Hänvisning till del A i bilagan till förordning (EU) nr 283/2013 Testmetoder (2) Vägledningar (3)

1. DET VERKSAMMA ÄMNETS IDENTITET — WHO/FAO. 2002. Pesticide Specifications. Manual on development and use of FAO and WHO specifications for pesticides. Series FAO Plant Production and Protection Papers, Rome, 2002 (4) EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No. 1107/2009 (5) (SANCO/10597/2003 rev. 10.1)

2. DET VERKSAMMA ÄMNETS FYSIKALISKA OCH KEMISKA EGENSKAPER —

2.1. Smältpunkt och kokpunkt Method A.1 Melting/Freezing temperature (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 102: Melting Point/ Melting Range Method A.2 Boiling temperature (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 103: Boiling point —

2.2. Ångtryck och flyktighet Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Yttre egenskaper (fysikaliskt tillstånd, färg) — —

2.4. Spektrum (UV/VIS, IR, NMR, MS), molär absorption vid relevanta våglängder, optisk renhet OECD Test Guideline 101: UV-VIS Absorption Spectra —

2.5. Löslighet i vatten Method A.6 Water solubility (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 105: Water Solubility —

2.6. Löslighet i organiska lösningsmedel CIPAC Method MT 181: Solubility in organic solvents —

2.7. Fördelningskoefficient n-oktanol/vatten Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Om en förening är ytaktiv (enligt definitionen i metod A.5 ”Surface tension”) kan den skakkolvsmetod som beskrivs i metod A.8 användas om det i rapporten klart framgår att det inte uppstått några problem (t.ex. fasseparation). Den HPLC-metod som beskrivs i metod A.8 kan inte användas på ytaktiva föreningar. —

2.8. Dissociation i vatten OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Brandfarlighet och självupphettning Brandfarlighet: Methods A.10 Flammability (solids), A.11 Flammability (gases), A.12 Flammability (contact with water) (Annex to Regulation (EC) No 440/2008), as appropriate; Test N.1: test method for readily combustible solids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 33.2.1.4) Självupphettning: Methods A.15 Auto-ignition temperature (liquids and gases), A16 Relative self-ignition temperature for solids, (Annex to Regulation (EC) No 440/2008), as appropriate. Test N.4: test method for self-heating substances (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 33.3.1.6) —

2.10. Flampunkt Method A.9 Flash-point (Annex to Regulation (EC) No 440/2008) - only closed cup methods should be used. Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 (6) (liquids); —

2.11. Explosiva egenskaper Method A.14 Explosive properties (Annex to Regulation (EC) No 440/2008) United Nations Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/ Rev. 5 – Part I (Test series), section 11. —

2.12. Ytspänning Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oxiderande egenskaper Fast form: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Vätskeform: Method A.21 Oxidising properties (liquids) (Annex to Regulation (EC) No 440/2008) United Nations Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 4 – Part I (Test series). Test O.1: Test for oxidizing solids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 34.4.1) Test O.2: Test for oxidizing liquids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 34.4.2) —

2.14. Andra studier De testmetoder som nämns i del II i bilaga I till förordning (EG) nr 1272/2008 —

3. ÖVRIGA UPPGIFTER OM DET VERKSAMMA ÄMNET EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Det verksamma ämnets användning — —

3.2. Funktion — —

3.3. Effekter på skadegörare — —

3.4. Avsett användningsområde — —

3.5. Skadegörare som bekämpas och grödor eller andra produkter som skyddas eller behandlas — —

3.6. Verkningssätt — —

3.7. Information om resistensutveckling och lämpliga strategier för att hantera detta EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metoder och försiktighetsåtgärder vid hantering, lagring, transport eller brand — —

3.9. Metoder för destruktion eller dekontaminering — —

3.10. Nödåtgärder vid olyckor — —

4. ANALYSMETODER — Tekniskt material och preparat: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Restsubstanser: EU guidance document on analytical methods for the determination of residues (Post-registration monitoring and control) (SANCO/825/00 rev. 8.1, 2010) EU guidance document for generating and reporting methods of analysis in support of pre-registration data requirements (SANCO/3029/99 rev. 4). OECD (2007). Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment No. 72 and Series on Pesticides No. 39.

