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Regulation (EU) No 528/2012 as it applies in Great Britain (the
GB Biocidal Products Regulation (GB BPR))
Evaluation of active substances
Draft Risk Assessment Report
<active substance>
<product type>
Great Britain
<date>
1
<applicant> <active substance> <PT>
Guidance
For further guidance visit https://www.hse.gov.uk/biocides/active-substance-approval.htm.
Where there is no GB-specific guidance, reference is made to relevant technical guidance for the EU Biocidal Products Regulation (EU BPR), as the two sets of legislation are very similar.
Sections 1 and 2 are to be completed by the Competent Authority only.
Applicants should complete the summary on page 3 and all other sections from Section 3 onwards.
Explanatory notes and other text that should be deleted is marked as follows:
[Italics – green writing]
Examples and indications of the text that should be provided for some areas are marked as follows:
<Italics – purple writing>
2
<applicant> <active substance> <PT>
Summary
Substance name
CAS number
EC number
Applicant
3
<applicant> <active substance> <PT>
Table of contents1. Statement of subject matter or purpose.......................................................112. Conclusion......................................................................................................12
2.1. Overall conclusion...................................................................................122.2. Draft opinion.............................................................................................122.3. Draft conclusions of the evaluation.......................................................122.4. Exclusion, substitution and POP criteria...............................................15
2.4.1. Exclusion and substitution criteria........................................................15
2.4.2. POP criteria..........................................................................................17
2.4.3. Public consultation for potential candidates for substitution.................17
2.5. Opinion on the application for approval of the active substance <active substance> in product type <PT>.......................................................172.6. Elements to be taken into account when authorising products..........182.7. Requirement for further information......................................................19
3. Assessment Report........................................................................................203.1. Summary presentation of the active substance....................................20
3.1.1. Identity of the active substance............................................................20
3.1.2. Intended uses and effectiveness..........................................................20
3.1.3. Classification and labelling...................................................................22
4. Summary of the human health risk assessment.........................................265. Summary of the environmental risk assessment........................................306. Assessment of exclusion, substitution criteria and POP...........................34Part A – Assessment of intrinsic properties and effects of the active substance...............................................................................................................351. General substance information.....................................................................35
1.1. Identification of the substance...............................................................351.2. Composition of the substance (reference specifications)...................361.3. Physical and chemical properties of the active substance..................371.4. Physical hazards and respective characteristics..................................401.5. Hazard identification for physico-chemical properties........................431.6. Analytical methods or detection and identification..............................43
2. Effects against target organisms..................................................................442.1. Function and field of use envisaged......................................................442.2. Intended uses...........................................................................................442.3. Summary on efficacy...............................................................................45
4
<applicant> <active substance> <PT>
2.3.1. Efficacy.................................................................................................46
2.3.2. Mode of action......................................................................................47
2.3.3. Resistance...........................................................................................47
2.4. Conclusion on efficacy............................................................................473. Assessment of effects on human health......................................................48
3.1. Toxicokinetics..........................................................................................483.1.1. Short summary of the toxicokinetic information...................................48
3.1.2. Values and conclusions used for the risk assessment.........................48
3.2. Acute toxicity............................................................................................503.2.1. Acute oral toxicity.................................................................................50
3.2.2. Acute dermal toxicity............................................................................51
3.2.3. Acute inhalation toxicity........................................................................53
3.2.4. Overall conclusion on acute toxicity.....................................................55
3.3. Irritation and corrosion............................................................................553.3.1. Skin corrosion and irritation..................................................................55
3.3.2. Eye irritation.........................................................................................58
3.3.3. Respiratory tract irritation.....................................................................60
3.3.4. Overall conclusion on corrosion and irritation......................................61
3.4. Sensitisation.............................................................................................623.4.1. Skin sensitisation.................................................................................62
3.4.2. Respiratory sensitisation......................................................................64
3.4.3. Overall conclusion on sensitisation......................................................65
3.5. Short-term repeated dose toxicity..........................................................653.5.1. Short-term oral toxicity.........................................................................66
3.5.2. Short-term dermal toxicity....................................................................67
3.5.3. Short-term inhalation toxicity................................................................69
3.5.4. Overall conclusion on short-term repeated dose toxicity.....................71
3.6. Sub-chronic repeated dose toxicity.......................................................723.6.1. Sub-chronic oral toxicity.......................................................................72
3.6.2. Sub chronic dermal toxicity..................................................................74
3.6.3. Sub-chronic inhalation toxicity..............................................................75
3.6.4. Overall conclusion on sub-chronic repeated dose toxicity...................77
3.7. Long-term repeated dose toxicity...........................................................78
5
<applicant> <active substance> <PT>
3.7.1. Long-term oral toxicity..........................................................................78
3.7.2. Long-term dermal toxicity.....................................................................80
3.7.3. Long-term inhalation toxicity................................................................81
3.7.4. Overall conclusion on long-term repeated dose toxicity.......................83
3.8. Genotoxicity..............................................................................................843.8.1. In vitro..................................................................................................84
3.8.2. In vivo...................................................................................................85
3.8.3. Overall conclusion on genotoxicity.......................................................87
3.9. Carcinogenicity........................................................................................873.10. Reproductive toxicity............................................................................89
3.10.1. Developmental toxicity......................................................................90
3.10.2. Fertility..............................................................................................91
3.10.3. Effects on or via lactation..................................................................93
3.10.4. Overall conclusion on reproductive toxicity.......................................95
3.11. Neurotoxicity.........................................................................................953.12. Immunotoxicity......................................................................................973.13. Disruption of the endocrine system....................................................993.14. Further human data............................................................................1013.15. Other data............................................................................................102
4. Environmental effects assessment.............................................................1044.1. Fate and distribution in the environment.............................................104
4.1.1. Degradation........................................................................................104
4.1.2. Distribution.........................................................................................123
4.1.3. Bioaccumulation.................................................................................126
4.1.4. Monitoring data..................................................................................131
4.2. Effects on environmental organisms...................................................1314.2.1. Atmosphere........................................................................................131
4.2.2. Sewage treatment plant (STP)...........................................................131
4.2.3. Aquatic compartment.........................................................................132
4.2.4. Terrestrial compartment.....................................................................145
4.2.5. Groundwater......................................................................................150
4.2.6. Birds and mammals...........................................................................151
4.2.7. Primary and secondary poisoning......................................................152
4.3. Endocrine disrupting properties...........................................................1544.4. Derivation of PNECs..............................................................................155
5. Assessment of exclusion criteria, substitution criteria and POP............1586
<applicant> <active substance> <PT>
5.1. Exclusion criteria...................................................................................1585.1.1. Assessment of CMR properties.........................................................158
5.1.2. Assessment of endocrine disrupting properties.................................158
5.1.3. PBT Assessment (following Annex XIII to GB REACH).....................159
5.2. Substitution criteria...............................................................................1625.3. Assessment of long-range environmental transportation and impact on environmental compartments...................................................................163
Part B – Exposure assessment and effects of the active substance in the biocidal product(s)..............................................................................................1656. General product information.......................................................................165
6.1. Identification of the product..................................................................1656.2. Complete qualitative and quantitative composition of the biocidal product.............................................................................................................1656.3. Physical, chemical and technical properties.......................................1676.4. Hazard identification for physical and chemical properties..............1756.5. Analytical methods for detection and identification...........................176
7. Efficacy..........................................................................................................1817.1. Efficacy....................................................................................................1817.2. Mode of action........................................................................................1827.3. Resistance..............................................................................................1827.4. Conclusion on efficacy..........................................................................182
8. Human exposure assessment.....................................................................1838.1. Identification of main paths of human exposure towards the active substance from its use in the biocidal product............................................1838.2. List of scenarios.....................................................................................1838.3. Industrial user exposure........................................................................184
8.3.1. Scenario (n)........................................................................................184
8.3.2. Combined scenarios..........................................................................186
8.4. Professional user exposure..................................................................1868.4.1. Scenario (n)........................................................................................186
8.4.2. Combined scenarios..........................................................................188
8.5. General public user exposure...............................................................1888.5.1. Scenario (n)........................................................................................188
8.5.2. Combined scenarios..........................................................................190
8.6. Secondary exposure of the general public (bystanders) excluding dietary exposure..............................................................................................190
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<applicant> <active substance> <PT>
8.6.1. Scenario (n)........................................................................................190
8.6.2. Combined scenarios..........................................................................192
8.7. Dietary exposure....................................................................................1928.7.1. List of scenarios.................................................................................192
8.7.2. Information on non-biocidal use of the active substance...................192
8.7.3. Estimating livestock exposure to active substances used in biocidal products..........................................................................................................193
8.7.4. Estimating transfer of biocidal active substances into foods as a result of professional and / or industrial application(s).............................................194
8.8. Exposure associated with the production, formulation and disposal of the biocidal product........................................................................................194
8.8.1. Scenario (n)........................................................................................195
8.8.2. Combined scenarios..........................................................................196
8.9. Combined residential scenarios...........................................................1969. Environmental exposure assessment........................................................197
9.1. Emission estimation..............................................................................1989.1.1. Scenario (n)........................................................................................198
9.2. Fate and distribution in exposed environmental compartments.......2009.3. Calculated PEC values...........................................................................2039.4. Primary and secondary poisoning.......................................................204
10. Assessment of effects on human health for the product......................20510.1. Product(s)............................................................................................20510.2. Dermal absorption..............................................................................20510.3. Acute toxicity.......................................................................................207
10.3.1. Overall conclusion on acute toxicity................................................208
10.4. Corrosion and irritation......................................................................20810.4.1. Skin corrosion and irritation............................................................209
10.4.2. Serious eye damage and eye irritation...........................................211
10.4.3. Respiratory tract irritation................................................................214
10.4.4. Overall conclusion on corrosion and irritation.................................216
10.5. Sensitisation........................................................................................21610.5.1. Skin sensitisation............................................................................217
10.5.2. Respiratory sensitisation.................................................................219
10.5.3. Overall conclusion on sensitisation.................................................220
10.6. Other.....................................................................................................22111. Environmental effects assessment for the product...............................222
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<applicant> <active substance> <PT>
11.1. Atmosphere.........................................................................................22211.2. STP.......................................................................................................22211.3. Aquatic compartment.........................................................................22211.4. Terrestrial compartment.....................................................................22211.5. Primary and secondary poisoning....................................................222
Part C – Risk characterisation of the biocidal product(s)...............................22312. Risk characterisation for human health..................................................223
12.1. Critical endpoints................................................................................22312.1.1. Systemic effects..............................................................................223
12.1.2. Local effects....................................................................................223
12.1.3. Absorption.......................................................................................223
12.2. Reference values.................................................................................22412.2.1. Uncertainties and assessment factors............................................224
12.2.2. Reference values to be used in risk characterisation.....................226
12.2.3. Maximum residue limits or equivalent.............................................227
12.2.4. Specific reference value for groundwater.......................................227
12.3. Industrial uses.....................................................................................22712.3.1. Systemic effects..............................................................................227
12.3.2. Local effects....................................................................................228
12.3.3. Conclusion......................................................................................228
12.4. Professional uses...............................................................................22812.4.1. Systemic effects..............................................................................228
12.4.2. Local effects....................................................................................229
12.4.3. Conclusion......................................................................................229
12.5. General public uses............................................................................22912.5.1. Systemic effects..............................................................................229
12.5.2. Local effects....................................................................................230
12.5.3. Conclusion......................................................................................230
12.6. Secondary (indirect) exposure as a result of use............................23012.6.1. Systemic effects..............................................................................230
12.6.2. Local effects....................................................................................231
12.6.3. Conclusion......................................................................................231
12.7. Indirect exposure via food.................................................................23112.8. Production / formulation of active substance..................................231
9
<applicant> <active substance> <PT>
12.8.1. Systemic effects..............................................................................231
12.8.2. Local effects....................................................................................232
12.8.3. Conclusion......................................................................................232
12.9. Aggregated exposure.........................................................................23213. Risk characterisation for the environment..............................................233
13.1. Atmosphere.........................................................................................23313.2. Sewage treatment plant (STP)...........................................................23313.3. Aquatic compartment.........................................................................23313.4. Terrestrial compartment.....................................................................23313.5. Groundwater........................................................................................23413.6. Primary and secondary poisoning....................................................23413.7. Aggregated exposure (combined for relevant emission sources).235
14. Risk characterisation for the physico-chemical properties......................23714. Measures to protect man, animals and the environment......................237Part D – Appendices...........................................................................................238Appendix I: List of endpoints.............................................................................238
Chapter 1: Identity, physical and chemical properties, classification and labelling............................................................................................................238Chapter 2: Methods of analysis......................................................................241Chapter 3: Impact on human health...............................................................242Chapter 4: Fate and behaviour in the environment......................................247Chapter 5: Effects on non-target species......................................................250Chapter 6: Other end points...........................................................................252
Appendix II: Human exposure calculations......................................................253Appendix III: Environmental emission (and exposure) calculations..............254Appendix IV: List of terms and abbreviations..................................................255Appendix V: Overall reference list (including data owner and confidentiality claim)....................................................................................................................256Appendix VI: Confidential information..............................................................257
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<applicant> <active substance> <PT>
1. Statement of subject matter or purpose
[To be completed by the Competent Authority only.]
This assessment report has been established as a result of the evaluation of the active substance <active substance> in product-type <PT and full name>, carried out in the context of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (herein referred to as ‘GB BPR’), with a view to the possible approval of this substance.
Through agency agreements, the United Kingdom’s Health and Safety Executive (HSE) performs the functions of the GB biocidal competent authority, and hereafter is referred to as ‘the competent authority’ for the purposes of this document.
On <date> the competent authority received a dossier from the applicant. The competent authority accepted the dossier as complete for the purpose of the evaluation on <date>.
The aim of the assessment report is to provide a decision on the approval of <active substance> for product-type <PT>, and, should it be approved, to facilitate the authorisation of individual biocidal products. In the evaluation of applications for product authorisation, the provisions of GB BPR shall be applied, in particular the provisions of Chapter IV, as well as the common principles laid down in Annex VI.
For the implementation of the common principles of Annex VI, the content and conclusions of the assessment report shall be taken into account.
However, where conclusions of this assessment report are based on data protected under the provisions of GB BPR, such conclusions may not be used to the benefit of another applicant, unless access to these data for that purpose has been granted to that applicant.
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<applicant> <active substance> <PT>
2. Conclusion
[Section 2 (and all subsections) to be completed by the Competent Authority. This section will require amendment for a PT21 active substance.]
2.1. Overall conclusion
The overall conclusion is that <active substance> in product type <PT> <may / may not> be approved. The detailed grounds for the overall conclusion are described in the assessment report.
2.2. Draft opinion
<Enter draft opinion>
2.3. Draft conclusions of the evaluation
[This will include the section “Overall conclusions” of the assessment report following the structure below. This section shall be in the order of 6-8 pages containing a concise summary of the evaluation and conclusions of the risk assessment and which uses have been assessed.]
a) Presentation of the active substance including the classification and labelling of the active substance
This evaluation covers the use of <active substance> in product type <PT>. <active substance> acts by <short description of the mode of action; if possible refer to chemical class, for example pyrethroids or arylpyrroles.> <If relevant, click or tap here to enter description of isomeric composition: for example: The active substance is a reaction mass of stereoisomer a (x % w/w) and stereoisomer b (y % w/w).> Specifications for the reference source are established.
