90th %ile short-cut value used for the acute assessment, mean value used for the reproduction assessment. EFSA,

(EFSA 2009), Table 6 p28 (90th %ile) and Table 10 p 34 (mean). 4 The exposure assessment of the reproduction assessment uses time-weighted average (TWA) exposure estimates

over 1, 2, 3 or 21 days for different phases of the assessment. 1 day = 1.0; 2 days = 0.93; 3 days = 0.9; 21 days = 0.53. EFSA, (EFSA 2009), Table 11 p34.

5 90th %ile MAF value used for the acute assessment, mean value used for the reproduction assessment. EFSA, (EFSA 2009), Table 7 p29 (90th %ile) and Table 11 p 34 (mean).

At the screening level assessment, acute risks from Scorpio Ornamental Fungicide and the two

individual active ingredients are acceptable for non-threatened species. The acute TER for the end

use product indicates a potential risk. However, the endpoint from that study (LD50 >2291 mg

formulation/kg bw) was a threshold concentration based on no mortality at the highest tested rate and

if higher doses were tested the value could therefore also be higher. If the risks of the individual active

ingredients are evaluated, no acute risks for threatened and non-threatened species were identified.

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December 2017

Therefore, it is reasonable to conclude the acute avian risk from use of Scorpio Ornamental Fungicide

is acceptable.

The reproduction risk assessment was undertaken for the individual active ingredients. While

trifloxystrobin had an acceptable TER for non-threatened species, the TER was below that for

threatened species which indicates a potential risk.

The reproduction risk assessment for tebuconazole results in a TER below the LOC for both

threatened and non-threatened species indicating an overall potential chronic risk to birds. It should

be noted that tebuconazole is already registered in New Zealand at rates higher than those proposed

here, and that approving the product is unlikely to increase the current risks in common scenarios.

However, the scenario for which the applicant seeks approval has not been evaluated before and is

also likely to expose more sensitive bird populations. Therefore, the overall risk is increased.

Calculation of TERs

Additional TERs can be calculated by applying slight refinements in indicator species and

consideration of dietary items. However, the TER at the screening level for tebuconazole

(reproduction) is ten times lower than the acceptable level for non-threatened species, and 20 times

lower than the acceptable level for threatened species. Therefore, more detailed refinement

considerations are required than initial calculation of TERs.

The applicant has supplied a higher tier risk assessment for birds based on their own knowledge.

However, that assessment is undertaken for an application rate of 1 L/ha (compared to 3 L/ha in this

application). The focal species is identified for highly managed turf and has a much lower shortcut

value than the focal species identified in the EFSA guidance document (EFSA 2009) for ornamentals.

One possible refinement can be made based on residues decline. While the applicant has provided a

study considering residue decline in cereal shoots, the screening risk assessment for this use pattern

is undertaken for, and shows an unacceptable risk to small insectivorous birds. No residues decline

data on insects have been provided so no refinement in this area can be undertaken.

The long term NOEC to mallard duck is 170 mg tebuconazole/kg diet. Applying the group mean body

weights and daily food consumption, a Daily Dietary Dose (DDD) of 17.7 mg/kg bw/d and a geometric

mean NOEC of 10.1 mg/kg bw/d are derived. This is an accepted mitigation measure in the EFSA

guidance document (EFSA 2009), and if this was applied, the TER increases to 0.79 (maintaining the

TWA = 0.53), which is still indicative of a reproductive risk to birds, even for non-threatened species.

Following this methodology, birds would need to consume ~92% of their diet from outside the treated

area for the TER to be acceptable for threatened species (~84% from outside the treated area will

result in an acceptable TER for non-threatened species).

In a second bobwhite quail study, the lowest level tested of 156 mg tebuconazole/kg diet was

considered the study Lowest Observable Effect Concentration (LOEC) due to statistically significant

effects at that level. However, for practical purposes, a further refinement option may be to consider

156 mg/kg diet (12.4 mg/kg bw/d) as an appropriate bobwhite quail study NOEC given the effects

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December 2017

seen at this rate were <10% inhibited compared to the control at this dose. If that value is used

instead of the initial NOEC for the bobwhite quail, the geometric mean NOEC becomes 14.8 mg/kg

bw/d and the TER = 1.16. This still results in a presumption of risk to both threatened and non-

threatened species.

TER calculations for the reproductive risk assessment of tebuconazole are shown in Table 48.

Table 48: TER values for reproductive risk assessment, Tebuconazole (TWA = 0.53;

MAF=2.2).

Crops & BBCH

class

Generic focal

species1 DDD

Toxicity endpoint

value (mg/kg

bw/d)*

TER ratio Conclusion

Application rate 0.6 (kg/ha) –Number of applications = 3, 5 day spray interval

Ornamentals

Small

insectivorous

bird, “tit”

12.73 mg/kg

bw/d

5.8 mg/kg bw/d 0.46 High risk



* Normally the NOAEL has to be converted from units of ppm (mg/kg diet) to mg/kg bw/day. In the first instance a factor of 0.1 is used for such conversion. If specific information is available from the test reports, this is preferable. When reported as ppm in the studies, daily dose (mg/kg/day) = [Concentration in food (mg/kg) * Daily food consumption (g/bird/day)] / body weight (g) (over the entire exposure period).

Conclusions of the bird screening risk assessment

The acute screening risk assessment indicates an acceptable acute to birds from the use of Scorpio

Ornamental Fungicide for non-threatened species. The TER for threatened species indicates a risk

above the LOC, however, taking into account the acute toxicity study showing no statistical effects at

the highest rate tested, the acute risk to threatened species is considered acceptable.

In the reproductive screening assessments, the TER values also indicate a chronic risk to birds

(threatened species) for both active ingredients. The TER value for tebuconazole is particularly low

and refinement arguments have focussed on this active ingredient. Refinements have been

considered with respect to application of geometric mean LD50 values, and increasing the

reproductive end-point from the bobwhite quail study based on effects being <10% at the lowest

tested level from one of the bobwhite quail studies.

Applying these refinements, the risk to non-threatened and threatened species still cannot be

mitigated.

For the TER values to be acceptable with these different refinement arguments, birds would need to

forage outside the treated area for ~95.5%, 92% and 88% of the time over the 21 day assessment

period for the risks to be considered acceptable to threatened species in refinements 1, 2 and 3

respectively. This is considered to be unlikely.

Secondary poisoning

Tebuconazole and trifloxystrobin are not bioaccumulative so no risk assessment for secondary

poisoning is necessary for these active ingredients.

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December 2017

Pollinator risk assessment

The basis for the pollinator risk assessment is a comparison of the environmental exposure

concentration (EEC) with toxicity endpoints to which safety factors have been applied. The EEC is

divided by the toxicity endpoint to calculate an RQ value. The results of the bee risk assessment are

shown in Table 49.

Table 49: Bee exposure estimates and RQ values

Use scenario Application rate

(kg ai/ha)

EEC (µg

ai/bee)

Toxicity

endpoint

value (µg

ai/bee)

RQ Conclusion

Acute / Adult bees – contact

Ornamentals 3 7.2 >298.4 <0.024 Low risk

Acute / Adult bees – oral

Ornamentals 3 85.8 >273.9 <0.31 Low risk

Conclusions of the pollinator risk assessment

The acute risks to pollinators are below the LOC. No chronic data were available, this is considered a

data gap and thus this uncertainty should be taken in consideration especially considering the use

pattern on attractive ornamentals (eg flowering Pōhutukawa).

Non-target arthropod risk assessment

The non-target arthropod risk assessment is a comparison of the predicted environmental

concentration (PEC) with toxicity endpoints to which safety factors have been applied. The PEC is

divided by the toxicity endpoint to calculate a hazard quotient (HQ) value.

Results of the in-field and off-field non-target arthropod risk assessment are shown in Table 50 and

Table 51, respectively.

Table 50: In-field HQ values for non-target arthropods

Species LR50

(mL/ha)

Application rate

(mL/ha) MAF

Hazard

Quotient Conclusion

Predatory mites 1091 3000 2.3 6.3 High risk

Parasitic wasps >2000 3000 2.3 <3.45 High risk

Predatory bugs 321 3000 2.3 21.5 High risk

Ladybirds 3093 3000 2.3 2.2 High risk

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December 2017

Table 51: Off-field HQ values for non-target arthropods (drift factor =6.9% for ground and 50% for air)1

Species

LR50

(g ai/ha or

mL ai/ha)

Application rate

(g ai/ha or mL

ai/ha)

MAF Hazard

Quotient Conclusion

Ground application

Predatory mites 1091 3000 2.3 0.43 Low risk

Parasitic wasps >2000 3000 2.3 <0.24 Low risk

Predatory bugs 321 3000 2.3 1.48 Low risk

Ladybirds 3093 3000 2.3 0.15 Low risk

Aerial application

Predatory mites 1091 3000 2.3 3.16 High risk

Parasitic wasps >2000 3000 2.3 <1.72 Low risk

Predatory bugs 321 3000 2.3 10.7 High risk

Ladybirds 3093 3000 2.3 1.12 Low risk

1 Ground drift factor based on BBA. Aerial drift factor based on NZ EPA default agriculture aircraft deposition curve, medium

droplets at 1 m off-crop.

Conclusion for non-target arthropod risk assessments

Risks to non-target arthropods in-field are above the LOC. Risks to non-target arthropods off-field are

below the LOC for ground application but above the LOC for aerial application.

Conclusions of the ecological risk assessment

Scorpio Ornamental Fungicide, and its active ingredients trifloxystrobin and tebuconazole have been

shown to have a potential risk to aquatic organisms through off-target exposure. This risk can be

managed through appropriate downwind buffer zones to protect against spray drift exposure, and for

appropriate downslope buffer zones to protect against runoff exposure.

The groundwater assessment identifies potential concerns for tebuconazole, its soil metabolite 1,2,4-

triazole and the trifloxystrobin soil metabolite CGA321112 with modelled concentrations of these

substances exceeding 0.1-1 µg/L in vulnerable soils. For NOA413161, insufficient information was

available to model the concentration, however, it has been indicated in overseas assessment that this

metabolite should be evaluated.

The risk to sediment organisms is above the LOC but are likely mitigated by the buffer zones to

protect waterbodies.

The terrestrial risk assessment considered risks to soil organisms, terrestrial plants, birds, bees and

non-target arthropods. Use of Scorpio Ornamental Fungicide as assessed here was shown to have

an acceptable risk to soil microorganisms, terrestrial plants and bees. The acute risk to earthworms is

acceptable. However, predicted chronic exposures to soil organisms (earthworms) indicate a high risk

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December 2017

from in-field application, a high risk to threatened species off-field from ground application and a high

risk to threatened and non-threatened species from off-field aerial application.

A long term risk to birds is identified primarily through tebuconazole exposure to both non-threatened

and threatened species. Several refinement options have been considered in an attempt to mitigate

this risk. At the highest level of refinement possible with the available data, a potential risk remains for

threatened and non-threatened bird species.

For non-target arthropods, the risk was above the LOC for in-field, and for off-field following aerial

application. The off-field risk was acceptable for ground application.

