Regulation (EU) No 528/2012 concerning the making available on the market and use
of biocidal products
Evaluation of active substances
DRAFT RISK ASSESSMENT REPORT(submitted by the applicant)
[or]
COMPETENT AUTHORITY REPORT(submitted by the evaluating Competent Authority)
<Active substance name>Product type <PT>
(Name of product type)
<eCA> <Active substance> <PT>
Evaluating Competent Authority: <eCA>
<Date>
<eCA> <Active substance> <PT>
In this template:
Explanatory notes are marked as follows:
[Times New Roman – Italics – brackets]
Examples provided for some areas are marked as follows:
Times New Roman – Italics – red writing
Other text that should be deleted is marked as follows:
[Times New Roman – Italics – brackets]
The eCA should delete all these texts when providing the CAR.
Substance Name: < ISO name or common name or IUPAC name>
EC Name: <If available>
EC Number: <If available>
CAS Number: < If available>
Applicant: <Legal entity name>
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Table of Contents1. STATEMENT OF SUBJECT MATTER AND PURPOSE..............................................22. CONCLUSION.....................................................................................................23. ASSESSMENT REPORT........................................................................................2SUMMARY...............................................................................................................21 PRESENTATION OF THE ACTIVE SUBSTANCE........................................................2
1.1 IDENTITY OF THE ACTIVE SUBSTANCE.........................................................................................................21.2 INTENDED USES AND EFFECTIVENESS........................................................................................................21.3 CLASSIFICATION AND LABELLING...............................................................................................................2
1.3.1 Classification and labelling for the active substance.................................................................21.3.2 Classification and labelling for the representative product(s)...................................................2
2 SUMMARY OF THE HUMAN HEALTH RISK ASSESSMENT........................................23 SUMMARY OF THE ENVIRONMENTAL RISK ASSESSMENT......................................24 ASSESSMENT OF EXCLUSION, SUBSTITUTION CRITERIA AND POP.........................2PART A ASSESSMENT OF INTRINSIC PROPERTIES AND EFFECTS OF THE ACTIVE SUBSTANCE.............................................................................................................21 GENERAL SUBSTANCE INFORMATION..................................................................2
1.1 IDENTIFICATION OF THE SUBSTANCE..........................................................................................................21.2 COMPOSITION OF THE SUBSTANCE (REFERENCE SPECIFICATIONS)....................................................................21.3 PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE...................................................................21.4 PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS.................................................................................21.5 HAZARD IDENTIFICATION FOR PHYSICO-CHEMICAL PROPERTIES.......................................................................21.6 ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION.........................................................................2
2 EFFECTS AGAINST TARGET ORGANISMS..............................................................2
2.1 FUNCTION AND FIELD OF USE ENVISAGED...................................................................................................22.2 INTENDED USES.....................................................................................................................................22.3 SUMMARY ON EFFICACY.........................................................................................................................2
2.3.1 Efficacy.....................................................................................................................................22.3.2 Mode of action.........................................................................................................................22.3.3 Resistance.................................................................................................................................2
2.4 CONCLUSION ON EFFICACY......................................................................................................................2
3 ASSESSMENT OF EFFECTS ON HUMAN HEALTH...................................................2
3.1 TOXICOKINETICS....................................................................................................................................23.1.1 Short summary of the toxicokinetic information.......................................................................23.1.2 Values and conclusions used for the risk assessment................................................................2
3.2 ACUTE TOXICITY....................................................................................................................................23.2.1 Acute oral toxicity.....................................................................................................................23.2.2 Acute dermal toxicity................................................................................................................23.2.3 Acute inhalation toxicity...........................................................................................................23.2.4 Overall conclusion on acute toxicity..........................................................................................2
3.3 IRRITATION AND CORROSION...................................................................................................................23.3.1 Skin corrosion and irritation......................................................................................................23.3.2 Eye irritation.............................................................................................................................23.3.3 Respiratory tract irritation........................................................................................................23.3.4 Overall conclusion on corrosion and irritation..........................................................................2
3.4 SENSITISATION......................................................................................................................................23.4.1 Skin sensitisation......................................................................................................................23.4.2 Respiratory sensitisation...........................................................................................................23.4.3 Overall conclusion on sensitisation...........................................................................................2
3.5 SHORT TERM REPEATED DOSE TOXICITY.....................................................................................................23.5.1 Short-term oral toxicity.............................................................................................................23.5.2 Short-term dermal toxicity........................................................................................................2
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3.5.3 Short-term inhalation toxicity...................................................................................................23.5.4 Overall conclusion on short-term repeated dose toxicity..........................................................2
3.6 SUB-CHRONIC REPEATED DOSE TOXICITY....................................................................................................23.6.1 Sub-chronic oral toxicity...........................................................................................................23.6.2 Sub-chronic dermal toxicity......................................................................................................23.6.3 Sub-chronic inhalation toxicity..................................................................................................23.6.4 Overall conclusion on sub-chronic repeated dose toxicity.........................................................2
3.7 LONG-TERM REPEATED DOSE TOXICITY.......................................................................................................23.7.1 Long-term oral toxicity.............................................................................................................23.7.2 Long-term dermal toxicity.........................................................................................................23.7.3 Long-term inhalation toxicity....................................................................................................23.7.4 Overall conclusion on long-term repeated dose toxicity...........................................................2
3.8 GENOTOXICITY......................................................................................................................................23.8.1 In vitro......................................................................................................................................23.8.2 In vivo.......................................................................................................................................23.8.3 Overall conclusion on genotoxicity...........................................................................................2
3.9 CARCINOGENICITY.................................................................................................................................23.10 REPRODUCTIVE TOXICITY.........................................................................................................................2
3.10.1 Developmental toxicity.............................................................................................................23.10.2 Fertility.....................................................................................................................................23.10.3 Effects on or via lactation.........................................................................................................23.10.4 Overall conclusion on reproductive toxicity..............................................................................2
3.11 NEUROTOXICITY....................................................................................................................................23.12 IMMUNOTOXICITY.................................................................................................................................23.13 DISRUPTION OF THE ENDOCRINE SYSTEM...................................................................................................23.14 FURTHER HUMAN DATA.........................................................................................................................23.15 OTHER DATA........................................................................................................................................2
4 ENVIRONMENTAL EFFECTS ASSESSMENT............................................................24.1 FATE AND DISTRIBUTION IN THE ENVIRONMENT...........................................................................................2
4.1.1 Degradation..............................................................................................................................24.1.2 Distribution...............................................................................................................................24.1.3 Bioaccumulation.......................................................................................................................24.1.4 Monitoring data.......................................................................................................................2
4.2 EFFECTS ON ENVIRONMENTAL ORGANISMS.................................................................................................24.2.1 Atmosphere..............................................................................................................................24.2.2 Sewage treatment plant (STP)..................................................................................................24.2.3 Aquatic compartment...............................................................................................................24.2.4 Terrestrial compartment...........................................................................................................24.2.5 Groundwater............................................................................................................................24.2.6 Birds and mammals..................................................................................................................24.2.7 Primary and secondary poisoning.............................................................................................2
4.3 ENDOCRINE DISRUPTING PROPERTIES.........................................................................................................24.4 DERIVATION OF PNECS..........................................................................................................................2
5 ASSESSMENT OF EXCLUSION CRITERIA, SUBSTITUTION CRITERIA AND POP..........25.1 EXCLUSION CRITERIA..............................................................................................................................2
5.1.1 Assessment of CMR properties.................................................................................................25.1.2 Assessment of endocrine disrupting properties........................................................................25.1.3 PBT Assessment (following Annex XIII to Regulation (EC) No 1907/2006)................................2
5.2 SUBSTITUTION CRITERIA..........................................................................................................................25.3 ASSESSMENT OF LONG-RANGE ENVIRONMENTAL TRANSPORTATION AND IMPACT ON ENVIRONMENTAL COMPARTMENTS...............................................................................................................................................2
PART B EXPOSURE ASSESSMENT AND EFFECTS OF THE ACTIVE SUBSTANCE IN THE BIOCIDAL PRODUCT(S).............................................................................................26 GENERAL PRODUCT INFORMATION.....................................................................2
6.1 IDENTIFICATION OF THE PRODUCT.............................................................................................................26.2 COMPLETE QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE BIOCIDAL PRODUCT......................................26.3 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES.......................................................................................2
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6.4 HAZARD IDENTIFICATION FOR PHYSICAL AND CHEMICAL PROPERTIES................................................................26.5 ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION.........................................................................2
7 EFFICACY..........................................................................................................27.1 EFFICACY.............................................................................................................................................27.2 MODE OF ACTION.................................................................................................................................27.3 RESISTANCE.........................................................................................................................................27.4 CONCLUSION ON EFFICACY......................................................................................................................2
8 HUMAN EXPOSURE ASSESSMENT.......................................................................28.1 IDENTIFICATION OF MAIN PATHS OF HUMAN EXPOSURE TOWARDS ACTIVE SUBSTANCE FROM ITS USE IN BIOCIDAL PRODUCT.........................................................................................................................................................28.2 LIST OF SCENARIOS................................................................................................................................28.3 INDUSTRIAL EXPOSURE...........................................................................................................................2
8.3.1 Scenario [n]...............................................................................................................................28.3.2 Combined scenarios..................................................................................................................2
8.4 PROFESSIONAL EXPOSURE.......................................................................................................................28.4.1 Scenario [n]...............................................................................................................................28.4.2 Combined scenarios..................................................................................................................2
8.5 NON-PROFESSIONAL EXPOSURE................................................................................................................28.5.1 Scenario [n]...............................................................................................................................28.5.2 Combined scenarios..................................................................................................................2
8.6 SECONDARY EXPOSURE OF THE GENERAL PUBLIC EXCLUDING DIETARY EXPOSURE................................................28.6.1 Scenario [n]...............................................................................................................................28.6.2 Combined scenarios..................................................................................................................2
8.7 DIETARY EXPOSURE................................................................................................................................28.7.1 List of scenarios........................................................................................................................28.7.2 Information of non-biocidal use of the active substance..........................................................28.7.3 Estimating Livestock Exposure to Active Substances used in Biocidal Products........................28.7.4 Estimating transfer of biocidal active substances into foods as a result of professional and/or industrial application(s)............................................................................................................................28.7.5 Estimating transfer of biocidal active substances into foods as a result of non-professional use 2
8.8 EXPOSURE ASSOCIATED WITH PRODUCTION, FORMULATION AND DISPOSAL OF THE BIOCIDAL PRODUCT..................28.8.1 Scenario [n]...............................................................................................................................28.8.2 Combined scenarios..................................................................................................................2