<Enter statement on physico-chemical properties e.g. “The physico-chemical properties of the active substance and biocidal product have been evaluated and are deemed acceptable for the appropriate use, storage and transportation of the active substance and biocidal product.”>
<Enter statement on analytical methods e.g. “ Validated analytical methods are available for the active substance as manufactured and for the relevant and significant impurities. Validated analytical methods are required and available for the relevant matrices x, y, z.”> < If relevant, indicate matrices for which validated analytical methods are missing and required at product authorisation and refer to the section 2.5>
< If relevant, enter a statement that the active substance has been assessed under another European Regulatory Framework(s), e.g. opinion adopted by an EFSA panel, EMA, SCCS etc>
<Click or tap here to enter the classification of the active substance. Indicate if a harmonised classification is available. If not, indicate status of CLH dossier. If available, indicate first the harmonised classification and second if a proposal is made to amend the harmonised classification. Indicate again the status of CLH dossier.>
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<applicant> <active substance> <PT>
[Present only the classification and labelling according to GB CLP. Do not present the pictogram but only the pictogram codes. Do not include the precautionary statements. Use the table below to present the current and, where relevant, proposed classification.]
The (proposed) classification and labelling for <active substance> according to Regulation (EC) No 1272/2008 as it applies in Great Britain (GB) (GB Classification, Labelling and Packaging of substances and mixtures Regulation (GB CLP)) is:
(Proposed) Classification according to GB CLP
Hazard Class and Category Codes
Labelling
Pictogram codes
Signal Word
Hazard Statement Codes
Specific concentration limits, M-Factors<Enter M-Factor values and indicate if for acute, chronic or both.>
Justification for the proposal<Enter a concise justification for the proposed classification and labelling.>
b) Intended use, target species and effectiveness
<Enter a description of the uses: applied for, evaluated and if considered relevant possible other uses that may be applied for at product authorisation. Include a description of the users: industrial, professionals and / or general public.>
<Enter a description of the mode of action.>
<Enter a description of the effectiveness of the active substance and representative biocidal product, for example: “The data on the active substance and the representative biocidal product have demonstrated sufficient efficacy against the target species.” Include a concise statement on resistance.>
c) Overall conclusion of the evaluation including need for risk management measures
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<applicant> <active substance> <PT>
Human health
<Enter a brief description of the key hazards / risks driving the risk assessment.>
The table below summarises the exposure scenarios assessed.
Scenario Primary or secondary exposure and description of scenario
Exposed group
Conclusion
<Indicate whether the exposure is acceptable or not acceptable and any PPE or other RMMs if required to be acceptable.>
[Add new rows as required.]
<Enter a description of the overall outcome of the evaluation focussing on the scenarios for which unacceptable risks were identified and the subsequent need for risk mitigation measures and indicate which risk mitigation measures are appropriate. This can be limited to several paragraphs. If possible, add a statement if a specific concern was identified with respect to the use of the active substance in treated articles or that no concerns were identified with respect to the use of the active substance in treated articles.>
Environment
<Enter a brief description of the key hazards / risks driving the risk assessment.>
The table below summarises the exposure scenarios assessed.
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<applicant> <active substance> <PT>
Scenario Description of scenario including environmental compartments
Conclusion
<Indicate whether the exposure is acceptable or not acceptable and any PPE or other RMMs if required to be acceptable.>
[Add new rows as required.]
<Enter a description of the overall outcome of the evaluation focussing on the scenarios for which unacceptable risks were identified and the subsequent need for risk mitigation measures and indicate which risk mitigation measures are appropriate. This can be limited to several paragraphs. If possible, add a statement if a specific concern was identified with respect to the use of the active substance in treated articles or that no concerns were identified with respect to the use of the active substance in treated articles.>
Overall conclusion
<Enter a description the overall outcome of the evaluation focussing on the acceptable uses.>
2.4. Exclusion, substitution and POP criteria2.4.1. Exclusion and substitution criteria
The tables below summarise the relevant information with respect to the assessment of exclusion and substitution criteria:
CMR properties
Property Conclusions
Carcinogenicity (C) <Indicate Cat 1A, 1B, 2 or no classification required>
Mutagenicity (M) <Indicate Cat 1A, 1B, 2 or no classification required>
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<applicant> <active substance> <PT>
Property Conclusions
Toxic for reproduction (R) <Indicate Cat 1A, 1B, 2 or no classification required>
<Enter an overall conclusion on CMR properties e.g. The active substance does / does not fulfil criterion (a), (b) and (c) of Article 5 (1). If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe for which criteria the evaluation is based on the metabolite(s) or impurity(ies).>
PBT and vPvB properties
Property Conclusions
Persistent (P) or very Persistent (vP) <Indicate P, vP or not P or vP or potential P/vP>
Bioaccumulative (B) or very Bioaccumulative (vB)
<Indicate B, vB or not B or vB or potential B/vB>
Toxic (T) <Indicate T or not T or potential T>
<Enter an overall conclusion on PBT and vPvB properties e.g. The active substance does / does not fulfil criterion (e) of Article 5 (1) and does not fulfil criterion (d) of Article 10 (1). If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe for which criteria the evaluation is based on the metabolite(s) or impurity(ies).>
[Potential P/vP, B/vB or T refers to situations where there are indications that the active substance is meeting one or more of the criteria (for example if the screening criteria are met) but there is insufficient information to come to a definite conclusion. In such a case, additional information under section 2.5 has to be requested and normally discussion has to take place. If an active substance is regarded as “potential P/vP, B/vB or T” this does not imply that it shall be regarded as meeting the exclusion criteria according to Article 5(1) or as a candidate for substitution according to Article 10. This has to be reflected here.]
Endocrine disrupting properties
<Enter a statement according to (EU) 2017/2100 as it has effect in Great Britain (GB endocrine disrupting criteria) e.g. “The active substance is not considered to have endocrine disrupting properties” or “The active substance is considered to have endocrine disrupting properties”. Include a justification for the latter statement. If the active substance meets substitution due to the properties of metabolite(s) or
16
<applicant> <active substance> <PT>
impurity(ies), describe this here.>
Respiratory sensitisation properties
<Indicate Cat 1, 1A, 1B or no classification required>
Concerns linked to critical effects
<Enter a statement whether the active substance fulfils this criterion. If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe this here.>
Proportion of non-active isomers or impurities
<Enter a statement whether the active substance fulfils this criterion. If the active substance meets substitution due to the properties of metabolite(s) or impurity(ies), describe this here.>
Overall conclusion
Consequently, the following is concluded:
<active substance> <does / does not> meet the exclusion criteria laid down in Article 5 of GB BPR.
<active substance> <does / does not meet the conditions laid down in Article 10 of GB BPR and is therefore / therefore not considered as a candidate for substitution. <Specify if any conditions are met, and in such a case also consider the results from public consultation.> The exclusion and substitution criteria were assessed in line with CA-March14-Doc.4.1 - Final - Principles for substance approval (https://circabc.europa.eu/sd/a/c41b4ad4-356c-4852-9512-62e72cc919df/CA-March14-Doc.4.1%20-%20Final%20-%20Principles%20for%20substance%20approval.doc) and in line with CA-Nov14-Doc.4.4 - Final - Further guidance on Art10(1) (https://circabc.europa.eu/sd/a/dbac71e3-cd70-4ed7-bd40-fc1cb92cfe1c/CA-Nov14-Doc.4.4%20-%20Final%20-%20Further%20guidance%20on%20Art10(1).doc). This implies that the assessment of the exclusion criteria is based on Article 5(1) and the assessment of substitution criteria is based on Article 10(1)(a, b, d, e and f).
2.4.2. POP criteria
<Enter a description of which of the POP criteria are met, as follows. The criteria for a substance being a persistent organic pollutant (POP) are P, B and having the potential for long range transport. In addition, high toxicity can breach the B criterion, in which case a substance will be a persistent organic pollutant if it is P, demonstrates the potential for long range transport, and is either B or T. The scientific and technical justification is not required as this is described in the AR.>
2.4.3. Public consultation for potential candidates for substitution
<Enter a description of the outcome of the public consultation and specify the type of information received, e.g. information on the availability of alternative active substances, information related to essentiality.>
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<applicant> <active substance> <PT>
2.5. Opinion on the application for approval of the active substance <active substance> in product type <PT>
In view of the conclusions of the evaluation, it is proposed that <active substance> <shall not be approved / shall be approved and be included in the GB list of approved active substances, subject to the following specific conditions:>
[The text below should be deleted if non-approval is proposed.]
1. Specification: minimum purity of the active substance evaluated: <Enter minimum purity in % w/w. Where relevant, add characterisation of identity with respect to stereoisomers. If the approval covers a nanomaterial this shall be mentioned explicitly.>
<Where relevant, enter maximum content of relevant impurities.>
2. The authorisations of biocidal products are subject to the following condition(s):
a. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the GB risk assessment of the active substance.
b. In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:
i. <Indicate the user category / population and / or the environmental compartment at risk, as well as the use related to this risk described in a general way.>
ii. <Indicate any additional requirements of the product assessment.>
c. <Indicate any specific restrictions (when no “unless clause” is feasible) or other conditions for product authorisation in accordance with CA-Sept15-Doc.5.4 (https://circabc.europa.eu/sd/a/6521f842-126d-4dbe-b4a3-63187d8b4514/CA-Sept15-Doc.5.4%20-%20Approval%20conditions.doc).>
d. <Indicate any additional conditions that are required if the active substance meets the substitution and/or exclusion criteria: see the document “Catalogue of standard phrases”.>
3. The placing on the market of treated articles is subject to the following condition(s):
[This section should be completed if: i) A specific use is fully restricted; ii) The substance meets the exclusion criteria, but is nevertheless approved; iii) The substance is a skin sensitizer category 1 or sub-category1A and/or respiratory sensitizer and/or vP or vB and/or and B and/or SVHC identified under Article 57 of EC 1907/2006 as it applies in Great Britain (GB REACH).]
a. The person responsible for the placing on the market of a treated article treated with or incorporating the active substance <active substance> shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of GB BPR.
18
<applicant> <active substance> <PT>
b. <Indicate any specific labelling requirements, when a specific use of a treated article is fully restricted.>
<Indicate either “The active substance fulfils the criteria according to Article 28 (1) to enable inclusion on the GB Simplified Active Substance List of GB BPR.” or “The active substance does not fulfil the criteria according to Article 28(2)(…) to enable inclusion on the GB Simplified Active Substance List of GB BPR.” Indicate on which grounds the active substance cannot be included.>
2.6. Elements to be taken into account when authorising products
[This section should be deleted if non-approval is proposed.]
1. [If applicable] The active substance <active substance> is considered as a candidate for substitution, and consequently GB shall perform a comparative assessment as part of the evaluation of an application for authorisation.
2. The following recommendations and risk mitigation measures have been identified for the uses assessed. The Competent Authority should consider these risk mitigation measures when authorising products, together with possible other risk mitigation measures, and decide whether these measures are applicable for the concerned product:
a. <Enter details of any elements that need to be taken into account at product authorisation. Elements need to be specific for the active substance under consideration, but not too prescriptive, leaving some flexibility at product authorisation. See also the document “Catalogue of standard phrases”. For example: i) If an unacceptable risk is identified for industrial and / or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.ii) An unacceptable risk for [describe the user / environmental compartment / area of use] is identified. If the risk can be mitigated then specify the risk mitigation measure recommended, and if not use the following standard phrase: “If the risk cannot be reduced to an acceptable level by appropriate risk mitigation measures or by other means, these uses should not be authorised.”>
2.7. Requirement for further information
Sufficient data have been provided to verify the conclusions on the active substance, permitting the proposal for the approval of <active substance>.
< If appropriate, indicate whether further tests or studies shall be required and the dates at which these shall be submitted and to whom. With respect to the date of submission use the following standard phrasing: “… data must be provided as soon as possible but no later than 6 months before the date of approval to the Competent Authority”. It should be noted that a different phrase has to be used for new active substances; see document “Catalogue of standard phrases”.Data requirements for the biocidal product shall not be included in the opinion but in the Assessment Report.>
19
<applicant> <active substance> <PT>
3. Assessment Report3.1. Summary presentation of the active substance3.1.1. Identity of the active substance
Main constituents
ISO name
IUPAC name
CAS number
EC number
Index number in Annex VI of GB CLP
Minimum purity / content
Structural formula
Relevant impurities and additives
IUPAC name or chemical name
Maximum concentration in % (w/w)
Index number in Annex VI of GB CLP
[Add new rows as required.]
3.1.2. Intended uses and effectiveness
Use of the active substance
Product type
Intended use pattern(s)
20
<applicant> <active substance> <PT>
Users
Effectiveness of the active substance
Function
Organisms to be controlled
Limitation of efficacy including resistance
Mode of action
21
<applicant> <active substance> <PT>
3.1.3. Classification and labelling
3.1.3.1. Classification and labelling for the active substance
Physical hazards
Hazard class / property Proposed classification
Explosives
Flammable gases
Flammable aerosols
Oxidising gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances that in contact with water emit flammable gases
Oxidising liquids
Oxidising solids
22
<applicant> <active substance> <PT>
Hazard class / property Proposed classification
Organic peroxides
Corrosive to metals
Human health hazards
Hazard class / property Proposed classification
Acute toxicity via oral route
Acute toxicity via dermal route
Acute toxicity via inhalation route
Skin corrosion / irritation
Serious eye damage / eye irritation
Respiratory sensitisation
Skin sensitisation
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity-single exposure
Specific target organ toxicity-repeated exposure
23
<applicant> <active substance> <PT>
Hazard class / property Proposed classification
Aspiration hazard
Environmental hazards
Hazard class / property Proposed classification
Hazardous to the aquatic environment
Hazardous to the ozone layer
Current classification according to GB CLP
Hazard class and category Hazard statements
Current labelling according to GB CLP
Pictograms Signal word Hazard statements
Supplementary hazard statements
Proposed classification according to GB CLP [if deviating from current classification]
Hazard class and category Hazard statements
Proposed labelling according to GB CLP [if deviating from current labelling]
Pictograms Signal word Hazard statements
Supplementary hazard statements
24
<applicant> <active substance> <PT>
3.1.3.2. Classification and labelling for the representative product(s)
Proposed classification according to GB CLP
Hazard class and category Hazard statements
Proposed labelling according to GB CLP
Pictograms Signal word Hazard statements
Supplementary hazard statements
Packaging of the biocidal product
Type of packaging
Size / volume of the packaging
Material of the packaging
Type and material of closure(s)
Intended user (e.g. professional, general public)
25
<applicant> <active substance> <PT>
4. Summary of the human health risk assessmentSummary of the assessment of effects of human health
Endpoint Brief description
Toxicokinetics <Enter a very short description covering absorption, distribution, metabolism and excretion.>
Acute toxicity <Enter a very short description.>
Corrosion and irritation <Enter a very short description.>
Sensitisation <Enter a very short description.>
Repeated dose toxicity <Enter a very short description.>
Genotoxicity <Enter a very short description.>
Carcinogenicity <Enter a very short description.>
Reproductive toxicity <Enter a very short description.>
Neurotoxicity <Enter a very short description.>
Immunotoxicity <Enter a very short description.>
Disruption of the endocrine system <Enter a very short description.>
Other effects <Enter a very short description.>
26
<applicant> <active substance> <PT>
Reference values
Reference value
Study NOAEL / LOAEL
Overall assessment factor
Value
AELshort-term
AELmedium-term
AELlong-term
[Add new rows as required.]