5. TOXIKOLOGISKA STUDIER OCH METABOLISMSTUDIER — —

5.1. Studier av absorption, distribution, metabolism och utsöndring hos däggdjur — EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO 7531 rev. 10, 10.07.2006) OECD (2010) Guidance for the Derivation of an Acute Reference Dose” OECD Series on testing and assessment, No. 124, 08-Jun-2010

5.1.1. Absorption, distribution, metabolism och utsöndring efter exponering genom oral tillförsel Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorption, distribution, metabolism och utsöndring efter exponering genom andra tillförselsätt Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Akut toxicitet — —

5.2.1. Oralt Method B.1 bis Acute oral toxicity - fixed dose procedure (Annex to Regulation (EC) No 440/2008). Method B.1 tris Acute oral toxicity - Acute toxic class method (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure OECD Test Guideline 423: Acute oral toxicity: acute toxic class method OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure OECD Test Guideline No 401: Acute oral toxicity (only acceptable, if performed before December 2002) —

5.2.2. Dermalt Method B.3 Acute toxicity (dermal) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 402: Acute Dermal Toxicity —

5.2.3. Inhalation Method B.2 Acute toxicity (inhalation) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 403: Acute Inhalation Toxicity OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method —

5.2.4. Hudirritation Method B.4 Acute toxicity: dermal irritation/corrosion (Annex to Regulation (EC) No 440/2008). Method B.40 In vitro skin corrosion: transcutaneous electrical resistance test (TER) (Annex to Regulation (EC) No 440/2008). Method B.40 bis In vitro skin corrosion: human skin model test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 404: Acute Dermal Irritation/Corrosion OECD Test Guideline 431: In vitro Skin Corrosion: Human Skin Model Test OECD Test Guideline 430: In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method Method B.46 In vitro skin irritation: reconstructed human epidermis model test (Annex III of Regulation (EC) No 761/2009 (8)). —

5.2.5. Ögonirritation Method B.5 Acute toxicity: eye irritation/corrosion (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 405: Acute eye irritation/corrosion OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants Method B.47 Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010 (9)) Method B.48 Isolated chicken eye test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010) —

5.2.6. Hudsensibilisering Method B.42 Skin sensitisation: Local lymph node assay (Annex to Regulation (EC) No 440/2008). Method B.6 Skin sensitisation (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay OECD Test Guideline 406: Skin sensitisation OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA —

5.2.7. Fototoxicitet Method B.41 In vitro 3T3 NRU phototoxicity test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test OECD Test Guideline 101: UV-VIS Absorption Spectra —

5.3. Korttidstoxicitet — —

5.3.1. Oral 28-dagarsstudie Method B.7 Repeated dose (28 days) toxicity (oral) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 407: Repeated dose 28-day oral toxicity study in rodents —

5.3.2. Oral 90-dagarsstudie Method B.26 Sub-chronic oral toxicity test. Repeated dose 90-day oral toxicity study in rodents (Annex to Regulation (EC) No 440/2008). Method B.27 Sub-chronic oral toxicity test. Repeated dose 90-day oral toxicity study in non-rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 408: Repeated dose 90-day oral toxicity study in rodents OECD Test Guideline 409: Repeated dose 90-day oral toxicity study in non-rodents —

5.3.3. Andra exponeringsvägar Method B8 Repeated dose (28 days) toxicity (inhalation) (Annex to Regulation (EC) No 440/2008). Method B.9 Repeated dose (28 days) toxicity (dermal) (Annex to Regulation (EC) No 440/2008). Method B.28 Sub-chronic dermal toxicity test: 90-day repeated dermal dose study using rodent species (Annex to Regulation (EC) No 440/2008). Method B.29 Sub-chronic inhalation toxicity study 90-day repeated inhalation dose study using rodent species (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study. OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study. OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study. OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study. —