8.9 COMBINED RESIDENTIAL SCENARIOS..........................................................................................................2
9 ENVIRONMENTAL EXPOSURE ASSESSMENT.........................................................29.1 EMISSION ESTIMATION...........................................................................................................................2
9.1.1 Scenario [n]...............................................................................................................................29.2 FATE AND DISTRIBUTION IN EXPOSED ENVIRONMENTAL COMPARTMENTS..........................................................29.3 CALCULATED PEC VALUES........................................................................................................................29.4 PRIMARY AND SECONDARY POISONING......................................................................................................2
10 ASSESSMENT OF EFFECTS ON HUMAN HEALTH FOR THE PRODUCT...................210.1 PRODUCT(S).........................................................................................................................................210.2 DERMAL ABSORPTION............................................................................................................................210.3 ACUTE TOXICITY....................................................................................................................................2
10.3.1 Overall conclusion on acute toxicity..........................................................................................210.4 CORROSION AND IRRITATION...................................................................................................................2
10.4.1 Skin corrosion and irritation......................................................................................................210.4.2 Serious eye damage and eye irritation......................................................................................210.4.3 Respiratory tract irritation........................................................................................................210.4.4 Overall conclusion on corrosion and irritation.........................................................................2
10.5 SENSITISATION......................................................................................................................................210.5.1 Skin sensitisation......................................................................................................................210.5.2 Respiratory sensitisation...........................................................................................................210.5.3 Overall conclusion on sensitisation...........................................................................................2
10.6 OTHER................................................................................................................................................2
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11 ENVIRONMENTAL EFFECTS ASSESSMENT FOR THE PRODUCT............................211.1 ATMOSPHERE.......................................................................................................................................211.2 STP....................................................................................................................................................211.3 AQUATIC COMPARTMENT.......................................................................................................................211.4 TERRESTRIAL COMPARTMENT...................................................................................................................211.5 PRIMARY AND SECONDARY POISONING......................................................................................................2
PART C RISK CHARACTERISATION OF THE BIOCIDAL PRODUCT(S)...........................212 RISK CHARACTERISATION FOR HUMAN HEALTH................................................2
12.1 CRITICAL ENDPOINTS..............................................................................................................................212.1.1 Systemic effects........................................................................................................................212.1.2 Local effects..............................................................................................................................212.1.3 Absorption................................................................................................................................2
12.2 REFERENCE VALUES................................................................................................................................212.2.1 Uncertainties and assessment factors......................................................................................212.2.2 Reference values to be used in Risk Characterisation...............................................................212.2.3 Maximum residue limits or equivalent......................................................................................212.2.4 Specific reference value for groundwater.................................................................................2
12.3 INDUSTRIAL USES...................................................................................................................................212.3.1 Systemic effects........................................................................................................................212.3.2 Local effects..............................................................................................................................212.3.3 Conclusion................................................................................................................................2
12.4 PROFESSIONAL USES..............................................................................................................................212.4.1 Systemic effects........................................................................................................................212.4.2 Local effects..............................................................................................................................212.4.3 Conclusion................................................................................................................................2
12.5 NON-PROFESSIONAL USERS.....................................................................................................................212.5.1 Systemic effects........................................................................................................................212.5.2 Local effects..............................................................................................................................212.5.3 Conclusion................................................................................................................................2
12.6 SECONDARY (INDIRECT) EXPOSURE AS A RESULT OF USE................................................................................212.6.1 Systemic effects........................................................................................................................212.6.2 Local effects..............................................................................................................................212.6.3 Conclusion................................................................................................................................2
12.7 INDIRECT EXPOSURE VIA FOOD.................................................................................................................212.8 PRODUCTION / FORMULATION OF ACTIVE SUBSTANCE..................................................................................2
12.8.1 Systemic effects........................................................................................................................212.8.2 Local effects..............................................................................................................................212.8.3 Conclusion................................................................................................................................2
12.9 AGGREGATED EXPOSURE.........................................................................................................................2
13 RISK CHARACTERISATION FOR THE ENVIRONMENT...........................................213.1 ATMOSPHERE.......................................................................................................................................213.2 SEWAGE TREATMENT PLANT (STP)...........................................................................................................213.3 AQUATIC COMPARTMENT.......................................................................................................................213.4 TERRESTRIAL COMPARTMENT...................................................................................................................213.5 GROUNDWATER....................................................................................................................................213.6 PRIMARY AND SECONDARY POISONING......................................................................................................213.7 AGGREGATED EXPOSURE (COMBINED FOR RELEVANT EMMISSION SOURCES)......................................................2
14 RISK CHARACTERISATION FOR THE PHYSICO-CHEMICAL PROPERTIES................215 MEASURES TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT.....................2APPENDIX I: LIST OF ENDPOINTS..............................................................................2
Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling........................2Chapter 2: Methods of Analysis.........................................................................................................2Chapter 3: Impact on Human Health.................................................................................................2Chapter 4: Fate and Behaviour in the Environment..........................................................................2Chapter 5: Effects on Non-target Species..........................................................................................2Chapter 6: Other End Points..............................................................................................................2
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APPENDIX II: HUMAN EXPOSURE CALCULATIONS.......................................................2APPENDIX III: ENVIRONMENTAL EMISSION (AND EXPOSURE) CALCULATIONS..............2APPENDIX IV: LIST OF TERMS AND ABBREVIATIONS..................................................2APPENDIX V: OVERALL REFERENCE LIST (INCLUDING DATA OWNER AND CONFIDENTIALITY CLAIM)........................................................................................2Appendix VI: Confidential information............................................................................................2
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1. STATEMENT OF SUBJECT MATTER AND PURPOSE
This assessment report has been established as a result of the evaluation of the active substance <name active substance> in product-type <number> (<full name of product-type>), carried out in the context of Regulation (EU) No 528/2012, with a view to the possible approval of this substance.
On <date> the <name Evaluating Competent Authority> competent authorities received a dossier from the applicant. The Evaluating Competent Authority accepted the dossier as complete for the purpose of the evaluation on <date>.
On <date>, the Evaluating Competent Authority submitted to ECHA a copy of the assessment report containing the conclusions of the evaluation, hereafter referred to as the competent authority report (CAR). Before submitting the CAR to ECHA, the applicant was given the opportunity to provide written comments in line with Article 8(1) of Regulation (EU) No 528/2012.
In order to review the CAR and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by ECHA. Revisions agreed upon were presented at the Biocidal Products Committee and its Working Groups meetings and the competent authority report (CAR) was amended accordingly.
The aim of the assessment report is to support the opinion of the Biocidal Products Committee and a decision on the approval of <name active substance> for product-type <number> and, should it be approved, to facilitate the authorisation of individual biocidal products. In the evaluation of applications for product authorisation, the provisions of Regulation (EU) No 528/2012 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, which is available from the web-site of ECHA shall be taken into account.
However, where conclusions of this assessment report are based on data protected under the provisions of Regulation (EU) No 528/2012, 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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2. CONCLUSION
[As the conclusion, the evaluating CA should provide a draft BPC opinion.]
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3. ASSESSMENT REPORT
Summary
1 PRESENTATION OF THE ACTIVE SUBSTANCE
1.1 IDENTITY OF THE ACTIVE SUBSTANCE
Main constituent(s)ISO name
IUPAC or EC nameEC number
CAS numberIndex number in Annex VI of CLP
Minimum purity / contentStructural formula
Relevant impurities and additivesIUPAC name or chemical name or EC name
Maximum concentration in % (w/w)
Index number in Annex VI of CLP
1.2 INTENDED USES AND EFFECTIVENESS
Use of the active substance
Product typeIntended use pattern(s)
Users
Effectiveness of the active substance
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Function
Organisms to be controlled
Limitation of efficacy including resistance
Mode of action
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1.3 CLASSIFICATION AND LABELLING
1.3.1 Classification and labelling for the active substance
Hazard class/ property Proposed classificationPhysical hazards
ExplosivesFlammable gases Flammable aerosolsOxidising gasesGases under pressureFlammable liquidsFlammable solidsSelf-reactive substancesPyrophoric liquidsPyrophoric solidsSelf-heating substances and mixturesSubstances which in contact with water emit flammable gasesOxidising liquidsOxidising solidsOrganic peroxidesCorrosive to metals
Human health hazards
Acute toxicity via oral routeAcute toxicity via dermal route
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Hazard class/ property Proposed classificationAcute toxicity via inhalation route
Skin corrosion/irritation
Serious eye damage/eye irritationRespiratory sensitisationSkin sensitisationGerm cell mutagenicityCarcinogenicityReproductive toxicitySpecific target organ toxicity-single exposureSpecific target organ toxicity-repeated exposureAspiration hazard
Environmental hazards
Hazardous to the aquatic environmentHazardous to the ozone layer
Current Classification and Labelling according to Regulation (EC) No 1272/2008:
Classification LabellingHazard Class and Category
Hazard statements
Pictograms Signal word Hazard statements
Suppl. Hazard statements
Precautionary statements
SCLs and M-factors
Current Classification and Labelling according to the Directive 67/548/EEC:
Classification Labelling
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Indications of danger
R-phrases Indications of danger
R-phrases S-phrases Concentration limits
Proposed Classification and Labelling [If deviating from current classification and labelling] according to Regulation (EC) No 1272/2008:
Classification Labelling
Hazard Class and Category
Hazard statements
Pictograms Signal word Hazard statements
Suppl. Hazard statements
Precautionary statements
SCLs and M-factors
Proposed Classification and Labelling [If deviating from current classification and labelling] according to the Directive 67/548/EEC:
Classification LabellingIndications of danger
R-phrases Indications of danger
R-phrases S-phrases Concentration limits
1.3.2 Classification and labelling for the representative product(s)
Proposed Classification and Labelling according to Regulation (EC) No 1272/2008:
Classification Labelling
Hazard Class and Category
Hazard statements
Pictograms Signal word Hazard statements
Suppl. Hazard statements
Precautionary statements
SCLs and M-factors
Proposed Classification and Labelling according to the Directive 1999/45/EC:
Classification Labelling
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Indications of danger
R-phrases Indications of danger
R-phrases S-phrases Concentration limits
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, non-professional)
Compatibility of the product with the proposed packaging materials (Yes/No)
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2 SUMMARY OF THE HUMAN HEALTH RISK ASSESSMENT
Summary of the assessment of effects on human health
Endpoint Brief description
Toxicokinetics [Please include a very short description covering absorption, distribution, metabolism and excretion.]
Acute toxicity [Please include a very short description.]
Corrosion and irritation [Please include a very short description.]
Sensitisation [Please include a very short description.]
Repeated dose toxicity [Please include a very short description.]
Genotoxicity [Please include a very short description.]
Carcinogenicity [Please include a very short description.]
Reproductive toxicity [Please include a very short description.]
Neurotoxicity [Please include a very short description.]
Immunotoxicity [Please include a very short description.]
Disruption of the endocrine system
[Please include a very short description.]
Other effects [Please include a very short description.]
Reference values
Study NOAEL/ LOAEL
Overall assessment factor
Value
AELshort-term
AELmedium-term
AELlong-term
[Please include further rows if relevant.]
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Risk characterisation
[Please delete subheadings and tables that are not relevant.]
Summary table: scenarios1
Scenario number
Scenario(e.g. mixing/ loading)
Primary or secondary exposure Brief description of scenario
Exposed group(e.g. professionals, non-professionals, bystanders)
1.2.
Conclusion of risk characterisation for industrial user
Scenario, Tier, PPE
Relevant reference value2
Estimated uptakemg/kg bw/d
Estimated uptake/reference value (%)
Acceptable(yes/no)
[Please include the results of local risk characterisation if relevant.]
Conclusion of risk characterisation for professional user
Scenario, Tier
Relevant reference value2
Estimated uptakemg/kg bw/d
Estimated uptake/reference value (%)
Acceptable(yes/no)
[Please include the results of local risk characterisation if relevant.]
Conclusion of risk characterisation for non-professional user
Scenario, Tier
Relevant reference value2
Estimated uptakemg/kg bw/d
Estimated uptake/reference value (%)
Acceptable(yes/no)
[Please include the results of local risk characterisation if relevant.]
1 This table is a copy of the table in Chapter 8.3 of the Assessment Report. 2 Indicate which reference value is used (e.g. AELshort-term, AELmedium-term) and the value.
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Conclusion of risk characterisation for indirect exposure
Scenario, Tier
Relevant reference value2
Estimated uptakemg/kg bw/d
Estimated uptake/reference value (%)
Acceptable(yes/no)
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3 SUMMARY OF THE ENVIRONMENTAL RISK ASSESSMENT
Fate and behaviour in the environment
[Please delete subheadings/tables that are not relevant.]