Risk characterisation
[Sub-headings and tables that are not relevant can be deleted.]
Summary of scenarios
Scenario number
Scenario (e.g. mixing / loading)
Primary or secondary exposure and description of scenario
Exposed group (e.g. professionals, general public, bystanders)
1.
2.
Conclusion of risk characterisation for industrial user
Scenario, Tier, PPE
Relevant reference value
Estimated uptake (mg/kg bw/d)
Estimated uptake / reference value (%)
Acceptable (yes/no)
27
<applicant> <active substance> <PT>
Scenario, Tier, PPE
Relevant reference value
Estimated uptake (mg/kg bw/d)
Estimated uptake / reference value (%)
Acceptable (yes/no)
[Add new rows as required.]
[Please indicate which reference value is used (e.g. AELshort-term, AELmedium-term) and the value, plus include the results of local risk characterisation if relevant.]
Conclusion of risk characterisation for professional user
Scenario, Tier, PPE
Relevant reference value
Estimated uptake (mg/kg bw/d)
Estimated uptake / reference value (%)
Acceptable (yes / no)
[Add new rows as required.]
[Please indicate which reference value is used (e.g. AELshort-term, AELmedium-term) and the value, plus include the results of local risk characterisation if relevant.]
Conclusion of risk characterisation for general public user
Scenario, Tier, PPE
Relevant reference value
Estimated uptake (mg/kg bw/d)
Estimated uptake / reference value (%)
Acceptable (yes / no)
28
<applicant> <active substance> <PT>
Scenario, Tier, PPE
Relevant reference value
Estimated uptake (mg/kg bw/d)
Estimated uptake / reference value (%)
Acceptable (yes / no)
[Add new rows as required.]
[Please indicate which reference value is used (e.g. AELshort-term, AELmedium-term) and the value, plus include the results of local risk characterisation if relevant.]
Conclusion of risk characterisation for indirect exposure
Scenario, Tier, PPE
Relevant reference value
Estimated uptake (mg/kg bw/d)
Estimated uptake / reference value (%)
Acceptable (yes / no)
[Add new rows as required.]
29
<applicant> <active substance> <PT>
5. Summary of the environmental risk assessmentFate and behaviour in the environment
[Please delete sub-headings and tables that are not relevant.]
Summary table on compartments exposed and assessed
Compartment Exposed (yes / no) Assessed (yes / no)
[Add new rows as required.]
Summary table on relevant metabolites
Metabolite / transformation or reaction product
Compartment % active substance
[Add new rows as required.]
Summary table on relevant physico-chemical and fate and behaviour parameters of the active substance
Parameter Value Unit Remarks
Molecular weight N/A
30
<applicant> <active substance> <PT>
Parameter Value Unit Remarks
Log Octanol / eater partition coefficient
Log 10
Organic carbon/water partition coefficient (Koc)
l/kg
Henry’s Law Constant (20 °C)
Pa/m3/mol
Biodegradability N/A
DT50 for biodegradation in surface water
d or hr (at 12 ºC)
DT50 for hydrolysis in surface water
d or hr (at 12 ºC /pH)
DT50 for photolysis in surface water
d or hr
DT50 for degradation in soil
d or hr (at 12 ºC)
DT50 for degradation in air
d or hr
DT50 for degradation in sediment
d or hr
[Add new rows as required.]
[Please include a similar table for relevant metabolites and/or degradation products.]
31
<applicant> <active substance> <PT>
Effects assessmentSummary table on calculated PNEC values
Compartment PNEC
[Add new rows as required.]
[Please include a similar table for relevant metabolites and/or degradation products.]
Exposure assessmentSummary table on calculated PEC values
Scenario number
PECSTP (mg/m3)
PECwater (mg/l)
PECsed (mg/kgwwt)
PECseawater (mg/l)
PECseased (mg/kgwwt)
PECsoil (mg/m3)
PECGW (μg/l) PECair (mg/m3)
1.
2.
[Add new rows as required.]
[Insert / delete additional environmental compartments if relevant.]
[Please include a similar table for relevant metabolites and/or degradation products.]
32
<applicant> <active substance> <PT>
Risk characterisationSummary table on calculated PEC / PNEC values
Scenario number
PEC / PNECSTP
PEC / PNECwater
PEC / PNECsed
PEC / PNECseawater
PEC / PNECseased
PEC / PNECsoil
PEC / PNECGW
PEC/PNECair
1.
2.
[Add new rows as required.]
[Insert / delete additional environmental compartments if relevant.]
[Please include a similar table for relevant metabolites and/or degradation products.]
Conclusion<Enter a short summary on the conclusion of the risk assessment.>
33
<applicant> <active substance> <PT>
6. Assessment of exclusion, substitution criteria and POP
Conclusion on exclusion criteria
Conclusion on CMR
Conclusion on ED assessment
Conclusion on PBT and vP/vB criteria
Conclusion on substitution criteria
Conclusion on LRTAP / POP assessment
34
<applicant> <active substance> <PT>
Part A – Assessment of intrinsic properties and effects of the active substance1. General substance information1.1. Identification of the substanceSummary table on substance identity
Common name (ISO name, synonyms)
Chemical name (EC name, CA name, IUPAC name)
CAS number
EC number
Other CAS numbers (e.g. deleted, related, preferred, alternate)
Molecular formula
SMILES notation
Molar mass
Structural formula
Origin of the natural active substance or precursor(s) of the active substance
35
<applicant> <active substance> <PT>
Method of manufacture
[Please include here a note if this information will be included in the confidential annex.]
1.2. Composition of the substance (reference specifications)
[Please include here a note if this information will be included in the confidential annex.]
Main constituent(s)
Constituent (chemical name)
Typical concentration (% w/w)
Concentration range (% w/w)
Remarks / Discussion
[Add rows as required.]
Impurities
Constituent (chemical name)
Typical concentration (% w/w)
Concentration range (% w/w)
Remarks / Discussion
<Origin of impurity (e.g. manufacturing process, starting material)>
[Add rows as required.]
Additives
Constituent (chemical name)
Function Typical concentration (% w/w)
Concentration range (% w/w)
Remarks / Discussion
[Add rows as required.]
36
<applicant> <active substance> <PT>
1.3. Physical and chemical properties of the active substance
Property Result Test method applied or description in case of deviation
Remarks / Discussion References
Aggregate state at 20°C and 101.3 kPa
Physical state (appearance) at 20°C and 101.3 kPa
Colour at 20°C and 101.3 kPa
Odour at 20°C and 101.3 kPa
Melting / freezing point
Boiling point
Relative density
Granulometry
37
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion References
Vapour pressure
Henry’s law constant
Surface tension
Water solubility at 20 °C
Partition coefficient (n-octanol/water) and its pH dependency Surface tension at 20 °C
Thermal stability and identity of breakdown products
Reactivity towards container material
Dissociation constant
38
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion References
Granulometry
Viscosity
Solubility in organic solvents, including effect of temperature on solubility
Stability in organic solvents used in biocidal products and identity of relevant degradation products
39
<applicant> <active substance> <PT>
1.4. Physical hazards and respective characteristics
Property Result Test method applied or description in case of deviation
Remarks / Discussion References
Explosives
Flammable gases
Flammable aerosols
Oxidising gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances and mixture
Pyrophoric liquids
40
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion References
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures that in contact with water emit flammable gases
Oxidising liquids
Oxidising solids
Organic peroxide
Corrosive to metals
Auto-ignition temperature (liquids and gases)
41
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion References
Relative self-ignition temperature for solids
Dust explosion hazard
42
<applicant> <active substance> <PT>
1.5. Hazard identification for physico-chemical properties
<Enter a summary on the hazard identification for physical-chemical properties.>
1.6. Analytical methods for detection and identificationAnalytical methods
Analyte (type of analyte e.g. active substance, metabolite etc)
Compartment Linearity Specificity Recovery rate (%): Fortification range / Number of measurements
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ), Maximum Residue Limits or other limits
Reference
[Add rows as required.]
43
<applicant> <active substance> <PT>
2. Effects against target organisms2.1. Function and field of use envisaged
<Enter information on function and field of use.>
2.2. Intended usesSummary table of intended uses
Product Type
Product description
Target organisms (including development stage)
Description of use(s)
Mode of action
Objects to be protected
Concentration of product in the in-use formulation/product
44
<applicant> <active substance> <PT>
Concentration of active substance in the in-use formulation/product
Application rate(s)
Frequency of application
Season/period for use (where relevant)
Field of use (indoors/outdoors)
Category(ies) of user(s)
Instruction for use
2.3. Summary on efficacy
45
<applicant> <active substance> <PT>
2.3.1. Efficacy
Experimental data on the efficacy of the active substance against target organism(s)
Function Field of use envisaged
Test substance
Test organism(s)
Test method Test system / concentrations applied / exposure time
Test results: effects
Reference
[Add rows as required.]
46
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
2.3.2. Mode of action
<Enter any information on the mode of action.>
2.3.3. Resistance
<Enter any information on resistance.>
2.4. Conclusion on efficacy
<Enter a brief conclusion.>
47
<applicant> <active substance> <PT>
3. Assessment of effects on human health3.1. ToxicokineticsSummary table of toxicokinetic studies
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no data are available.]
3.1.1. Short summary of the toxicokinetic information
<Summarise the toxicokinetic information and the proposed metabolic pathway, if relevant.>
3.1.2. Values and conclusions used for the risk assessment
Value used in the risk assessment – Oral absorption
Value(s) <Include the concentration range(s) and type of formulation(s) the values are applicable for, if relevant.>
Justification
Value used in the risk assessment – Dermal absorption
Value(s) <Include the concentration range(s) and type of formulation(s) the values are applicable for, if relevant.>
Justification
[The dermal absorption value is applicable for the active substance and might not be usable in product authorisation.]
48
<applicant> <active substance> <PT>
Value used in the risk assessment – Inhalatory absorption
Value(s) <Include the concentration range(s) and type of formulation(s) the values are applicable for, if relevant.>
Justification
Value used in the risk assessment – Distribution
Conclusion
Justification
[If not relevant, delete the table.]
Value used in the risk assessment – Metabolism
Conclusion
Justification
[If not relevant, delete the table.]
Value used in the risk assessment – Elimination
Conclusion
Justification
[If not relevant, delete the table.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
49
<applicant> <active substance> <PT>
3.2. Acute toxicity3.2.1. Acute oral toxicity
Summary table of animal studies on acute oral toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Type of administration (gavage, in diet, other)
Signs of toxicity (nature, onset, duration, severity, reversibility)
ValueLD50
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no data are available.]
Summary table of human data on acute oral toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
50
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data are available.]
Value used in the risk assessment – Acute oral toxicity
Value
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.2.2. Acute dermal toxicity
Summary table of animal studies on acute dermal toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Vehicle,Dose levels,Surface area
ValueLD50
Remarks (e.g. major deviations)
Reference
51
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Vehicle,Dose levels,Surface area
ValueLD50
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no data are available.]
Summary table of human data on acute dermal toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data are available.]
Value used in the risk assessment – Acute dermal toxicity
Value
52
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.2.3. Acute inhalation toxicity
Summary table of animal studies on acute inhalation toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance, form (gas, vapour, dust, mist) and particle size (MMAD)Actual and nominal concentration,Type of administration (nose only / whole body/ head only)
ValueLC50
Remarks (e.g. major deviations)
Reference
53
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no data are available.]
Summary table of human data on acute inhalation toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data are available.]
Value used in the risk assessment – Acute inhalation toxicity
Value
Justification
Data waiving
Information requirement
54
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
3.2.4. Overall conclusion on acute toxicity
Value used in the risk assessment – Acute systemic toxicity
Value
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
Value / conclusion used in the risk assessment – Acute local effects
Value / conclusion
Justification
3.3. Irritation and corrosion3.3.1. Skin corrosion and irritation
[If no data are available, delete all the tables and indicate only that no data are available.]
55
<applicant> <active substance> <PT>
Summary table of in vitro studies on skin corrosion / irritation
Method,Guideline,GLP status,Reliability
Test substanceDoses
Relevant information about the study
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of animal studies on skin corrosion / irritation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Vehicle,Dose levels,Duration of exposure
ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility, other adverse local/systemic effects, histopathological findings
Remarks (e.g. major deviations)
Reference
56
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table of human data on skin corrosion / irritation
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Skin irritation and corrosivity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
57
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
3.3.2. Eye irritation
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of in vitro studies on serious eye damage and eye irritation
Method,Guideline,GLP status,Reliability
Test substanceDoses
Relevant information about the study
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of animal studies on serious eye damage and eye irritation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility
Remarks (e.g. major deviations)
Reference
58
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on serious eye damage and eye irritation
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Eye irritation and corrosivity
Value / conclusion
59
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.3.3. Respiratory tract irritation
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on respiratory tract irritation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
Resultsclinical signs, histopathology, reversibility
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
60
<applicant> <active substance> <PT>
Summary table of human data on respiratory tract irritation
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Respiratory tract irritation
Conclusion
Justification
3.3.4. Overall conclusion on corrosion and irritation
Conclusion used in the risk assessment – Corrosion and irritation
Value
Justification
61
<applicant> <active substance> <PT>
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.4. Sensitisation3.4.1. Skin sensitisation
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on skin sensitisation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Vehicle,Dose levels,Route of exposure (topical/intradermal, if relevant),Duration of exposure
Results(EC3-value or amount of sensitised animals at induction dose
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
62
<applicant> <active substance> <PT>
Summary table of human data on skin sensitisation
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Skin sensitisation
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
63
<applicant> <active substance> <PT>
3.4.2. Respiratory sensitisation
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on respiratory sensitisation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on respiratory sensitisation
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
64
<applicant> <active substance> <PT>
Conclusion used in the risk assessment – Respiratory sensitisation
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.4.3. Overall conclusion on sensitisation
Conclusion used in the risk assessment – Sensitisation
Value
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.5. Short-term repeated dose toxicity
65
<applicant> <active substance> <PT>
3.5.1. Short-term oral toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on short-term oral toxicity (usually 28-day studies)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Route of exposure (gavage, in diet, other),Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on short-term oral toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
66
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Short-term oral toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.5.2. Short-term dermal toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
67
<applicant> <active substance> <PT>
Summary table of animal studies on short-term dermal toxicity (usually 28-day studies)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Surface areaDuration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on short-term dermal toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
68
<applicant> <active substance> <PT>
Value used in the risk assessment – Short-term dermal toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.5.3. Short-term inhalation toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
69
<applicant> <active substance> <PT>
Summary table of animal studies on short-term inhalation toxicity (usually 28-day studies)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance, form (gas, vapour, dust, mist) and particle size (MMAD),Actual and nominal concentration,Type of administration (nose only / whole body/ head only),Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on short-term inhalation toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
70
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Short-term inhalation toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.5.4. Overall conclusion on short-term repeated dose toxicity
Value used in the risk assessment – Short-term repeated dose toxicity
Value
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
71
<applicant> <active substance> <PT>
Value / conclusion used in the risk assessment – Short-term repeated dose local effects
Value / conclusion
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.6. Sub-chronic repeated dose toxicity3.6.1. Sub-chronic oral toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on sub-chronic oral toxicity (usually 90-day studies)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Route of exposure (gavage, in diet, other),Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
72
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table of human data on sub-chronic oral toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Sub-chronic oral toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
73
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
3.6.2. Sub chronic dermal toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on sub-chronic dermal toxicity (usually 90-day studies)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Surface areaDuration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on sub-chronic dermal toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
74
<applicant> <active substance> <PT>
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Sub-chronic dermal toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.6.3. Sub-chronic inhalation toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
75
<applicant> <active substance> <PT>
Summary table of animal studies on sub-chronic inhalation toxicity (usually 90-day studies)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance, form (gas, vapour, dust, mist) and particle size (MMAD),Actual and nominal concentration,Type of administration (nose only / whole body/ head only),Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on sub-chronic inhalation toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
76
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Sub-chronic inhalation toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.6.4. Overall conclusion on sub-chronic repeated dose toxicity
Value used in the risk assessment – Sub-chronic repeated dose toxicity
Value
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
77
<applicant> <active substance> <PT>
Value / conclusion used in the risk assessment – Sub-chronic repeated dose local effects
Value / conclusion
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.7. Long-term repeated dose toxicity3.7.1. Long-term oral toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on long-term oral toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Route of exposure (gavage, in diet, other),Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
78
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table of human data on long-term oral toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Long-term oral toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
79
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
3.7.2. Long-term dermal toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on long-term dermal toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Surface areaDuration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on long-term dermal toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
80
<applicant> <active substance> <PT>
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Long-term dermal toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.7.3. Long-term inhalation toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
81
<applicant> <active substance> <PT>
Summary table of animal studies on long-term inhalation toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance, form (gas, vapour, dust, mist) and particle size (MMAD),Actual and nominal concentration,Type of administration (nose only / whole body/ head only),Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on long-term inhalation toxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
82
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Long-term inhalation toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.7.4. Overall conclusion on long-term repeated dose toxicity
Value used in the risk assessment – Long-term repeated dose systemic toxicity
Value
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
83
<applicant> <active substance> <PT>
Value / conclusion used in the risk assessment – Long-term repeated dose local effects
Value / conclusion
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.8. Genotoxicity3.8.1. In vitro
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of in vitro genotoxicity studies
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study (e.g. cell type, strains)
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
84
<applicant> <active substance> <PT>
Conclusion used in the risk assessment – Genotoxicity in vitro
Conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.8.2. In vivo
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of in vivo genotoxicity studies
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study (e.g. species and strain, duration of exposure)
Observations Remarks (e.g. major deviations)
Reference
85
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study (e.g. species and strain, duration of exposure)
Observations Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on genotoxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Genotoxicity in vivo
Conclusion
86
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.8.3. Overall conclusion on genotoxicity
Conclusion used in the risk assessment – Genotoxicity
Conclusion
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.9. Carcinogenicity
[If no data are available, delete all the tables and indicate only that no data are available.]