5.4. Genotoxicitetstester — —

5.4.1. In vitro-studier Method B.13/14 Mutagenicity - reverse mutation test using bacteria (Annex to Regulation (EC) No 440/2008). Method B.10 Mutagenicity - In vitro mammalian chromosome aberration test (Annex to Regulation (EC) No 440/2008). Method B.17 – Mutagenicity – In vitro mammalian cell gene mutation test (Annex to Regulation (EC) No 440/2008). - For this test mouse lymphoma assay is recommended. OECD Test Guideline 471: Bacterial Reverse Mutation Test OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test OECD Test Guideline 476: In vitro Mammalian Cell Gene Mutation Test - For this test mouse lymphoma assay is recommended. OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test. In vitro Comet assay could be used when justified. —

5.4.2. In vivo-studier med somatiska celler Method B.12 - Mutagenicity - In vivo mammalian erythrocyte micronucleus test (Annex to Regulation (EC) No 440/2008). Method B.11 - Mutagenicity – In vivo mammalian bone-marrow chromosome aberration test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo. OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays Method B.39 Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo (Annex to Regulation (EC) No 440/2008). In vivo Comet assay could be used when justified and considering EFSA (2012). Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports. EFSA Journal 2012;10(11):2977

5.4.3. In vivo-studier med könsceller Method B.23 Mammalian spermatogonial chromosome aberration test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test. OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays. —

5.5. Långtidstoxicitet och cancerogenitet Method B.30 Chronic toxicity test (Annex to Regulation (EC) No 440/2008). Method B.32 Carcinogenicity test (Annex to Regulation (EC) No 440/2008). Method B.33 Combined chronic toxicity/carcinogenicity test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 451: Carcinogenicity Studies. OECD Test Guideline 452: Chronic Toxicity Studies. OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies. —

5.6. Reproduktionstoxicitet —

5.6.1. Generationsstudier Method B.35 Two-generation reproduction toxicity study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 416: Two-Generation Reproduction Toxicity. OECD Test Guideline 443: Extended One-generation Reproduction Toxicity. —

5.6.2. Utvecklingstoxikologiska studier Method B.31 Prenatal developmental toxicity study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 414: Prenatal developmental toxicity study. OECD Test Guideline 426: Developmental neurotoxicity study. —

5.7. Neurotoxicitetsstudier —

5.7.1. Neurotoxicitetsstudier på gnagare Method B.43 Neurotoxicity study in rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 424: Neurotoxicity study in rodents. —

5.7.2. Studier avseende fördröjd polyneuropati Method B.37 Delayed neurotoxicity of organophosphorus substances after acute exposure (Annex to Regulation (EC) No 440/2008). Method B.38 Delayed neurotoxicity of organophosphorus substances 28-day repeated dose study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure. OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study. —

5.8. Andra toxikologiska studier — —

5.8.1. Toxicitetsstudier av metaboliter EU Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC (SANCO/221/2000 – rev.10. final)

5.8.2. Kompletterande studier av det verksamma ämnet — OECD (2010) Guidance for conducting a single exposure toxicity study. IN: OECD (2010) Guidance for the Derivation of an Acute Reference Dose” OECD Series on testing and assessment, No. 124, 08-Jun-2010

5.8.3. Hormonstörande egenskaper OECD Test Guideline 456: H295R Steroidogenesis Assay OECD Test Guideline 441: Hershberger Bioassay in Rats, A Short-term Screening Assay for (Anti)Androgenic Properties OECD Test Guideline 455: Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals OECD Test Guideline 440: Uterotrophic Bioassay in Rodents A short-term screening test for oestrogenic properties OCSPP Guideline 890.1500: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Male Rats Assay OCSPP Guideline 890.1450: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female Rats Assay U.S. Environmental Protection Agency (2007): 15-Day Intact Adult Male Rat Assay —

5.9. Medicinska data — —

6. RESTHALTER I ELLER PÅ BEHANDLADE PRODUKTER, LIVSMEDEL OCH FODER OECD (2009). Guidance Document on Overview of Residue Chemistry Studies (as revised in 2009). Environment, Health and Safety Publications. Series on Testing and Assessment No. 64 and Series on Pesticides No. 32.