Summary table on compartments exposed and assessed
Compartment Exposed (Y/N) Assessed (Y/N)
Summary table on relevant metabolites
Metabolite/transformation- or reaction product
Compartment % Active Substance
Summary table on relevant physico-chemical and fate and behaviour parameter of the active substance
Value Unit Remarks
Molecular weightLog Octanol/water partition coefficient Log 10Organic carbon/water partition coefficient (Koc) l/kg
Henry’s Law Constant (20 °C) Pa/m3/molBiodegradabilityDT50 for biodegradation in surface water d or hr (at 12ºC)
DT50 for hydrolysis in surface water d or hr (at 12ºC /pH)
DT50 for photolysis in surface water d or hrDT50 for degradation in soil d or hr (at 12ºC)DT50 for degradation in air d or hrDT50 for degradation in sediment d or hr[Please insert/delete additional parameters if relevant. Please include a similar table for relevant metabolites and/or degradation products]
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Effects assessment
Summary table on calculated PNEC values
Compartment PNEC
[Please insert relevant environmental compartments. Please include a similar table for relevant metabolites and/or degradation products]
Exposure assessment
Summary table on calculated PEC valuesPECSTP PECwater PECsed PECseawater PECseased PECsoil PECGW
1 PECair
[mg/m3] [mg/l] [mg/kgwwt] [mg/l] [mg/kgwwt] [mg/m3] [μg/l] [mg/m3]
Scenario 1Scenario n[Please insert/delete additional environmental compartments if relevant. Adapte the number of scenarios as necessary. Please include a similar table for relevant metabolites and/or degradation products]
Risk characterization
Summary table on calculated PEC/PNEC values
PEC/PNECSTP PEC/PNECwater PEC/PNECsed PEC/PNECseawater PEC/PNECseased PEC/PNECsoil
Scenario 1Scenario n[Please insert/delete additional environmental compartments if relevant. Adapte the number of scenarios as necessary. Please include a similar table for relevant metabolites and/or degradation products]
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Conclusion: [Please include a short text summarising the conclusion on the riks assessment]
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4 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
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Part A Assessment of intrinsic properties and effects of the active substance
1 GENERAL SUBSTANCE INFORMATION
1.1 IDENTIFICATION OF THE SUBSTANCE
Summary table on substance identity
Common name (ISO name, synonyms)Chemical name (EC name, CA name, IUPAC nameEC numberCAS numberother CAS numbers (e.g. deleted, related, preferred, alternate)Molecular formulaSMILES notationMolar mass
Structural formula
Origin of the natural active substance or precursor(s) of the active substance
Method of manufacture
[Please include here a note if this information will be included in the confidential annex]
4.2 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 Typical Concentration range Remarks /
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(chemical name) concentration (%(w/w))
(%(w/w)) Discussion
Impurities
Constituent (chemical name)
Typical concentration (%(w/w))
Concentration range (%(w/w))
Remarks / Discussion
Origin of impurity (e.g. manufacturing process, starting material)
Additives
Constituent (chemical name)
Function Typical concentration (%(w/w))
Concentration range (%(w/w))
Remarks / Discussion
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4.3 PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
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 at
Relative density
Granulometry
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
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
breakdown products
Reactivity towards container material
Dissociation constant
Granulometry
Viscositiy
Solubility in organic solvents, including effect of temperature on solubility
Stability in organic solvents used in biocidal products and identity of relevant degradation products
4.4 PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS
Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Explosives
Flammable gases
Flammable aerosols
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Oxidising gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances and mixture
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures which in contact with water emit flammable gases
Oxidising liquids
Oxidising solids
Organic peroxide
Corrosive to metals
Auto-ignition temperature (liquids and gases)
Relative self ignition temperature for solids
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Dust explosion hazard
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4.5 HAZARD IDENTIFICATION FOR PHYSICO-CHEMICAL PROPERTIES
[Please include a summary on the hazard identification for physical-chemical properties]
4.6 ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
Analytical methods
Analyte (type of analyte e.g. active substance, metabolite etc.)
Compartment Linearity Specificity Recovery rate (%) Limit of quantification (LOQ), Maximum Residue Limits or other limits
Reference Fortification range / Number of measurements
Mean RSD
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<eCA> <Active substance> <PT>
5 EFFECTS AGAINST TARGET ORGANISMS
2.1 FUNCTION AND FIELD OF USE ENVISAGED
[Please include information on function and field of use.]
2.2 INTENDED USES
Summary table of intended use(s)Product Type
Product description Target organisms (including development stage)Description of use(s)Mode of actionObjects to be protectedConcentration of product in the in-use formulation/productConcentration of active substance in the in-use formulation/productApplication rate(s)Frequency of applicationSeason/period for use (where relevant)Field of use (indoors/outdoors)Category(ies) of user(s)Instruction for use
29
<eCA> <Active substance> <PT>
5.2 SUMMARY ON EFFICACY
5.2.1 Efficacy
Experimental data on the efficacy of the active substance against target organism(s)Function Field of use
envisagedTest substance
Test organism(s)
Test method Test system / concentrations applied / exposure time
Test results: effects Reference
Data waivingInformation requirementJustification
[If not relevant, please delete the table.]
5.2.2 Mode of action
[Please include any information on the mode of action.]
5.2.3 Resistance
[Please include any information on resistance.]
30
<eCA> <Active substance> <PT>
5.3 CONCLUSION ON EFFICACY
[Please include a brief conclusion.]
31
<eCA> <Active substance>
6 ASSESSMENT OF EFFECTS ON HUMAN HEALTH
3.1 TOXICOKINETICS
Summary table of toxicokinetic studies
MethodGuideline, GLP status,Reliability
Species, Strain, Sex, No/Group
Test substance,Dose levelsDuration of exposure
Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no data are available.]
6.2.1 Short summary of the toxicokinetic information
[Please summarise the toxicokinetic information and the proposed metabolic pathway, if relevant.]
6.2.2 Values and conclusions used for the risk assessment
Value(s) used in the Risk Assessment – Oral absorptionValue(s)*Justification for the selected value(s)* please include the concentration range(s) and type of formulation(s) the values are applicable for, if
relevant
Value(s) used in the Risk Assessment – Dermal absorptionValue(s)*, **Justification for the selected value(s)* please include the concentration range(s) and type of formulation(s) the values are applicable for, if
relevant ** the dermal absorption value is applicable for the active substance and might not be usable in
product authorization
Value(s) used in the Risk Assessment – Inhalatory absorptionValue(s)*Justification for the selected value(s)* please include the concentration range(s) and type of formulation(s) the values are applicable for, if
relevant
32
<eCA> <Active substance>
Conclusion(s) used in the Risk Assessment – DistributionConclusionJustification for the conclusion
[If not relevant, delete the table.]
Conclusion(s) used in the Risk Assessment – MetabolismConclusionJustification for the conclusion
[If not relevant, delete the table.]
Conclusion(s) used in Risk Assessment – EliminationConclusionJustification for the conclusion
[If not relevant, delete the table.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
33
<eCA> <Active substance> <PT>
6.3 ACUTE TOXICITY
6.3.1 Acute oral toxicity
Summary table of animal studies on acute oral toxicity
Method,Guideline,GLP status,Reliability
Species,Strain,Sex,No/group
Test substanceDose levels, Type of administration (gavage, in diet, other)
Signs of toxicity (nature, onset, duration, severity, reversibility)
ValueLD50
Remarks (e.g. major deviations)
Reference
[Please insert/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
[Please insert/delete rows as needed. If not relevant, delete the table and include a statement that no human data is available.]
Value used in the Risk Assessment – Acute oral toxicityValueJustification for the selected value
Data waivingInformation requirement
34
<eCA> <Active substance> <PT>
Justification[If not relevant, delete the table.]
6.3.2 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
[Please insert/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/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in the Risk Assessment – Acute dermal toxicityValueJustification for the selected value[If not relevant, delete the table.]
35
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification[If not relevant, delete the table.]
6.3.3 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
[Please insert/delete rows according to the number of studies.]
Summary table of human data on acute inhalation toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
36
<eCA> <Active substance> <PT>
Value used in the Risk Assessment – Acute inhalation toxicityValueJustification for the selected value
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.3.4 Overall conclusion on acute toxicity
Value used in the Risk Assessment – Acute systemic toxicityValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
Value/conclusion used in the Risk Assessment – Acute local effectsValue/conclusionJustification for the selected value/conclusion
37
<eCA> <Active substance> <PT>
6.4 IRRITATION AND CORROSION
6.4.1 Skin corrosion and irritation
[If no data is available, delete all the tables and indicate only that no data is 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
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
[Please insert/delete rows according to the number of studies.]
38
<eCA> <Active substance> <PT>
Summary table of human data on skin corrosion/irritation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in the Risk Assessment – Skin irritation and corrosivityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.4.2 Eye irritation
[If no data is available, delete all the tables and indicate only that no data is available.]
39
<eCA> <Active substance> <PT>
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
Summary table of animal studies on serious eye damage and eye irritation
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/group
Test substanceDose levels, Duration of exposure
ResultsAverage score (24, 48, 72 h), observations and time point of onset, reversibility
Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
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
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Eye irritation and corrosivity
Value/conclusion
40
<eCA> <Active substance> <PT>
Justification for the value/conclusion
Data waiving
Information requirementJustification
[If not relevant, delete the table.]
6.4.3 Respiratory tract irritation
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of animal studies on respiratory tract irritation
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/group
Test substanceDose levels, Duration of exposure
Resultsclinical signs, histopathology, reversibility
Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on respiratory tract irritation
Type of data/report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
41
<eCA> <Active substance> <PT>
Conclusion used in the Risk Assessment – Respiratory tract irritationConclusionJustification for the conclusion
6.4.4 Overall conclusion on corrosion and irritation
Conclusion used in the Risk Assessment – Corrosion and irritationValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
6.5 SENSITISATION
6.5.1 Skin sensitisation
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
42
<eCA> <Active substance> <PT>
Summary table of animal studies on skin sensitisation
[Please insert/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
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Skin sensitisationValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.5.2 Respiratory sensitisation
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of animal data on respiratory sensitisation
Method,Guideline, GLP
Species,Strain,
Test substanceDose levels,
Results Remarks (e.g. major deviations)
Reference
43
<eCA> <Active substance> <PT>
Summary table of animal data on respiratory sensitisation
status, Reliability Sex,No/group
Duration of exposure
[Please insert/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
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in the Risk Assessment – Respiratory sensitisationValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
44
<eCA> <Active substance> <PT>
6.5.3 Overall conclusion on sensitisation
Conclusion used in the Risk Assessment – SensitisationValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
6.6 SHORT TERM REPEATED DOSE TOXICITY
6.6.1 Short-term oral toxicity
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of oral short-term animal studies (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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on short-term oral toxicity
Type of data/report, Reliability
Test substance Relevant information about the study
Observations Reference
45
<eCA> <Active substance> <PT>
Summary table of human data on short-term oral toxicity
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in the Risk Assessment – Short-term oral toxicity
Value/conclusionJustification for the value/conclusion
Data waiving
Information requirementJustification
[If not relevant, delete the table.]
6.6.2 Short-term dermal toxicity
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of dermal short-term animal studies (usually 28-day studies)
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/ group
Test substance, Vehicle Dose levels, Surface area, Duration of exposure
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
46
<eCA> <Active substance> <PT>
Summary table of dermal short-term animal studies (usually 28-day studies)
[Please insert/delete rows according to the number of studies.]
Summary table of human data on short-term dermal toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in the Risk Assessment – Short-term dermal toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.6.3 Short-term inhalation toxicity
[If dataare not available, delete all the tables and indicate only that no data is available.]
Summary table of inhalatory short-term animal studies (usually 28-day studies)
Method,Guideline, GLP
Species,Strain,
Test substance, form (gas, vapour,
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
47
<eCA> <Active substance> <PT>
Summary table of inhalatory short-term animal studies (usually 28-day studies)
status, Reliability
Sex,No/ group
dust, mist) and particle size (MMAD), Actual and nominal concentration, Type of administration (nose only / whole body/ head only),Duration of exposure
[Please insert/delete rows according to the number of studies.]
Summary table of human data on short-term inhalation toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in Risk Assessment – Short-term inhalation toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirement
48
<eCA> <Active substance> <PT>
Justification[If not relevant, delete the table.]
6.6.4 Overall conclusion on short-term repeated dose toxicity
Value used in the Risk Assessment – Short-term repeated dose systemic toxicityValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
Value/conclusion used in the Risk Assessment – Short-term repeated dose local effectsValue/conclusionJustification for the selected value/conclusionClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
49
<eCA> <Active substance> <PT>
6.7 SUB-CHRONIC REPEATED DOSE TOXICITY
6.7.1 Sub-chronic oral toxicity
Summary table of oral sub-chronic animal studies (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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on sub-chronic oral toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in Risk Assessment – Sub-chronic oral toxicityValue/conclusionJustification for the value/conclusion
50
<eCA> <Active substance> <PT>
Data waiving
Information requirement
Justification[If not relevant, delete the table.]