The risks to the environment are considered to be non-negligible. The risks from aerial application

were considered too high and therefore it is recommended for this use pattern not to be approved.

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December 2017

Appendix I: Proposed controls

The EPA Labelling, Packaging, Safety Data Sheet (SDS), Disposal and Hazardous Property Controls

(HPC) Part 1, 3 and 4 apply to Scorpio Ornamental Fungicide.

Exposure thresholds

Exposure thresholds proposed for tebuconazole and trifloxystrobin are shown in Table 52. Acceptable

Daily Exposure (ADE) and Potential Daily Exposure (PDE) values are not controls as such, but are

health based exposure guidance values which can be used to inform risk assessments as well as the

setting of controls, such as Maximum Residue Levels (MRLs) under the Agricultural Compounds and

Veterinary Medicines (ACVM) Act 1997.

Table 52: Active ingredient(s) exposure thresholds

Active ingredient(s) ADE (mg/kg

bw/d)

PDE (mg/kg bw/d) Tolerable Exposure

Limit (TEL)

mg/L (water)

mg/kg (soil)

mg/m3 (air)

Acute reference

dose

(ARfD) mg/kg bw

Tebuconazole Not set at this time Not set at this time Not set at this time 0.03

Trifloxystrobin Not set at this time Not set at this time Not set at this time Not set at this time

No Tolerable Exposure Limit (TEL) values have been set because it is considered that exposure to

this substance is not likely to result in an appreciable toxic effect to people, provided conditions of use

are followed.

Environmental Exposure Limit (EEL) values have been specified previously for tebuconazole but do

not apply for this substance.

Maximum application rate

A maximum application rate is proposed to be set for Scorpio Ornamental Fungicide, as shown in

Table 53.

Table 53: Active ingredient(s) maximum application rates

Maximum application rate5

600 g tebuconazole/ha and 300 g trifloxystrobin/ha, maximum 3 applications/year with a minimum interval

between applications of 5 days

Other ecotoxicity controls

The following controls are not sufficient to mitigate all identified risks:

5 These regulations relate to the requirement to set an application rate for a class 9 substance that is to be sprayed or applied to an area of land (or air or water) and for which an EEL has been set.

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December 2017

Application method

6.11. Apply only with ground-based equipment and minimum medium droplets, as defined by the

American Society of Agricultural and Biological Engineers (ASABE) Standard (S572) or the

British Crop Production Council guideline.

6.12. Scorpio Ornamental Fungicide must not be applied using spray equipment when wind speeds

are less than 3 km/hr or more than 20 km/hr as measured at the application site.

Buffer zones

6.13. When applied using ground boom, Scorpio Ornamental Fungicide must not be applied within 2

m of upwind bystanders.

6.14. When applied using ground boom, Scorpio Ornamental Fungicide must not be applied within 20

m of any downwind waterbody.

6.15. Scorpio Ornamental Fungicide must not be applied within 20 m of a waterbody for mitigation

from runoff.

6.16. The EPA staff do not recommend approval of aerial application. If aerial application is approved

then it is suggested that the following controls should apply:

6.17. When applied using aerial methods Scorpio Ornamental Fungicide must not be applied within

12 m of an upwind place where bystanders may be.

6.18. When applied aerially Scorpio Ornamental Fungicide must not be applied within 400 m of any

downwind waterbody.

Label statements

Label statement controls requiring the following information:

A recommendation that users apply a 4 m downwind buffer zone to protect sensitive non-target

plants.

An appropriate Integrated Pest Management (IPM) statement to advise users of the potential

adverse effects on beneficial insects.

That workers should not re-enter the spray area until the spray has dried.

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December 2017

Appendix J: Study summaries

Ecotoxicity study summaries

Several studies on the toxicity of trifloxystrobin and tebuconazole have been reviewed, in combination

with that for the end use product, Scorpio Ornamental Fungicide (100 + 200, SC). These studies are

used to describe the key impacts of Scorpio Ornamental Fungicide on environmental organisms. In

most studies the test item is “Trifloxystrobin and tebuconazole SC300” which is confirmed to be the

same formulation as Scorpio Ornamental Fungicide. The data from the studies for classifying the

substance were used in the risk assessment. A summary of these studies is provided in Table 54 to

Table 77.

Avian toxicity

Table 54: Avian toxicity, end use product: key study

Study type Acute, oral; Bobwhite quail (Colinus virginanus)

Flag Key study

Test Substance Trifloxystrobin and tebuconazole SC300

Endpoint LD50

Value >2291 mg formulation/kg

Reference

Barfknecht R, 2003. Trifloxystrobin & Tebuconazole SC300 (100+200) Acute

Oral Toxicity for Bobwhite Quail (Colinus virginianus). Bayer Crop Science

AG, Monheim, Germany. Study: E2042566-5

Klimisch Score 1

Amendments/Deviations None

GLP Yes

Test Guideline/s US EPA 71-1; OPPTS 850.2100

Dose Levels 0, 1146, 2291 mg/kg bw

Analytical measurements None performed.

Study Summary

Ten birds per treatment level (five males and five females) were used. Birds

were observed over 14 days following administration of a single dose. No

mortality was observed at any treatment level. Diarrhoea, soft excrements

and reduced food consumption from day 0-3 in highest test group were

observed. Food consumption was reduced in the 1146 mg/kg treatment

group at day 0-3.

Gross necropsy did not reveal any pathological changes in any test group.

Comments None.

Conclusion Acute LD50 >2291 mg/kg bw.

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December 2017

Aquatic toxicity - Fish

Table 55: Aquatic toxicity, end use product: key study

Study type Acute toxicity, fish, Rainbow trout (Oncorhynchus mykiss).

Flag Key study


Endpoint LC50

Value 0.286 mg formulation/L

Reference

Dorgerloh M, 2003a. Acute toxicity of Trifloxystrobin & Tebuconazole SC 300

to fish (Oncorhynchus mykiss). Bayer CropScience AG - Development –

Ecotoxicology. Monheim, Germany. Study no. DOM 23080.

Klimisch Score 1


GLP Yes

Test Guideline/s OECD 203; US EPA 72-1

Dose Levels 0, 0.0625, 0.125, 0.250, 0.500 and 1.00 mg formulation/L.

Analytical measurements High Pressure Liquid Chromatography (HPLC)-Ultra violet (UV)

Study Summary

5 groups with 10 fish per concentration were tested in a static test system for

a duration of 96 h.

Concentrations were based on the tebuconazole concentration. At the start of

the test, the concentration, were in the range of the nominal concentration

and remained stable during the test (89-100% of nominal), therefore,

endpoints were expressed in terms of analytical confirmed nominal

concentrations.

There were behavioural observations on fish caused by the test item over the

whole exposure period at all levels ≥0.25 mg formulation/L. No mortality or

adverse effects occurred in the control group. After 96 h, mortality of 20%,

100% and 100% was observed in the 0.25, 0.50 and 1.0 mg formulation/L

groups with no mortality in lower exposure groups.

Conclusion 96 h LC50 = 0.286 mg formulation/L (95% CI 0.203-0.403 mg formulation/L).

Table 56: Tebuconazole; Fish, chronic: key study

Study type Fish early life stage test

Flag Key study.

Test Substance Tebuconazole (96.3% pure)

Endpoint 83 d NOEC

Value 0.012 mg/L

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December 2017

Reference

Surprenant D, 1987d. The Toxicity of HWG 1608 Technical to Rainbow Trout

(Salmo gairdneri) embryos and larvae Mobay Corporation, Kansas, USA.

Report 87-11-2545.

Klimisch Score 1

Amendments/Deviations Slightly higher temperature and drop in oxygen content in some samples. Not

considered to have impacted the test outcome.

GLP Yes

Test Guideline/s US EPA Guideline 72-4

Dose Levels Nominal 0.015 to 0.24 mg ai/L; Mean measured 0.012, 0.025, 0.061, 0.12

and 0.23 mg/L.

Analytical measurements Yes.

Study Summary

Rainbow trout unfertilised eggs and sperm, embryos and larvae were

continuously exposed to a control, solvent control and test concentrations.

The study duration was 83 days under flow-through conditions. Observations

were made on embryo viability, organism survival at hatch and larval survival

and growth after 60 days post hatch.

There was no effect on embryo viability at any concentration and survival of

organisms at the completion of the hatching period was comparable to the

control. The larval survival was significantly reduced at the four highest test

concentrations. Throughout the post-hatch period, larvae exhibited abnormal

appearance and behaviour at concentrations of 0.025 mg/L and higher.

Comments

Conclusion NOEC = 0.012 mg/L.

Aquatic toxicity – aquatic invertebrates


Study type Acute toxicity, aquatic invertebrate, Daphnia magna.

Flag Key study


Endpoint EC50

Value 224 µg formulation/L

Reference

Dorgerloh M, 2004a Acute Toxicity of Trifloxystrobin & Tebuconazole SC 100

+ 200 to the Waterflea Daphnia magna. Bayer CropScience AG -

Development – Ecotoxicology. Monheim, Germany. Study no. DOM 23061.

Klimisch Score 1

Amendments/Deviations None that impacted the study

GLP Yes


Dose Levels 0, 47.7, 76.3, 122, 195, 313 and 500 µg formulation/L.

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December 2017

Analytical measurements HPLC-UV

Study Summary

For each test concentration and the control there were six replicates, each

with five daphnids.

Concentrations were based on the trifloxystrobin concentration. At the start of

the test, the concentrations were in the range of nominal concentration (81-

104% of nominal) and remained stable during the test (82-88% of initial)),

therefore, endpoints were expressed in terms of analytical confirmed nominal

concentrations.

After 48 h, no immobilisation was observed in the control and 47.7 µg

formulation/L groups. Mean immobilisation of 7%, 13%, 33%, 77% and 100%

was found in the 76.3, 122, 195, 313 and 500 µg formulation/L groups

respectively.

Conclusion 48 h EC50 = 224 µg formulation/L (95% CI 188-267 µg formulation/L).

Table 58: Tebuconazole; Aquatic invertebrate, acute: key study

Study type Daphnia magna 48 h acute toxicity test

Flag Key study.


Endpoint 48 h EC50

Value 2.79 mg/L

Reference

Dorgerloh M, 2004b. Acute Flow-Through Toxicity of HWG-1608 Technical to

Daphnia magna. Bayer CropScience AG, Monheim, Germany. Report

number DOM 24045

Klimisch Score 1


GLP Yes (recalculation is non-GLP)

Test Guideline/s OECD Test Guideline 211

Dose Levels 0, 0 (solvent), 0.46, 0.74, 1.6, 2.6 and 6.2 mg ai/L (mean measured).


Study Summary

1st instar Daphnia magna (<24 h old, 40 per concentration) were exposed in a

flow-through test system for 48 h to a control, solvent control and treatment

concentrations.

Abnormal effects of mortality, quiescence and/or daphnids lying on the

bottom of the test vessels were observed in the top three concentrations.

Comments

Conclusion 48 h EC50 = 2.79 mg ai/L.