6.1 Resthalters stabilitet vid lagring OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Metabolism, distribution och definition av resthalter — —

6.2.1. Växter OECD Test Guideline 501: Metabolism in crops —

6.2.2. Fjäderfä OECD Test Guideline 503: Metabolism in livestock —

6.2.3. Lakterande idisslare OECD Test Guideline 503: Metabolism in livestock —

6.2.4. Grisar OECD Test Guideline 503: Metabolism in livestock —

6.2.5. Fisk — —

6.3. Försök avseende förekomst av rester i växter OECD Test Guideline 509: Crop field trials OECD (2011) Guidance Document on Crop Field Trials (Series on Testing and Assessment No. 164 and Series on Pesticides No. 66)

6.4. Utfodringsstudier — —

6.4.1. Fjäderfä OECD Test Guideline 505: Residues in livestock. —

6.4.2. Idisslare OECD Test Guideline 505: Residues in livestock. —

6.4.3. Grisar OECD Test Guideline 505: Residues in livestock. —

6.4.4. Fisk — —

6.5. Effekter av bearbetning — —

6.5.1. Resternas beskaffenhet OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis. —

6.5.2. Resthalternas fördelning mellan oätligt skal och innanmäte (pulpa/kärna) OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Förekomst av rester i bearbetade produkter OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD (2008). Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment No. 96.

6.6. Resthalter i grödor i växtföljd — —

6.6.1. Metabolism i grödor i växtföljd OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Förekomst av rester i grödor i växtföljd OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Föreslagna resthaltsdefinitioner och gränsvärden — —

6.7.1. Föreslagna resthaltsdefinitioner — OECD (2009). Guidance Document on the Definition of Residues. Environment, Health and Safety Publications. Series on Testing and Assessment No. 63 and Series on Pesticides No. 31

6.7.2. Föreslagna gränsvärden för resthalter (MRL) och motivering till att de föreslagna nivåerna anses acceptabla — EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011). OECD MRL calculator (2011)

6.7.3. Föreslagna gränsvärden för resthalter (MRL) och motivering till att de föreslagna nivåerna anses acceptabla för importerade produkter (importtolerans) — EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011). OECD MRL calculator (2011)

6.8. Föreslagna säkerhetsperioder — EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95, 22/7/1997)

6.9. Uppskattning av potentiell och faktisk exponering via föda och andra källor — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Andra studier — —

6.10.1. Resthaltsnivå i pollen och biodlingsprodukter — —

7. OMVANDLING, SPRIDNING OCH FÖRDELNING I MILJÖN — —

7.1. Omvandling, spridning och fördelning i jord OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. ISO 10381-6:2009 Soil quality. Sampling. Guidance on the collection, handling and storage of soil under aerobic conditions for the assessment of microbiological processes, biomass and diversity in the laboratory —

7.1.1. Nedbrytningsvägar i jord — —

7.1.1.1. Aerob nedbrytning OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaerob nedbrytning OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Fotolys i jord — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Nedbrytningshastighet i jord — EFSA (2010). EFSA Panel on Plant Protection Products; Guidance for evaluating laboratory and field dissipation studies to obtain DegT50 values of plant protection products in soil. EFSA Journal 2010;8(12):1936.

7.1.2.1. Laboratoriestudier OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water FOCUS Degradation Kinetics EFSA (2007). Scientific Opinion on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil. The EFSA Journal (2007) 622, 1-32.