6.7.2 Sub-chronic dermal toxicity
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of dermal sub-chronic animal studies (usually 90-day studies)
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/ group
Test substance, Vehicle, Dose levels, Surface area,Duration of exposure
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on sub-chronic dermal toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
51
<eCA> <Active substance> <PT>
Value used in Risk Assessment – Sub-chronic dermal toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.7.3 Sub-chronic inhalation toxicity
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of inhalatory sub-chronic animal studies (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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
52
<eCA> <Active substance> <PT>
Summary table of human data on sub-chronic inhalation toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in Risk Assessment – Sub-chronic inhalation toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.7.4 Overall conclusion on sub-chronic repeated dose toxicity
Value used in the Risk Assessment – Sub-chronic repeated dose systemic toxicityValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
53
<eCA> <Active substance> <PT>
Value/conclusion used in the Risk Assessment – Sub-chronic repeated dose local effectsValue/conclusionJustification for the selected value/conclusionClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
6.8 LONG-TERM REPEATED DOSE TOXICITY
6.8.1 Long-term oral toxicity
Summary table of oral long-term animal 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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on long-term oral toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
54
<eCA> <Active substance> <PT>
Value used in Risk Assessment – Long-term oral toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.8.2 Long-term dermal toxicity
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of dermal long-term animal studies
Method,Guideline, GLP status, Realibility
Species,Strain,Sex,No/ group
Test substance, Vehicle, Dose levels, Surface area,Duration of exposure
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
55
<eCA> <Active substance> <PT>
Summary table of human data on long-term dermal toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Value used in Risk Assessment – Long-term dermal toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
56
<eCA> <Active substance> <PT>
6.8.3 Long-term inhalation toxicity
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of inhalatory long-term animal 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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on long-term inhalation toxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
57
<eCA> <Active substance> <PT>
Value used in Risk Assessment – Long-term inhalation toxicityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.8.4 Overall conclusion on long-term repeated dose toxicity
Value used in the Risk Assessment – Long-term repeated dose systemic toxicityValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
Value/conclusion used in the Risk Assessment – Long-term repeated dose local effectsValue/conclusionJustification for the selected value/conclusionClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
58
<eCA> <Active substance> <PT>
6.9 GENOTOXICITY
6.9.1 In vitro
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
[Please insert/delete rows according to the number of studies.]
Conclusion used in Risk Assessment – Genotoxicity in vitro ConclusionJustification for the conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]6.9.2 In vivo
[If no data is available, delete all the tables and indicate only that no data is available.]
59
<eCA> <Active substance> <PT>
Summary table of in vivo genotoxicity studies
Method,Guideline, GLP status, Realibility
Test substance, Doses
Relevant information about the study (e.g. species and strain, duration of exposure)
Observations Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on genotoxicity
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Genotoxicity in vivo ConclusionJustification for the conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
60
<eCA> <Active substance> <PT>
6.9.3 Overall conclusion on genotoxicity
Conclusion used in the Risk Assessment – GenotoxicityConclusionJustification for the conclusionClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
6.10 CARCINOGENICITY
Summary table of carcinogenicity studies in animals
Method,Guideline, GLP status, Realibility
Species,Strain,Sex,No/ group
Test substance, Dose levels, Route of exposure, Duration of exposure
NOAEL, LOAEL Results (Please indicate any results that might suggest carcinogenic effects, as well as other toxic effects)
Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human carcinogenicity data
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
61
<eCA> <Active substance> <PT>
Conclusion used in Risk Assessment – CarcinogenicityValue/conclusionJustification for the value/conclusionClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.11 REPRODUCTIVE TOXICITY
6.11.1 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
NOAELs, LOAELs (also for maternal effects)
Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
62
<eCA> <Active substance> <PT>
Summary table of human data on adverse effects on development
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Effects on developmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.11.2 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
NOAELs, LOAELs Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
63
<eCA> <Active substance> <PT>
Summary table of human data on adverse effects on fertility
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – FertilityValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
6.11.3 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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
64
<eCA> <Active substance> <PT>
Summary table of human data on adverse effects on or via lactation
Type of data/ report Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table.]
Conclusion used in Risk Assessment – Effects on or via lactationValue/conclusionJustification for the value/conclusion
6.11.4 Overall conclusion on reproductive toxicity
Conclusion used in the Risk Assessment – Reproductive toxicityValueJustification for the selected valueClassification according to CLP and DSD
[Please include the existing classification and/or a proposal if relevant]
65
<eCA> <Active substance> <PT>
6.12 NEUROTOXICITY
[If no data is available, delete all the tables and indicate only that no data is 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
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on neurotoxicity
Type of data/report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Neurotoxicity
Value/conclusion
Justification for the value/conclusion
66
<eCA> <Active substance> <PT>
Data waiving
Information requirement
Justification[If not relevant, delete the table.]
6.13 IMMUNOTOXICITY
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of in vitro immunotoxicity studies
Method,Guideline, GLP status, Reliability
Test substance, Doses
Relevant information about the study
NOAEL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/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
NOEAL, LOAEL Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
67
<eCA> <Active substance> <PT>
Summary table of human data on immunotoxicityType of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Immunotoxicity
Conclusion
Justification for the conclusion
Data waiving
Information requirement
Justification[If not relevant, delete the table.]
68
<eCA> <Active substance> <PT>
6.14 DISRUPTION OF THE ENDOCRINE SYSTEM
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of in vitro studies on endocrine disruption
Method,GuidelineGLP status, Reliability
Test substance Relevant information about the study
Observations Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of animal data on endocrine disruption
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/ group
Test substance,Dose levels, Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on endocrine disruptionType of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
69
<eCA> <Active substance> <PT>
Summary table of other evidence on endocrine disruption
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/ group
Test substance, Dose levels, Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table]
Conclusion used in Risk Assessment – Endocrine disruption
Conclusion
Justification for the conclusion
Data waiving
Information requirement
Justification[If not relevant, delete the table.]
70
<eCA> <Active substance> <PT>
6.15 FURTHER HUMAN DATA
[Include here only information that is not described elsewhere in sections 3.1 to 3.13. If no further data is available, delete the table and indicate only that no further data is available.]
Summary table of further human dataType of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies.]
Conclusion used in Risk Assessment – Further human data
Conclusion
Justification for the conclusion
6.16 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 data is available, delete the table and indicate only that no further data is available.]
Summary table of other dataType of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies.]
71
<eCA> <Active substance> <PT>
Conclusion used in Risk Assessment – Other data
Conclusion
Justification for the conclusion
72
<eCA> <Active substance> <PT>
7 ENVIRONMENTAL EFFECTS ASSESSMENT
4.1 FATE AND DISTRIBUTION IN THE ENVIRONMENT
7.2.1 Degradation
7.2.1.1 Abiotic degradation
HydrolysisSummary table - Hydrolysis
Method,Guideline, GLP status, Realibility
pH Temp. [°C]
Initial TS concentration, C0[mol/l]
Half-life, DT50 [d]
Coefficient of correlation, r2
Remarks Reference
[Please insert/delete rows according to the number of studies. Please provide information (as free text) on breakdown products.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
73
<eCA> <Active substance> <PT>
Phototransformation in waterSummary table – Photolysis in water
Method,Guideline, GLP status, Realibility
Initial molar TS concentra-tion
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
to be adapted for photo-oxidation in air
[Please insert/delete rows according to the number of studies. Please provide information (as free text) on breakdown products.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Usually this endpoints is not used in the risk assessment, only relevant in very specific cases.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
74
<eCA> <Active substance> <PT>
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
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Usually this endpoints is not used in the risk assessment, only relevant in very specific cases.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
75
<eCA> <Active substance> <PT>
7.2.1.2 Biotic degradation
7.2.1.2.1 Biodegradability (ready/inherent)
Summary table - biodegradation studies (ready/inherent)Method,Guideline, GLP status, Realibility
Test type1
Test parameter
Inoculum Additional substrate
Test sub-stance
concentr.
Degradation Remarks ReferenceType Conce
ntrationAdap-tation
Incuba-tion
period
Degree[%]
1 Test on inherent or ready biodegradability according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
76
<eCA> <Active substance> <PT>
7.2.1.3 Rate and route of degradation including indentification of metabolites and degradation products
7.2.1.3.1 Biological sewage treatment
Aerobic biodegradationSummary table - STP aerobic biodegradationMethod,Guideline, GLP status, Realibility
Test type1
Test parameter
Inoculum Additional substrate
Test substance concentr.
Degradation Remarks ReferenceType Conce
n-tration
Adap-tation
Incubation period
Degree[%]
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
Anaerobic biodegradationSummary table - STP anaerobic biodegradationMethod, Test Test Inoculum Additional Test Degradation Remarks Reference
77
<eCA> <Active substance> <PT>
Guideline, GLP status, Reliability
type1 parameter substrate substance concentr.
Type Concen-
tration
Adap-tation
Incubation period
Degree[%]
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
STP simulation testSummary table - STP simulation testMethod, Guideline, GLP status, Reliability
Test type1
Test parameter
Inoculum Additional substrate
Test sub-stance
con-centr.
Degradation Remarks ReferenceType Conce
n-tration
Adap-tation
Incuba-tion period
De-gree[%]
78
<eCA> <Active substance> <PT>
1 Test on STP simulation according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.2.1.3.2 Biodegradation in freshwater
Aerobic aquatic degradationSummary table – freshwater aerobic biodegradationMethod, Guideline, GLP status, Reliability
Test type1
Exposure Test substance concentra-
tion
Incubation period
Degradation(DT50)
Remarks Reference
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
79
<eCA> <Active substance> <PT>
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
Water/sediment degradation testSummary table – fresh water/sediment degradationMethod, Guideline, GLP status, Reliability
Test type1
Exposure Test system Test substance concentra-
tion
Incubation period
Degradation(DT50)
Remarks Reference
Water Sediment
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
80
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.2.1.3.3 Biodegradation in seawater
Seawater degradation studySummary table – seawater aerobic biodegradationMethod, Guideline, GLP status, Reliability
Test type1
Exposure Test substance concentra-
tion
Incubation period
Degradation(DT50)
Remarks Reference
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
Seawater/sediment degradation study
81
<eCA> <Active substance> <PT>
Summary table – seawater/sediment degradationMethod, Guideline, GLP status, Reliability
Test type1
Exposure Test system Test substance concentra-
tion
Incubation period
Degradation(DT50)
Remarks Reference
Water Sediment
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.2.1.3.4 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 us the the table provided under 4.1.1.3.3. and adapt it according to the respective study design.]
82
<eCA> <Active substance> <PT>
7.2.1.3.5 Biodegradation during manue storage
Summary table - bio Biodegradation during manure storageMethod, Guideline, GLP status, Reliability
Test type1
Test parameter
Inoculum Additional substrate
Test substance concenta-
tion
Degradation Remarks ReferenceType Conce
ntrationAdap-tation
Incubation period
Degree[%]
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.2.1.3.6 Biotic degradation in soil
7.2.1.3.6.1 Laboratory soil degradation studies
Aerobic biodegradationSummary table – aerobic biodegradation in soil- laboratory study
83
<eCA> <Active substance> <PT>
Method, Guideline, GLP status, Reliability
Test type1
Exposure Test system Test sub-stance
concentra-tion
Incu-bation period
Degra-dationDT50
Remarks Reference
Soil origin
Soil type
pH OC %
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
Anaerobic biodegradationSummary table – anaerobic biodegradation in soil- laboratory studyMethod, Guideline, GLP status, Reliability
Test type1
Exposure Test system Test sub-stance
concentra-tion
Incu-bation period
Degra-dationDT50
Remarks Reference
Soil origin
Soiltype
pH OC %
84
<eCA> <Active substance> <PT>
1 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.2.1.3.6.2 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.