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December 2017

Table 59: Tebuconazole; Aquatic invertebrate, chronic: key study

Study type Daphnia magna 21 day reproduction test

Flag Key study.


Endpoint 21 day NOECreproduction

Value 0.01 mg/L

Reference Noack M, 1999. HT 308 Technical. Daphnia magna Reproduction Test (21

d). Irvita Plant Protection, Netherlands. Project No: 980811MS

Klimisch Score 1


GLP Yes

Test Guideline/s OECD Test Guideline 211

Dose Levels 0, 0.01, 0.03, 0.1, 0.3 and 0.9 mg ai/L.

Analytical measurements

Yes. Mean values of recovery rates including new and old media were in the

range of 87-136% nominal. Results are expressed in terms of nominal

concentrations.

Study Summary

Daphnia (ten per test concentration; one per replicate) were exposed in a

static renewal test system for 21 days. Mortality, reproduction, body length

and body weight of parents were recorded at the end of the study.

No significant mortality/immobilisation was recorded. Statistically significant

reduction in the number of juveniles occurred in all but the lowest test rate

with reduction compared to the control daphnids of 2, 43, 51, 29 and 95% in

the 0.01, 0.03, 0.1, 0.3 and 0.9 mg ai/L treatment groups respectively. At the

highest test rate there was a statistically significant number of stillborn

juveniles.

Comments

Conclusion NOECreproduction = 0.01 mg/L.

Aquatic toxicity – algae and aquatic plants


Study type Algae growth inhibition study (Pseudokirchneriella subcapitata)

Flag Key study


Endpoint ErC50

Value 0.99 mg formulation/L

Reference

Dorgerloh M, 2004c. Influence of Trifloxystrobin & Tebuconazole SC 100 +

200 on the Growth of the Green Alga, Pseudokirchneriella subcapitata. Bayer

CropScience AG - Development – Ecotoxicology. Monheim, Germany. Study

no. DOM 23094

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December 2017

Klimisch Score 1


GLP Yes


Dose Levels 0, 0.031, 0.10, 0.31, 1.0, 3.1 and 10 mg formulation/L.

Analytical measurements High Pressure Liquid Chromatography-Mass Spectrometry (HPLC-MS/MS)

Study Summary

Initial cell densities of 1X104 cells/mL were exposed per test concentration for

three days (72 h) in a static test. There were six replicates in the control

group and three replicates per treatment group.

Concentrations were based on the trifloxystrobin concentration. At the start of

the test the concentrations were in the range of the nominal concentration

(82-89% of nominal) and did not remain stable during the test (58-63 of

nominal). A formulation was tested.

Mean inhibition of growth rates were calculated to be 0%, 20.2%, 31.4%,

47.0%, 76.9% and 76.8% in the 0.031, 0.10, 0.31, 1.0, 3.1 and 10 mg

formulation/L treatment groups respectively.

Conclusion 72 h ErC50 = 0.99 mg formulation/L (95% CI 0.52-1.96 mg formulation/L).

Table 61: Tebuconazole; aquatic macrophyte: key study

Study type Vascular aquatic plant growth inhibition

Flag Key study.


Endpoint 14 d EC50

Value 0.1444 (frond count); 0.1798 (biomass)

Reference

Bowers L, 1997. Toxicity of Folicur Technical to Lemna gibba G3. Study

number MBayer Corporation, Kansas City, USA. Bayer Report Number:

107681

Klimisch Score 1


GLP Yes

Test Guideline/s US EPA Guideline 123.2

Dose Levels Nominal 31.3, 62.5, 125, 250 and 500 µg/L.


Study Summary

The initial measured concentrations were 30.7, 62.3, 127.9, 208.6 and 488.5

µg/L (76-110% of nominal). New test solutions were prepared on Day 0 and

Day 7. The average stability of the parent compound in the test system was

85%.

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December 2017

Over a 14 day period Lemna gibba G3 was exposed under static renewal

conditions to a control, solvent control and five different treatment levels.

Each treatment group was replicated three times and at the start of the

experiment, each replicate contained 12-14 fronds. Endpoints were biomass

development and frond count.

The following results were found:

Dose (µg/L) Frond count (mean values) Biomass (g, mean values)

Day 14 % of control Day 14 % of control

Pooled

controls

1180.2 - 0.1201 -

30.7 1031.7 87 0.1314 109

62.3 1107.0 94 0.1052 88

127.9 650.7 55 0.0817 68

208.6 353.7 30 0.0510 42

488.5 37.3 3 0.0309 26

Comments

Conclusion The 14 d EC50 was calculated to be 144.4 µg/L based on frond count and

179.8 µg/L based on biomass.

Sediment organisms toxicity

Table 62: Tebuconazole, sediment organisms toxicity: key study

Study type Long term toxicity to sediment organisms

Flag Key study

Test Substance Tebuconazole (technical) 97.0% purity.

Endpoint Emergence ratio and development rate.

Value NOEC (emergence) 2.33 mg ai/L.

Reference

Dorgerloh M, 2003b. Influence of tebuconazole (tech.) on development and

emergence of larvae of Chironomus riparius in a water-sediment system.

Bayer AG, Monheim, Germany. Bayer Crop report number: DOM 22066

Klimisch Score 1


GLP Yes

Test Guideline/s OECD Guideline 219

Dose Levels Spiked water, nominal 1.0, 1.8, 3.2, 5.6 and 10.0 mg ai/L. Initial measured

0.729, 1.31, 2.33, 4.08 and 7.29 mg ai/L.

Analytical measurements Yes. Tebuconazole concentration determined in overlying water and pore

water on days 0 (1 hour), 7 and 28.

Study Summary The control and each treatment level consisted of three replicate beakers

with 20 larvae each. The bottom of the test containers were covered with a

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December 2017

1.5 cm layer of sediment (2% organic carbon) and 6.0 cm overlying water.

The test material was applied to the water surface.

The concentration of the active ingredient gradually declined in water and

pore water over the course of the study. The results indicated that the

substance degraded continuously over the course of the study and/or

absorbed to the sediment.

The test vessels were observed at least three times per week to make a

visual assessment of any behavioural differences to the control. The sex,

time and number of emerged or not fully emerged adults were recorded daily.

No emergence occurred prior to day 14 of the study. There was no significant

difference between numbers of males and females emerged. The following

results are summarised:

Initial measured

concentration

(mg ai/L)

Number of

inserted

midges

Number of

emerged

midges

Emergence (%)

of inserted

larvae

Mean

development

rate (/day)

Control 60 57 95.0 0.061

0.729 60 53 88.3 0.057

1.31 60 52 86.7 0.058

2.33 60 55 91.7 0.054

4.08 60 0 0 -

7.29 60 0 0 -

Comments

The dose/response for emergence in this study was very steep with no

statistically significant effect on emergence at 2.33 mg ai/L and no

emergence at all at the next highest test concentration.

No statistical analysis was undertaken with respect to development rate

because there were no statistically significant effects at the highest

concentration considered for development (2.33 mg/L). At this concentration,

the combined development rate of males and females was 11.2% lower than

the control development rate.

Conclusion The NOEC (emergence) is 2.33 mg ai/L.

Table 63: Tebuconazole, sediment organisms toxicity: key study

Study type Long term toxicity to sediment organisms

Flag Key study

Test Substance Tebuconazole (technical) 96.4% purity.

Endpoint Emergence ratio and development rate.

Value NOEC (emergence) 40 mg/kg sediment.

Reference

Bruns E, 2010. Chironomus riparius 28 day chronic toxicity test with

tebuconazole (tech.) in a water-sediment system using spiked sediment.

Bayer CropScience AG, Monheim, Germany. Study report EBHWL007

Klimisch Score 1


GLP Yes

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December 2017

Test Guideline/s OECD Guideline 218

Dose Levels

Spiked sediment; initial nominal 5.0, 10.0, 20.0, 40.0 and 80.0 mg/kg dw.

Recoveries ranged from 92-97% (day -2), results are based on initial nominal

concentrations.

Analytical measurements Yes. Tebuconazole concentration determined in overlying water and pore

water and the sediment on days 0, 7 and 28.

Study Summary

There was a gradual decline in sediment concentrations over time. At day 0

(two days after spiking) recoveries of 84-95.2% of the nominal concentration

were recorded. By day 28, measured levels ranged from 68.3-76.8% of

nominal levels.

The control contained eight replicates (four x control, four x solvent control)

with 20 midges each and each treatment level consisted of four replicate

beakers with 20 midges each. The bottom of the test containers were

covered with a 1.5 cm layer of spiked sediment (1.9% organic carbon) and

6.0 cm overlying water. Midges were introduced to the test vessels on the

day after preparation of the test vessels.

The test vessels were observed at least three times per week to make a

visual assessment of any behavioural differences to the control. The sex,

time and number of emerged or not fully emerged adults were recorded daily.

No emergence occurred prior to day 14 of the study. There was no significant

difference between numbers of males and females emerged. The following

results are summarised:

Initial nominal

concentration

(mg/kg dw)

Number of

inserted

midges

Number of

emerged

midges

Emergence (%)

of inserted

larvae

Mean

development

rate (/day)

Control 160 151 94.4 0.062

5.0 80 74 92.5 0.063

10.0 80 75 93.8 0.064

20.0 80 76 95.0 0.062

40.0 80 74 92.5 0.059

80.0 80 0 0 -

Comments

The dose/response for emergence in this study was very steep with no

statistically significant effect on emergence at 40 mg/kg and no emergence at

all at the next highest test concentration.

Conclusion The NOEC (emergence) is 40 mg/kg sediment.

Terrestrial invertebrates - bees

Table 64: Terrestrial invertebrate toxicity, end use product: key study

Study type Adult acute oral toxicity to bees

Flag Key study

Test Substance Trifloxystrobin + Tebuconazole Water miscible suspension concentrate 100 +

200 g/L.

Endpoint LD50

Value >273.86 µg formulation/bee.

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December 2017

Reference

Waltersdorfer A, 2003 Oral toxicity (LD50) to bees (Apis mellifera L.)

Trifloxystrobin & Tebuconazole water miscible suspension concentrate

100+200 g/L. Bayer CropScience GmbH, Frankfurt am Main, Germany.

Study no. CW04/024.

Klimisch Score 1


GLP Yes.

Test Guideline/s OECD 213

Dose Levels 0, 13.12, 31.06, 78.37 and 273.86 µg formulation/bee (based on

consumption)

Analytical measurements None

Study Summary

Groups of 30 worker honey bees (three replicates per treatment, ten bees per

replicate) were offered four concentrations of the test item in a sucrose diet

for 5 h. Actual food consumption was measured after five hours and the

number of dead/damaged bees in each cage assessed at 5, 24 and 48

hours.

There was an apparent dose response in terms of food consumption. In the

13.12, 31.06, 78.37 and 273.86 µg formulation/bee groups, mean net food

consumption per bee was reduced compared to the control value by 25, 55,

72 and 75% respectively.

There was no mortality in the control or treatment groups up to 78.37 µg

formulation/bee. In the highest treatment, eight bees were dead (27%) at the

end of the study.

Comments

Conclusion Acute oral LD50 >273.86 µg formulation/bee.

