PART 5 OECD, EU, US, CANADIAN, JAPANESE AND AUSTRALIAN NUMBERING SYSTEMS FOR DATA AND INFORMATION ON FORMULATED PRODUCT

Transcription

1 - A6/61 - Appendix 6 Format for the listing of test and study reports PART 5,, US, CANADIAN, JAPANESE AND AUSTRALIAN NUMBERING SYSTEMS FOR DATA AND INFORMATION ON FORMULATED PRODUCT 1 As indicated in subparagraph xviii, the ing systems used in many countries for the data and information relating to formulated products to be submitted, are different. It is suggested that applicants use the ing system, for the purposes of submitting data and information appropriate to the country (or countries) to which application(s) is (are) being made. Alternatively, applicants can use the country-specific ing system for the country to which application is being made. The ing system for data and information concerning formulated products together with the ing systems used in some countries is provided in the following pages. 2 The ing system was developed to facilitate the development of a common format for dossiers prepared by industry. The tabular presentation of the system side by side with the, US,, and systems, is intended to assist industry in converting from ing systems used nationally to the ing system. 3 Applicants and registrants are advised that use of a common ing system does not imply a common set of data requirements. It is still necessary for applicants and registrants to ensure that each particular submission complies with the data requirements of the relevant national regulatory authority.

2 - A6/62 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 1 Identity of the Plant Protection Product OPPTS 13 OPP IIIA 1.1 Applicant (name, address, contact, telephone and telefax s) 1.1 Forms (5), (1) Forms (5), (1) Yes 1.2 IIIA 1.2 Manufacturer of the preparation, manufacturer and purity of the active substance(s) 1.2 Yes IIIA Manufacturer(s) of the preparation (name, address, contact, telephone and telefax s) 1.2 Forms (1), (2) Forms (1), (2) Yes 2-5.2(f) IIIA Manufacturer(s) of the active substance(s) (name, address, contact, telephone and telefax s) 1.2 Forms (1), (2), (11) Forms (1), (2), (11) 2.2 Yes IIIA Statement of purity (and detailed information on impurities) of the active substance 1.2 Forms (13) Forms (13) Yes IIIA 1.3 Trade name or proposed trade name and manufacturers code (s), for the preparation and similar preparations (differences to be specified) 1.3 Forms (1), (4), (3), (10) Forms (1), (4), (3), (10) Yes 1.2 IIIA 1.4 Detailed quantitative and qualitative information on the composition of the preparation 1.4 Yes IIIA Contents of: -Technical active substance -Pure active substance -Formulants Form (13) Form (13) Yes 2-5.2(d) 13 Office of Pollution Prevention and Toxics of the US Environmental Protection Agency 14 Office of Pesticide Programs of the US Environmental Protection Agency 15 Data code used by the Pest Management Regulatory Agency 16 Data point ing system being developed

3 - A6/63 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 1 Identity of the Plant Protection Product IIIA Certified limits of each component Form (14) Form (14) Yes 2-5.2(e) IIIA ISO common name proposed or accepted for active substances, and synonyms Form (10) Form (10) Yes 2-5.2(d) IIIA Existing CIPAC, EINECS and ELINCS s for the active substance IIIA Salt, ester, anion or cation present for each active substance No Yes 2-5.2(d) IIIA For each formulant, or component in formulants - Chemical name as in I to Directive 67/548/EEC, if not included in that, in accordance with IUPAC and CA nomenclature - Structure or structural formula - Existing CAS, CIPAC, EINECS and ELINCS s -Trade name - Specification of the formulant - Function of each formulant Form (10) (15) Form (10) (15) Yes 2-5.2(d) IIIA Description of formulation process IIIA Discussion of the formation of impurities of toxicological concern Yes 2-5.2(g) Yes 2-5.2(h) IIIA 1.5 Type of preparation (formulation) and code Yes 2-5.2(b)

4 - A6/64 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 1 Identity of the Plant Protection Product IIIA 1.6 Function (herbicide, insecticide, etc.) 1.6 Form (15) Form (15) Yes 1.2 IIIA 1.7 Other/special studies 3.7, 10.6 No -