Field disipation studies (field studies, two soil types)Summary table – Field dissipationMethod, Guideline, GLP status, Reliability
Site Applica-tion rate (g
AS/ha)
Surface Soil type Soil tex-ture
Test duration
Degra-dationDT50
Degra-dationDT90
Remarks Reference
Soil 1
Soil 2
Soil 31 Test according to OECD criteria
[Please insert/delete rows according to the number of studies.]
85
<eCA> <Active substance> <PT>
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
7.2.2 Distribution
7.2.2.1 Adsorption onto/desorption from soilsKa =
Adsorption coefficientKaOC = Adsorption coefficient based on organic carbon contentKd = Desorption coefficientKdOC = Desorption coefficient based on organic carbon contentKa/ Kd = Adsorption / Desorption distribution coefficient
[Please insert/delete rows according to the number of studies.]
86
Summary table – Adsorption/desorptionMethod, Guideline, GLP status, Reliability
Soil Adsorbed AS [%]
Ka KaOC Kd KdOC
Ka/Kd
Kf 1/n Remarks Reference
Soil 1
Soil 2
Soil 3
Soil n
<eCA> <Active substance> <PT>
Ka =
Adsorption coefficientKaOC = Adsorption coefficient based on organic carbon contentKd = Desorption coefficientKdOC = Desorption coefficient based on organic carbon contentKa/ Kd = Adsorption / Desorption distribution coefficient
[Please insert a table for each metabolite. If not relevant, delete the table.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]7.2.2.2 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 us the the table provided under 4.1.2.1 and adapt it according to the respective study design.
87
Summary table – Adsorption/desorption metabolite/transformation- or reaction productMethod, Guideline, GLP status, Reliability
Soil % of AS Ka KaOC Kf l/n Kd KdOC
Ka/Kd
Remarks Reference
Soil 1
Soil 2
Soil 3
Soil n
<eCA> <Active substance> <PT>
7.2.3 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)
Metabo-lites
Remarks Reference
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
Estimated aquatic bioconcentration
88
Summary table – Estimated aquatic bioconcentrationBasis for estimation
Log Kow (measured)
Estimated BCF for fish (freshwater)
Estimated BCF for fish eating bird/predator
Remarks Reference
<eCA> <Active substance> <PT>
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, please delete the table.]
Measured terrestrial 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)
Metabo-lites
Remarks Reference
89
<eCA> <Active substance> <PT>
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
Estimated terrestrial bioconcentration
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
90
Summary table – Estimated terrestrial bioconcentrationBasis for estimation
Log Kow (mea-sured)
Estimated BCF for Re-marks
Refe-renceTerrestrial food chain I Terrestrial food chain II
Soil dwelling species
Predatory bird/vertebrate
Terrestrial plant
Grazing non-target organism
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification
[If not relevant, please delete the table.]
7.2.4 Monitoring data
If monitoring data in any environmental compartment are available, please describe them here.
91
<eCA> <Active substance> <PT>
7.3 EFFECTS ON ENVIRONMENTAL ORGANISMS
7.3.1 Atmosphere
[Include text here if relevant]
7.3.2 Sewage treatment plant (STP)
Inhibition of microbial activity (aquatic)Summary table – inhibition of microbial activity
Method, Guideline, GLP status, Reliability
Species/Inoculum
Endpoint Exposure Results Remarks Refe-rence
Design Duration EC20 EC50 EC80
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
92
<eCA> <Active substance> <PT>
7.3.3 Aquatic compartment
7.3.3.1 Freshwater compartment
Acute toxicity (freshwater)
[Please insert/delete rows according to the number of studies.]
93
Summary table – acute aquatic toxicityMethod, Guideline, GLP status, Reliability
Species Endpoint Exposure Results Remarks Reference
Design Duration LC/EC0 LC/EC50 LC/EC100
Fish
Invertebrates
Algae (growth inhibition) NOErC ErC501 ErC50
2
1 calculated from the area under the growth curve2 calculated from growth rate
<eCA> <Active substance> <PT>
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Maybe not relevant if chronic data are available. Please indicate accordingly.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
Chronic toxicity (freshwater)
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[If necessary, please include a discussion on pooling data (freshwater/seawater) or discussion on SSD here.]
94
Summary table – chronic aquatic toxicityMethod, Guideline, GLP status, Reliability
Species End point/ Type of test
Exposure Results Remarks Reference
Design Duration LOEC/NOEC/EC10
Fish
Invertebrates
other aquatic plants
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
7.3.3.2 Sediment compartment
Acute toxicity (freshwater sediment)
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Maybe not relevant if chronic data are available. Please indicate accordingly.]
95
Summary table – acute toxicity to sediment dwelling organismsMethod, Guideline, GLP status, Reliability
Species Endpoint Exposure Results Remarks Reference
Design Duration LC/EC0 LC/EC50 LC/EC100
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
Chronic toxicity (freshwater sediment)
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion[If necessary, please include a discussion on pooling data (freshwater/seawater) or discussion on SSD here.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
96
Summary table – chronic toxicity to sediment dwelling organismsMethod, Guideline, GLP status, Reliability
Species Endpoint/ Type of test
Exposure Results Remarks Reference
Design Duration LOEC/NOEC/EC10
<eCA> <Active substance> <PT>
7.3.3.3 Marine compartment
Acute toxicity (seawater)
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Maybe not relevant if chronic data are available. Please indicate accordingly.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
Chronic toxicity (seawater)
97
Summary table – acute aquatic toxicityMethod, Guideline, GLP status, Reliability
Species Endpoint Exposure Results Remarks Reference
Design Duration LC/EC0 LC/EC50 LC/EC100
Summary table – chronic aquatic toxicityMethod, Guideline, GLP status, Reliability
Species Endpoint/ Type of test
Exposure Results Remarks Reference
Design Duration LOEC/NOEC/EC10
<eCA> <Active substance> <PT>
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[If necessary, please include a discussion on pooling data (freshwater/seawater) or discussion on SSD here.]
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.3.3.4 Sea sediment compartment
Acute toxicity (sea sediment)
[Please insert/delete rows according to the number of studies.]
98
Summary table – acute toxicity to sea sediment dwelling organismsMethod, Guideline, GLP status, Reliability
Species Endpoint Exposure Results Remarks Reference
Design Duration LC/EC0 LC/EC50 LC/EC100
<eCA> <Active substance> <PT>
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion[Maybe not relevant if chronic data are available. Please indicate accordingly.]
Data waivingInformation requirementJustification[If not relevant, delete the table.]
Chronic toxicity (sea sediment)
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[If necessary, please include a discussion on pooling data (freshwater/seawater) or discussion on SSD here.]
99
Summary table – chronic toxicity to sea sediment dwelling organismsMethod, Guideline, GLP status, Reliability
Species End point/ Type of test
Exposure Results Remarks Reference
Design Duration LOEC/NOEC/EC10
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification[If not relevant, delete the table.]
7.3.3.5 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 us the the table provided under 4.1.3.1 and adapt it according to the respective study design.
7.3.4 Terrestrial compartment
Toxicity to terrestrial organisms, acute testsSummary table – acute terrestrial toxicity
Method, Guideline, GLP status, Reliability
Species End point/ Type of test
Exposure Organic mater (mg/Kg
dw)
Results (in dry weight) Remarks Reference
Design Duration LC/EC0 LC/EC10 LC/EC50
Earthworm/soil-dwelling non-target invertebrates
Soil microflora
Non target plants
100
<eCA> <Active substance> <PT>
Bees and other (non-target) arthropods
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Maybe not relevant if chronic data are available. Please indicate accordingly.]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
101
<eCA> <Active substance> <PT>
Toxicity to terrestrial organisms, chronic tests
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
102
Summary table – long term terrestrial toxicityMethod, Guideline, GLP status, Reliability
Species End point/ Type of test
Exposure Results Remarks Reference
Design Duration LOEC/NOEC/EC10
Earthworm/soil-dwelling non-target invertebrates reproduction
Non target plants
Bees and other (non-target) arthropods
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification
[If not relevant, please delete the table.]
7.3.5 Groundwater
Please include any tests or monitoring sata in groundwater here.
7.3.6 Birds and mammals
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
[Maybe not relevant if chronic data are available. Please indicate accordingly.]
103
Summary table –toxicity to birds and mammalsMethod, Guideline, GLP status, Reliability
Species Endpoint Exposure Results[mg a.i./kg bw or feed ]
Remarks Reference
Design Duration LD/LC50 LOEL/ LOEC
NOEL/NOEC
<eCA> <Active substance> <PT>
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
7.3.7 Primary and secondary poisoning
Primary poisoning
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
104
Summary table – Primary poisoningMethod, Guideline, GLP status, Reliability
Species End point/ Type of test
Duration Remarks Reference
<eCA> <Active substance> <PT>
Secondary poisoning
[Please insert/delete rows according to the number of studies.]
Value used in Risk AssessmentValue/conclusionJustification for the value/conclusion
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
Waiving example: substance is unlike 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.
105
Summary table – Secondary poisoningMethod, Guideline, GLP status, Reliability
Species End point/ Type of test
Duration Remarks Reference
<eCA> <Active substance> <PT>
7.4 ENDOCRINE DISRUPTING PROPERTIES
Summary table of ecotoxicological data on endocrine disruption
Method, Guideline, GLP status, Reliability
Species,Strain,Sex,No/ group
Test substanceDose levels, Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.If not relevant delete the table]
Conclusion used in Risk Assessment – Endocrine disruption
Conclusion
Justification for the conclusion
Data waiving
Information requirement
Justification[If not relevant, delete the table.]
7.5 DERIVATION OF PNECS
Compartment PNEC Remarks/Justification
Freshwater PNECfreshwater: xx.x mg/L Organism: Fish (O. mykiss)Endpoint: LC50 (96 h) 0.52 mg/lAssessment factor: 1000Extrapolation 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:Organism:
106
<eCA> <Active substance> <PT>
Compartment PNEC Remarks/JustificationEndpoint:Assessment factor:Extrapolation method:Justification:Organism:Endpoint:Assessment factor:Extrapolation method:Justification:
[Include relevant environmental compartments or species for which PNECs have been derived.]
107
<eCA> <Active substance> <PT>
8 ASSESSMENT OF EXCLUSION CRITERIA, SUBSTITUTION CRITERIA AND POP
6.1 EXCLUSION CRITERIA
8.2.1 Assessment of CMR properties
Criteria (BPR Article 5[1]) AssessmentActive substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which 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 which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which 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 which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which 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.
8.2.2 Assessment of endocrine disrupting properties
Criteria (BPR Article 5) AssessmentActive substances which, on the basis of the criteria specified pursuant to the first subparagraph of paragraph 3 are considered as having endocrine-disrupting properties that may cause adverse effects in humans and to the environment.
(The criteria are not yet published)
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Criteria (BPR Article 5) AssessmentPending the adoption of those criteria1, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 22.
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 Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs3.
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 which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties
Active substance has not been identified as having endocrine disrupting properties.
1 This refers to the criteria mentioned in the first row.2 These active substances shall be considered as having endocrine-disrupting properties3 These active substances may be considered as having endocrine-disrupting properties
Conclusion on ED properties
The exclusion criteria in BPR Article 5(1)d are not met.
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8.2.3 PBT Assessment (following Annex XIII to Regulation (EC) No 1907/2006)
Assessment of persistence
Screening
Include a persistence assessment based on the criteria for identification of persistent or very pesistent substancesbased based on 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
Assessment
P Criteria AssessmentT1/2 > 60 days in seawater, orT1/2 > 40 days in fresh- or estuarine water, orT1/2 > 180 days in seawater sediment, orT1/2 > 120 days in freshwater- or estuarine sediment, orT1/2 <= 120 days in soil.
vP Criteria AssessmentT1/2 > 60 days in sea-, fresh- or estuarine water water, orT1/2 > 180 days in seawater-, freshwater- or estuarine sediment, orT1/2 > 180 days in soil.