Table 65: Terrestrial invertebrate toxicity, end use product: key study

Study type Adult acute contact toxicity to bees

Flag Key study

Test Substance Trifloxystrobin + Tebuconazole Water miscible suspension concentrate 100 +

200 g/L.

Endpoint LD50

Value >298.4 µg formulation/bee.

Reference

Waltersdorfer A, 2003b. Contact toxicity (LD50) to honey bees (Apis mellifera

L.) Trifloxystrobin + Tebuconazole Water miscible suspension concentrate

100 + 200 g/L. Bayer CropScience GmbH, Frankfurt am Main, Germany.

Study no. CW03/020.

Klimisch Score 1


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December 2017

GLP Yes.


Dose Levels 0, 125.9, 167.9, 223.8 and 298.4 µg formulation/bee

Analytical measurements None

Study Summary

Groups of 30 worker honey bees (three replicates per treatment, ten bees per

replicate) were exposed to a single dose of 1.0 µL test item concentration,

reference substance or drinking water (control) on the ventral thorax. After

four, 24 and 48 hours the number of dead bees per cage were assessed.

There was no mortality in the control or the lowest treatment group. After 48

h, there was 10%, 6.7% and 6.7% mortality in the 167.9, 223.8 and 298.4 µg

formulation/bee treatment groups.

Comments

Conclusion Acute contact LD50 >298.4 µg formulation/bee.

Terrestrial invertebrates, non-target arthropods

Table 66: Terrestrial invertebrate, end use product: key study

Study type Parasitoid – extended laboratory study dose/response test (Aphidius

rhopalosiphi)

Flag Key study.

Test Substance Trifloxystrobin and tebuconazole SC 100 + 200 g/L

Endpoint LR50; parasitisation (post exposure).

Value 1091 mL product/ha (95% CI 933-1276 mL product/ha). No significant effects

on reproduction at 1000 mL product/ha.

Reference

Moll and Bützler, 2004a. Effects of Trifloxystrobin & Tebuconazle SC 100 +

200 on the Parasitoid Aphidius rhopalosiphi, Extended Laboratory Study –

Dose Response Test. Bayer CropScience GmbH, Frankfurt am Main,

Germany. Study no. 18211002.

Klimisch Score 1


GLP Yes

Test Guideline/s Mead-Briggs et al, 2000; Mead-Briggs et al, 2002.

Dose Levels 0, 400, 632, 1000, 1581 and 2500 mL product/ha.

Analytical measurements None undertaken.

Study Summary

For the exposure phase of the test, there were six replicates per treatment

with five females per replicate. For the post-exposure phase, there was a

maximum of 20 replicates per group with one female per replicate. In addition

to the test formulation and control groups, a toxic reference (perfekthion at

10mL/ha) was tested. This is an extended laboratory test with application to

potted barley seedlings.

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December 2017

The settling rate of wasps on the sprayed plants was 38.7% in the control

group. Settling rate was higher in all treatment groups ranging from 42.0% to

53.3%. These differences were not considered statistically different. The

following mortality and reproduction outcomes were recorded:

Treatment

(mL

product/ha)

48 h corrected

mortality (%)

Mummies per

female

Reduction of

parasitisation

efficiency (%)

Control - 33.4

400 0.0 26.8 19.9

632 6.7 12.9* 61.2

1000 60.0* 23.5 29.7

1581 80.0* -

2500 83.3* -

* statistically significant, Fisher Exact Test, p = 0.05

Comments

Conclusion The 48 h LR50 was calculated to be 1091 mL product/ha.

Table 67: Terrestrial invertebrate, end use product: rejected study

Study type Parasitoid – extended laboratory test – single application rate, fresh and aged

residues (Aphidius rhopalosiphi)

Flag Rejected study

Test Substance Trifloxystrobin and tebuconazole SC 100 + 200 g/L

Endpoint Length of time of toxicity from residues.

Value

Reference

Moll and Bützler, 2004b. Effects of Trifloxystrobin & Tebuconazle SC 100 +

200 on the Parasitoid Aphidius rhopalosiphi, Extended Laboratory Study –

Aged Residue Test. Bayer CropScience AG - Development – Ecotoxicology.

Monheim, Germany. Study no. 19841003.

Klimisch Score 3

Amendments/Deviations There were some deviations to the test conditions in some of the bioassays

due to technical reasons.

GLP Yes

Test Guideline/s Mead-Briggs et al, 2000; Mead-Briggs et al, 2002.

Dose Levels 0, 1000 mL product/ha.

Analytical measurements Spray volume was verified with volumetric flow instrument.

Study Summary

Applications and aging of the test item were done in the field under natural

conditions and protected from rain. Two applications were made prior to

commencing the aging period. In each bioassay, wasps were exposed to the

treated barley plants after aging of a determined time, namely, ~30 minutes

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December 2017

(fresh residues), then after day 14, 21 and 35 following the second

application. The exposure period at each time was approximately 48 h.

For each exposure period there were six replicates per treatment group with

five to seven females per replicate. In the post exposure period (reproduction

assessment) there were 20 replicates per treatment group with 1 female per

replicate. The post exposure period consisted of a 24 h parasitisation period

and an 11-12 day post parasitisation period.

The following results are reported:

Bioassay 1 (0 d) 2 (14 d) 3 (21 d) 4 (35 d)

Corrected mortality (%) 100 0 0 8.6

Reduction of parasitisation

efficiency (%)

- -4.6 21.9 23.6

There was no effect on the numbers of wasps settling on the plants from any

bioassay. The reductions in parasitisation efficiency observed in the 3rd and

4th bioassays were not considered statistically significantly different to the

control.

Comments

One of the tests validity criteria is that control mortality should not exceed

17%. There were deviations in the test conditions (higher temperature and

humidity than recommended in the test guidelines) in some of the bioassays.

While control mortality in the 1st bioassay (10%) met the validity criterion for

mortality, control mortality in the 2nd bioassay (30%) and the third bioassay

(23.3%) failed this criterion. This is noted by the study authors as mainly

being due to wasps that could not be retrieved in the test system.

Control reproduction values met validity criteria. However, the control

mortality in the 2nd and 3rd bioassays is a concern.

Conclusion The study is not considered further due to high control mortality.


Study type Predatory mite – extended laboratory study dose/response test

(Typhlodromus pyri)

Flag Key study.

Test Substance Trifloxystrobin and tebuconazole SC 300

Endpoint LR50; reproduction

Value >2000 mL/ha

Reference

Waltersdorfer, 2004. Trifloxystrobin & Tebuconazole SC 300. Toxicity to the

predatory mite Typhlodromus pyri Scheuten (Acari, Phytoseiidae) using an

extended laboratory test. Bayer CropScience GmbH, Frankfurt am Main,

Germany. Study no. CW04/012.

Klimisch Score 1


GLP Yes

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December 2017

Test Guideline/s IOBC (Blümel et al, 2000)



Study Summary

For the exposure phase of the test, there were four replicates per treatment

with 20 females per replicate. In addition to the test formulation and control

groups, a toxic reference (dimethoate at 99.7 mL/ha) was tested. This is an

extended laboratory test with application to bean leaves.

Mortality of protonymphs was assessed three, seven, ten, 12 and 14 days

after exposure. The reproduction rate of surviving mites was then evaluated

over the period of 7-14 days after treatment by counting the offspring (eggs

and larvae) produced. Control mortality was 3.8% and considered acceptable.

Mortality as well as the reduction in reproduction was considered not to be

significantly impacted.

The following mortality and reproduction outcomes were recorded:

Treatment

(mL

product/ha)

7 d corrected

mortality (%)

Reproduction (%) Reduction in

reproduction (%)

Control 0.0 7.6 -

200 0.0 8.0 -5.2

356 6.2 7.3 4.7

632 -1.3 8.5 -11.5

1125 5.2 6.9 9.2

2000 3.9 7.0 8.4


Comments

Conclusion The 7 d LR50 was >2000 mL product/ha.


Study type Predatory bug – extended laboratory study dose/response test (Orius

laevigatus)

Flag Key study.



Value 321 mL/ha

Reference

Barth, 2003. Dose-response toxicity of Trifloxystrobin & Tebuconazole SC

300 to the predatory bug Orius laevigatus (Fieber) (Heteroptera:

Anthocoridae) under extended laboratory conditions. Bayer CropScience AG

- Development – Ecotoxicology. Monheim, Germany. Study no. 03 10 48 097.

Klimisch Score 1

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December 2017

Amendments/Deviations Application on natural substrate was used instead of glass plates.

GLP Yes

Test Guideline/s IOCB (Bakker et al, 2000), modified



Study Summary

For the exposure phase of the test, there were six replicates per treatment

with ten insects per replicate on grape vine. During the reproduction phase

there were 15 replicates, each with a single female. In addition to the test

formulation and control groups, a toxic reference (dimethoate at 20 mL/ha)

was tested. This is an extended laboratory test with application to grape vine

leaves.

The exposure phase consisted of nine days followed by a four day mating

phase. The reproduction phase consisted of four days with an additional five

days for hatching after 1st and 2nd egg counting for a total test duration of 22

days.

All validity criteria were met.

The following mortality and reproduction outcomes were recorded:

Treatment

(mL

product/ha)

9 d corrected

mortality (%)

Reproduction in

fecundity (%)

Reduction in

fertility (%)

Control 0.0 - -

20 -4.3 -45.1 -13.0

51 4.3 21.8 -18.5

128 29.8* 18.1 10.4

320 48.9* - -

800 74.5* - -


Comments

Conclusion

The LR50 was 321 mL product/ha (95% CI 234-442 mL product/ha). There

were no significant differences in reproductive parameters up to 128 mL

product/ha.


Study type Predatory bug – extended laboratory study dose/response test (Orius

laevigatus)

Flag Key study.


Endpoint Effects on survival and reproduction after exposure to aged residues.

Value

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December 2017

Reference

Barth, 2004. Toxicity of Trifloxystrobin & Tebuconazole SC 300 to the predatory

bug Orius laevigatus (Fieber) (Heteroptera: Anthocoridae) under extended

laboratory conditions using semi-field-aged residues on grape-vine. Bayer


no. 04 10 48 027.

Klimisch Score 1

Amendments/Deviations Under semi-field conditions applied and aged residues on natural substrate

(grape vine leaves) were used instead of glass plates.

GLP Yes

Test Guideline/s IOCB (Bakker et al, 2000), modified

Dose Levels 0, 1 L product/ha (X 2). Toxic reference, dimethoate.


Study Summary

Two single applications each with an application rate of 1.0 L product/ha and

an interval of 28 d were done. Endpoints were mortality of exposed nymphs

and the reproductive performance of adult bugs compared to control.

Test plants (potted grape-vine plants) were treated from both row sides. They

were treated twice at -28 days and at Day 0. Four bioassays were then initiated

exposing adult bugs to the treated leaves at 0, 14, 28 and 42 days after the

second application. From the treated leaves at each ageing period, leaf discs

were cut and transferred to exposure test cages.

The exposure periods for these different bioassays were 11, nine, nine, and

nine days for the 0, 14, 28 and 42 day aged residues test units respectively.