5 - A6/65 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 2 Physical, Chemical and Technical Properties of the Plant Protection Product IIIA 2.1 Description of the physical state of the preparation (formulation) and its colour and odour Yes 2-5.2(e) IIIA 2.2 IIIA IIIA IIIA 2.3 IIIA IIIA IIIA IIIA 2.4 IIIA IIIA Explosivity and oxidizing properties Explosive properties of the preparation Oxidizing properties of the preparation Flash point and other indication of flammability or spontaneous ignition The flash point of the preparation The flammability of the preparation The auto-flammability of the preparation Acidity/alkalinity and if necessary ph value Acidity or alkalinity and ph value ph of a 1 % aqueous dilution, emulsion or dispersion 2.2 Yes Yes 2-5.2(e) Yes 2-5.2(e) 2,3 Yes Yes 2-5.2(e) Yes 2-5.2(e) Yes 2-5.2(e) 2.4 Yes Yes 2-5.2(e) No 2-5.2(e) IIIA 2.5 Viscosity and surface tension 2.5 Yes IIIA Kinematic viscosity of the preparation No 2-5.2(e)

6 - A6/66 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 2 Physical, Chemical and Technical Properties of the Plant Protection Product IIIA IIIA IIIA 2.6 IIIA Viscosity of the preparation and details of the test conditions Surface tension of the preparation Relative density and bulk density Relative density of the preparation Yes 2-5.2(e) Yes 2-5.2(e) 2.6 Yes No 2-5.2(e) IIIA Bulk or tap density of the preparation Form (7) Form (7) Yes 2-5.2(e) IIIA 2.7 Storage stability and shelf-life 2.7 Yes IIIA Stability after storage for 14 days at 54 C No 2-5.2(k) IIIA IIIA IIIA IIIA Stability after storage for other periods and/or temperatures Minimum content after heat stability testing Effect of low temperature on stability Shelf life following storage at ambient temperature Yes 2-5.2(k) No 2-5.2(k) No 2-5.2(k) No 2-5.2(k) IIIA Shelf life in months No 2-5.2(k) IIIA 2.8 Technical characteristics of the plant protection product 2.8 Yes IIIA Wettability Yes 2-5.2(e) IIIA Persistent foaming No 2-5.2(e)

7 - A6/67 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 2 Physical, Chemical and Technical Properties of the Plant Protection Product IIIA Suspensibility Yes 2-5.2(e) IIIA Spontaneity of dispersion No 2-5.2(e) IIIA Dilution stability Yes 2-5.2(e) IIIA Dry sieve test Yes 2-5.2(e) IIIA Wet sieve test Yes 2-5.2(e) IIIA Size distribution of particles Yes 2-5.2(e) IIIA Nominal size range of granules No 2-5.2(e) IIIA Dust content Yes 2-5.2(e) IIIA Particle size of dust Yes 2-5.2(e) IIIA Friability and attrition characteristics of granules Yes 2-5.2(e) IIIA Emulsifiability Yes 2-5.2(e) IIIA Emulsion stability No 2-5.2(k) IIIA Re-emulsifiability No 2-5.2(k) IIIA Stability of dilute emulsions Yes 2-5.2(k) IIIA Stability of emulsions No 2-5.2(k) IIIA Flowability Yes 2-5.2(e) IIIA Pourability (including rinsed residue) IIIA Dustability following accelerated storage Yes 2-5.2(e) No 2-5.2(k) IIIA 2.9 Physical and chemical compatibility with other products 2.9 No

8 - A6/68 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 2 Physical, Chemical and Technical Properties of the Plant Protection Product IIIA IIIA IIIA 2.10 Physical compatibility of tank mixes Chemical compatibility of tank mixes Distribution and adherence to seeds No No No IIIA Distribution (seed treatment) No - IIIA Adhesion (seed treatment) No - IIIA 2.11 Miscibility No 2-5.2(e) IIIA 2.12 Dielectric breakdown voltage No - IIIA 2.13 Corrosion characteristics No 2-5.2(e) IIIA 2.14 Container Material Form (2) Form (2) Yes 2-5.2(m) IIIA 2.15 Other/special studies 3.7 Yes (i.e. angle of repose, dispersion in water etc.) - IIIA 2.16 Summary and evaluation of points 2.1 to No -

9 - A6/69 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 3 Data on Application IIIA 3.1 Fields of use e.g. forestry CFR (i)(c)(2)(iii) IIIA 3.2 Nature of the effects on harmful organisms e.g. contact action IIIA 3.3 Details of intended use CFR (i)(c)(2)(iii ) Yes Yes IIIA Details of existing and intended uses (crops, groups of crops, plants or plant products treated or protected) CFR (i)(c)(2)(iii) CFR (i)(c)(2)(iii) Yes IIIA Details of harmful organisms against which protection is afforded CFR (i)(c)(2)(iii) CFR (i)(c)(2)(iii) Yes IIIA Effects achieved e.g. sprout suppression Yes IIIA 3.4 Rate of application per unit treated (ha, m 2, m 3, tonne) treated, in terms of g or kg of preparation and active substance Yes IIIA 3.5 Concentration of active substance in material used (e.g. diluted spray, baits, treated seed) in g/l, g/kg, mg/kg or g/tonne Yes 8-3.3