Conclusion on P / vP properties
Assessment of bioaccumulation
Screening
[Include assessment of screening information provided in 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
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B Criteria AssessmentBCF > 2000
vB Criteria AssessmentBCF > 5000
Conclusion on B / vB properties
Assessment of toxicity
Screening
[Include assessment of screening information provided in 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 AssessmentNOEC/EC10 (long-term) < 0.01 mg/L for freshwater or seawater organisms, orsubstance 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 the CLP Regulation, orthere is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification:specific target organ toxicity after repeated exposure(STOT RE category 1 or 2) according to the CLP Regulation.
Conclusion on T properties
Summary and overall conclusions on PBT or vPvB properties
Overall conclusion:
Based on the assessment described in the subsections above the submission substance is not a PBT / vPvBsubstance.
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8.3 SUBSTITUTION CRITERIA
[Include an assessment if the active substance meets any of the following conditions:]
Substitution criteria (BPR, Article 10) AssessmentOne 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 Regulation (EC) No 1272/2008, as a respiratory sensitiser is metThe 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 scenarioTwo of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006 are metThere are reasons for concern linked to the nature of the critical effects which, 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 measuresThe AS contains a significant proportion of non-active isomers or impurities.
Conclusion on substitution criteria The substitution criteria in BPR Article 10(1)a-f are not met.
8.4 ASSESSMENT OF LONG-RANGE ENVIRONMENTAL TRANSPORTATION AND IMPACT ON ENVIRONMENTAL COMPARTMENTS
AssessmentThe active substance or a degradation product is a persistent organic pollutant (POP) listed in Annex I of EC 850/2004Assessment 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 modellingThe active substance or a degradation
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AssessmentThe active substance or a degradation product is a persistent organic pollutant (POP) listed in Annex I of EC 850/2004product is vP/vB or T?
Conclusion on LRTAP/POP asessment
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Part B Exposure assessment and effects of the active substance in the biocidal product(s)
9 GENERAL PRODUCT INFORMATION
6.1 IDENTIFICATION OF THE PRODUCT
Name(s) of the productTrade name(s) or proposed Trade name(s)Manufacturer’s development code and number of the productFromulation type
9.2 COMPLETE QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE BIOCIDAL PRODUCT
Active substance(s)ISO or Trivial name
IUPAC name or other accepted chemical name
EC number CAS number Composition / all constituents (upper and lower concentration limit in % (w/w))
Concentration in the product in % (w/w)
Please include here a note if this information will be included in the confidential annex
Other components / ingredients of the productISO or Trivial name
IUPAC name or other accepted chemical name
EC number CAS number Concentration in in the product in % (w/w)
Function
Please include here a note if this information will be included in the confidential annex
[Please insert/delete rows accordingly.]
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9.3 PHYSICAL, CHEMICAL AND TECHNICAL 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
Storage stability, stability and shelf-life
Accelerated storage
Long term storage at ambient temperature
Low temperature stability (liquids)
Effects on content of the active substance
Light
Temperature and humidity
Reactivity towards container material
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Technical characteristics
Wettability
Suspensibility, spontaneity and dispersion stability
Wet sieve analysis and dry sieve test
Emulsifiability, reemulsifiability and emulsion stability
Disintergration time
Particle size distribution, content of dust / fines, attrition, friability
Persistent foaming
Flowability, pourability, dustability
Burning rate – smoke generators
Burning completeness – smoke generators
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Composition of smoke – smoke generators
Spraying pattern - aerosols
Other technical characteristics
Physical and chemical compatibility with other products including other biocidal products with which its ues is to be authorised
Physical compatibility
Chemical compatibility
Degree of dissolution and dilution stability
Surface tension
Viscosity
Physical hazards and characteristics
Explosives
Flammable gases
Flammable aerosols
Oxidising gases
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances and mixtures
Pyrophoric liquids
Pyrophoric solids
Substances and mixtures which in contact with water emit flammable gases
Oxidising liquids
Oxidising solids
Organic peroxides
Corrosive metals
Auto-ignition temperature of products (liquid and gas)
Relative self-igniton temperature of solids
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Property Result Test method applied or description in case of deviation
Remarks / Discussion / Justification for waiving
References
Dust explosion hazard
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9.4 HAZARD IDENTIFICATION FOR PHYSICAL AND CHEMICAL PROPERTIES
[Please include a summary on the hazard identification for physical-chemical properties]
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9.5 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 residuesAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
Analytical methods for monitoringAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
Analytical methods for soilAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
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Analytical methods for airAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
Analytical methods for waterAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
Analytical methods for animal and human body fluids and tisuesAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
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Analytical methods for monitoring of active substances and residues in food and feeding stuffAnalyte (type of analyte e.g. active substance)
Analytical method
Fortification range / Number of measurements
Linearity Specificity Recovery rate (%) Limit of quantification (LOQ) or other limits
ReferenceRange Mean RSD
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10 EFFICACY
8.1 EFFICACY
Experimental data on the efficacy of the biocidal product against target organism(s)Function Field of use
envisagedTest substance Test
organism(s)Test method Test system /
concentrations applied / exposure time
Test results: effects
Reference
Data waivingInformation requirementJustification
[If not relevant, please delete the table.]
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10.2 MODE OF ACTION
[Please include any information on the mode of action.]
10.3 RESISTANCE
[Please include any information on resistance.]
10.4 CONCLUSION ON EFFICACY
[Please include a brief conclusion.]
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11 HUMAN EXPOSURE ASSESSMENT
8.1 IDENTIFICATION OF MAIN PATHS OF HUMAN EXPOSURE TOWARDS ACTIVE SUBSTANCE FROM ITS USE IN BIOCIDAL PRODUCT
Summary table: relevant paths of human exposure
Exposure path
Primary (direct) exposure Secondary (indirect) exposure Industrial use
Professional use
Non-professional use
Industrial use
Professional use
General public
Via food
InhalationDermalOral
[Please indicate the main paths of human exposure by stating “yes”,“no” or “n.a.” (not applicable) for each cell.]
11.2 LIST OF SCENARIOS
[This list should contain all scenarios for industrial, professional, non-professional and secondary exposure, but exclude dietary exposure which is covered in Chapter 8.7]
Summary table: scenariosScenario number
Scenario(e.g. mixing/ loading)
Primary or secondary exposure Description of scenario
Exposed group(e.g. professionals, non-professionals, bystanders)
1.2.
[Please insert or delete rows for additional scenarios as needed. 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.]
11.3 INDUSTRIAL EXPOSURE
11.3.1 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.]
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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.]
Parameters1 ValueTier 1
Tier 22
Tier 32
Reverse reference scenario2
1 Include generic parameters (e.g. respiration rates, exposed skin areas, exposure times) and protection/penetration rates for PPE. Use footnotes for references and justifications.2 Only include the parameters changed with respect to the previous Tier.
[Add and delete lines as needed. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
Calculations for Scenario [ n ]
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]Exposure scenario
Tier/PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenario [n]Scenario [n]
[Output tables from exposure assessment tools may be included to complement the table.]
Further information and considerations 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.]
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11.3.2 Combined scenarios
Scenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenarios [n,…]*
Scenarios [n,…]* Please include the Tier where relevant
[Output tables from exposure assessment tools may be included to complement the table.]
11.4 PROFESSIONAL EXPOSURE
11.4.1 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.]
Parameters* ValueTier 1
Tier 2**
Tier 3**
Reverse reference scenario**
* Include e.g. generic parameters and protection/penetration rates for PPE. Use footnotes for references and justifications.** Only include the parameters changed with respect to the previous Tier.
[Add and delete lines as needed. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
Calculations for Scenario [ n ]
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[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table: systemic exposure from professional usesExposure scenario
Tier/PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenario [n]Scenario [n][Output tables from exposure assessment tools may be included to complement the table.]
Further information and considerations 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.]
11.4.2 Combined scenarios
Summary table: combined systemic exposure from professional usesScenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated total uptake
Scenarios [n,…]1
Scenarios [n,…]1 Please include the Tier where relevant
[Output tables from exposure assessment tools may be included to complement the table.]
11.5 NON-PROFESSIONAL EXPOSURE
11.5.1 Scenario [n]
[Please include a section for each scenario where primary or secondary non-professional exposure is foreseen. If no non-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 non-professional 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.]
Parameters1 ValueTier 1
Tier 22
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Description of Scenario [n]
Tier 32
Reverse reference scenario2
1 Include e.g. generic parameters and protection/penetration rates for PPE if relevant. Use footnotes for references and justifications.2 Only include the parameters changed with respect to the previous Tier.
[Add and delete lines as needed. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
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 non-professional usesExposure scenario
Tier/PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenario [n]Scenario [n]
[Output tables from exposure assessment tools may be included to complement the table.]
Further information and considerations 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.]
11.5.2 Combined scenarios
Summary table: combined systemic exposure from non-professional usesScenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenarios [n,…]1
Scenarios [n,…]1 Please include the Tier where relevant
[Output tables from exposure assessment tools may be included to complement the table.]
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11.6 SECONDARY EXPOSURE OF THE GENERAL PUBLIC EXCLUDING DIETARY EXPOSURE
11.6.1 Scenario [n]
[Please include a section for each scenario where secondary exposure of the general public is foreseen. If no exposure is foreseen, then only indicate this and delete the tables and text.]
Description of Scenario [n][Please give detailed information on the scenario, general public exposed, 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.]
Parameters1 ValueTier 1
Tier 22
Tier 32
Reverse reference scenario2
1 Include e.g. generic parameters and protection/penetration rates for PPE if relevant. Use footnotes for references and justifications.2 Only include the parameters changed with respect to the previous Tier.
[Add and delete lines as needed. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
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 the general public
Exposure scenario
Tier/PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenario [n]Scenario [n]
[Output tables from exposure assessment tools may be included to complement the table.]
Further information and considerations on scenario [n]
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[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.]
11.6.2 Combined scenarios
Summary table: combined systemic exposure of the general publicScenarios combined
Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenarios [n,…]1
Scenarios [n,…]1 Please include the Tier where relevant
[Output tables from exposure assessment tools may be included to complement the table.]
11.7 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.]
11.7.1 List of scenarios
Summary table of main representative dietary exposure scenariosScenario number
Type of use1 Description of scenario Subject of exposure2
1.2.1 e.g. animal husbandry, food industry, professional use, residential use. 2 e.g. chicken, milk, beer
[Please insert or delete rows for additional exposure scenarios as needed. 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.]
11.7.2 Information of non-biocidal use of the active substance
[Please include a section for each area of other (non-biocidal) use of the active substance. Please insert or delete rows as needed.]
Summary table of other (non-biocidal) usesSector of use1
Intended use Reference value(s) 2
1.2.1 e.g. plant protection products, veterinary use, food or feed additives
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2 e.g. MRLs. Use footnotes for references.
11.7.3 Estimating Livestock Exposure to Active Substances used in Biocidal Products
11.7.3.1 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.]
Parameters1 ValueTier 1
Tier 22
Tier 32
Reverse reference scenario2
[Add and delete lines as needed. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
1 Include e.g. generic parameters. Use footnotes for references and justifications.2 Only include the parameters changed with respect to the previous Tier.
Calculations for estimating livestock exposure for Scenario [ n ]
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Internal dose received by the animal and WCCE*[Indicate the model/calculations/ database used]
Parameters** Inhalation exposure
Dermal exposure
Oral exposure
Total 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); **describe the parameters used to derive the WCCE. Use footnotes for references and justifications.
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Further information and considerations 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.]
11.7.4 Estimating transfer of biocidal active substances into foods as a result of professional and/or industrial application(s)
11.7.4.1 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.]
11.7.5 Estimating transfer of biocidal active substances into foods as a result of non-professional use
11.7.5.1 Scenario [n]
[Please include for each intended use scenario a description of scenario; assumptions, parameters and data used for exposure estimation; calculations and result.]
Conclusion
[Please give a brief conclusion on the acceptability of the scenario.]
11.8 EXPOSURE ASSOCIATED WITH PRODUCTION, FORMULATION AND DISPOSAL OF THE BIOCIDAL PRODUCT
11.8.1 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.]