The following mortality results were found:

Ageing period

(days)

Control

mortality (%)

1 L/ha, corrected

mortality (%)

Toxic reference corrected

mortality (%)

0 18.3 87.8 91.8

14 18.3 67.3 100.0

28 3.3 55.2 98.3

42 10 33.3 100

No reproduction phase was conducted in bioassays 1 and 2. In bioassays three

and four the relative effect on reproductive performance was 13.5%

(decreased) and -18.2% (increased) in the test item treatment group,

respectively.

Comments Control mortality was below the validity criteria of ≤25%.

Conclusion

Mortality exceeding 50% at 2 applications of 1 L product/ha with a 28-day spray

interval continued for 28 days after the second application. With exposure to

residues aged for 42 days there was <50% adult mortality and no detrimental

effects on reproduction per female.

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December 2017


Study type Ladybird – extended laboratory study dose/response test (Coccinella

septempunctata)

Flag Key study.



Value 3093 mL/ha

Reference

Röhlig, 2004. Dose-response toxicity (LR50) of Trifloxystrobin & Tebuconazole

SC 300 to larvae of the ladybird Coccinella septempunctata L. under

extended laboratory conditions. Bayer CropScience AG - Development –

Ecotoxicology. Monheim, Germany. Study no. EBTFX036.

Klimisch Score 1


GLP Yes

Test Guideline/s IOCB (Schmuck et al, 2000), modified (application to bean leaves instead of

glass plates)



Study Summary

For the exposure phase of the test, there were 40 replicates per treatment

with one larvae per replicate. In addition to the test formulation and control

groups, a toxic reference (dimethoate at 30 mL/ha) was tested. This is an

extended laboratory test with application to bean leaves.

The number of dead larvae and pupae and hatched beetles, as well as the

number of eggs laid and larvae hatched (F1) were recorded over a 53 day

period. The following mortality and reproduction outcomes were recorded:

Treatment

(mL

product/ha)

20 d corrected

mortality (%)

Reproduction in

fecundity (%)

Reduction in

fertility (%)

Control 0.0 - -

250 10.8 21.1 2.2

500 16.2 21.1 0 (+3.1)

1000 21.6 0 (+2.6) 0 (+3.2)

2000 37.8* 5.3 0 (+4.1)

4000 59.5* - -


Comments Test validity criteria were met.

Conclusion

The LR50 was 3093 mL product/ha (95% CI 1829-5231 mL product/ha). There

were no significant differences in reproductive parameters up to 2000 mL

product/ha.

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December 2017

Soil organism toxicity

Table 72: Earthworm toxicity, end use product: key study

Study type Acute earthworm toxicity

Flag Key study

Test Substance Trifloxystrobin and Tebuconazole SC 300

Endpoint LC50

Value >1000 mg product/kg soil dw.

Reference

Lechelt-Kunze, 2004a. Trifloxystrobin (CGA279202) & Tebuconazole (HWG

1608) SC 300: Acute Toxicity to Earthworms (Eisenia fetida) tested in

Artificial Soil with 5% Peat. Bayer CropScience AG - Development –

Ecotoxicology. Monheim, Germany. Study no. LKC/Rg-A-22/04.

Klimisch Score 1

Amendments/Deviations 5% peat was used instead of 10% due to test item properties (LogKow >2).

GLP Yes

Test Guideline/s OECD 207.

Dose Levels 0, 100, 178, 316, 562 and 1000 mg product/kg soil dw.

Analytical measurements None.

Study Summary

For each test substance concentration and the control group, four replicates

of ten worms were tested. The animals were not fed during the study.

Worms at the start of the test were more than two months old. Exposure

conditions and artificial soil were standard as per the test guideline with 5%

peat. A toxic reference (chloroacetamide up to 32 mg/kg soil dw) was also

tested.

Individually weighed worms were added to the test vessels directly after

application.

Mortality was assessed at seven and 14 days. After 14 days, the weight,

abnormal behaviour and observed symptoms were determined.

Complete mortality in the toxic control at the highest treatment rate was

observed. There was no mortality in the control or any test item treatment

group up to 562 mg product/kg soil. At the top treatment rate, 3% mortality

was observed (one individual). There were statistically significant weight

alterations in the top two treatment groups. No morphological or behavioural

effects were observed. The NOEC for weight was 316 mg product/kg dw soil.

Comments

Conclusion The 14 d LC50 was >1000 mg product/kg soil dw.

Table 73: Earthworm toxicity, end use product: key study

Study type Chronic earthworm toxicity

Flag Key study

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December 2017


Endpoint Survival, growth and reproduction.

Value NOEC (survival; growth) = 17800 mL product/ha;

NOEC (reproduction) = 1710 mL product/ha.

Reference

Lechelt-Kunze, 2004b. Trifloxystrobin & Tebuconazole SC 300: Effects on

survival and reproduction on the earthworm Eisenia fetida tested in artificial

soil with 5% peat. Bayer CropScience AG - Development – Ecotoxicology.

Monheim, Germany. Study no. LKC-Rg-R-6/04.

Klimisch Score 1

Amendments/Deviations 5% peat was used instead of 10% due to test item properties (LogKow >2).

GLP Yes

Test Guideline/s ISO 11268-2; BBA Guideline Part VI, 2-2.

Dose Levels 0, 1800, 3200, 5600, 10000 and 17800 mL product/ha (1st run); and

0, 200, 340, 580, 1000 and 1710 mL product/ha (2nd run).


Study Summary

For each run, four replicates each with ten adult earthworms were exposed.

Worms in the first run were 11 months old and those in the second run were

eight months old. Spray solutions were applied onto the surface of the soil in

a laboratory spraying cabinet. After 28 days, the number of surviving adults

and their weight alteration was determined. The adult worms were removed

from the artificial soil. After a further 28 days the number of offspring was

determined.

Two runs were performed since a NOEC for reproduction could not be

determined in the first run. The second run was performed with lower

concentrations. Both tests were valid and used to determine the appropriate

NOEC values.

In the first run, there was no adult mortality up to the highest tested

concentration. The mean number of offspring in the control group was 16.4

per adult after 56 days. The numbers in the exposure group were all

statistically reduced compared to the control group with reductions of 21% at

the lowest treatment rate to 68% at the highest. A NOEC for reproduction

could not be determined.

In the second run of the study, there was no adult mortality recorded except

for 2.5% in the 1710 mL product/ha group. After 56 days, offspring in the

control group averaged 13.2 juveniles/adult. This rate or higher was recorded

in all treatment groups and there was no statistically significant effect on

reproduction at any test rate.

Comments Test validity criteria were met.

Conclusion

The study NOEC for growth was 17800 mL product/ha (the highest test rate).

The NOEC for reproduction was 1710 mL product/ha, the highest test rate in

the second run.

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December 2017

Soil microorganism toxicity

Table 74: Soil microorganism toxicity, end use product: key study

Study type Nitrogen transformation

Flag Key study


Endpoint Nitrogen transformation deviation from control.

Value <25% at highest rate of 14.8 mg product/kg soil dw (corresponding to 10 L

product/ha).

Reference

Lechelt-Kunze, 2004c. Trifloxystrobin & Tebuconazole SC 300:

Determination of effects on nitrogen transformation in soil. Bayer


no. E 337 2574-1.

Klimisch Score 1


GLP Yes


Dose Levels 1.33 µL product/kg soil and 13.3 µL product/kg soil.


Study Summary

A silty sand soil was exposed for 28 days to 1.33 and 13.33 µL product/kg

soil dw. These concentrations were chosen to represent 1 L product/ha and

10 L product/ha assuming soil density of 1500 kg/m3 mixed into the top 5 cm

soil. Based on the density of the product, they equate to ~1.48 and 14.8 mg

product/kg soil dw. Application rates were selected to 1x and 10x the

maximum recommended field rate (no crop interception). Lucerne grass

green meal was added to the soil at 5 g/kg dw to stimulate nitrogen

transformation.


In both treatment groups there was an initial stimulation of nitrate levels (0-7

day period). There was <25% difference in nitrogen, measured as

Ammonium-N and Nitrate-N, in either treatment level compared to the control

after 28 days of exposure.

Comments

The highest coefficient of variation between nitrate-N concentrations in

replicate control samples was 16% at seven days after treatment. This

slightly exceeds the recommended limit of ±15%. The slight exceedance only

occurred on day 7 and is not considered to have impact the validity of the

study.

Conclusion The formulated product should not have an impact on nitrogen transformation

in soils up to a soil concentration of 14.8 mg product/kg soil dw.

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December 2017

Table 75: Soil microorganism toxicity, end use product: key study

Study type Carbon transformation

Flag Key study


Endpoint Carbon transformation deviation from control.

Value <25% at highest rate of 14.8 mg product/kg soil dw.

Reference

Lechelt-Kunze, 2004d. Trifloxystrobin & Tebuconazole SC 300:

Determination of effects on carbon transformation in soil. Bayer CropScience

AG - Development – Ecotoxicology. Monheim, Germany. Study no. E 330

2573-3.

Klimisch Score 1


GLP Yes


Dose Levels 1.33 µL product/kg soil and 13.3 µL product/kg soil.


Study Summary

A silty sand soil was exposed for 29 days to 1.33 and 13.33 µL product/kg

soil dw. Application rates were selected to 1x and 10x the maximum

recommended field rate (no crop interception). These concentrations were

chosen to represent 1 L product/ha and 10 L product/ha assuming soil

density of 1500 kg/m3 mixed into the top 5 cm soil. Based on the density of

the product, they equate to ~1.48 and 14.8 mg product/kg soil dw. Glucose

was added to the soil at 2 g/kg dw to induce maximum respiration rate.

Validity criteria were met.

There was no statistically significant difference in respiration rates between

the treated and untreated soil samples following application or at day 7. In

the highest treatment group, respiration at 14 days after treatment was

statistically lower than the control values (11% reduction), and at 29 days,

was still statistically reduced (8%). However, these reductions were well

below the allowable 25% variation to control values.

Comments

Conclusion The formulated product should not have an impact on carbon transformation

in soils up to a soil concentration of 14.8 mg product/kg soil dw.

Non-target terrestrial plant toxicity

Table 76: Terrestrial plant toxicity, end use product: key study

Study type Tier 1 Vegetative vigour

Flag Key study

Test Substance Trifloxystrobin and Tebuconazole SC100 + 200

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December 2017

Endpoint ER50

Value >1 L product/ha.

Reference

Nguyen and Gosch, 2004a. Non-target terrestrial plants: an evaluation of the

effects of Trifloxystrobin & Tebuconazole SC100 200 in the vegetative vigour

test (Tier 1). Bayer CropScience GmbH, Frankfurt am Main, Germany. Study

No. EBTFX068

Klimisch Score 2


GLP No

Test Guideline/s OECD 208 B (draft, 2000)

Dose Levels 0, 1 L product/ha


Study Summary

In this limit, non GLP study, six species of terrestrial non-target plants (two

monocots and four dicots) were treated with the test item at 1 L/ha. Plants

were treated at the 2-4 leaf stage with foliar spray application.