87
<applicant> <active substance> <PT>
Summary table of animal studies on carcinogenicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Route of exposure,Duration of exposure
NOAELLOAEL
Results (Please indicate any results that might suggest carcinogenic effects, as well as other toxic effects)
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on carcinogenicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
88
<applicant> <active substance> <PT>
Conclusion used in the risk assessment – Carcinogenicity
Value / conclusion
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.10. Reproductive toxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
89
<applicant> <active substance> <PT>
3.10.1. Developmental toxicity
Summary table of animal studies on adverse effects on development
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELsLOAELs(also for maternal effects)
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on adverse effects on development
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
90
<applicant> <active substance> <PT>
Conclusion used in the risk assessment –Effects on development
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.10.2. Fertility
Summary table of animal studies on adverse effects on fertility
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELsLOAELs
Results Remarks (e.g. major deviations)
Reference
91
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELsLOAELs
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on adverse effects on fertility
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Fertility
Value / conclusion
92
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
3.10.3. Effects on or via lactation
Summary table of animal studies on adverse effects on or via lactation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
93
<applicant> <active substance> <PT>
Summary table of human data on adverse effects on or via lactation
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Effects on or via lactation
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
94
<applicant> <active substance> <PT>
3.10.4. Overall conclusion on reproductive toxicity
Conclusion used in the risk assessment – Reproductive toxicity
Value
Justification
Classification according to GB CLP
<Include the existing classification and / or a proposal if relevant.>
3.11. Neurotoxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of animal studies on neurotoxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
95
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table of human data on neurotoxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Neurotoxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
96
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
3.12. Immunotoxicity
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of in vitro immunotoxicity studies
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of animal studies on immunotoxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
97
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table of human data on immunotoxicity
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Immunotoxicity
Conclusion
Justification
Data waiving
Information requirement
Justification
98
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
3.13. Disruption of the endocrine system
[If no data are available, delete all the tables and indicate only that no data are available.]
Summary table of in vitro studies on endocrine disruption
Method,Guideline,GLP status,Reliability
Test substance,
Relevant information about the study
Observations Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of animal studies on endocrine disruption
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / Group
Test substance,Dose levels,Duration of exposure
NOAELLOAEL
Results Remarks (e.g. major deviations)
Reference
99
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table of human data on endocrine disruption
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Endocrine disruption
Conclusion
Justification
Data waiving
Information requirement
Justification
100
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
3.14. Further human data
[Include here only information that is not described elsewhere in sections 3.1 to 3.13. If no further data are available, delete the table and indicate only that no further data are available.]
Summary table of further human data
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Further human data
Conclusion
Justification
3.15. Other data
[Include here only information that is not described elsewhere in sections 3.1 to 3.14, e.g. data on aspiration hazard if available. If no further data are available, delete the table and indicate only that no further data are available.]
101
<applicant> <active substance> <PT>
Summary table of other data
Type of data/ reportReliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Other data
Conclusion
Justification
102
<applicant> <active substance> <PT>
4. Environmental effects assessment4.1. Fate and distribution in the environment4.1.1. Degradation
4.1.1.1. Abiotic degradation
HydrolysisSummary table – Hydrolysis
Method,Guideline,GLP status,Reliability
pH Temp (°C) Initial TS concentration, C0(mol/l)
Half-life, DT50(d)
Coefficient of correlation, r2
Remarks Reference
[Add / delete rows according to the number of studies. Please provide information (as free text) on breakdown products.]
Value used in the risk assessment – Hydrolysis
Value / conclusion
Justification
103
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Phototransformation in waterSummary table – Photolysis in water
Method,Guideline,GLP status,Reliability
Initial molar TS concentration
Total recovery of test substance (% of appl. AS.)
Photolysis rate constant (kc
p)Direct photolysis sunlight rate constant (kpE)
Reaction quantum yield (φcE)
Half-life (t1/2E)
Remarks Reference
[Add / delete rows according to the number of studies. Please provide information (as free text) on breakdown products.]
Value used in the risk assessment – Photolysis in water
Value / conclusion
104
<applicant> <active substance> <PT>
[Usually this endpoint is not used in the risk assessment; only relevant in very specific cases.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Estimated photo-oxidation in airSummary table – Photo-oxidation in air
Model Light protection (yes/no)
Estimated daily (24h) OH concentration (OH/cm³)
Overall OH rate constant (cm³/molecule ec)
Half-life (hr) Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Photo-oxidation in air
Value / conclusion
105
<applicant> <active substance> <PT>
Justification
[Usually this endpoint is not used in the risk assessment; only relevant in very specific cases.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.1.1.2. Biotic degradation
4.1.1.2.1.Biodegradability (ready / inherent)Summary table – Biodegradation studies (ready / inherent)
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
106
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Biodegradation studies (ready / inherent)
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
107
<applicant> <active substance> <PT>
4.1.1.3. Rate and route of degradation including identification of metabolites and degradation products
4.1.1.3.1.Biological sewage treatmentAerobic biodegradationSummary table – STP aerobic biodegradation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – STP aerobic biodegradation
Value / conclusion
Justification
108
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Anaerobic biodegradationSummary table – STP anaerobic biodegradation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
[Add / delete rows according to the number of studies.]
109
<applicant> <active substance> <PT>
Value used in the risk assessment – STP anaerobic biodegradation
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
STP simulation testSummary table – STP simulation test
Method,Guideline,GLP status,Reliability
Test type(according to OECD criteria)
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
110
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Test type(according to OECD criteria)
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – STP simulation test
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
111
<applicant> <active substance> <PT>
4.1.1.3.2.Biodegradation in freshwaterAerobic aquatic degradationSummary table – Freshwater aerobic biodegradation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Exposure Test substance conc.
Incubation period Degradation (DT50) Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Freshwater aerobic biodegradation
Value / conclusion
Justification
Data waiving
Information requirement
112
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
Water / sediment degradation testSummary table – Freshwater / sediment degradation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Exposure Test system: Water
Test system: Sediment
Test substance conc.
Incubation period
Degradation (DT50)
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Freshwater / sediment degradation
Value / conclusion
Justification
113
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.1.1.3.3.Biodegradation in seawaterSeawater degradation studySummary table – Seawater aerobic biodegradation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Exposure Test substance conc.
Incubation period Degradation (DT50) Remarks Reference
[Add / delete rows according to the number of studies.]
114
<applicant> <active substance> <PT>
Value used in the risk assessment – Seawater aerobic biodegradation
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Seawater / sediment degradation studySummary table – Seawater / sediment degradation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Exposure Test system: Water
Test system: Sediment
Test substance conc.
Incubation period
Degradation (DT50)
Remarks Reference
115
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Seawater / sediment degradation
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.1.1.3.4.Higher tier degradation studies in water or sediment
[Since higher tier studies can have a very specific study design, no general template is provided. Please use the table provided under 4.1.1.3.3. and adapt it according to the respective study design.]
116
<applicant> <active substance> <PT>
4.1.1.3.5.Biodegradation during manure storageSummary table – Biodegradation during manure storage
Method,Guideline,GLP status,Reliability
Test type(according to OECD criteria)
Test parameter
Inoculum: Type
Inoculum: Concentration
Inoculum: Adaptation
Additional substrate
Test substance conc.
Degradation: Incubation period
Degradation: Degree (%)
Remarks
Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Biodegradation during manure storage
Value / conclusion
Justification
Data waiving
Information requirement
117
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
4.1.1.3.6.Biotic degradation in soil4.1.1.3.6.1. Laboratory soil degradation studiesAerobic biodegradationSummary table – Aerobic biodegradation in soil – laboratory study
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Exposure Test system: Soil origin
Test system: Soil type
Test system: pH
Test system: OC %
Test substance conc.
Incubation period
Degradation (DT50)
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Aerobic biodegradation in soil
Value / conclusion
118
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Anaerobic biodegradationSummary table – Anaerobic biodegradation in soil – laboratory study
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Exposure Test system: Soil origin
Test system: Soil type
Test system: pH
Test system: OC %
Test substance conc.
Incubation period
Degradation (DT50)
Remarks Reference
[Add / delete rows according to the number of studies.]
119
<applicant> <active substance> <PT>
Value used in the risk assessment – Anaerobic biodegradation in soil
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.1.1.3.6.2. Higher tier degradation studies in soil
[Since higher tier degradation studies can have a very specific study design, in the following only a table for field dissipation studies is provided. In case of additional higher tier studies please use this table as basis and adapt it according to the respective study design.]
120
<applicant> <active substance> <PT>
Field dissipation studies (field studies, two soil types)Summary table – Field dissipation
Method,Guideline,GLP status,Reliability
Test typeaccording to OECD criteria
Site Application rate (g AS/ha)
Surface Soil type Soil texture
Test duration
Degradation (DT50)
Degradation (DT90)
Remarks Reference
<Soil 1>
<Soil 2>
<Soil 3>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Field dissipation
Value / conclusion
Justification
121
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.1.2. Distribution
4.1.2.1. Adsorption onto / desorption from soils
Summary table – Adsorption / desorption
Method,Guideline,GLP status,Reliability
Soil Adsorbed AS (%)
Ka KaOC Kd
KdOC
Ka/Kd
Kf 1/n Remarks Reference
<Soil 1>
<Soil 2>
<Soil 3>
Ka = Adsorption coefficient
KaOC = Adsorption coefficient based on organic carbon content
122
<applicant> <active substance> <PT>
Kd = Desorption coefficient
KdOC = Desorption coefficient based on organic carbon content
Ka/ Kd = Adsorption / Desorption distribution coefficient
[Add / delete rows according to the number of studies.]
Summary table – Adsorption / desorption metabolite / transformation or reaction product
Method,Guideline,GLP status,Reliability
Soil % of AS Ka KaOC Kf l/n Kd
KdOC
Ka/Kd
Remarks Reference
<Soil 1>
<Soil 2>
<Soil 3>
Ka = Adsorption coefficient
KaOC = Adsorption coefficient based on organic carbon content
Kd = Desorption coefficient
KdOC = Desorption coefficient based on organic carbon content
123
<applicant> <active substance> <PT>
Ka/ Kd = Adsorption / Desorption distribution coefficient
[Please insert a table for each metabolite. If not relevant, delete the table.]
Value used in the risk assessment – Adsorption / desorption
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.1.2.2. Higher tier soil adsorption studies
[Since higher tier studies like column leaching studies, lysimeter studies or field leaching studies can have a very specific study design, no general template is provided. Please use the table provided under 4.1.2.1 and adapt it according to the respective study design.]
124
<applicant> <active substance> <PT>
4.1.3. Bioaccumulation
Measured aquatic bioconcentrationSummary table – Measured aquatic bioconcentration
Method,Guideline,GLP status,Reliability
Exposure
Log Kow of AS
Initial concentration of AS
Steady state BCF
Uptake rate constant (K1)
Depur. rate constant (K2)
Depur. time (DT50)
Metabolites
Remarks
Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Measured aquatic bioconcentration
Value / conclusion
Justification
125
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Estimated aquatic bioconcentrationSummary table – Measured aquatic bioconcentration
Basis for estimation Log Kow (measured) Estimated BCF for fish (freshwater)
Estimated BCF for fish eating bird / predator
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Measured aquatic bioconcentration
Value / conclusion
126
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Measured terrestrial bioconcentrationSummary table – Measured terrestrial bioconcentration
Method,Guideline,GLP status,Reliability
Exposure
Log Kow of AS
Initial concentration of AS
Steady state BCF
Uptake rate constant (K1)
Depur. rate constant (K2)
Depur. time (DT50)
Metabolites
Remarks
Reference
[Add / delete rows according to the number of studies.]
127
<applicant> <active substance> <PT>
Value used in the risk assessment – Measured terrestrial bioconcentration
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Estimated terrestrial bioconcentrationSummary table – Estimated terrestrial bioconcentration
Basis for estimation
Log Kow (measured)
Estimated BCF for terrestrial food chain I: Soil dwelling species
Estimated BCF for terrestrial food chain I: Predatory bird / vertebrate
Estimated BCF for terrestrial food chain II: Terrestrial plant
Estimated BCF for terrestrial food chain II: Grazing non-target organism
Remarks Reference
128
<applicant> <active substance> <PT>
Basis for estimation
Log Kow (measured)
Estimated BCF for terrestrial food chain I: Soil dwelling species
Estimated BCF for terrestrial food chain I: Predatory bird / vertebrate
Estimated BCF for terrestrial food chain II: Terrestrial plant
Estimated BCF for terrestrial food chain II: Grazing non-target organism
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Estimated terrestrial bioconcentration
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
129
<applicant> <active substance> <PT>
4.1.4. Monitoring data
<If monitoring data in any environmental compartment are available, please describe them here.>
4.2. Effects on environmental organisms4.2.1. Atmosphere
<Include text here if relevant.>
4.2.2. Sewage treatment plant (STP)
Inhibition of microbial activity (aquatic)Summary table – Inhibition of microbial activity
Method,Guideline,GLP status,Reliability
Species / Inoculum
Endpoint Exposure: Design
Exposure: Duration
Results: EC20
Results: EC50
Results: EC80 Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Inhibition of microbial activity
Value / conclusion
130
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.2.3. Aquatic compartment
4.2.3.1. Freshwater compartment
Acute toxicity (freshwater)Summary table – Acute aquatic toxicity (freshwater) – Fish
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: LC/EC0
Results: LC/EC50
Results: LC/EC100
Remarks Reference
131
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table – Acute aquatic toxicity (freshwater) – Invertebrates
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: LC/EC0
Results: LC/EC50
Results: LC/EC100
Remarks Reference
[Add / delete rows according to the number of studies.]