10 - A6/70 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 3 Data on Application IIIA 3.6 Description of the method of application, type of equipment used and type and volume of diluent per unit of area or volume Yes IIIA 3.7 Number and timing of applications and duration of protection 3.7 Yes IIIA Maximum of applications and their timing Yes IIIA For each application, growth stages of the crop or plants to be protected Yes IIIA For each application, development stages of the harmful organism concerned Yes IIIA Duration of protection afforded by each application Yes IIIA Duration of protection afforded by the maximum of applications Yes IIIA 3.8 Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops 3.8 Yes

11 - A6/71 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 3 Data on Application IIIA Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops Yes IIIA IIIA Limitations on choice of succeeding crops Description of damage to rotational crops Yes No IIIA 3.9 Proposed instructions for use as printed, or to be printed, on labels CFR (i) Yes IIIA 3.10 Other/special studies 5.14, 10.6 No to 8-6.7

12 - A6/72 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 4 Further Information on the Plant Protection Product IIIA 4.1 Packaging and compatibility with the preparation 4.1 Yes IIIA Description and specification of the packaging and materials used in packaging, size, capacity, size of openings, types of closure and seals Form (1) Form (1) Yes 2-5.2(m) IIIA IIIA IIIA 4.2 Suitability of the packaging and closures - Strength - Leakproofness - Resistance to normal transport and handling Resistance of the packaging material to its contents Procedures for cleaning application equipment No 2-5.2(m) Yes 2-5.2(m) 4.2 Yes IIIA Procedures for cleaning application equipment and protective clothing CFR (i)(c)(2)(viii) 5.2 Yes - IIIA III 4.3 Effectiveness of the cleaning procedures Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment No Yes IIIA Pre-harvest interval (in days) for each relevant crop CFR (i)(c)(2)(x)(a) Yes Residue Guideline 10

13 - A6/73 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 4 Further Information on the Plant Protection Product IIIA Re-entry period (in days) for livestock, to areas to be grazed CFR (i)(c)(2)(viii) No Residue Guideline 10 IIIA Re-entry period (in hours or days) for man to crops, buildings or spaces treated CFR (i)(c)(2)(viii) Yes 6-7.5(b) IIIA IIIA Withholding period (in days) for animal feedingstuffs Waiting period (in days) between application and handling treated products No Residue Guideline No 6-7.5(b) IIIA Waiting period (in days) between last application and sowing or planting succeeding crops CFR (i)(2)(x)(b) No IIIA Information on any specific agricultural, plant health or environmental conditions under which the preparation may or may not be used CFR (i)(2)(x) No 8-5 IIIA 4.4 Statement of the risks arising from the recommended methods, precautions and handling procedures to minimize those risks, relating to Yes - IIIA Warehouse storage CFR (a) - (h) IIIA User level storage CFR (a) - (h) Yes Yes -

14 - A6/74 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 4 Further Information on the Plant Protection Product IIIA Transport CFR (a)(4)(ii)(a) IIIA Fire CFR (g) No 2-5.2(e) Yes 2-5.2(e) IIIA Protective clothing and equipment proposed for use in storage, transport or in the event of fire Nature CFR (d) Yes - IIIA Protective clothing and equipment proposed for use in storage, transport or in the event of fire characteristics Yes - IIIA Sufficient data to evaluate suitability and effectiveness of the protective clothing and equipment under realistic conditions of use No - IIIA Procedures to minimize the generation of waste CFR (a) - (b) No - IIIA Information on combustion products likely to be generated in the event of fire CFR (g) No - IIIA 4.5 Detailed procedures for the use in the event of an accident during transport, storage or use 4.5 Yes - IIIA Containment of spillages No - IIIA Decontamination of areas, vehicles and buildings CFR (a) - (c) No -

15 - A6/75 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 4 Further Information on the Plant Protection Product IIIA Disposal of damaged packaging, adsorbents and other materials CFR (a) - (d) No - IIIA Protection of emergency workers and bystanders CFR (h)(1) No - IIIA First aid measures CFR (h)(1)(i) Yes 3-7 IIIA 4.6 Neutralization procedures (e.g. reaction with alkali to form less toxic compounds) for use in the event of accidental spillages CFR (a) - (c) No - IIIA Details of proposed procedures for small quantities CFR (a) - (c) No - IIIA IIIA IIIA IIIA IIIA Evaluation of products of neutralization (small quantities) Procedures for disposal of neutralized waste (small quantities) Details of proposed procedures for large quantities Evaluation of products of neutralization (large quantities) Procedures for disposal of neutralized waste (large quantities) No No No No No -