Spray treatments were applied once. Control pots were sprayed with

deionised water. Four replicates with five seeds per pot per species were

tested. Plants were assessed for mortality and phytotoxicity on days 7, 14

and 21. At study termination, biomass end-point determinations were

performed for plant dry weights.

All validity criteria were met. The following results were recorded:

Percent (%) Inhibition compared to controls

Mortality Phytotoxicity Dry weight

Oilseed rape 0 0 -12

Sunflower 0 0 -19

Soybean 0 0 -3

Cucumber 0 0 -2

Corn 0 0 4

Oats 0 0 -11

Sunflower was the most sensitive species based on the quantitative

determination of biomass with a 19% reduction in growth compared to the

control plants. Growth inhibition exceeding 10% was also observed in oilseed

rape and oats. None of these values were statistically significant compared to

control values.

Comments KS score of 2 due to non-GLP. The study was well reported and considered

acceptable for risk assessment purposes.

Conclusion Vegetative vigour ER50 >1 L product/ha

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December 2017

Table 77: Terrestrial plant toxicity, end use product: key study

Study type Tier 1 Seedling Emergence

Flag Key study

Test Substance Trifloxystrobin and Tebuconazole SC100 + 200

Endpoint ER50

Value >1 L product/ha.

Reference

Nguyen and Gosch, 2004b. Non-target terrestrial plants: an evaluation of the

effects of Trifloxystrobin & Tebuconazole SC100 200 in the seedling

emergence and growth test (Tier 1). Bayer CropScience GmbH, Frankfurt am

Main, Germany. Study No. EBTFX067

Klimisch Score 2


GLP No

Test Guideline/s OECD 208 A (draft, 2000)

Dose Levels 0, 1 L product/ha


Study Summary

In this limit, non GLP study, six species of terrestrial non-target plants (two

monocots and four dicots) were treated with the test item at 1 L/ha. All seeds

were planted one day before application and the test duration was 21 days

after 50% emergence in the controls for each species.

Spray treatments were applied once. Control pots were sprayed with

deionised water. Four replicates with 5 seeds per pot per species were

tested. Plants were assessed for emergence, survival and rated for

phytotoxicity on days seven, 14 and 21 after 50% of the control seeds had

emerged. At study termination, biomass endpoint determinations were

performed for plant dry weights.

All validity criteria were met. The following results were recorded:

Percent (%) Inhibition compared to controls

Germination Mortality Phytotoxicity Dry weight

Oilseed rape -7 -13 0 -17

Sunflower +11 0 0 -19

Soybean -27 +15 0 +24

Cucumber 0 +6 0 -32

Corn 0 0 0 +1

Oats 0 0 0 +19

No phytotoxic effects were observed. Cucumber was the most sensitive

species based on the quantitative determination of biomass with a 32%

reduction in growth compared to the control plants. Growth inhibition between

15 and 20% was also observed in oilseed rape and sunflower. None of these

values were statistically significant compared to control values.

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December 2017

Comments KS score of two due to non-GLP. The study was well reported and

considered acceptable for risk assessment purposes.

Conclusion Seedling emergence ER50 >1 L product/ha.

Environmental fate studies

Aerobic soil metabolism

Table 78: Tebuconazole: Aerobic soil metabolism

Study type Aerobic soil metabolism

Flag Key study

Test Substance Tebuconazole

Endpoint Soil DT50

Value >365 days

Reference Lee S and Hanna-Bey L, 1987. The Metabolism of ®Folicur in Soil. Study

Bayer AG, Leverkusen, Germany. Report No; MR 94369

Klimisch Score 2

Amendments/Deviations None.

GLP No (not required at the time of the study)

Test Guideline/s US EPA 162-1

Dose Levels

14C-Tebuconazole was applied at a rate of 10 mg/kg soil (corresponding

nominally to 13 kg/ha).

Analytical measurements Soil extracts were radioassayed by liquid scintillation counting (LSC) and

residues characterised by TLC and HPLC.

Study Summary

The study was performed in sandy loam soil. The application rate was 10

mg/kg soil. Experiments were performed in the dark at 23°C. Carbon dioxide

was trapped using KOH-traps.

Duplicate flasks containing soil treated with the chlorophenyl label were

sampled at 0, 7, 14, 28, 56, 84 and 112 days, and at six and 12 months

following treatment. An additional study was carried out using triazole

labelled Folicur with fewer time intervals.

After 12 months, 67.4% of the initially applied chlorophenyl-labelled

tebuconazole remained (85% after 58 days in the triazole labelled test). Non-

extractable residues climbed to 29.1% applied after 12 months.

Comments

This is an older study and pre-dates the OECD test guideline. However, it

largely conforms to the OECD guideline and is an acceptable test. Recovery

at day 0 was 88.5%, which is slightly below the minimum 90% recovery

identified in the OECD guideline for radiolabelled chemicals. However, at all

other time points, recovery was between 90 and 110%, conforming with the

OECD guideline.

The current OECD guideline states that rate and pathway studies should

normally not exceed 120 days because after that period a decrease of soil

97


December 2017

microbial activity would be expected. The study was undertaken for a period

of 1 year. Degradation was slow over the whole period and after 112 days,

tebuconazole had only reduced from 98.3% to 82.0%.

Conclusion The aerobic soil DT50 from this study is >365 days.

Table 79: Tebuconazole: Aerobic soil metabolism


Flag Key study


Endpoint Soil DT50

Value 78, 147 and 46 days.

Reference

Heinemann O, 2016. Amendment No. 1 to Formation Fraction of 1,2,4-

Triazole from Tebuconazole in Three European Soils. Bayer CropScience

AG, Monheim, Germany. MEF-09/890

Klimisch Score 1


GLP Yes

Test Guideline/s OECD Test Guideline 307.

Dose Levels 0.50 mg/kg soil dw (~375 g ai/ha).

Analytical measurements Combined extracts were analysed separately for tebuconazole and 1,2,4-

triazole by HPLC/MS/MS.

Study Summary

Test systems consisted of open flasks each containing 100 g soil dw. Three

soils were tested (sandy loam, silty clay and loam from Germany, France and

Spain respectively). The incubation period was 120 days in the dark at

20±2oC and 55±5% MWHC.

Samples were analysed at 0, 7, 15, 21, 30, 45, 60, 91 and 120 days. Over

this period tebuconazole decreased in all soils and at study termination

accounted for 34.9, 57.7 and 16.6% applied in the German, French and

Spanish soils respectively. 1,2,4-triazole increased throughout the incubation

period and accounted for 14.2, 11.5 and 32.1% applied in the German,

French and Spanish soils respectively.

The experimental data for tebuconazole were best described by SFO kinetic

models and the following results were calculated:

Soil DT50 (d) DT90 Kinetic model,

Chi2 error

Sandy loam 78 258 SFO, 1.5%

Silty clay 147 488 SFO, 1.6%

Loam 46 152 SFO, 5.4%

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December 2017

Comments The measured 1,2,4-triazole levels did not represent a peak or plateau

concentration as they were still rising after 120 days.

Conclusion The aerobic soil DT50s from this study were 78, 147 and 46 days.

Table 80: Trifloxystrobin soil metabolite CGA321113: Aerobic soil metabolism


Flag Key study

Test Substance Trifloxystrobin - CGA321113

Endpoint Soil DT50

Value 71.6, 55.5, 77.4 and 70.1 days

Reference

Laboratory study: Ströch and Weuthen, 2013. Formation Fraction of

NOA413161 from Trifloxystrobin in Four European Soils. Bayer CropScience

AG, Monheim, Germany. Study ID M1252056-1

Kinetics analysis: Reinken G, Bolekhan A and Kaune M, 2013. Kinetic

Evaluation of the Degradation of Trifloxystrobin and its Metabolites under

Aerobic Soil Conditions in Laboratory According to FOCUS Kinetics using the

KinGUI 2 Tool. Bayer CropScience Ag, Monheim, Germany. Study Number

M-467669-01-1

Klimisch Score 1


GLP Yes


Dose Levels 0.48 mg trifloxystrobin/kg soil dw (based on application rate of 187.5 g/ha)

Analytical measurements Soil extracts were characterised for parent and metabolites by reversed

phase HPLC-MS/MS.

Study Summary

Degradation behaviour of trifloxystrobin and its metabolites CGA 321113,

NOA413161 and CGA357276 was tested in four soils (pH5.1-7.1; OC 1.5-

4.8%) under aerobic conditions in the dark at 20.10C and 53.4% MWHC. The

test was performed in static systems each containing 100 g soil dw. Duplicate

samples were processed and analysed at 0, 0.08, 0.25, 1, 3, 7, 14, 30, 58, 93

and 120 days after treatment.

Trifloxystrobin degraded rapidly with DT50s <0.5 days for all soils.

Only metabolite, CGA321113, was found at levels >10% of applied

concentration (trifloxystrobin equivalents). This metabolite was measured at

peak levels of 96.9% (3 DAT, sandy loam), 91.6% (3 DAT, silt loam), 91.5%

(3 DAT, clay loam) and 92.0% (3 DAT, sandy loam).

The DT50 values for other metabolites were calculated but considered not

relevant (small fractions formed during test) and are therefore not

summarized below.

The following results were obtained for CGA-321113:

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December 2017

Model DT50 (d) Chi2

Sandy loam SFO 71.6 3.6

Silt loam SFO 55.5 1.9

Clay loam SFO 77.4 2.9

Sandy loam SFO 70.1 4.6

Comments

Conclusion The aerobic soil DT50s from this study for CGA321113 were 71.6, 55.5, 77.4

and 70.1 days.

Soil adsorption

Table 81: Tebuconazole: Soil adsorption study

Study type Soil adsorption

Flag Key study


Endpoint Lowest non-sand Kd/Koc

Value Kd = 16.39 L/kg; Koc = 910.4

Reference

Fritz R, 1988. Adsorption/Desorption of ®FOLICUR (HWG 1608) on Soil.

Study number M-005616-03-2. Bayer AG, Leverkusen, Germany. Report No

100101

Klimisch Score 1


GLP Yes


Dose Levels Approximately 0.05, 0.25, 0.38 and 0.5 times water solubility.

Analytical measurements Liquid samples were measured by LSC and tebuconazole determined by

Thin Layer Chromatography (TLC).

Study Summary

Concentrations corresponding to 0.5, 0.375, 0.25 and 0.05x the maximum

water solubility were added to 2 g air dried sieved soil (2mm) and stirred for

48 hours.

Freundlich adsorption isotherms were developed for four soils at four

concentrations. The following results were found:

Soil type %OC Kd Koc r2 1/n

Sandy loam 1.40 12.69 906.3 0.998 0.739

Silt 1.80 16.39 910.4 0.998 0.721

Low-humus sand 0.75 7.67 1022.8 0.995 0.711

Sandy loam 1.27 15.86 1249.2 0.999 0.738

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December 2017

Comments

The Freundlich exponent in all soils was well below one indicating

concentration dependence with sorption increasing as concentrations

decrease.

Conclusion Lowest non-sand Kd = 16.39 L/kg.