Summary table – Acute aquatic toxicity (freshwater) – Algae (growth inhibition)
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: NOErC
Results: ErC50 (calculated from the area under the growth curve)
Results: ErC50 (calculated from growth rate)
Remarks Reference
132
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: NOErC
Results: ErC50 (calculated from the area under the growth curve)
Results: ErC50 (calculated from growth rate)
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Acute aquatic toxicity (freshwater)
Value / conclusion
Justification
[May not be relevant if chronic data are available. Please indicate accordingly.]
Data waiving
Information requirement
Justification
133
<applicant> <active substance> <PT>
[If not relevant, delete the table.]
Chronic toxicity (freshwater)Summary table – Chronic aquatic toxicity (freshwater) – Fish
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
Summary table – Chronic aquatic toxicity (freshwater) – Invertebrates
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
134
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table – Chronic aquatic toxicity (freshwater) – Other aquatic plants
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Chronic aquatic toxicity (freshwater)
Value / conclusion
Justification
[If necessary, please include a discussion on pooling data (freshwater / seawater) or discussion on SSD here.]
Data waiving
Information requirement
135
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
4.2.3.2. Sediment compartment
Acute toxicity (freshwater sediment)Summary table – Acute toxicity to sediment dwelling organisms (freshwater)
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: LC/EC0
Results: LC/EC50
Results: LC/EC100
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Acute toxicity to sediment dwelling organisms (freshwater)
Value / conclusion
Justification
136
<applicant> <active substance> <PT>
[May not be relevant if chronic data are available. Please indicate accordingly.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Chronic toxicity (freshwater sediment)Summary table – Chronic toxicity to sediment dwelling organisms (freshwater)
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
137
<applicant> <active substance> <PT>
Value used in the risk assessment – Chronic toxicity to sediment dwelling organisms (freshwater)
Value / conclusion
Justification
[If necessary, please include a discussion on pooling data (freshwater / seawater) or discussion on SSD here.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
138
<applicant> <active substance> <PT>
4.2.3.3. Marine compartment
Acute toxicity (seawater)Summary table – Acute aquatic toxicity (seawater)
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: LC/EC0
Results: LC/EC50
Results: LC/EC100
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Acute aquatic toxicity (seawater)
Value / conclusion
Justification
[May not be relevant if chronic data are available. Please indicate accordingly.]
139
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Chronic aquatic toxicity (seawater)Summary table – Chronic aquatic toxicity (seawater)
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Chronic aquatic toxicity (seawater)
Value / conclusion
140
<applicant> <active substance> <PT>
Justification
[If necessary, please include a discussion on pooling data (freshwater / seawater) or discussion on SSD here.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.2.3.4. Sea sediment compartment
Acute toxicity (sea sediment)Summary table – Acute toxicity to sea sediment dwelling organisms
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results: LC/EC0
Results: LC/EC50
Results: LC/EC100
Remarks Reference
141
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Acute toxicity to sediment dwelling organisms (freshwater)
Value / conclusion
Justification
[May not be relevant if chronic data are available. Please indicate accordingly.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
142
<applicant> <active substance> <PT>
Chronic toxicity (sea sediment)Summary table – Chronic toxicity to sea sediment dwelling organisms
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Chronic toxicity to sea sediment dwelling organisms
Value / conclusion
Justification
[If necessary, please include a discussion on pooling data (freshwater / seawater) or discussion on SSD here.]
Data waiving
Information requirement
143
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
4.2.3.5. Higher tier studies on aquatic organisms
[Since higher tier studies like mesocosm studies can have a very specific study design, no general template is provided. Please use the table provided under 4.1.3.1 and adapt it according to the respective study design.]
4.2.4. Terrestrial compartment
Toxicity to terrestrial organisms, acute testsSummary table – Acute terrestrial toxicity – Earthworm / soil dwelling non-target invertebrates
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration
Organic matter (mg/Kg dw)
Results (in dry weight): LC/EC0
Results (in dry weight): LC/EC10
Results (in dry weight): LC/EC50
Remarks Reference
[Add / delete rows according to the number of studies.]
144
<applicant> <active substance> <PT>
Summary table – Acute terrestrial toxicity – Soil microflora
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration
Organic matter (mg/Kg dw)
Results (in dry weight): LC/EC0
Results (in dry weight): LC/EC10
Results (in dry weight): LC/EC50
Remarks Reference
[Add / delete rows according to the number of studies.]
Summary table – Acute terrestrial toxicity – Non-target plants
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration
Organic matter (mg/Kg dw)
Results (in dry weight): LC/EC0
Results (in dry weight): LC/EC10
Results (in dry weight): LC/EC50
Remarks Reference
145
<applicant> <active substance> <PT>
[Add / delete rows according to the number of studies.]
Summary table – Acute terrestrial toxicity – Bees and other (non-target) arthropods
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Exposure: Design
Exposure: Duration
Organic matter (mg/Kg dw)
Results (in dry weight): LC/EC0
Results (in dry weight): LC/EC10
Results (in dry weight): LC/EC50
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Acute terrestrial toxicity
Value / conclusion
Justification
[May not be relevant if chronic data are available. Please indicate accordingly.]
146
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Toxicity to terrestrial organisms, chronic testsSummary table – Chronic terrestrial toxicity – Earthworm / soil dwelling non-target invertebrates reproduction
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test Exposure: Design Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
147
<applicant> <active substance> <PT>
Summary table – Chronic terrestrial toxicity – Non-target plants
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test Exposure: Design Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
Summary table – Chronic terrestrial toxicity – Bees and other (non-target) arthropods
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test Exposure: Design Exposure: Duration ResultsLOEC / NOEC / EC10
Remarks Reference
[Add / delete rows according to the number of studies.]
148
<applicant> <active substance> <PT>
Value used in the risk assessment – Chronic terrestrial toxicity
Value / conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.2.5. Groundwater
[Please include any tests or monitoring data in groundwater here.]
149
<applicant> <active substance> <PT>
4.2.6. Birds and mammals
Summary table – Toxicity to birds and mammals
Method,Guideline,GLP status,Reliability
Species Endpoint Exposure: Design
Exposure: Duration
Results (mg a.i./kg bw or feed): LD/LC0
Results (mg a.i./kg bw or feed): LOEL/LOEC
Results (mg a.i./kg bw or feed): NOEL/NOEC
Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Toxicity to birds and mammals
Value / conclusion
Justification
Data waiving
Information requirement
150
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
4.2.7. Primary and secondary poisoning
Summary table – Primary poisoning
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Duration Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Primary poisoning
Value / conclusion
Justification
151
<applicant> <active substance> <PT>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
Summary table – Secondary poisoning
Method,Guideline,GLP status,Reliability
Species Endpoint / Type of test
Duration Remarks Reference
[Add / delete rows according to the number of studies.]
Value used in the risk assessment – Secondary poisoning
Value / conclusion
152
<applicant> <active substance> <PT>
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
<Waiving example: Substance is unlikely to bioaccumulate in aquatic or terrestrial environment according to the TGD: It has a low log Kow (x.xx), it is not highly adsorptive, it does not belong to a class of substances known to have a potential to accumulate in living organisms, its structural features does not indicate accumulation and it is readily biodegradable and has a short degradation half-life of 11 h in the water/sediment test. The low accumulation potential is supported by low BCF and BMF for fish and earthworms determined by EUSES 2.1.2. The bioconcentration factor for fish is x.xx l/kg and a default BMF of 1. The bioconcentration factor for earthworms is x.xx l/kg and a default BMF of 1. No further assessment of secondary exposure via the food chain is therefore considered necessary.>
4.3. Endocrine disrupting propertiesSummary table of ecotoxicological data on endocrine disruption (GB endocrine disrupting criteria)
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Dose levels,Duration of exposure
Results Remarks (e.g. major deviations)
Reference
153
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Dose levels,Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table.]
Conclusion used in the risk assessment – Endocrine disruption
Conclusion
Justification
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
4.4. Derivation of PNECs
154
<applicant> <active substance> <PT>
Compartment PNEC Remarks / Justification
<Freshwater> <PNECfreshwater: xx.x mg/L> Organism: <Fish (O. mykiss)>
Endpoint: LC50 (96 h): <0.52 mg/l>
Assessment factor: <1000>
Extrapolation method: <assessment factor (alternative: partitioning coefficient)>
Justification: <Since the three taxonomic groups (fish, invertebrates, algae) are covered but only short-term toxicity data are available for fish and invertebrates, an assessment factor of 1000 is applied.>
Organism:
Endpoint:
Assessment factor:
Extrapolation method:
Justification:
155
<applicant> <active substance> <PT>
Compartment PNEC Remarks / Justification
Organism:
Endpoint:
Assessment factor:
Extrapolation method:
Justification:
Organism:
Endpoint:
Assessment factor:
Extrapolation method:
Justification:
[Include relevant environmental compartments or species for which PNECs have been derived.]
156
<applicant> <active substance> <PT>
5. Assessment of exclusion criteria, substitution criteria and POP5.1. Exclusion criteria5.1.1. Assessment of CMR properties
Criteria (GB BPR Article 5 (1)) Assessment
Active substances that have been classified in accordance with GB CLP as, or that meet the criteria to be classified as, carcinogen category 1A or 1B
<Active substance is not classified and does not meet the criteria to be classified as Carc. Cat. 1A or 1B.>
Active substances that have been classified in accordance with GB CLP as, or that meet the criteria to be classified as, mutagen category 1A or 1B
<Active substance is not classified and does not meet the criteria to be classified as Muta. Cat. 1A or 1B.>
Active substances that have been classified in accordance with GB CLP as, or that meet the criteria to be classified as, toxic for reproduction category 1A or 1B
<Active substance is not classified and does not meet the criteria to be classified as Repr. Cat. 1A or 1B.>
Conclusion on CMR properties
<The exclusion criteria in BPR Article 5 (1) (a) – (c) are not met.>
5.1.2. Assessment of endocrine disrupting properties
Criteria Assessment
Active substances that, on the basis of GB endocrine disrupting criteria, are considered as having endocrine-disrupting properties that may cause adverse effects in humans and to the environment.
<The new criteria must be satisfied.>
157
<applicant> <active substance> <PT>
Criteria Assessment
Active substances that are classified in accordance with GB CLP as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2.(Such substances shall be considered as having endocrine disrupting properties.)
<Active substance is not classified and does not meet the criteria to be classified as Carc Cat. 2.
Active substance is not classified and does not meet the criteria to be classified as Repr. Cat. 2>.
Substances such as those that are classified in accordance with GB CLP as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs.(Such substances may be considered as having endocrine disrupting properties.)
< Active substance is not classified and does not meet the criteria to be classified as Repr. Cat. 2.
Active substance has not been shown to have toxic effects on endocrine organs.>
Active substances that are identified in accordance with GB endocrine disrupting criteria as having endocrine disrupting properties.
<Active substance has not been identified as having endocrine disrupting properties.>
Conclusion on ED properties
<The exclusion criteria in BPR Article 5 (1) (d) are not met.>
5.1.3. PBT Assessment (following Annex XIII to GB REACH)
Assessment of persistenceScreening
[Include a persistence assessment based on the criteria for identification of persistent or very persistent substances based on GB REACH Annex XIII and summarised in the tables below.
In this context it is important to note that a substance may consist of more than one constituent or that it may form transformation or degradation products. If the substance contains one or more constituents with PBT / vPvB properties in individual amounts ≥ 0.1 % (w/w) or if transformation / degradation products with the respective properties in individual amounts ≥ 0.1 % are being generated, the substance must be treated like a PBT / vPvB.]
158
<applicant> <active substance> <PT>
Assessment
P Criteria Assessment
T1/2 > 60 days in seawater; or
T1/2 > 40 days in fresh or estuarine water; or
T1/2 > 180 days in seawater sediment; or
T1/2 > 120 days in freshwater or estuarine sediment; or
T1/2 <= 120 days in soil.
P Criteria Assessment
T1/2 > 60 days in sea, fresh or estuarine water; or
T1/2 > 180 days in sea, freshwater or estuarine sediment; or
T1/2 > 180 days in soil.
Conclusion on P / vP properties
<The criteria for P / vP are not met.>
159
<applicant> <active substance> <PT>
Assessment of bioaccumulationScreening[Include assessment of screening information provided in GB REACH Annex XIII:
Octanol-water partitioning coefficient experimentally determined or estimated by (Q)SAR models
Other information provided that its suitability and reliability can be reasonably demonstrated.]
Assessment
B Criteria Assessment
BCF > 2000
vB Criteria Assessment
BCF > 5000
Conclusion on B / vB properties
<The criteria for B / vB are not met.>
Assessment of toxicityScreening[Include assessment of screening information provided in GB REACH Annex XIII:
Short-term aquatic toxicity in accordance with Section 9.1 of Annex VII and Section 9.1.3 of Annex VIII;
Other information provided that its suitability and reliability can be reasonably demonstrated.]
Assessment
T Criteria Assessment
NOEC/EC10 (long-term) < 0.01 mg/L for freshwater or seawater organisms; or
160
<applicant> <active substance> <PT>
T Criteria Assessment
substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to GB CLP; or
there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification as specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to GB CLP.
Conclusion on T properties
<The criteria for T are not met.>
Summary and overall conclusions on PBT or vPvB propertiesOverall conclusion:
<Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.>
5.2. Substitution criteria
[Include an assessment if the active substance meets any of the following conditions:]
Substitution criteria (GB BPR, Article 10)
Assessment
One of the exclusion criteria listed in Article 5 (1) is met but AS may be approved in accordance with Article 5 (2).
The criteria to be classified, in accordance with GB CLP, as a respiratory sensitiser is met.
161
<applicant> <active substance> <PT>
Substitution criteria (GB BPR, Article 10)
Assessment
The acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario.
Two of the criteria for being PBT in accordance with Annex XIII to GB REACH are met.
There are reasons for concern linked to the nature of the critical effects that, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures.
The AS contains a significant proportion of non-active isomers or impurities.
Conclusion on substitution criteria
<The substitution criteria in GB BPR Article 10 (1) (a) – (f) are not met.>
5.3. Assessment of long-range environmental transportation and impact on environmental compartments
Assessment
The active substance or a degradation product is a persistent organic pollutant (POP) listed in Annex I of EC 850/2004 as it applies in Great Britain (GB POP).
162
<applicant> <active substance> <PT>
Assessment
Assessment of long-range transport potential (LRTAP):
Vapour pressure <1000 Pa
and
half-life in air > 2 days; or
Monitoring data in remote area showing that the substance is found in remote regions; or
Result of multi-media modelling.