16 - A6/76 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 4 Further Information on the Plant Protection Product IIIA 4.7 IIIA 4.8 IIIA IIIA Pyrolytic behaviour of the active substance under controlled conditions at 800 C and the content of polyhalogenated dibenzo-pdioxins in the products of pyrolysis Disposal procedures for the plant protection product Detailed instructions for safe disposal of the plant protection product and its packaging Methods other than controlled incineration for disposal - detailed description of such methods - data to establish their effectiveness and safety No Yes Yes No - IIIA 4.9 Other/special studies 3.7, 5.14, 8.6 No -

17 - A6/77 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis IIIA 5.1 Analytical standards and samples 5 Yes IIIA Samples of the preparation Yes - IIIA Analytical standards for pure active substance Yes - IIIA Samples of the active substance as manufactured Yes - IIIA Analytical standards for relevant metabolites and all other components included in the residue definition No - IIIA IIIA 5.2 Samples of reference substances for relevant impurities Methods for the analysis of plant protection products No - IIIA Description of analytical methods for the determination of the active substance in plant protection products For each method submitted - Specificity - Extent of interference by other substances present in the preparation - Explanation of interferences which contribute more than ± 3% of the total quantity determined Yes 2-5.2(i)

18 - A6/78 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis For each method submitted, linearity over an appropriate range - Equation of the calibration line - Correlation co-efficient - Representative labelled documentation e.g. chromatograms For each method submitted, accuracy - Pure active substance - Impurities For each method submitted, repeatability (at least 5 determinations) - % relative standard deviation (RSD) - Indication as to whether outliers identified have been discarded - Reasons for the occurrence of outliers IIIA For preparations containing more than one active substance, a description of a method capable of determining each in the presence of the other For each method submitted - Specificity - Extent of interference by other substances present in the preparation - Explanation of interferences which contribute more than ± 3% of the total quantity determined Yes 2-5.2(i)

19 - A6/79 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis For each method submitted, linearity over an appropriate range - Equation of the calibration line - Correlation co-efficient - Representative labelled documentation e.g. chromatograms For each method submitted, accuracy - Pure active substance - Impurities For each method submitted, repeatability (at least 5 determinations) - % relative standard deviation (RSD) - Indication as to whether outliers identified have been discarded - Reasons for the occurrence of outliers IIIA Applicability of existing CIPAC methods No 2-5.2(i)

20 - A6/80 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis IIIA Description of analytical methods for the determination of impurities (non-active components arising from the manufacturing process or from degradation during storage) which are of toxicological, ecotoxicological or environmental concern, in the preparation For each method submitted - Specificity - Extent of interference by other substances present in the preparation - Explanation of interferences which contribute more than ± 3% of the total quantity determined Yes 2-5.2(k)

21 - A6/81 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis For each method submitted, linearity over an appropriate range - Equation of the calibration line - Correlation co-efficient - Representative labelled documentation e.g. chromatograms For each method submitted, accuracy - Pure active substance - Impurities For each method submitted, repeatability (at least 5 determinations) - % relative standard deviation (RSD) - Indication as to whether outliers identified have been discarded - Reasons for the occurrence of outliers IIIA Description of analytical methods for the determination of formulants or constituents of formulants in the plant protection product For each method submitted - Specificity - Extent of interference by other substances present in the preparation - Explanation of interferences which contribute more than ± 3% of the total quantity determined No 2-5.2(i)

22 - A6/82 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis For each method submitted, linearity over an appropriate range - Equation of the calibration line - Correlation co-efficient - Representative labelled documentation e.g. chromatograms For each method submitted, accuracy - Pure active substance - Impurities For each method submitted, repeatability (at least 5 determinations) - % relative standard deviation (RSD) - Indication as to whether outliers identified have been discarded - Reasons for the occurrence of outliers IIIA 5.3 Description of analytical methods for the determination of residues (all components included in the residue definition proposed (see point IIIA 8) to enable compliance with MRLs to be determined or to determine dislodgeable residues) a, b 171-4c, d 171-4m Yes 5A-4.9 Residue Guideline 19

23 - A6/83 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis For each method and representative matrix - Specificity (using a confirmatory method, if appropriate) - Repeatability - Validation - independent laboratory - Limit of determination - Individual and mean recovery, overall standard deviation and relative standard deviation at each fortification level Storage stability of working solutions in analytical methodology IIIA 5.4 Description of methods for analysis of soil for parent compound and metabolites of toxicological, ecotoxicological or environmental concern For each method - Specificity (using a confirmatory method, if appropriate) - Repeatability - Limit of determination - Individual and mean recovery, overall standard deviation and relative standard deviation at each fortification level 5.2 Yes -