Table 82: 1,2,4-triazole: Soil adsorption study

Study type Soil adsorption

Flag Key study

Test Substance 1,2,4-triazole

Endpoint Lowest non-sand Koc

Value 43 L/kg

Reference Hawkin D, 1988. Soil Adsorption and Desorption of 1,2,4-triazole. Rohm and

Haas, Pennsylvania, USA. Report No 35S-88-27

Klimisch Score 1

Amendments/Deviations

GLP Yes


Dose Levels Approximately 0.05, 0.25, 0.38 and 0.5 times water solubility.

Analytical measurements Liquid samples were measured by LSC and tebuconazole determined by TLC.

Study Summary

Solutions were added to 2 g soil (except sandy soil which received 4 g soil).

Freundlich adsorption isotherms were developed for five soils at four

concentrations with a 95 h equilibration period. The following results were

found:

Soil type %OC Kd (ads) Koc r2 1/n Kd (des)

Silty clay 0.70 0.833 120 0.996 0.897 2.130

Clay loam 1.74 0.748 43 0.997 0.827 1.143

Sand 0.12 0.234 202 0.997 0.885 0.610

Silty clay

loam

0.70 0.722 104 0.998 0.922 0.816

Sandy loam 0.81 0.719 89 0.997 1.016 1.065

Comments

Conclusion Lowest non-sand Koc = 43 L/kg.

Table 83: Trifloxystrobin soil metabolite CGA321113: Soil adsorption study

Study type Soil mobility: Adsorption

Flag Key study

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December 2017

Test Substance Trifloxystrobin - CGA321113

Endpoint Soil sorption Kd/Koc

Value Lowest non-sand Koc = 84 L/kg

Reference

Schäffer A, 1996. Adsorption/Desorption uf (u)-14C-Phenyl-Glyoxylate-labeled

CGA 321113 in various soil types. Ciba-Geigy Ltd, Basel, Switzerland.

Report Number 94AS03

Klimisch Score 1


GLP Yes


Dose Levels 0.1-3 mg/L

Analytical measurements Soil extracts were characterised by HPLC.

Study Summary

Freundlich adsorption isotherms were developed for four soils at four

concentrations. The following results were found:

Soil type %OC Kf Kfoc r2 1/n

Loamy sand 0.80 0.83 104 0.999 1.01

Sand 0.30 0.58 194 0.997 1.11

Loam 2.00 2.33 116 0.999 0.99

Silt loam 4.70 3.96 84 0.999 0.95

Humic soil 19.80 18.61 94 1.00 0.97

Comments The Freundlich exponent in all soils was approximately 1 indicating the Kf is a

suitable surrogate for Kd.

Conclusion Lowest non-sand Koc = 84 L/kg.

Field dissipation

Table 84: Tebuconazole: Field dissipation study

Study type Field dissipation study

Flag Key Study


Endpoint Field DT50

Value 25.8 days and 48.4 days (two soils).

Reference

Field study: Sommer H, 1997. Dissipation of Tebuconazole in Soils under

Field Conditions. Bayer AG, Leverkusen, Germany. Report RA-2086/95

Kinetics Analysis: Chapple A, 2009. Kinetic Evaluation of the Dissipation from

Soil of Tebuconazole under European Field Conditions, with Revised Q10

Value. Bayer CropScience AG, Monheim.

Klimisch Score 1

102


December 2017


GLP Yes

Test Guideline/s BBA Guideline IV-4.1 (1986).

Dose Levels 1 X application of 300 g/ha.

Analytical measurements Residues were extracted with quantitation performed by gas chromatography

(LOQ = 10 µg/kg).

Study Summary

The field dissipation study was performed on two bare soil fields in Southern

Europe (Italy loamy sand and France loamy silt). Soil samples were taken to

a depth of 30 cm and segmented into 10 cm layers prior to analysis. After 12

months, <5% of the applied amount was recovered from the soil.

Tebuconazole remained in the 0-10 cm layer throughout the study.

This study has been summarised in the EU DAR and used for EFSA

registration. The EPA staff agree with the information provided in that

summary.

The study authors calculated DT50 values of 19 days and 11 days in the

Italian and French soils respectively. However, the method used (square root,

first order) is no longer applied in kinetics analysis. In the re-calculation,

Chappelle (2009) determined non-normalised half-lifes for the Italian and

French soils applying the “First order multi compartment” (FOMC) model to

be 36.4 and 7.7 days respectively.

Comments

The DT50 values were evaluated using an outdated method. Kinetics were re-

evaluated to EU FOCUS methods to determined normalised field values

(20°C, field capacity). The best fit models were single first order (SFO) for the

Italian soil and first order multi compartment (FOMC) in the French soil.

Conclusion Normalised Field DT50 values are 25.8 days (French soil) and 48.4 days

(Italian soil).

Table 85: Tebuconazole: Field dissipation study


Flag Key study

Test Substance Tebuconazole in Folicur 250 EW

Endpoint Field DT50

Value 57.5; 28.9; 29.5; 65.3.

Reference

Field study: Schramel O, 2001. Dissipation of Tebuconazole (Folicur 250

EW) in Soil under Field Conditions (France, Germany, Great Britain). Study.

Bayer AG, Leverkusen, Germany. Report No. RA-2095/00

Kinetics Analysis: Chapple A, 2009. Kinetic Evaluation of the Dissipation from

Soil of Tebuconazole under European Field Conditions, with Revised Q10

Value. Bayer CropScience AG, Monheim. BCS Report No: MEF_08/454

Klimisch Score 1


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December 2017

GLP Yes

Test Guideline/s

ECPA Guidance Document on Field Soil Dissipation Studies

(D/97/NM/2047); SETAC-Europe: Procedures for Assessing the

Environmental Fate and Ecotoxicity of Pesticides, March 1995.

Dose Levels 1 x 400 g ai/ha

Analytical measurements Resides were extracted from soil with supernatants following centrifugation

directly measured by HPLC-MS-MS. The LOQ was 5 µg/kg.

Study Summary

Four trials were conducted with a single spray to bare soil at a rate of 400 g

ai/ha. Soil samples were taken to a depth of 30 cm and segmented into 10

cm layers. Samples were taken at intervals up to approximately one year at

two of the sites and 470 days at a further two sites.



summary.

DT50 values were calculated by the study authors using 1st order kinetics and

non-normalised residue levels to be 77, 57, 36 and 58 days for the UK,

France and two locations in Germany respectively.

Comments

The DT50 values were evaluated using an outdated method. Kinetics were re-

evaluated to EU FOCUS methods. The best fit models were first order multi

compartment (FOMC) in the UK soil and two German soils, and single first

order (SFO) in the French soil.

Conclusion Normalised Field DT50 values are 57.7 days (UK); 28.9 days (France); 29.5

days (Germany) and 65.3 days (Germany).

Table 86: Tebuconazole metabolite 1,2,4-triazole: Field dissipation study


Flag Key study

Test Substance 1,2,4-triazole

Endpoint Field DT50

Value 70.7, 59.8, 25.1, 126 (slow phase)

Reference

Field study: Tahara G, 2010. Determination of the Residue of 1,2,4-triazole

in/on soil after spraying of 1,2,4-triazole (1000 XX) in the field in Germany, Italy,

Great Britain and Spain. Study Number M-364861-01-1. Bayer CropScience

AG, Monheim, Germany. Report Np: RA-2145/04

Kinetics Analysis: Chapple A, 2010. Kinetic Evaluation of the Dissipation in Soil

of 1,2,4-triazole Field Conditions. Bayer CropScience AG, Monheim. MEF-

10/069

Klimisch Score 1

Amendments/Deviations

GLP Yes

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December 2017

Test Guideline/s

ECPA Guidance Document on Field Soil Dissipation Studies; SETAC-Europe:

Procedures for Assessing the Environmental Fate and Ecotoxicity of Pesticides;

BBA Guideline Par IV, 4-1.

Dose Levels 1 x 100 g/ha (0.0667 mg/kg soil, 10 cm soil incorporation).

Analytical measurements Resides were measured by HPLC-MS/MS. The LOQ was 3 µg/kg.

Study Summary

Four trials were conducted with a single spray to bare soil with incorporation

after which the plots were sown with grass. The grass was kept short and

mulched afterwards with the exception of the site in Spain were no grass

emerged during the course of the study. Soil samples were taken from 0-454

days post application to a maximum depth of 50 cm.

Generally, the potential for residues movement downwards was low with 1,2,4-

triazole primarily being detected in the top 20 cm soil layer.

The degradation kinetics were assessed following temperature normalisation for

standard FOCUS reference conditions. The following results were obtained:

Field Normalised DT50 (20°C,

field capacity)

Location Model

DT50

(d),

DT50

(d),

fast

phase

DT50

(d),

slow

phase

Chi2

Germany (silt

loam)

FOMC/DFOP 7.8 2.5 70.7 18.8

Italy (silt clay loam) DFOP 21.2 1.4 59.8 10.6

United Kingdom

(sandy loam)

DFOP 6.8 0.5 25.1 18.1

Spain (loam) DFOP 28.1 4.6 126 12.7

Comments

Conclusion Field DT50 values (slow phase from 2-phase exponential decline (DFOP))

modelling were 70.7, 59.8, 25.1 and 126 days.

Water/sediment studies

Table 87: Tebuconazole: Water/sediment metabolism

Study type Outdoor microcosm

Flag Key study

Test Substance Tebuconazole EW 250 (measured 256 g ai/L formulation).

Endpoint Degradation/ DT50in outdoor microcosm

Value DT50 whole system = 38.7 days.

Reference

Heimbach F, 2003. Fate of tebuconazole EW 250 in outdoor microcosms.

Bayer CropScience AG, Monheim, Germany. Study number M-089965-02-1

Report No HBF/MT15

Klimisch Score 2

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GLP Yes

Test Guideline/s No specific test guideline. OECD Guidance Document “Freshwater Lentic

Field Tests (Outdoor Microcosms and Mesocosms).

Dose Levels 3.1 and 32 µg ai/L

Analytical measurements Yes. HPLC-MS/MS

Study Summary

Three test microcosms 1 m water depth, 2 m diameter were established. The

bottoms were covered with natural sediment. They were set up half a year

prior to application of the test substance. During the half year of

establishment, the microcosms were interconnected to ensure similar

development conditions. Prior to application the microcosms were isolated.

The test substance was applied once onto the water surface of two

microcosms (3.2 and 32 µg/L) with a third maintained as a control. The

microcosms were investigated for a period of 196 days. Several times water

and sediment samples were taken and analysed.

Initial concentrations were measured at 87.8-116.6% of nominal indicating

the expected dose was achieved. There was a consistent dissipation

behaviour for both treatments. Until day 56 the concentration of tebuconazole

increased continuously in the sediment of both treatments. Thereafter the

analysed amount in sediment fluctuated due to heterogeneous sampling

caused by the increasing abundance of macrophytes. Less than 10% of the

applied test substance was found in the sediment throughout the study. In the

3.2 µg/L microcosm, the maximum sediment concentration found was 13.3

µg/kg sediment dw. In the 32 µg/L microcosm, the maximum sediment

concentration found was 113 µg/kg sediment dw.