The active substance or a degradation product is vP/vB or T.
Conclusion on LRTAP / POP assessment
163
<applicant> <active substance> <PT>
Part B – Exposure assessment and effects of the active substance in the biocidal product(s)6. General product information6.1. Identification of the productName(s) of the product
Trade name(s) or proposed trade name(s)
Manufacturer’s development code and number of the product
Formulation type
6.2. Complete qualitative and quantitative composition of the biocidal product
Active substance(s)
ISO or trivial name
IUPAC name or other accepted chemical name
CAS number
EC number Composition / all constituents (upper and lower concentration limit in % w/w/)
Concentration in the product in % w/w)
[Add / delete rows as required.]
[Include here a note if this information will be included in the confidential annex.]
164
<applicant> <active substance> <PT>
Other components / ingredients of the product
ISO or trivial name
IUPAC name or other accepted chemical name
CAS number
EC number Concentration in the product in % w/w)
Function
[Add / delete rows as required.]
[Include here a note if this information will be included in the confidential annex.]
165
<applicant> <active substance> <PT>
6.3. Physical, chemical and technical propertiesGeneral properties
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Physical state at 20°C and 101.3 kPa
Colour at 20°C and 101.3 kPa
Odour at 20°C and 101.3 kPa
Acidity / alkalinity
Relative density
166
<applicant> <active substance> <PT>
Storage stability, stability and shelf-life
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Accelerated storage
Long term storage at ambient temperature
Low temperature stability (liquids)
Effects on content of the active substance
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Light
Temperature and humidity
167
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Reactivity towards container material
Technical characteristics
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Wettability
Suspensibility, spontaneity and dispersion stability
Wet sieve analysis and dry sieve test
Emulsifiability, re-emulsifiability and emulsion stability
168
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Disintegration time
Particle size distribution, content of dust / fines, attrition, friability
Persistent foaming
Flowability, pourability, dustability
Burning rate – smoke generators
Burning completeness – smoke generators
Composition of smoke – smoke generators
169
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Spraying pattern - aerosols
Other technical characteristics
Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Physical compatibility
Chemical compatibility
Degree of dissolution and dilution stability
Surface tension
170
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Viscosity
Physical hazards and characteristics
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Explosives
Flammable gases
Flammable aerosols
Oxidising gases
Gases under pressure
Flammable liquids
171
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Flammable solids
Self-reactive substances and mixtures
Pyrophoric liquids
Pyrophoric solids
Substances and mixtures that in contact with water emit flammable gases
Oxidising liquids
Oxidising solids
172
<applicant> <active substance> <PT>
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Organic peroxides
Corrosive metals
Auto-ignition temperature of products (liquid and gas)
Relative self-ignition temperature of solids
Dust explosion hazard
173
<applicant> <active substance> <PT>
6.4. Hazard identification for physical and chemical properties
<Please include a summary on the hazard identification for physical-chemical properties.>
174
<applicant> <active substance> <PT>
6.5. Analytical methods for detection and identification
<Description of analytical methods used for the analysis of the active substance as manufactured including impurities and additives.>
Analytical methods for the analysis of the product as such, including the active substance, impurities and residues
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
[Add /delete rows as required.]
175
<applicant> <active substance> <PT>
Analytical methods for monitoring
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
[Add /delete rows as required.]
Analytical methods for soil
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
176
<applicant> <active substance> <PT>
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
[Add /delete rows as required.]
Analytical methods for air
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
177
<applicant> <active substance> <PT>
[Add /delete rows as required.]
Analytical methods for water
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
[Add /delete rows as required.]
178
<applicant> <active substance> <PT>
Analytical methods for monitoring of active substances and residues in food and feeding stuffs
Analyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%): Range
Recovery rate (%): Mean
Recovery rate (%): RSD
Limit of quantification (LOQ) or other limits
Reference
[Add /delete rows as required.]
179
<applicant> <active substance> <PT>
7. Efficacy7.1. EfficacyExperimental data on the efficacy of the biocidal product against target organism(s)
Function Field of use envisaged
Test substance Test organism(s)
Test method Test system / concentrations applied / exposure time
Test results: effects
Reference
[Add /delete rows as required.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
180
<applicant> <active substance> <PT>
7.2. Mode of action
<Please include any information on the mode of action.>
7.3. Resistance
<Please include any information on resistance.>
7.4. Conclusion on efficacy
<Please include a brief conclusion.>
181
<applicant> <active substance> <PT>
8. Human exposure assessment8.1. Identification of main paths of human exposure towards the active
substance from its use in the biocidal productSummary table – Relevant paths of human exposure – Primary (direct) exposure
Exposure path Industrial use Professional use General public use
Inhalation
Dermal
Oral
[Please indicate the main paths of human exposure by stating “yes”,“no” or “n.a.” (not applicable) for each cell.]
Summary table – Relevant paths of human exposure – Secondary (indirect) exposure
Exposure path
Industrial use Professional use
General public bystanders
Via food
Inhalation
Dermal
Oral
[Please indicate the main paths of human exposure by stating “yes”,“no” or “n.a.” (not applicable) for each cell.]
8.2. List of scenarios
[This list should contain all scenarios for industrial, professional, general public use and secondary exposure, but exclude dietary exposure that is covered in Chapter 8.7.]
182
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Summary table – Exposure scenarios
Scenario number
Scenario (e.g. mixing / loading)
Primary or secondary exposureDescription of scenario
Exposed group (e.g. professionals, general public users, bystanders)
1.
2.
[Add / delete rows as required. Include all scenarios in this table and then refer to them by their running number given in column 1. If exposure may take place to one person performing different tasks, please include a separate scenario for each type of (sub)task. If the same people may be exposed in several scenarios, there may be the need to evaluate the combined exposure occurring when performing these tasks.]
8.3. Industrial user exposure8.3.1. Scenario (n)
[Industrial users use biocides in the course of their job or business and they have received suitable information, instruction and training in their use. Industrial users are involved in manufacturing, handling and / or packaging of actives or products in industry and in producing end-products containing biocidal products.
Please include a section for each scenario where primary or secondary industrial exposure is foreseen. If no industrial exposure is foreseen, then only indicate this and delete the tables and text.]
Description of Scenario (n)
<Please give detailed information on the scenario and tasks, exposed worker, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>
Tier Parameters Value
Tier 1
Tier 2
Tier 3
183
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Tier Parameters Value
Reverse reference scenario
[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
[Include generic parameters (e.g. respiration rates, exposed skin areas, exposure times) and protection / penetration rates for PPE. Use footnotes for references and justifications.]
[For each Tier, only include the parameters changed with respect to the previous Tier.]
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table – Systemic exposure from industrial uses
Exposure scenario
Tier / PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenario (n)
Scenario (n)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
Further information and consideration on Scenario (n)
[Please include relevant information and considerations not covered above, e.g. information relevant for risk characterisation for local effects. If not relevant, delete the title.]
184
<applicant> <active substance> <PT>
8.3.2. Combined scenarios
Summary table – Combined systemic exposure from industrial uses
Scenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenarios (n….)
Scenarios (n…..)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
[Please include the Tier where relevant.]
8.4. Professional user exposure8.4.1. Scenario (n)
[Professional users use biocides in the course of their job or business and they have received suitable information, instruction and training in their use. Professional users use end-products outside industry.
Please include a section for each scenario where primary or secondary professional exposure is foreseen. If no professional exposure is foreseen, then only indicate this and delete the tables and text.]
Description of Scenario (n)
<Please give detailed information on the scenario and tasks, exposed worker, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>
Tier Parameters Value
Tier 1
Tier 2
Tier 3
185
<applicant> <active substance> <PT>
Tier Parameters Value
Reverse reference scenario
[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
[Include generic parameters (e.g. generic parameters and protection / penetration rates for PPE.) Use footnotes for references and justifications.]
[For each Tier, only include the parameters changed with respect to the previous Tier.]
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table – Systemic exposure from professional uses
Exposure scenario
Tier / PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenario (n)
Scenario (n)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
Further information and consideration on Scenario (n)
[Please include relevant information and considerations not covered above, e.g. information relevant for risk characterisation for local effects. If not relevant, delete the title.]
186
<applicant> <active substance> <PT>
8.4.2. Combined scenarios
Summary table – Combined systemic exposure from professional uses
Scenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenarios (n….)
Scenarios (n…..)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
[Please include the Tier where relevant.]
8.5. General public user exposure8.5.1. Scenario (n)
[General public users use biocides in their own homes / for personal use. They have not received specific instruction and training in their use.
Please include a section for each scenario where primary or secondary general public user exposure is foreseen. If no general public user exposure is foreseen, then only indicate this and delete the tables and text.]
Description of Scenario (n)
<Please give detailed information on the scenario and tasks, exposed general public user, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>
Tier Parameters Value
Tier 1
Tier 2
Tier 3
187
<applicant> <active substance> <PT>
Tier Parameters Value
Reverse reference scenario
[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
[Include generic parameters (e.g. generic parameters and protection / penetration rates for PPE if relevant.) Use footnotes for references and justifications.]
[For each Tier, only include the parameters changed with respect to the previous Tier.]
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table – Systemic exposure from general public uses
Exposure scenario
Tier / PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenario (n)
Scenario (n)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
Further information and consideration on Scenario (n)
[Please include relevant information and considerations not covered above, e.g. information relevant for risk characterisation for local effects. If not relevant, delete the title.]
188
<applicant> <active substance> <PT>
8.5.2. Combined scenarios
Summary table – Combined systemic exposure from general public uses
Scenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenarios (n….)
Scenarios (n…..)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
[Please include the Tier where relevant.]
8.6. Secondary exposure of the general public (bystanders) excluding dietary exposure
8.6.1. Scenario (n)
[Secondary exposure to the general public as bystanders may occur from use by any user group.
Please include a section for each scenario where secondary general public bystander exposure is foreseen. If no general public bystander exposure is foreseen, then only indicate this and delete the tables and text.]
Description of Scenario (n)
<Please give detailed information on the scenario and tasks, exposed general public bystanders, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>
Tier Parameters Value
Tier 1
Tier 2
Tier 3
189
<applicant> <active substance> <PT>
Tier Parameters Value
Reverse reference scenario
[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
[Include generic parameters (e.g. generic parameters and protection / penetration rates for PPE if relevant.) Use footnotes for references and justifications.]
[For each Tier, only include the parameters changed with respect to the previous Tier.]
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table – Systemic secondary exposure of general public bystanders
Exposure scenario
Tier / PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenario (n)
Scenario (n)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
Further information and consideration on Scenario (n)
[Please include relevant information and considerations not covered above, e.g. information relevant for risk characterisation for local effects. If not relevant, delete the title.]
190
<applicant> <active substance> <PT>
8.6.2. Combined scenarios
Summary table – Combined systemic secondary exposure of general public bystanders
Scenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenarios (n….)
Scenarios (n…..)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
[Please include the Tier where relevant.]
8.7. Dietary exposure
[Please include a section for each scenario where food, drinking water or livestock exposure is foreseen. If no exposure is foreseen, then only indicate this and delete the tables and text.]
8.7.1. List of scenarios
Summary table of main representative dietary exposure scenarios
Scenario number
Type of use (e.g. animal husbandry, food industry, professional use, residential use)
Description of scenario
Subject of exposure (e.g. chicken, milk, beer)
1.
2.
[Add / delete rows as required. Include all scenarios in this table and then refer to them by their running number given in column 1. Do not use the same numbers already used in Chapter 8.2 List of scenarios.]
8.7.2. Information on non-biocidal use of the active substance
[Please include a section for each area of other (non-biocidal) use of the active substance. Add / delete rows as required.]
191
<applicant> <active substance> <PT>
Summary table of other (non-biocidal uses)
Use number Sector of use (e.g. plant protection products, veterinary use food or feed additives)
Intended use Reference value(s) (e.g. MRLs – use footnotes for references))
1.
2.
8.7.3. Estimating livestock exposure to active substances used in biocidal products
8.7.3.1. Scenario (n)
[Please include a section for each relevant scenario. If not relevant, then only indicate this and delete the tables and text.]
Description of Scenario (n)
<Please give detailed information on the scenario; concentration of active substance in product and any other variables and assumptions used in the calculations.>
Tier Parameters Value
Tier 1
Tier 2
Tier 3
Reverse reference scenario
[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
[Include generic parameters Use footnotes for references and justifications.]
[For each Tier, only include the parameters changed with respect to the previous Tier.]
192
<applicant> <active substance> <PT>
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table – Internal dose received by the animal and WCCE*
<Indicate the model / calculations / database used.>
Exposure scenario
Parameters Inhalation exposure
Dermal exposure
Oral exposure
WCCE
Scenario (n)
Scenario (n)
*Worst case consumer exposure: combined estimate of the internal dose with the standard food basket (300 g muscle, 100 g liver, 50 g fat, 50 g kidney, plus 1500 g milk, 100 g eggs and 20 g honey).
[Add / delete rows as required.]
[Describe the parameters used to derive the WCCE. Use footnotes for references and justifications.]
Further information and consideration on Scenario (n)
[Please include relevant information and considerations not covered above. If not relevant, delete the title.]
Conclusion
<Please give a brief conclusion on the acceptability of the scenario.>
8.7.4. Estimating transfer of biocidal active substances into foods as a result of professional and / or industrial application(s)
8.7.4.1. Scenario (n)
<Please include for each intended representative use scenario a description of scenario; assumptions, parameters and data used for exposure estimation, including refinements if applicable; calculations and result.>
Conclusion
<Please give a brief conclusion on the acceptability of the scenario.>
8.8. Exposure associated with the production, formulation and disposal of 193
<applicant> <active substance> <PT>
the biocidal product8.8.1. Scenario (n)
[Please include a section for each relevant scenario. If not relevant, delete the title.]
Description of Scenario (n)
<Please give detailed information on the scenario and tasks, exposed worker, application method, indoor and / or outdoor use; frequency and (route specific) duration of exposure; concentration of active substance in product; absorption values (or equivalent) and any other variables and assumptions used in the calculations. Indicate the model / tool / software / database used.>
Tier Parameters Value
Tier 1
Tier 2
Tier 3
Reverse reference scenario
[Add / delete rows as required. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
[Include generic parameters (e.g. respiration rates, exposed skin areas, exposure times) and protection/penetration rates for PPE.) Use footnotes for references and justifications.]
[For each Tier, only include the parameters changed with respect to the previous Tier.]
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
194
<applicant> <active substance> <PT>
Summary table – Systemic exposure associated with production, formulation and disposal
Exposure scenario
Tier / PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenario (n)
Scenario (n)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
Further information and consideration on Scenario (n)
[Please include relevant information and considerations not covered above, e.g. information relevant for risk characterisation for local effects. If not relevant, delete the title.]
8.8.2. Combined scenarios
Summary table – Combined systemic exposure associated with production, formulation and disposal
Scenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenarios (n….)
Scenarios (n…..)
[Add / delete rows as required. Output tables from exposure assessment tools may be included to complement the table.]
[Please include the Tier where relevant.]
8.9. Combined residential scenarios
[Please include any combined residential uses, e.g. general public dietary exposure in combination with other general public user exposure or secondary exposure. Please delete this chapter if not used.]
195
<applicant> <active substance> <PT>
9. Environmental exposure assessment
[If several PTs are considered, please repeat the following chapters per PT accordingly.]