24 - A6/84 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis IIIA 5.5 Description of methods for analysis of sediment For each method - Specificity (using a confirmatory method, if appropriate) - Repeatability - Limit of determination - Individual and mean recovery, overall standard deviation and relative standard deviation at each fortification level none No - IIIA 5.6 Description of methods for analysis of water (drinking water, ground water and surface water) for parent compound and metabolites of toxicological, ecotoxicological or environmental concern For each method - Specificity (using a confirmatory method, if appropriate) - Repeatability - Limit of determination - Individual and mean recovery, overall standard deviation and relative standard deviation at each fortification level f Yes -

25 - A6/85 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 5 Methods of Analysis IIIA 5.7 Description of methods for analysis of air for active substance and metabolites, formed during or shortly after application, of toxicological concern For each method - Specificity (using a confirmatory method, if appropriate) - Repeatability - Limit of determination - Individual and mean recovery, overall standard deviation and relative standard deviation at each fortification level 5.2 No - IIIA 5.8 Analytical methods for parent compound and toxicologically, ecotoxicologically or environmentally significant metabolites in body fluids and tissues For each method - Specificity (using a confirmatory method, if appropriate) - Repeatability - Limit of determination - Individual and mean recovery, overall standard deviation and relative standard deviation at each fortification level No - IIIA 5.9 Other/special studies 3.7, 5.14, 7.8, 8.6 No -

26 - A6/86 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 6 Efficacy Data and Information (including Value Data) IIIA 6.1 Efficacy data Yes IIIA IIIA IIIA Efficacy trials: laboratory, growth chamber Efficacy trials: small scale field or greenhouse Efficacy trials: operational, large scale No Yes Yes 8-4 IIIA Effects on yield and quality Yes - IIIA 6.2 Adverse effects IIIA Phytotoxicity to host crop Yes Yes IIIA IIIA IIIA IIIA Adverse effects on health of host animals Adverse effects on site of application (discoloration, corrosion, etc.) Adverse effects on beneficial organisms Adverse effects on parts of plants used for propagating purposes (e.g. seeds, cuttings, runners) No Vet Yes Yes No IIIA Impact on succeeding crops No IIIA Impact on other plants including adjacent crops Yes 8-5.4

27 - A6/87 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 6 Efficacy Data and Information (including Value Data) IIIA Information on the possible occurrence of the development of resistance or cross-resistance No IIIA 6.3 Economics 10.4 No - IIIA 6.4 Benefits - IIIA IIIA Survey of alternative pest control measures (chemical and non-chemical) Compatibility with current management practices including IPM No No IIIA Contribution to risk reduction No - IIIA 6.5 Other/special studies 10.6 No to 8-6.7

28 - A6/88 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 7 Toxicological Studies and Exposure Data and Information IIIA 7.1 Acute toxicity 7.1 Yes IIIA Acute oral toxicity Yes IIIA Acute percutaneous (dermal) toxicity Yes IIIA Acute inhalation toxicity to rats Yes IIIA Skin irritation Yes IIIA Eye irritation Yes IIIA Skin sensitization Yes IIIA Supplementary studies for combinations of plant protection products No IIIA 7.2 Short-term toxicity studies No IIIA 7.3 Operator exposure No IIIA IIIA Estimation of operator exposure assuming personal protective equipment is not used Estimation of operator exposure assuming personal protective equipment is used Optional Optional 5.3 No Optional Optional 5.3 No IIIA Measurement of operator exposure - (Mixer/Loader/Applicator) No 6-7.5

29 - A6/89 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 7 Toxicological Studies and Exposure Data and Information IIIA 7.4 Bystander exposure No IIIA Estimation of bystander exposure assuming personal protective equipment is not used Optional Optional No - IIIA Measurement of bystander exposure No - IIIA 7.5 Worker exposure No IIIA IIIA Estimation of worker exposure assuming personal protective equipment is not used Estimation of worker exposure assuming personal protective equipment is used Optional Optional Optional Optional No No IIIA Estimation of worker exposure assuming personal protective equipment is used and using data generated on dislogeable residues under the proposed conditions of use Optional Optional No IIIA Measurement of worker exposure Optional Optional No IIIA 7.6 Dermal absorption 7.3 No IIIA IIIA Dermal absorption, in vivo in the rat Comparative dermal absorption, in vitro using rat and human skin No No 4-5