Disappearance of tebuconazole can be described as first order kinetics.

Comments This is a non-guideline study.

Conclusion DT50 (water) 29.5 – 32.2 days; average = 30.9 days;

DT50 (whole system) 37.2 – 40.2 days; average = 38.7 days.


Study type Water/sediment aerobic metabolism

Flag Key study


Endpoint Identification of relevant metabolites

Value HWG Pentanoic Acid up to 40.2% applied.

Reference

Fritz R and Brauner A, 1990a. Experiments on the environmentally relevant

degradation of tebuconazole in water. Study number M-005626-01-2. Bayer

AG, Leverkusen, Germany Report no PF-3594

Klimisch Score 2

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December 2017


GLP Yes

Test Guideline/s None

Dose Levels 0.376 mg/L, 1.86 mg/L and 7.36 mg/L.


Study Summary



summary.

The test was performed with natural water from two aquatic test systems

(euthropic and oligotrophic). Tebuconazole was labelled in either the phenyl

ring or the triazole ring. The test temperature was 20oC with incubation

periods of 58 days (natural sunlight), 243 days (natural sunlight) or 132 days

(Xenon lamp).

The water from both systems was removed and lyophilised. The residues

were dissolved three times each in methanol and water. Radioactivity was

determined by LSC and metabolite identification by TLC.

Following 58 days incubation, only one metabolite (HWG 1608-pentanoic

acid) was found at levels >10% of applied amount, being in methanol extract

at 28.8% of applied amount and in water at 11.4% of applied amount (total

40.2% of applied amount). After 243 days, no metabolite was found at levels

>10% of applied amount, except for 22.7% of unidentified compounds. Parent

tebuconazole was still found in the methanol extract at 29.7% of applied

amount.


Conclusion Major aquatic metabolite HWG 1608-Pentanoic acid up to 40.2% of applied

amount.


Study type Water/sediment aerobic metabolism

Flag Key study


Endpoint Identification of relevant metabolites

Value

HWG 1608-Pentanoic Acid up to 37.8% applied;

HWG 1608-lactone up to 21% applied;

1,2,4-triazole up to 14.0% applied.

Reference

Fritz R and Brauner A, 1990b. Balance experiments on the degradation of

tebuconazole in natural water with exposure to artificial light. Bayer AG,

Leverkusen, Germany Report No PF-3596

Klimisch Score 2


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December 2017

GLP Yes

Test Guideline/s None

Dose Levels 3.48-4.68 mg/L depending on test system.


Study Summary



summary.

The test was performed with natural water (sterile and non-sterile). Incubation

occurred under irradiation with a Xenon lamp with a spectral distribution of

natural light. Incubation periods for non-sterile test systems ranges were 26,

28 or 53 days. Tebuconazole was labelled in either the phenyl ring or the

triazole ring.

The water from both systems was removed and lyophilised. The residues

were dissolved three times each in methanol and water. Radioactivity was

determined by LSC and metabolite identification by TLC.

After 28 days two metabolites exceeded 10% of applied amount. HWG 1608-

lactone was found up to 13.2% (methanol extract) while HWG 1608-

pentanoic acid was found up to 37.8% (26.4% in methanol and 11.4% in

water). After 53 days, HWG 1608-lactone had increased to 21.0% of applied

amount in the methanol extract in one system and was found at a total of

21% in the second system (sum of both methanol and water) 1,2,4-triazole

was found at 14.0% of applied amount, all in the water phase.

Parent tebuconazole had reduced to 39.9-44.2% of the applied amount in the

methanol extract by day 28 and declined further to 3.4-7.8% of applied

amount at day 53.


Conclusion

Major aquatic metabolites:

HWG 1608-Pentanoic acid up to 37.8% of applied amount;

HWG 1608-lactone up to 21.0%

1,2,4-triazole up to 14.0%.

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December 2017

Appendix K: Standard terms and abbreviations

Abbreviation Definition

ACVM Agricultural Compounds and Veterinary Medicines

ADE Acceptable Daily Exposure

ADI Acceptable Daily Intake

ai Active ingredient

AOEL Acceptable Operator Exposure Level

AOCS Australian Office of Chemical Safety

AR Applied Radioactivity

ARfD Acute Reference Dose

ASABE American Society of Agricultural and Biological Engineers

BBA Federal Biological Research Centre for Agriculture and Forestry

BBCH Biologische Bundesanstalt, Bundessortenamt und CHemische Industrie

BCF BioConcentration Factor

bw body weight

CAS # Chemical Abstract Service Registry Number

CCID Chemical Classification and Information Database

cm centimetres

CRfD Chronic Reference Dose

DAR Draft Assessment Report

DDD Daily Dietary Dose

DT50 Dissipation Time (days) for 50% of the initial residue to be lost

dw dry weight

EbC50 EC50 with respect to a reduction of biomass

EC European Commission

EC25 Effective Concentration at which an observable adverse effect is caused in 25 %

of the test organisms

EC50 Effective Concentration at which an observable adverse effect is caused in 50 %

of the test organisms

EEC Estimated Environmental Concentration

EEL Environmental Exposure Limit

EFSA European Food Safety Authority

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December 2017

EPA Environmental Protection Authority

ER50 Effective Residue concentration to 50% of test organisms

ErC50 EC50 with respect to a reduction of growth rate (r)

EU European Union

FAO Food and Agriculture Organization

FFLC Fish Full Life Cycle

FSDT Fish Sexual Development Test

g grams

GAP Good Agricultural Practice

GENEEC Generic Estimated Environmental Concentration

GLP Good Laboratory Practices

ha hectare

HPLC High Pressure Liquid Chromatography

HPLC-MS/MS High Pressure Liquid Chromatography-Mass Spectrometry

HQ Hazard Quotient

HSNO Hazardous Substances & New Organisms

IPM Integrated Pest Management

JMPR Joint Meeting on Pesticide Residues

Kd partition (distribution) coefficient

kg Kilogram

Koc organic carbon adsorption coefficient

Kow octanol water partition coefficient

L litres

lb pounds

LC50 Lethal Concentration that causes 50% mortality

LD50 Lethal Dose that causes 50% mortality

LLNA Local Lymph Node Assay

LOAEL Lowest Observable Adverse Effect Level

LOC Level Of Concern

LOEC Lowest Observable Effect Concentration

LOEL Lowest Observable Effect Level

LOQ Limit of Quantification

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LR50 Lethal Rate that causes 50% mortality

LSC Liquid Scintillation Counting

m3 cubic metre

MAF Multiple Application Factor

mg milligram

MRL Maximum Residue Level

NOAEC No Observed Adverse Effect Concentration

NOAEL No Observed Adverse Effect Level

NOEC No Observed Effect Concentration

NOEL No Observed Effect Level

NOHSC National Occupational Health and Safety Commission

OECD Organisation for Economic Cooperation and Development

PDE Potential Daily Exposure

PEC Predicted Environmental Concentration

PHI Pre-Harvest Interval

PNEC Predicted No Effect Concentration

POW Partition coefficient between n-octanol and water

ppb parts per billion (10-9)

PPE Personal Protective Equipment

ppm parts per million (10-6)

RQ Risk Quotient

SC Suspension Concentrate

SDS Safety Data Sheet

TEL Tolerable Exposure Limit

TER Toxicology Exposure Ratio

TLC Thin Layer Chromatography

USEPA United States Environmental Protection Agency

WHO World Health Organization

μg microgram

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Appendix L: References

APVMA (2010). "Standard spray drift risk assessment scenarios."

EC (2003). Review report for the active substance trifloxystrobin. Brussels, EUROPEAN

COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL.

EC (2007). Draft Assessment Report - Initial risk assessment provided by the rapporteur Member

State Denmark for the exisiting active substance TEBUCONAZOLE of the third stage (part B) of the

review programme referred to in Article 8(2) of Council Directive 91/414/EEC. Denmark.

ECHA (2008). "Information on chemicals - cl inventory database - Harmonised classification - Annex

VI of Regulation (EC) No 1272/2008 (CLP Regulation)." Retrieved 2 July 2017, 2017, from

https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/995.

EFSA (2009). "Risk Assessment for Birds and Mammals." EFSA Journal 7(12): 1438.

EFSA (2013). "Guidance on tiered risk assessment for plant protection products for aquatic organisms

in edge-of-field surface waters." EFSA Journal 11(7): 3290.

EFSA (2014). "EFSA Guidance Document for evaluating laboratory and field dissipation studies to

obtain DegT50 values of active substances of plant protection products and transformation products

of these active substances in soil " EFSA Journal 12(5): 3662.

EFSA (2014). "Guidance on the assessment of exposure of operators, workers, residents and

bystanders in risk assessment for plant protection products." EFSA Journal 12(10): 3874.

Abstract Regulation (EC) No 1107/2009 ensures that the residues of plant protection products

(PPPs), consequent to application consistent with good plant protection practice and having

regard to realistic conditions of use, shall not have any harmful effects on human health. In

2010, the EFSA Panel on Plant Protection Products and their Residues (PPR) prepared a

Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure

Assessment for Workers, Operators, Residents and Bystanders”, which highlighted some

inconsistencies between the approaches adopted by regulatory authorities. Therefore, the

PPR Panel proposed a number of changes to those practices in use (e.g. routine risk

assessment for individual PPPs should continue to use deterministic methods, and a tiered

approach to exposure assessment remains appropriate; there is a need to introduce an acute

risk assessment for operators, workers and bystanders where PPPs are acutely toxic; for

acute risk assessments, exposure estimates should normally be based on 95th percentiles of

relevant datasets, whereas, for longer term risk assessments, the starting point should be a

75thpercentile). To prepare a Guidance Document, an ad hoc working group was established

to revise all available data and procedures to perform the operator, worker, resident and

bystander risk assessment. In addition to the data reported in the PPR opinion, further data

were made available to the working group which were analysed and considered. The opinion

also identifies those scenarios for which exposure estimates are least satisfactory, and makes

recommendations for further research that would reduce current uncertainties. An exposure

calculation spreadsheet, reflecting the Guidance content, is annexed to this Guidance

Document, to support stakeholders in performing the assessment of exposure and risk.

FOCUS (1997). Soil persistence models and EU registration.

https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/995

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JMPR (1994). Pesticide residues in food : 1994, toxicology evaluations, Joint Meeting of the FAO

Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on

Pesticide Residues. Geneva.

JMPR (2004). Pesticide Residues in Food 2004, Joint meeting of the FAO Panel of Experts on

Pesticide Residues in Food and the Environment and the WHO Core Assessment Group. Rome.

JMPR (2010). Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food

and the Environment and the WHO Core Assessment Group on Pesticide Residues. Rome: 307-312.

AOCS (2011). Health Risk Assessment Technical Report, Office of Chemical Safety.

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Appendix M: Confidential Composition

The composition of Scorpio Ornamental Fungicide is confidential.

Documents

APP203305 Scorpio Ornamental Fungicide...1 In the updated report the risk to the bystanders is reduced and no buffer zone for boom or aerial application on forestry is needed for tebuconazole