General information
Assessed PT <PT 2>
Assessed scenarios
<Scenario 1: Disinfection of rooms, furniture and objects>
<Scenario 2: Disinfection of instruments>
ESD(s) used <Emission Scenario Document for Product Type 2: Private and public health area disinfectants and other biocidal products (sanitary and medical sector), March 2001>
Approach [Please indicate per scenario if the approach is tonnage based, average consumption based or, if both are not applicable, describe the approach chosen.]
<Scenario 1: Average consumption>
<Scenario 2: Average consumption>
Distribution in the environment
<Calculated based on TGD 2003 (alternative: based on measured data>)
Groundwater simulation
[Please indicate per scenario if any simulation for leaching to groundwater using a higher tier model like e.g. one of the FOCUS models was performed.]
Confidential annexes
<NO / YES: In the confidential Annex VI to Part B the tonnage based scenarios 2 and 3 are provided>
Life-cycle steps assessed
Scenario n:
Production: <Yes/No>
Formulation: <Yes/No>
Use: <Yes/No>
Service life: <Yes/No>
196
<applicant> <active substance> <PT>
Remarks
Biocidal product specific data
<Please include here additional product specific data that may influence the fate, distribution or the toxicity of the active substance (e.g. results of leaching tests).>
9.1. Emission estimation9.1.1. Scenario (n)
[Please include a section for each scenario per PT per life cycle step.]
[Please note only the values that have been included as “Set values” in the emission scenario, default values that are under discussion or when it is possible to choose between different default values should be stated in the table.]
Input parameters for calculating the local emission – Scenario: <Disinfection of rooms, furniture and objects>
Input Value Unit Remarks
Application rate of biocidal product(alternative: annual tonnage in GB)
l/m²
Concentration of active substance in the product
g/l
[Add / delete rows according to the number of relevant set values or other necessary input parameters depending on the scenario chosen.]
Calculations for Scenario (n)
[Please include any relevant calculations here or in Appendix [III.] . If not relevant, delete the title.]
197
<applicant> <active substance> <PT>
Resulting local emission to relevant environmental compartments
Compartment Local emission (Elocalcompartment) (kg/d)
Remarks
Freshwater
Sediment
Seawater
Seawater sediment
STP
Air
Soil
Groundwater
[Add / delete additional compartments if relevant.]
198
<applicant> <active substance> <PT>
9.2. Fate and distribution in exposed environmental compartmentsIdentification of relevant receiving compartments based on the exposure pathway
Scenario Freshwater Sediment Seawater Seawater sediment STP Air Soil Groundwater Other
Scenario 1
Scenario n
[Please indicate relevant environmental compartments by stating “yes”,“no” or “not relevant” for each cell. Add / delete rows for the number of scenarios.]
Input parameters (only set values) for calculating the fate and distribution in the environment
Input Value Unit Remarks
Molecular weight g/mol
Melting point °C
Boiling point °C
Vapour pressure (at X °C) Pa
199
<applicant> <active substance> <PT>
Input Value Unit Remarks
Water solubility (at X °C) mg/l
Log10 Octanol/water partition coefficient ---
Organic carbon/water partition coefficient (Koc) l/kg
Henry’s Law Constant (at X °C)[if measured data available.] Pa/m3/mol
Biodegradability <Ready biodegradable>
Rate constant for STP[if measured data available] h-1
DT50 for biodegradation in surface water d or hr (at 12 ºC)
DT50 for hydrolysis in surface water d or hr (at 12 ºC / pH)
DT50 for photolysis in surface water d or hr
200
<applicant> <active substance> <PT>
Input Value Unit Remarks
DT50 for degradation in soil d or hr (at 12 ºC)
DT50 for degradation in air d or hr
[Add / delete rows according to the number of relevant input parameters.]
Calculated fate and distribution in the STP (if STP is a relevant compartment)
Compartment Percentage (%) Scenario 1 Percentage (%) Scenario n Remarks
Air
Water
201
<applicant> <active substance> <PT>
Compartment Percentage (%) Scenario 1 Percentage (%) Scenario n Remarks
Sludge
Degraded in STP
9.3. Calculated PEC valuesSummary table on calculated PEC values
Scenario PECSTP (mg/m3) PECwater (mg/l) PECsed
(mg/kgwwt)PECseawater
(mg/l)PECseased
(mg/kgwwt)PECsoil (mg/m3) PECGW (μ/l) PECair (mg/m3)
Scenario 1
Scenario n
[If the PECGW was calculated by using a simulation tool (e.g. one of the FOCUS models), please provide the results for the different simulated scenarios in a separate table.
[Please insert / delete additional environmental compartments if relevant. Add / delete rows according to the number of scenarios. Please include a similar table for relevant metabolites and/or degradation products.]
202
<applicant> <active substance> <PT>
9.4. Primary and secondary poisoningPrimary poisoning
<If applicable, please describe how the exposure through primary poisoning was assessed and report the outcome.>
Secondary poisoningSummary table on estimated theoretical exposition (ETE)
Scenario ETE (mg/kg*d-1) ETE (mg/kg*d-1)
Scenario 1
Scenario n
[Add / delete additional columns according to the number of species for which ETE was calculated. Add / delete rows according to the number of scenarios.]
<Waiving example if not relevant: Substance is unlikely to bioaccumulate in aquatic or terrestrial environment according to the TGD. It has a low log Kow (x.xx), it is not highly adsorptive, it does not belong to a class of substances known to have a potential to accumulate in living organisms, its structural features does not indicate accumulation and it is readily biodegradable and has a short degradation half-life of 11 h in the water/sediment test. The low accumulation potential is supported by low BCF and BMF for fish and earthworms determined by EUSES 2.1.2. The bioconcentration factor for fish is x.xx l/kg and a default BMF of 1. The bioconcentration factor for earthworms is x.xx l/kg and a default BMF of 1. No further assessment of secondary exposure via the food chain is therefore considered necessary.>
203
<applicant> <active substance> <PT>
10. Assessment of effects on human health for the product10.1. Product(s)
<Please give details of the product(s), the formulation, the in-use concentration(s), and substance(s) of concern, if relevant.>
10.2. Dermal absorption
[Please only include additional studies not covered in Part A. If a relevant study performed with the product is included in Part A, please only refer to the respective study. If no data are available, delete the tables and indicate only that no data are available.]
Summary table of in vitro studies on dermal absorption
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study
Absorption data for each compartment and final absorption value
Remarks (e.g. major deviations)
Reference
204
<applicant> <active substance> <PT>
Summary table of animal studies on dermal absorption
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Concentration of test substance / LabelDuration of exposure
Signs of toxicity Absorption data for each compartment and final absorption value
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies. If not relevant, delete the table.]
Value(s) used in the risk assessment – Dermal absorption
Value(s)
Justification
[Please include the concentration range(s) the values are applicable for, if relevant.]
Data waiving
Information requirement
205
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
10.3. Acute toxicity
[Please only include additional studies not covered in Part A. If a relevant study performed with the product is included in Part A, please only refer to the respective study. If no data are available, delete the tables and indicate only that no data are available.]
Summary table of acute toxicity studies performed with the product
Route Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Dose levels
Signs of toxicity (nature, onset, duration, severity, reversibility)
ValueLD50/LC50
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
206
<applicant> <active substance> <PT>
10.3.1. Overall conclusion on acute toxicity
Value(s) used in the risk assessment – Acute toxicity
Value(s)
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
[Please include the concentration range(s) the values are applicable for, if relevant.]
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
10.4. Corrosion and irritation
[Please only include additional studies not covered in Part A. If a relevant study performed with the product is included in Part A, please only refer to the respective study. If no data are available, delete the tables and indicate only that no data are available.]
207
<applicant> <active substance> <PT>
10.4.1. Skin corrosion and irritation
[If no data are available, delete the tables and indicate only that no data are available.]
Summary table of in vitro studies on skin corrosion / irritation
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of animal studies on skin corrosion / irritation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Vehicle,Dose levels,Duration of exposure
ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility, other adverse local/systemic effects, histopathological findings
Remarks (e.g. major deviations)
Reference
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<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Vehicle,Dose levels,Duration of exposure
ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility, other adverse local/systemic effects, histopathological findings
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on skin irritation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Skin corrosion / irritation
Value / conclusion
209
<applicant> <active substance> <PT>
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
10.4.2. Serious eye damage and eye irritation
[If no data are available, delete the tables and indicate only that no data are available.]
Summary table of in vitro studies on serious eye damage and eye irritation
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study
Results Remarks (e.g. major deviations)
Reference
210
<applicant> <active substance> <PT>
Method,Guideline,GLP status,Reliability
Test substance,Doses
Relevant information about the study
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of animal studies on serious eye damage and eye irritation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Dose levels,Duration of exposure
ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
211
<applicant> <active substance> <PT>
Summary table of human data on serious eye damage and eye irritation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Serious eye damage and eye irritation
Value / conclusion
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
212
<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
10.4.3. Respiratory tract irritation
[If no data are available, delete the tables and indicate only that no data are available.]
Summary table of animal studies on respiratory tract irritation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Dose levels,Duration of exposure
ResultsClinical signs, histopathology, reversibility
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
213
<applicant> <active substance> <PT>
Summary table of human data on respiratory tract irritation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Respiratory tract irritation
Conclusion
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
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<applicant> <active substance> <PT>
Justification
[If not relevant, delete the table.]
10.4.4. Overall conclusion on corrosion and irritation
Conclusion used in the risk assessment – Corrosion and irritation
Value(s) / Conclusion(s)
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
10.5. Sensitisation
[Please only include additional studies not covered in Part A. If a relevant study performed with the product is included in Part A, please only refer to the respective study. If no data are available, delete the tables and indicate only that no data are available.]
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<applicant> <active substance> <PT>
10.5.1. Skin sensitisation
[If no data are available, delete the tables and indicate only that no data are available.]
Summary table of animal studies on skin sensitisation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Vehicle,Dose levels,Duration of exposureRoute of exposure (topical/intradermal, if relevant)
Results (EC value or amount of sensitised animals at induction dose)Evidence for local or systemic toxicity (time course of onset)
Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on skin sensitisation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
216
<applicant> <active substance> <PT>
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
Conclusion used in the risk assessment – Skin sensitisation
Value / conclusion
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
217
<applicant> <active substance> <PT>
10.5.2. Respiratory sensitisation
[If no data are available, delete the tables and indicate only that no data are available.]
Summary table of animal studies on respiratory sensitisation
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No / group
Test substance,Dose levels,Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Add / delete rows according to the number of studies.]
Summary table of human data on respiratory sensitisation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Add / delete rows according to the number of studies.]
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<applicant> <active substance> <PT>
Conclusion used in the risk assessment – Respiratory sensitisation
Value / conclusion
Justification
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
10.5.3. Overall conclusion on sensitisation
Conclusion used in the risk assessment – Sensitisation
Value(s) / Conclusion(s)
Justification
219
<applicant> <active substance> <PT>
Classification for the product according to GB CLP
<Please include a proposal if relevant.>
Data waiving
Information requirement
Justification
[If not relevant, delete the table.]
10.6. Other
[Please include any relevant information and considerations not covered above e.g. synergistic or cumulative effects. If not relevant, delete the title.]
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<applicant> <active substance> <PT>
11. Environmental effects assessment for the product11.1. Atmosphere
[To be provided in line with section 4.2 if there are any compounds in the product that adversely affect the conclusions of the risk assessment for the active substance in the product.]
<Waiving example if not relevant: The ecotoxicological properties of the product may be derived from the properties of the active substance and other components of the product. Information on the ecotoxicity of the active substance is presented in Part A, Section 4.2. There are no compounds of concern in the formulated products that adversely affect the conclusions of the risk assessment for the active substance in the product , therefore no further assessment is needed.>
11.2. STP
[To be provided in line with section 4.2 if there are any compounds in the product that adversely affect the conclusions of the risk assessment for the active substance in the product.]
11.3. Aquatic compartment
[To be provided in line with section 4.2 if there are any compounds in the product that adversely affect the conclusions of the risk assessment for the active substance in the product.]
11.4. Terrestrial compartment
[To be provided in line with section 4.2 if there are any compounds in the product that adversely affect the conclusions of the risk assessment for the active substance in the product.]
11.5. Primary and secondary poisoning
[To be provided in line with section 4.2 if there are any compounds in the product that adversely affect the conclusions of the risk assessment for the active substance in the product.]
<Waiving example if not relevant: Substance is unlikely to bioaccumulate in aquatic or terrestrial environment according to the TGD. It has a low log Kow (x.xx), it is not highly adsorptive, it does not belong to a class of substances known to have a potential to accumulate in living organisms, its structural features does not indicate accumulation and it is readily biodegradable and has a short degradation half-life of 11 h in the water/sediment test. The low accumulation potential is supported by low BCF and BMF for fish and earthworms determined by EUSES 2.1.2. The bioconcentration factor for fish is x.xx l/kg and a default BMF of 1. The bioconcentration factor for earthworms is x.xx l/kg and a default BMF of 1. No further assessment of secondary exposure via the food chain is therefore considered necessary.>
221
<applicant> <active substance> <PT>
Part C – Risk characterisation of the biocidal product(s)12. Risk characterisation for human health12.1. Critical endpoints12.1.1. Systemic effects
Duration Study Route Relevant effects
NOAEL / LOAEL
References
Acute
Medium-term
Long-term
[Add / delete rows as required.]
12.1.2. Local effects
Route Effect Study Classification Hazard category
Dermal
Respiratory
[Add / delete rows as required.]
[Please provide the hazard category according to the guidance “Risk characterisation for local effects including sensitisation”.]
12.1.3. Absorption
Route Study Test substance
Concentration of test substance
Applicability (concentration ranges)
Value
Oral
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<applicant> <active substance> <PT>
Route Study Test substance
Concentration of test substance
Applicability (concentration ranges)
Value
Dermal
Inhalation
[Add / delete rows as required. If relevant, indicate “n.a.” in the table and use footnotes for references and justifications.]
12.2. Reference values12.2.1. Uncertainties and assessment factors
[Tables have been included below for the three AEL values that should be always derived. Please include tables for any further reference values to be derived.]
AELshort-term
Uncertainty AF Justification
Interspecies variability
Intraspecies variability
Route to route extrapolation
Time duration extrapolation
NOAEL to LOAEL extrapolation
Dose response
Severity of key health effects
Overall AF (n.a.)
223
<applicant> <active substance> <PT>
[Add / delete rows as required.]
AELmedium-term
Uncertainty AF Justification
Interspecies variability
Intraspecies variability
Route to route extrapolation
Time duration extrapolation
NOAEL to LOAEL extrapolation
Dose response
Severity of key health effects
Overall AF (n.a.)
[Add / delete rows as required.]
AELlong-term
Uncertainty AF Justification
Interspecies variability
Intraspecies variability
Route to route extrapolation
Time duration extrapolation
224
<applicant> <active substance> <PT>
Uncertainty AF Justification
NOAEL to LOAEL extrapolation
Dose response
Severity of key health effects
Overall AF (n.a.)
[Add / delete rows as required.]
12.2.2. Reference values to be used in risk characterisation
Reference Study NOAEL (LOAEL)
AF Correction for oral absorption
Value
AELshort-term
AELmedium-term
AELlong-term
ARfD
ADI
[Add / delete rows for additional reference values if necessary e.g. for local effects.]
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<applicant> <active substance> <PT>
12.2.3. Maximum residue limits or equivalent
MRLs or other relevant reference values
Reference Relevant commodities
Value
[Add / delete rows as required.]