30 - A6/90 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 7 Toxicological Studies and Exposure Data and Information IIIA 7.7 Dislodgeable residues No IIIA Dislodgeable residues - foliar No - IIIA Dislodgeable residues - soil No - IIIA Dislodgeable residues - indoor surface re-volatilization No - IIIA 7.8 Epidemiology 5.12 No IIIA 7.9 Data on formulants 7.4 No IIIA IIIA IIIA 7.10 Material safety data sheet for each formulant Available toxicological data for each formulant Domestic animal/livestock safety 7.4 No No No IIIA 7.11 Other/special studies 4.6.8, , 5.14 No 3-4.9

31 - A6/91 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 8 Metabolism and Residues Data IIIA 8.1 Stability of residues 8 No IIIA IIIA Stability of residues during storage of samples Stability of residues in sample extracts (e) 7.3 No 5A-4.12 Residue Guideline 8 8 No - IIIA 8.2 Supplementary studies on metabolism, distribution and expression of residues in plants or livestock Yes 5A-4.6 Residue Guideline 1 IIIA 8.3 Supplementary residue trials (supervised field trials) for crops or plant products used as food or feed on which use is proposed - if it is not possible to extrapolate from the data provided in the context of point IIA 6.3, e.g. special formulations, different application methods, additional crops 8.2 Yes - IIIA Pre-harvest use on major crops IIIA Pre-harvest use on minor crops IIIA Post-harvest use Yes Yes No 5A-4.1 5A-4.2 5A-4.3 5A-4.4 5A-4.1 5A-4.2 5A-4.3 5A-4.4 Residue Guideline 14 IIIA Tobacco No -

32 - A6/92 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 8 Metabolism and Residues Data IIIA 8.4 Supplementary livestock feeding studies - if it is not possible to extrapolate from the data provided in the context of point IIA 6.4, e.g. use on additional fodder crops is proposed, leading to an increased intake of residues by livestock Yes Residue Guideline 1 IIIA Poultry Yes Residue Guideline 1 IIIA Lactating ruminants (goat or cow) Yes Residue Guideline 1 IIIA Pigs No Residue Guideline 1 IIIA Nature of residue in fish (c) No - IIIA 8.5 Supplementary studies on the effects of industrial processing and/or household preparation on residue levels - if it is not possible to extrapolate from the data provided in the context of point IIA 6.5 e.g. additional crops No - IIIA Effects of industrial processing and/or household preparation (representative processing situations) on the nature of the residue No 5A-4.11 Residue Guideline 7 IIIA Distribution of the residue in peel/pulp No 5A-4.11 Residue Guideline 7

33 - A6/93 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 8 Metabolism and Residues Data IIIA Balance studies on a core set of representative processes No 5A-4.11 Residue Guideline 7 IIIA Follow-up studies to determine concentration or dilution factors Potable water Irrigated crops Yes - IIIA 8.6 Supplementary studies for residues in representative succeeding crops Yes - IIIA 8.7 Proposed residue definition and maximum residue levels 8.6 Yes IIIA Proposed residue definition Yes Residue Guideline 6 IIIA Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed, including details of statistical analyses used Yes 5A-4.13 Residue Guideline 10 IIIA 8.8 IIIA IIIA Proposed pre-harvest intervals, re-entry intervals or withholding periods to minimize residues in crops, plants, plant products, treated areas or spaces and a justification for each proposal Pre-harvest interval (in days) for each relevant crop Re-entry period (in days) for livestock, to areas to be grazed 8.7 Yes Yes 5A-4.13 Residue Guideline No 5A-4.13 Residue Guideline 10

34 - A6/94 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 8 Metabolism and Residues Data IIIA IIIA IIIA IIIA IIIA Re-entry period (in hours or days) for man to crops, buildings or spaces treated Withholding period (in days) for animal feedingstuffs Waiting period (in days) between last application and sowing or planting the crop to be protected Waiting period (in days) between application and handling treated products Waiting period (in days) between last application and sowing or planting succeeding crops No No 5A-4.13 Residue Guideline No No No - IIIA 8.9 Other/special studies 6.4, 7.8, 8.6 No - IIIA 8.10 Estimation of the potential and actual exposure through diet and other means 8.8 Yes - IIIA TMDI calculations 8.8 Yes - IIIA NEDI calculations 8.8 No - IIIA NESTI calculations 8.8 No - IIIA 8.11 Summary and evaluation of residue behaviour 8.9 Yes 5A-4.2