Parameters1 ValueTier 1
Tier 22
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Description of Scenario [n]
Tier 32
Reverse reference scenario2
1 Include generic parameters (e.g. respiration rates, exposed skin areas, exposure times) and protection/penetration rates for PPE. Use footnotes for references and justifications.2 Only include the parameters changed with respect to the previous Tier.
[Add and delete lines as needed. Output tables from exposure assessment tools may also be included to replace or to complement the table.]
Calculations for Scenario [ n ]
[Please include any relevant calculations here or in Appendix II. If not relevant, delete the title.]
Summary table: systemic exposure associated with production, formulation, and disposalExposure scenario
Tier/PPE Estimated inhalation uptake
Estimated dermal uptake
Estimated oral uptake
Estimated total uptake
Scenario [n]Scenario [n]
[Output tables from exposure assessment tools may be included to complement the table.]
Further information and considerations 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.]
11.8.2 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,…]1
Scenarios [n,…]1 Please include the Tier where relevant
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[Output tables from exposure assessment tools may be included to complement the table.]
11.9 COMBINED RESIDENTIAL SCENARIOS
[Please include any combined residential uses, e.g. non-professional dietary exposure in combination with other non-professional or secondary exposure. Please delete this chapter if not used.]
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12 ENVIRONMENTAL EXPOSURE ASSESSMENT
[If several PTs are considered, please repeat the following chapters per PT accordingly.]
General informationAssessed PT PT 2
Assessed scenariosScenario 1: Disinfection of rooms, furniture and objects
Scenario 2: Disinfection of instruments
ESD(s) usedEmission 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
Lifce cycle steps assessed
Scenario n:
Production: Yes/No
Formulation Yes/No
Use: Yes/No
Service life: Yes/No
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).
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9.1 EMISSION ESTIMATION
12.2.1 Scenario [n]
[Please include a section for each scenario per PT per life cycle step.]
Please note only the values which have been included as “Set values” in the emission scenario, default values which 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 emissionInput Value Unit RemarksScenario: Disinfection of rooms, furniture and objects
Application rate of biocidal product [alternative: annual tonnage in the EU] l/m²
Concentration of active substance in the product g/l
[Please insert/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.]
Resulting local emission to relevant environmental compartments
Compartment Local emission (Elocalcompartment) [kg/d] Remarks
Freshwater
Sediment
Seawater
Seawater sediment
STP
Air
Soil
Groundwater
[Please insert/delete additional compartments if relevant.]
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12.3 FATE AND DISTRIBUTION IN EXPOSED ENVIRONMENTAL COMPARTMENTS
Identification of relevant receiving compartments based on the exposure pathway
Fresh-water
Sediment
Sea-water
Seawater sediment STP Air Soil Ground-
water Other
Scenario 1 + - - + + + + -
Scenario n
[Please indicate relevant environmental compartments by stating “yes”,“no” or “not relevant” for each cell. Adapte the number of scenarios as necessary.]
Input parameters (only set values) for calculating the fate and distribution in the environment
Input Value Unit RemarksMolecular weight g/molMelting point °CBoiling point °CVapour pressure (at X °C) PaWater solubility (at X °C) mg/lLog10 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 12ºC)
DT50 for hydrolysis in surface water d or hr (at 12ºC /pH)
DT50 for photolysis in surface water d or hrDT50 for degradation in soil d or hr (at 12ºC)DT50 for degradation in air d or hr
[Please insert/delete rows according to the number of relevant input parameters.]
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Calculated fate and distribution in the STP [if STP is a relevant compartment]
CompartmentPercentage [%]
RemarksScenario 1 Scenario n
AirWaterSludgeDegraded in STP
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12.4 CALCULATED PEC VALUES
Summary table on calculated PEC values
PECSTP PECwater PECsed PECseawater PECseased PECsoil PECGW1 PECair
[mg/m3] [mg/l] [mg/kgwwt] [mg/l] [mg/kgwwt] [mg/m3] [μg/l] [mg/m3]
Scenario 1Scenario n1 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. Adapte the number of scenarios as necessary. Please include a similar table for relevant metabolites and/or degradation products]
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12.5 PRIMARY AND SECONDARY POISONING
Primary poisoning [If applicable, please describe how the exposure through primary poisoning was assessed and report the outcome]
Secondary poisoning
Summary table on estimated theoretical exposition (ETE)
ETE ETE[mg/kg*d-1] [mg/kg*d-1]
Scenario 1Scenario n
[Please insert/delete additional columns according to the number of species for which ETE was calculated. Adapt the number of scenarios as necessary]
Waiving example if not relevant: substance is unlike 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.
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13 ASSESSMENT OF EFFECTS ON HUMAN HEALTH FOR THE PRODUCT
10.1 PRODUCT(S)
[Please give details of the product(s), the formulation, the in-use concentration(s), and substance(s) of concern, if relevant]
13.2 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 is available, delete the tables and indicate only that no data is 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
Summary table of animal studies on dermal absorption
Method,Guideline,GLP status, Reliability
Species, Strain, Sex, No/group
Concentration of test substance/Label Duration of exposure
Signs of toxicity Absorption data for each compartment and final absorption value
Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table.]
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Value(s) used in the Risk Assessment – Dermal absorptionValue(s)*
Justification for the selected value(s)* please include the concentration range(s) the values are applicable for, if relevant
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
13.3 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 is available, delete the tables and indicate only that no data is available.]
Summary of acute toxicity studies performed with the productRoute Method
GuidelineGLP status, Reliability
Species/Strain/SexNo/group
Test substance, Dose levels
Signs of toxicity (nature, onset, duration, severity, reversibility)
ValueLD50/LC50
Remarks (e.g. major deviations)
Reference
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13.3.1 Overall conclusion on acute toxicity
Value used in the Risk Assessment – Acute toxicityValue(s)Justification for the selected valueClassification for the product according to CLP and DSD
[Please include a proposal if relevant]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
13.4 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 is available, delete the tables and indicate only that no data is available.]
13.4.1 Skin corrosion and irritation
[If no data is available, delete all the tables and indicate only that no data is available.]
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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
Summary table of animal studies on skin corrosion/irritationMethod,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
Summary table of human data on skin irritation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
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13.4.2 Serious eye damage and eye irritation
[If no data is available, delete all the tables and indicate only that no data is 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
Summary table of animal studies on serious eye damage and eye irritation Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/group
Test substanceDose levels, Duration of exposure
ResultsAverage score (24, 48, 72h), observations and time point of onset, reversibility
Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
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
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
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13.4.3 Respiratory tract irritation
[If no data is available, delete all the tables and indicate only that no data is available.]
Summary table of animal studies on respiratory tract irritationMethod,Guideline, GLP status, Reliability
Species,Strain,Sex,No/group
Test substanceDose levels, Duration of exposure
Resultsclinical signs, histopathology, reversibility
Remarks (e.g. major deviations)
Reference
[Please insert/delete rows according to the number of studies.]
Summary table of human data on respiratory tract irritation
Type of data/ report, Reliability
Test substance Relevant information about the study
Observations Reference
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in the Risk Assessment – Respiratory tract irritationConclusionJustification for the conclusion
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13.4.4 Overall conclusion on corrosion and irritation
Conclusion used in the Risk Assessment – Corrosion and irritationValue(s) or Conclusion(s)Justification for the selected value/ conclusionClassification of the product according to CLP and DSD
[Please include a proposal if relevant]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
13.5 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 is available, delete the tables and indicate only that no data is available.]
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13.5.1 Skin sensitisation
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 exposure Route 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
[Please insert/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
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
Conclusion used in Risk Assessment – Skin sensitisationValue/conclusionJustification for the value/conclusionClassification of the product according to CLP and DSD
[Please include a proposal if relevant]
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Data waivingInformation requirementJustification
[If not relevant, delete the table.]
13.5.2 Respiratory sensitisation
[If no data is available, delete all the tables and indicate only that no data is available.]Summary table of animal data on respiratory sensitisation
Method,Guideline, GLP status, Reliability
Species,Strain,Sex,No/ group
Test substanceDose levels, Duration of exposure
Results Remarks (e.g. major deviations)
Reference
[Please insert/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
[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]
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Conclusion used in the Risk Assessment – Respiratory sensitisationValue/conclusionJustification for the value/conclusionClassification of the product according to CLP and DSD
[Please include a proposal if relevant]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
13.5.3 Overall conclusion on sensitisation
Conclusion used in the Risk Assessment – SensitisationConclusion(s)Justification for the conclusion(s)Classification of the product according to CLP and DSD
[Please include a proposal if relevant]
Data waivingInformation requirementJustification
[If not relevant, delete the table.]
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13.6 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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14 ENVIRONMENTAL EFFECTS ASSESSMENT FOR THE PRODUCT
11.1 ATMOSPHERE
[To be provided accordingly to section 4.2 if there are any compounds in the product that adversively 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 adversively affect the conclusions of the risk assessment for the active substance in the product , therefore no further assessment is needed.
14.2 STP
[To be provided accordingly to section 4.2 if there are any compounds in the product that adversively affect the conclusions of the risk assessment for the active substance in the product. ]
14.3 AQUATIC COMPARTMENT
[To be provided accordingly to section 4.2 if there are any compounds in the product that adversively affect the conclusions of the risk assessment for the active substance in the product. ]
14.4 TERRESTRIAL COMPARTMENT
[To be provided accordingly to section 4.2 if there are any compounds in the product that adversively affect the conclusions of the risk assessment for the active substance in the product. ]
14.5 PRIMARY AND SECONDARY POISONING
[To be provided accordingly to section 4.2 if there are any compounds in the product that adversively affect the conclusions of the risk assessment for the active substance in the product. ]
Waiving example if not relevant: substance is unlike 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.
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Part C Risk characterisation of the biocidal product(s)
15 RISK CHARACTERISATION FOR HUMAN HEALTH
12.1 CRITICAL ENDPOINTS
15.2.1 Systemic effects
Duration
Study Route Relevant effects NOAEL/ LOAEL
References
Acute Medium-termLong-term
[Please insert additional rows, if necessary.]
15.2.2 Local effects
Route Effect Study Classification Hazard category1
DermalRespiratory1 According to the guidance “Risk characterisation for local effects including sensitisation” – reference to be
updated when the guidance is integrated into ECHA guidance.
[Please insert or delete rows, as appropriate.]
15.2.3 Absorption
Route Study Test substance Concentration of test
substance
Applicability(concentration
ranges)
Value
OralDermalInhalation
[Please insert additional rows, if necessary. Please insert n.a. and use footnote for references and justifications.]
15.3 REFERENCE VALUES
15.3.1 Uncertainties and assessment factors
[Tables have been included below for the three AEL values which should be always derived. Please include tables for any further reference values to be derived.]
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AELshort-term
Uncertainty AF JustificationInterspecies variabilityIntraspecies variabilityRoute to route extrapolationTime duration extrapolationNOAEL to LOAEL extrapolationDose responseSeverity of key health effectsOverall AF (n.a.)
[Please insert rows for additional uncertainties if necessary.]
AELmedium-term
Uncertainty AF JustificationInterspecies variabilityIntraspecies variabilityRoute to route extrapolationTime duration extrapolationNOAEL to LOAEL extrapolationDose responseSeverity of key health effectsOverall AF (n.a.)
[Please insert rows for additional uncertainties if necessary.]
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AELlong-term
Uncertainty AF JustificationInterspecies variabilityIntraspecies variabilityRoute to route extrapolationTime duration extrapolationNOAEL to LOAEL extrapolationDose responseSeverity of key health effectsOverall AF (n.a.)
[Please insert rows for additional uncertainties if necessary.]
15.3.2 Reference values to be used in Risk Characterisation
Reference Study NOAEL (LOAEL)
AF Correction for oral
absorption
Value
AELshort-term
AELmedium-term
AELlong-term
ARfDADI
[Please insert rows for additional reference values if necessary, e.g. for local effects.]
15.3.3 Maximum residue limits or equivalent
MRLs or other relevant reference
values
Reference Relevant commodities
Value
[Please insert or delete rows as appropriate.]
15.3.4 Specific reference value for groundwater
[If it is proposed to derive a value according to BPR Annex VI point 68, other than the maximum permissible concentration laid down by Directive 98/83/EC, please include the argumentation and the calculations here. Otherwise, please delete this chapter.]