12.2.4. Specific reference value for groundwater
[If it is proposed to derive a value according to GB BPR Annex VI point 68, other than the maximum permissible concentration laid down by UK Water Supply (Water Quality) Regulations, please include the argumentation and the calculations here. Otherwise, please delete this chapter.]
12.3. Industrial uses12.3.1. Systemic effects
Task / Scenario
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each task / scenario where industrial exposure is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]
226
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Combined scenarios
Scenarios combined
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each combination of scenarios assessed. If no combined exposure is foreseen, then only indicate this and delete the table.]
12.3.2. Local effects
[Please include an appropriate table for the assessment; please use the guidance document “Risk Characterisation for local effects and sensitisation“. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
12.3.3. Conclusion
<Please give a brief conclusion on the acceptability of the scenarios.>
12.4. Professional uses12.4.1. Systemic effects
Task / Scenario
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each task / scenario where professional exposure is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate
227
<applicant> <active substance> <PT>
this and delete the table.]
Combined scenarios
Scenarios combined
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each combination of scenarios assessed. If no combined exposure is foreseen, then only indicate this and delete the table.]
12.4.2. Local effects
[Please include an appropriate table for the assessment; please see Guidance for Human Health Risk Assessment Volume III, Part B. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
12.4.3. Conclusion
<Please give a brief conclusion on the acceptability of the scenarios.>
12.5. General public uses12.5.1. Systemic effects
Task / Scenario
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each task / scenario where general public exposure is
228
<applicant> <active substance> <PT>
foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]
Combined scenarios
Scenarios combined
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each combination of scenarios assessed. If no combined exposure is foreseen, then only indicate this and delete the table.]
12.5.2. Local effects
[Please include an appropriate table for the assessment; please see Guidance for Human Health Risk Assessment Volume III, Part B. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
12.5.3. Conclusion
<Please give a brief conclusion on the acceptability of the scenarios.>
12.6. Secondary (indirect) exposure as a result of use12.6.1. Systemic effects
Task / Scenario
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
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[Please include a row for each representative scenario where secondary (indirect) exposure of general public bystanders is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]
Combined scenarios
Scenarios combined
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each combination of scenarios assessed. If no combined exposure is foreseen, then only indicate this and delete the table.]
12.6.2. Local effects
[Please include an appropriate table for the assessment; please see Guidance for Human Health Risk Assessment Volume III, Part B. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
12.6.3. Conclusion
<Please give a brief conclusion on the acceptability of the scenarios.>
12.7. Indirect exposure via food
[Template structure to be further developed once the guidance is finalised.]
12.8. Production / formulation of active substance12.8.1. Systemic effects
Task / Scenario
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
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<applicant> <active substance> <PT>
Task / Scenario
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each scenario where exposure from production / formulation of the active substance is foreseen. If no exposure is foreseen and / or no systemic effect is observed, then only indicate this and delete the table.]
Combined scenarios
Scenarios combined
Tier Systemic NOAEL (mg/kg bw/d)
AEL (mg/kg bw/d)
Estimated uptake (mg/kg bw/d)
Estimated uptake / AEL (%)
Acceptable
(yes/no)
[Please include a row for each combination of scenarios assessed. If no combined exposure is foreseen, then only indicate this and delete the table.]
12.8.2. Local effects
[Please include an appropriate table for the assessment; please see Guidance for Human Health Risk Assessment Volume III, Part B. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
12.8.3. Conclusion
<Please give a brief conclusion on the acceptability of the scenarios.>
12.9. Aggregated exposure
[Template structure to be further developed once the guidance is finalised.]
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<applicant> <active substance> <PT>
13. Risk characterisation for the environment13.1. AtmosphereConclusion
<Please include a short conclusion on the assessment of the air compartment.>
13.2. Sewage treatment plant (STP)Summary table on calculated PEC / PNEC values
Scenario PEC / PNECSTP
Scenario 1
Scenario n
[Add / delete rows as required.]
Conclusion
<Please include a short text summarising the conclusion on the risk assessment.>
13.3. Aquatic compartmentSummary table on calculated PEC / PNEC values
Scenario PEC / PNECwater PEC / PNECsed PEC / PNECseawater PEC / PNECseased
Scenario 1
Scenario n
[Add / delete rows as required.]
Conclusion
<Please include a short text summarising the conclusion on the risk assessment.>
13.4. Terrestrial compartment
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Summary table on calculated PEC / PNEC values
Scenario PEC / PNECsoil
Scenario 1
Scenario n
[Add / delete rows as required.]
Conclusion
<Please include a short text summarising the conclusion on the risk assessment.>
13.5. Groundwater
[Please assess according to GB BPR Annex VI point 68 if the foreseeable concentration (PEC) of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in groundwater, exceeds the lower of the following concentrations:
the maximum permissible concentration laid down by UK Water Supply (Water Quality) Regulations, or
the maximum concentration as laid down following the procedure for approving the active substance under this Regulation, on the basis of appropriate data, in particular toxicological (please refer to section 14.2.4), unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.]
13.6. Primary and secondary poisoningPrimary poisoning
<Where relevant please summarise here the outcome of the primary poisoning assessment.>
Secondary poisoningSummary table on secondary poisoning
Scenario Concentration PECoral predator PEC / PNECbirds
PEC / PNECmammals
PEC / PNECfish
Scenario 1
233
<applicant> <active substance> <PT>
Scenario Concentration PECoral predator PEC / PNECbirds
PEC / PNECmammals
PEC / PNECfish
Scenario n
[Add / delete rows as required.]
Conclusion
<Please include a short text summarising the conclusion on primary and secondary poisoning.>
13.7. Aggregated exposure (combined for relevant emission sources)
[Please include an assessment if aggregated exposure is relevant based on the decision scheme developed by UBA (see Figure 1) and an overview on the results in the table below, if an aggregated exposure was conducted.]
Annual tonnage of a.s. for
biocide use
Same a.s./b.p. indifferent PTs
yes
Aggregatedexposure estimationrequired for a.s./b.p.*
no
Decision tree on need for estimation of aggregated exposure
Biocide use of a.s. < 10%
of total?
no/unknown
no
no
yes
Uses of a.s./b.p. within 1 PT Different user
categories
Wide dispersiveuse
Multiple b.p.for same purpose
Other a.s. affected
Overlapin time and
space?
No aggregated exposure estimation required for a.s./b.p.
No aggregated exposure
estimation for a.s./b.p.required
Otherregulatory
areas
or
or
or
Biocidalspecific emission
pattern
yes
yes
* a) aggregate only compartments and consider only PTs where overlap in time and space existsb) if production or formulation is within Europe, add a qualitative description of the respective environmental exposure e.g. in CAR
Different use/service life/waste
scenarios
Part 1§ Part 3
Part 2
a.s. is relevant metabolite
of other a.s., and vice versa
Main constituent of a.s. is part of
other a.s.
or
Uses of a.s./b.p. within >1 PTs
§ Part 1 has to be checked for all PTs affected
Different a.s. form the same
relevant metabolite
or
Figure 1: Decision tree on the need for estimation of aggregated exposure
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<applicant> <active substance> <PT>
Summary table on calculated PEC / PNEC values
Sources combined
PEC / PNECSTP
PEC / PNECwater
PEC / PNECsed
PEC / PNECseawater
PEC / PNECseased
PEC / PNECsoil
PEC / PNECGW
PEC / PNECair
[Add / delete rows / columns as required.]
Conclusion
<Please include a short text summarising the conclusion on the risk assessment based on aggregated exposure.>
[N.B.: This part of the template will be further elaborated as soon as the guidance on aggregated exposure is available.]
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<applicant> <active substance> <PT>
14. Risk characterisation for the physico-chemical properties
<Please include a conclusion on the risk characterisation.>
14. Measures to protect man, animals and the environment
<Please include a summary on relevant measures.>
236
<applicant> <active substance> <PT>
Part D – AppendicesAppendix I: List of endpointsChapter 1: Identity, physical and chemical properties, classification and labelling
Active substance (ISO name)
Product type
Identity
Chemical name (IUPAC)
Chemical name (CA)
CAS No
EC No
Other substance No.
Minimum purity of the active substance as manufactured (g/kg or g/l)
Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg)
Molecular formula
Molecular mass
Structural formula
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Physical and chemical properties
Melting point (state purity)
Boiling point (state purity)
Thermal stability / Temperature of decomposition
Appearance (state purity)
Relative density (state purity)
Surface tension (state temperature and concentration of the test solution)
Vapour pressure (in Pa, state temperature)
Henry’s law constant (Pa m3 mol -1)
Solubility in water (g/l or mg/l, state temperature)
pH 5 at <X> C:⁰
pH 9 at <X> C:⁰
pH <X> at <X> C:⁰
Solubility in organic solvents (in g/l or mg/l, state temperature)
Stability in organic solvents used in biocidal products including relevant breakdown products
Partition coefficient (log POW) (state temperature)
pH 5 at <X> C:⁰
pH 9 at <X> C:⁰
pH <X> at <X> C:⁰
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<applicant> <active substance> <PT>
Dissociation constant
UV/VIS absorption (max.) (if absorption > 290 nm state at wavelength)
Flammability or flash point
Explosive properties
Oxidising properties
Auto-ignition or relative self-ignition temperature
Classification and proposed labelling
with regard to physical hazards
with regard to human health hazards
with regard to environmental hazards
239
<applicant> <active substance> <PT>
Chapter 2: Methods of analysisAnalytical methods for the active substance
Technical active substance (principle of method)
Impurities in technical active substance (principle of method)
Analytical methods for residues
Soil (principle of method and LOQ)
Air (principle of method and LOQ)
Water (principle of method and LOQ)
Body fluids and tissues (principle of method and LOQ)
Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)
Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)
240
<applicant> <active substance> <PT>
Chapter 3: Impact on human healthAbsorption, distribution, metabolism and excretion in mammals
Rate and extent of oral absorption:
Rate and extent of dermal absorption*:
Distribution:
Potential for accumulation:
Rate and extent of excretion:
Toxicologically significant metabolite(s)
*The dermal absorption value is applicable for the active substance and might not be usable in product authorisation.
Acute toxicity
Rat LD50 oral
Rat LD50 dermal
Rat LC50 inhalation
Skin corrosion / irritation
Skin corrosion / irritation
Eye irritation
Eye irritation
Respiratory tract irritation
Respiratory tract irritation
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Skin sensitisation
Skin sensitisation (test method used and result)
Respiratory sensitisation
Respiratory sensitisation (test method used and result)
Repeated dose toxicityShort-term
Species / target / critical effect
Relevant oral NOAEL / LOAEL
Relevant dermal NOAEL / LOAEL
Relevant inhalation NOAEL / LOAEL
Sub-chronic
Species / target / critical effect
Relevant oral NOAEL / LOAEL
Relevant dermal NOAEL / LOAEL
Relevant inhalation NOAEL / LOAEL
Long-term
Species / target / critical effect
Relevant oral NOAEL / LOAEL
Relevant dermal NOAEL / LOAEL
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Relevant inhalation NOAEL / LOAEL
Genotoxicity
Genotoxicity
Carcinogenicity
Species / type of tumour
Relevant NOAEL / LOAEL
Reproductive toxicityDevelopmental toxicity
Species/ Developmental target / critical effect
Relevant maternal NOAEL
Relevant developmental NOAEL
Fertility
Species / critical effect
Relevant parental NOAEL
Relevant offspring NOAEL
Relevant fertility NOAEL
Neurotoxicity
Species / target / critical effect
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<applicant> <active substance> <PT>
Developmental neurotoxicity
Species / target / critical effect
Immunotoxicity
Species / target / critical effect
Developmental immunotoxicity
Species / target / critical effect
Other toxicological studies
Medical data
Summary
Value Study Safety factor
AELlong-term
AELmedium-term
AELshort-term
ADI (if residues in food or feed)
ARfD
MRLs
Relevant commodities
244
<applicant> <active substance> <PT>
Reference value for groundwater
According to GB BPR Annex VI, point 68
Dermal absorption
Study (in vitro / vivo), species tested
Formulation (formulation type and including concentration(s) tested, vehicle)
Dermal absorption values used in risk assessment
Acceptable exposure scenarios (including method of calculation)
Formulation of biocidal product
Intended uses
Industrial users
Professional users
General public users
General public bystanders
Exposure via residue in food
245
<applicant> <active substance> <PT>
Chapter 4: Fate and behaviour in the environmentRoute and rate of degradation in water
Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)
pH 5
pH 9
Other pH: <indicate the value>
Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolites
Readily biodegradable (yes / no)
Inherent biodegradable (yes / no)
Biodegradation in freshwater
Biodegradation in seawater
Non-extractable residues
Distribution in water / sediment systems (active substance)
Distribution in water / sediment systems (metabolites)
Route and rate of degradation in soil
Mineralisation (aerobic)
246
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Laboratory studies (range or median, with number of measurements, with regression coefficient)
DT50lab (20C, aerobic):
DT90lab (20C, aerobic):
DT50lab (10C, aerobic):
DT50lab (20C, anaerobic):
Degradation in the saturated zone:
Field studies (state location, range or median with number of measurements)
DT50f:
DT90f:
Anaerobic degradation
Soil photolysis
Non-extractable residues
Relevant metabolites – name and / or code, % of applied a.i. (range and maximum)
Soil accumulation and plateau concentration
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Adsorption / desorption
Ka , KdKaoc , Kdoc
pH dependence (yes / no) (if yes, type of dependence)
Fate and behaviour in air
Direct photolysis in air
Quantum yield of direct photolysis
Photo-oxidative degradation in air Latitude:Season:DT50:
Volatilization
Reference value for groundwater
According to GB BPR Annex VI, point 68
Monitoring data, if available
Soil (indicate location and type of study)
Surface water (indicate location and type of study)
Ground water (indicate location and type of study)
Air (indicate location and type of study)
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Chapter 5: Effects on non-target speciesToxicity data for aquatic species (most sensitive species of each group)Fish
Species Timescale Endpoint Toxicity
Invertebrates
Species Timescale Endpoint Toxicity
Algae
Species Timescale Endpoint Toxicity
Micro-organisms
Species Timescale Endpoint Toxicity
Effects on earthworms or other soil non-target organisms
Acute toxicity to <non-target organism>
Reproductive toxicity to <non-target organism>
Effects on soil micro-organisms
Nitrogen mineralisation
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Carbon mineralisation
Effects on terrestrial vertebrates
Acute toxicity to mammals
Acute toxicity to birds
Dietary toxicity to birds
Reproductive toxicity to birds
Effects on honeybees
Acute oral toxicity
Acute contact toxicity
Effects on other beneficial arthropods
Acute oral toxicity
Acute contact toxicity
Acute toxicity to <arthropod>
Bioconcentration
Bioconcentration factor (BCF)
Degradation time (DT50)
Degradation time (DT90)
Level of metabolites (%) in organisms accounting for > 10 % of residues
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Chapter 6: Other end points
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Appendix II: Human exposure calculations
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Appendix III: Environmental emission (and exposure) calculations
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Appendix IV: List of terms and abbreviations
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Appendix V: Overall reference list (including data owner and confidentiality claim)
Section No. / Reference No.
Author(s) Year Title, Source (where different from company), Company, Report No., GLP (where relevant) / (Un)Published
Vertebrate study(Yes / No)
Data protection claimed(Yes / No)
Data protection expiry date
Owner
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Appendix VI: Confidential information
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