35 - A6/95 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 9 Fate and Behaviour in the Environment IIIA 9.1 IIIA IIIA Rate of degradation in soil - if it is not possible to extrapolate from the data provided for the active substance and relevant metabolites, degradation and reaction products (e.g. slow release formulations) Aerobic degradation of the preparation in soil Anaerobic degradation of the preparation in soil No No No IIIA 9.2 Field studies No IIIA Soil dissipation testing on a range of representative soils No IIIA Soil residue testing IIIA Soil accumulation testing Yes No IIIA Aquatic (sediment) field dissipation No IIIA Forestry field dissipation No IIIA 9.3 Mobility of the plant protection product in soil No IIIA Column leaching No IIIA Lysimeter studies No IIIA Field leaching studies No 7-1.7

36 - A6/96 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 9 Fate and Behaviour in the Environment IIIA Volatility laboratory study covered in part by IIA point No IIIA Volatility field study No IIIA 9.4 Predicted environmental concentrations in soil (PECs) for the active substance at the highest rate of application proposed and relating to the maximum and highest rates of application proposed, for each relevant soil tested No IIIA Initial PEC s value No IIIA Short-term PEC s values - 24 hours, 2 and 4 days after last application IIIA Long-term PEC s values - 7, 28, 50 and 100 days after last application No No IIIA 9.5 Predicted environmental concentrations in soil (PEC s ) for relevant metabolites, degradation and reaction products, at the highest rate of application proposed and relating to the maximum and highest rates of application proposed, for each relevant soil tested No IIIA Initial PEC s value No IIIA Short-term PEC s value - 24 hours, 2 and 4 days after last application No 7-2.7

37 - A6/97 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 9 Fate and Behaviour in the Environment IIIA Long-term PEC s values - 7, 28, 50 and 100 days after last application No IIIA 9.6 Predicted environmental concentrations in ground water (PEC gw ) at the highest rate of application proposed and relating to the maximum and highest rates of application proposed No IIIA Active substance PEC gw value No IIIA Relevant metabolites, degradation and reaction products PEC gw values No IIIA Additional field testing No IIIA IIIA 9.7 IIIA IIIA Information on impact on water treatment procedures Predicted environmental concentrations in surface water (PEC sw ) for the active substance at the highest rate of application proposed and relating to the maximum and highest rates of application proposed, relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains Initial PEC sw value for static water bodies Initial PEC sw value for slow moving water bodies No No No No 7-2.7

38 - A6/98 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 9 Fate and Behaviour in the Environment IIIA IIIA IIIA IIIA IIIA 9.8 IIIA IIIA IIIA Short-term PEC sw values for static water bodies - 24 hours, 2 and 4 days after last application Short-term PEC sw values for slow moving water bodies - 24 hours, 2 and 4 days after last application Long-term PEC sw values for static water bodies - 7, 14, 21, 28, and 42 days after last application Long-term PEC sw values for slow moving water bodies - 7, 14, 21, 28, and 42 days after last application Predicted environmental concentrations in surface water (PEC sw ) for the relevant metabolites, degradation and reaction products at the highest rate of application proposed and relating to the maximum and highest rates of application proposed, relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains Initial PEC sw value for static water bodies Initial PEC sw value for slow moving water bodies Short-term PEC sw values for static water bodies - 24 hours, 2 and 4 days after last application No No No No No No No No 7-2.7

39 - A6/99 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 9 Fate and Behaviour in the Environment IIIA IIIA IIIA Short-term PEC sw values for slow moving water bodies - 24 hours, 2 and 4 days after last application Long-term PEC sw values for static water bodies - 7, 14, 21, 28, and 42 days after last application Long-term PEC sw values for slow moving water bodies - 7, 14, 21, 28, and 42 days after last application No No No IIIA Additional field testing No IIIA 9.9 Fate and behaviour in air 9.3 No IIIA Spray droplet size spectrum - laboratory studies No IIIA Drift - field evaluation No IIIA 9.10 Other/special studies Yes IIIA Other/special studieslaboratory studies , , 8.5.2, 8.5.3, 8.6 No - IIIA Other/special studies- field studies 8.5.3, 8.6 Yes (outdoor paddy field model study and paddy field dissipation study) -

40 - A6/100 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 10 Ecotoxicological Studies on the Plant Protection Product IIIA 10.1 Effects on birds 10.1 No IIIA Acute toxicity exposure ratio (TER A ) for birds IIIA Short-term toxicity exposure ratio (TER ST ) for birds IIIA In the case of baits, the concentration of active substance in the bait in mg/kg IIIA In the case of pellets, granules, prills or treated seed IIIA Amount of the active substance in or on each pellet, granule, prill or treated seed IIIA Proportion of the LD 50 for the active substance in 100 particles and per gram of particles IIIA In the case of pellets, granules, and prills, their size and shape IIIA Acute oral toxicity of the preparation to the more sensitive of the species identified in tests with the active substance No No No No No No No No IIIA Supervised cage or field trials No IIIA Acceptance of bait, granules or treated seeds by birds (palatability test) No IIIA Effects of secondary poisoning No IIIA 10.2 Effects on aquatic organisms 10.2 Yes 7-2.7