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15.4 INDUSTRIAL USES
15.4.1 Systemic effects
Task/Scenario
Tier Systemic NOAEL
mg/kg bw/d
AELmg/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 this and delete the table.]
Combined scenarios
Scenarios combined
Tier Systemic NOAEL
mg/kg bw/d
AELmg/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 if foreseen, then only indicate this and delete the table.]
15.4.2 Local effects
[Please include an appropriate table for the assessment3. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
15.4.3 Conclusion
[Please give a brief conclusion on the acceptability of the scenarios.]
3 Use the guidance document “Risk Characterisation for local effects and sensitisation“ – reference to be updated when the guidance is integrated into ECHA guidance.
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15.5 PROFESSIONAL USES
15.5.1 Systemic effects
Task/Scenario
Tier/PPE Systemic NOAELmg/kg bw/d
AELmg/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 this and delete the table.]
Combined scenarios
Scenarios combined
Tier/PPE Systemic NOAELmg/kg bw/d
AELmg/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 if foreseen, then only indicate this and delete the table.]
15.5.2 Local effects
[Please include an appropriate table for the assessment4. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
15.5.3 Conclusion
[Please give a brief conclusion on the acceptability of the scenarios.]
15.6 NON-PROFESSIONAL USERS
15.6.1 Systemic effects
Task/Scenario
Tier Systemic NOAEL
mg/kg bw/d
AELmg/kg bw/d
Estimated uptake
mg/kg bw/d
Estimated uptake/
AEL (%)
Acceptable(yes/no)
4 Guidance for Human Health Risk Assessment Volume III, Part B.
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[Please include a row for each task/scenario where non-professional exposure 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
AELmg/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 if foreseen, then only indicate this and delete the table.]
15.6.2 Local effects
[Please include an appropriate table for the assessment5. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
15.6.3 Conclusion
[Please give a brief conclusion on the acceptability of the scenarios.]
15.7 SECONDARY (INDIRECT) EXPOSURE AS A RESULT OF USE
15.7.1 Systemic effects
Scenario Tier Systemic NOAEL
mg/kg bw/d
AELmg/kg bw/d
Estimated uptake
mg/kg bw/d
Estimated uptake/
AEL (%)
Acceptable(yes/no)
[Please include a row for each representative scenario where secondary (indirect) exposure of the general public 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
AELmg/kg bw/d
Estimated uptake
mg/kg bw/d
Estimated uptake/
AEL (%)
Acceptable(yes/no)
5 Guidance for Human Health Risk Assessment Volume III, Part B.
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[Please include a row for each combination of scenarios assessed. If no combined exposure if foreseen, then only indicate this and delete the table.]
15.7.2 Local effects
[Please include an appropriate table for the assessment6. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
15.7.3 Conclusion
[Please give a brief conclusion on the acceptability of the scenarios.]
15.8 INDIRECT EXPOSURE VIA FOOD
[Template structure to be further developed once the guidance is finalised.]
15.9 PRODUCTION / FORMULATION OF ACTIVE SUBSTANCE
[Please include a section for each scenario where professional exposure is foreseen. If no professional exposure is foreseen, then only indicate this and delete the tables and text.]
15.9.1 Systemic effects
Scenario Tier Systemic NOAEL
mg/kg bw/d
AELmg/kg bw/d
Estimated uptake
mg/kg bw/d
Estimated uptake/
AEL (%)
Acceptable(yes/no)
[Please include a row for each scenario where professional exposure is foreseen. If no exposure is foreseen and/or no systemic effects observed, then only indicate this and delete the table.]
Combined scenarios
Scenarios combined
Tier Systemic NOAEL
mg/kg bw/d
AELmg/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 if foreseen, then only indicate this and delete the table.]
6 Guidance for Human Health Risk Assessment Volume III, Part B.
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15.9.2 Local effects
[Please include an appropriate table for the assessment7. If no exposure is foreseen and/or there is no need to consider local effects separately, then only indicate this.]
15.9.3 Conclusion
[Please give a brief conclusion on the acceptability of the scenarios.]
15.10 AGGREGATED EXPOSURE
[Template structure to be further developed once the methodology has been developed.]
7 Guidance for Human Health Risk Assessment Volume III, Part B.
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16 RISK CHARACTERISATION FOR THE ENVIRONMENT
13.1 ATMOSPHERE
Conclusion: [Please include a short conclusion on the assessment of the air compartment]
16.2 SEWAGE TREATMENT PLANT (STP)
Summary table on calculated PEC/PNEC values
PEC/PNECSTP
Scenario 1Scenario n
[Please insert/delete rows as needed.]
Conclusion: [Please include a short text summarising the conclusion on the risk assessment]
16.3 AQUATIC COMPARTMENT
Summary table on calculated PEC/PNEC values
PEC/PNECwater PEC/PNECsed PEC/PNECseawater PEC/PNECseased
Scenario 1Scenario n
[Please insert/delete rows as needed.]
Conclusion: [Please include a short text summarising the conclusion on the risk assessment]
16.4 TERRESTRIAL COMPARTMENT
Calculated PEC/PNEC values
PEC/PNECsoil
Scenario 1Scenario n
[Please insert/delete rows as needed.]
Conclusion: [Please include a short text summarising the conclusion on the risk assessment]
16.5 GROUNDWATER
[Please assess according to 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 Directive 98/83/EC, or
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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.]
16.6 PRIMARY AND SECONDARY POISONING
Primary poisoning
[Where relevant please summarise here the outcome of the primary poisoning assessment].
Secondary poisoning
Summary table on secondary poisoning
Scenario Concentration PECoral predatorPEC/
PNECbirds
PEC/PNECmammal
s
PEC/PNECfish
[Please insert/delete rows as needed.]
Conclusion: [Please include a short text summarising the conclusion on primary and secondary poisoning]
16.7 AGGREGATED EXPOSURE (COMBINED FOR RELEVANT EMMISSION 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.]
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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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Summary table on calculated PEC/PNEC values
PEC/PNECSTP PEC/PNECwater PEC/PNECsed PEC/PNECseawater PEC/PNECseased PEC/PNECsoil PECGW PECair
[Please insert/delete additional compartments if additional environmental compartments are relevant.]
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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17 RISK CHARACTERISATION FOR THE PHYSICO-CHEMICAL PROPERTIES
[Please include a conclusion on the risk characterisation]
18 MEASURES TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT
[Please include a summary on relevant measures]
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Part D: AppendicesAppendix I: List of endpoints
Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling
Active substance (ISO Name)Product-type
IdentityChemical name (IUPAC)Chemical name (CA)CAS NoEC NoOther 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 formulaMolecular massStructural formula
Physical and chemical propertiesMelting point (state purity)Boiling point (state purity)Thermal stability / Temperature of decompositionAppearance (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 ___ ⁰C:
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pH 9 at ___ ⁰C:pH [X] at ___ ⁰C:
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 ___ ⁰C:pH 9 at ___ ⁰C:pH [X] at ___ ⁰C:
Dissociation constantUV/VIS absorption (max.) (if absorption > 290 nm state at wavelength)
Flammability or flash pointExplosive propertiesOxidising propertiesAuto-ignition or relative self ignition temperature
Classification and proposed labellingwith regard to physical hazardswith regard to human health hazardswith regard to environmental hazards
Chapter 2: Methods of Analysis
Analytical methods for the active substance Technical active substance (principle of method) Impurities in technical active substance (principle of method)
Analytical methods for residuesSoil (principle of method and LOQ)Air (principle of method and LOQ)Water (principle of method and LOQ)
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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)
Chapter 3: Impact on Human Health
Absorption, distribution, metabolism and excretion in mammalsRate 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 authorization
Acute toxicityRat LD50 oralRat LD50 dermalRat LC50 inhalation
Skin corrosion/irritation
Eye irritation
Respiratory tract irritation
Skin sensitisation (test method used and result)
Respiratory sensitisation (test method used and result)
Repeated dose toxicityShort termSpecies / target / critical effect
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Relevant oral NOAEL / LOAELRelevant dermal NOAEL / LOAELRelevant inhalation NOAEL / LOAEL
Subchronic Species/ target / critical effectRelevant oral NOAEL / LOAELRelevant dermal NOAEL / LOAELRelevant inhalation NOAEL / LOAEL
Long term Species/ target / critical effectRelevant oral NOAEL / LOAELRelevant dermal NOAEL / LOAELRelevant inhalation NOAEL / LOAEL
Genotoxicity
CarcinogenicitySpecies/type of tumourRelevant NOAEL/LOAEL
Reproductive toxicityDevelopmental toxicity
Species/ Developmental target / critical effectRelevant maternal NOAELRelevant developmental NOAELFertility
Species/critical effectRelevant parental NOAELRelevant offspring NOAELRelevant fertility NOAEL
Neurotoxicity Species/ target/critical effect
Developmental Neurotoxicity
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Species/ target/critical effect
ImmunotoxicitySpecies/ target/critical effect
Developmental ImmunotoxicitySpecies/ target/critical effect
Other toxicological studies
Medical data
SummaryValue Study Safety
factorAELlong-term
AELmedium-term
AELshort-term
ADI8
ARfD
MRLs
Relevant commodities
Reference value for groundwater
According to BPR Annex VI, point 68
Dermal absorption
Study (in vitro/vivo), species testedFormulation (formulation type and including concentration(s) tested, vehicle)Dermal absorption values used in risk assessment
8 If residues in food or feed.
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Acceptable exposure scenarios (including method of calculation)Formulation of biocidal productIntended usesIndustrial usersProfessional usersNon professional usersGeneral publicExposure via residue in food
Chapter 4: Fate and Behaviour in the Environment
Route and rate of degradation in waterHydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)
pH 5pH 9Other pH: [indicate the value]
Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolitesReadily biodegradable (yes/no)Inherent biodegradable (yes/no)Biodegradation in freshwaterBiodegradation in seawaterNon-extractable residuesDistribution in water / sediment systems (active substance)Distribution in water / sediment systems (metabolites)
Route and rate of degradation in soilMineralization (aerobic)Laboratory studies (range or median, with number of measurements, with regression coefficient)
DT50lab (20C, aerobic):DT90lab (20C, aerobic):DT50lab (10C, aerobic):
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DT50lab (20C, anaerobic):degradation in the saturated zone:Field studies (state location, range or median with number of measurements)
DT50f:DT90f:
Anaerobic degradationSoil photolysisNon-extractable residues Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)Soil accumulation and plateau concentration
Adsorption/desorptionKa , KdKaoc , Kdoc
pH dependence (yes / no) (if yes type ofdependence)
Fate and behaviour in airDirect photolysis in airQuantum yield of direct photolysisPhoto-oxidative degradation in air Latitude: .............
Season: ................. DT50 ..............
Volatilization
Reference value for groundwaterAccording to BPR Annex VI, point 68
Monitoring data, if availableSoil (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 Species
Toxicity data for aquatic species (most sensitive species of each group)
Species Time-scale
Endpoint Toxicity
Fish
Invertebrates
Algae
Microorganisms
Effects on earthworms or other soil non-target organisms
Acute toxicity to …………………………………..
Reproductive toxicity to …………………………
Effects on soil micro-organismsNitrogen mineralizationCarbon mineralization
Effects on terrestrial vertebratesAcute toxicity to mammalsAcute toxicity to birdsDietary toxicity to birdsReproductive toxicity to birds
Effects on honeybeesAcute oral toxicityAcute contact toxicity
Effects on other beneficial arthropods
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Acute oral toxicityAcute contact toxicityAcute toxicity to …………………………………..
BioconcentrationBioconcentration factor (BCF)Depration time (DT50)Depration time (DT90)Level of metabolites (%) in organisms accounting for > 10 % of residues
Chapter 6: Other End Points
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Appendix II: Human exposure calculations
Appendix III: Environmental emission (and exposure) calculations
Appendix IV: List of terms and abbreviations
Appendix V: Overall reference list (including data owner and confidentiality claim)
Appendix VI: Confidential information
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