41 - A6/101 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 10 Ecotoxicological Studies on the Plant Protection Product IIIA Toxicity exposure ratios for aquatic species 10.2 No IIIA TER A for fish No IIIA TER LT for fish No IIIA TER A for Daphnia No IIIA TER LT for Daphnia No IIIA TER A for an aquatic insect species IIIA TER LT for an aquatic insect species IIIA TER A for an aquatic crustacean species IIIA TER LT for an aquatic crustacean species IIIA TER A for an aquatic gastropod mollusc species IIIA TER LT for an aquatic gastropod mollusc species No No No No No No IIIA TER LT for algae No IIIA Acute toxicity (aquatic) of the preparation Yes IIIA Fish acute toxicity LC 50, freshwater, cold-water species IIIA Acute toxicity (24 & 48 h) for Daphnia preferably Daphnia magna Yes Yes 7-2.4

42 - A6/102 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 10 Ecotoxicological Studies on the Plant Protection Product IIIA Effects on algal growth and growth rate No IIIA Marine or estuarine organisms acute toxicity LC 50 /EC No IIIA Marine sediment invertebrates, No acute toxicity LC 50 /EC 50 IIIA Microcosm or mesocosm study IIIA Residue data in fish (long term) No No IIIA Chronic fish toxicity data No IIIA Chronic toxicity (28 day exposure) to juvenile fish No Analytical data on concentrations in the test media IIIA Fish early life stage toxicity test No Analytical data on concentrations in the test media IIIA Fish life cycle test No Analytical data on concentrations in the test media IIIA Chronic toxicity to aquatic invertebrates No 7-2.4

43 - A6/103 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 10 Ecotoxicological Studies on the Plant Protection Product IIIA Chronic toxicity in Daphnia magna (21-day) No Analytical data on concentrations in the test media IIIA Chronic toxicity for a representative species of aquatic insects No Analytical data on concentrations in the test media IIIA Chronic toxicity for a representative species of aquatic gastropod molluscs No Analytical data on concentrations in the test media IIIA Accumulation in aquatic nontarget organisms Analytical data on concentrations in the test media No IIIA 10.3 Effects on terrestrial vertebrates other than birds 10.3 No IIIA Toxicity exposure ratios for terrestrial vertebrates other than birds IIIA Acute toxicity exposure ratio (TER A ) IIIA Short-term toxicity exposure ratio (TER ST ) IIIA Long-term toxicity exposure ratio (TER LT ) 10.3 No No No No 7-2.7

44 - A6/104 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 10 Ecotoxicological Studies on the Plant Protection Product IIIA Effects on terrestrial vertebrates other than birds, where the required information is not provided by testing in accordance with points IIA 5 and IIIA 7, and where exposure is likely IIIA Acute oral toxicity of the preparation IIIA Acceptance of bait, granules or treated seeds by terrestrial vertebrates (palatability test) 10.3 No No No IIIA Effects of secondary poisoning 10.3 No IIIA Supervised cage or field trials or other appropriate studies No IIIA 10.4 Effects on bees IIIA Hazard Quotients for bees 10.4 No IIIA Oral exposure Q HO 10.4 No IIIA Contact exposure Q HC 10.4 No IIIA Acute toxicity of the preparation to bees No IIIA Acute oral toxicity No IIIA Acute contact toxicity No IIIA Effects on bees of residues on crops No IIIA Cage tests No IIIA Field tests Yes IIIA Investigation of special effects No 7-2.5

45 - A6/105 - Appendix 6 Format for the listing of test and study reports Part 5,, US,, and Point 10 Ecotoxicological Studies on the Plant Protection Product IIIA Larval toxicity No IIIA Long residual effects No IIIA Disorienting effects on bees No IIIA Tunnel testing to investigate effects of feeding on contaminated honey dew or flowers No IIIA 10.5 Effects on arthropods other than bees Yes IIIA Effects on sensitive species already tested, using artificial substrates IIIA Effects on non-target terrestrial arthropods in extended laboratory tests IIIA Effects on non-target terrestrial arthropods in semi-field tests No Yes No IIIA Field tests on arthropod species No IIIA 10.6 Effects on earthworms and other soil macro-organisms 10.6 No IIIA Toxicity exposure ratios for No earthworms, TER A and TER LT IIIA Acute toxicity to earthworms No IIIA Sublethal effects on earthworms IIIA Field tests (effects on earthworms) No No IIIA Residue content of earthworms No 7-2.5