7.1.2.2. Fältstudier US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models De tekniska aspekterna för att bestämma nedbrytningshastighet i jord i fältstudier finns i Regulatory Directive DIR2006-01: Harmonization of Guidance for Terrestrial Field Studies of Pesticide Dissipation under the North American Free Trade Agreement. Pest Management Regulatory Agency (PMRA). Health Canada (11)

7.1.3. Adsorption och desorption i jord — —

7.1.3.1. Adsorption och desorption OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water European Commission. Scientific Committee on plants SCP/KOC/002-Final. Opinion of the Scientific Committee on Plants on methods for the determination of the organic carbon adsorption coefficient (K0c) for a plant protection product active substance in the context of Council Directive 91/414/EEC (18 July 2002) (12)

7.1.3.2. Tidsberoende sorption — FOCUS Ground Water

7.1.4. Rörlighet i jord — —

7.1.4.1. Kolonnstudier OECD Test Guideline 312: Leaching in Soil Columns —

7.1.4.2. Lysimeterstudier OECD Guidance Document 22: Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies FOCUS Ground Water

7.1.4.3. Utlakningsstudier i fält — FOCUS Ground Water

7.2. Omvandling, spridning och fördelning i vatten och sediment — —

7.2.1. Nedbrytningsväg och nedbrytningshastighet i vattensystem (kemisk och fotokemisk nedbrytning) — —

7.2.1.1. Hydrolytisk nedbrytning OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Direkt fotokemisk nedbrytning OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Indirekt fotokemisk nedbrytning — —

7.2.2. Biologisk nedbrytningsväg och nedbrytningshastighet i vattensystem — —

7.2.2.1. Biologisk lättnedbrytbarhet Method C.4 Determination of "ready" biodegradability (Annex to Regulation (EC) No 440/2008). OECD Guideline Test 301: Ready Biodegradability (301 A - F) —

7.2.2.2. Aerob mineralisering i ytvatten OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test ECHA Guidance on information requirements and chemical safety assessment Chapter R 11: PBT Assessment

7.2.2.3. Vatten/sedimentstudie OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Vatten/sedimentstudie under inverkan av ljus OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Nedbrytning i den mättade zonen — —

7.3. Omvandling, spridning och fördelning i luft FOCUS Air

7.3.1. Nedbrytningsväg och nedbrytningshastighet i luft — —

7.3.2. Transport via luft — —

7.3.3. Lokala och globala effekter — —

7.4. Definition av resthalt — —

7.4.1. Definition av resthalt för riskbedömning — —

7.4.2. Definition av resthalt för övervakning — —

7.5. Övervakningsdata — —

8. EKOTOXIKOLOGISKA STUDIER — OECD series of testing and assessment Number 54. "Current approaches in the statistical analysis of ecotoxicity data: a guidance to application"

8.1. Effekter på fåglar och andra landlevande ryggradsdjur — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Effekter på fåglar — —

8.1.1.1. Akut oral toxicitet för fåglar OECD Test Guideline No 223: Avian acute oral toxicity study eller US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Korttidstoxicitet för fåglar vid tillförsel via födan OECD Test Guideline 205: Avian Dietary Toxicity Test eller US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Subkronisk toxicitet och reproduktionstoxicitet för fåglar OECD Test Guideline 206: Avian Reproduction Test eller US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Effekter på andra landlevande ryggradsdjur än fåglar — —

8.1.2.1. Akut oral toxicitet för däggdjur — —

8.1.2.2. Långtidstoxicitet och reproduktionstoxicitet för däggdjur — —

8.1.3. Biokoncentration av det verksamma ämnet i bytesdjur för fåglar och däggdjur — —

8.1.4 Effekter på landlevande ryggradsdjur (vilda fåglar, däggdjur, kräldjur och groddjur) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Hormonstörande egenskaper — Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010.

8.2. Effekter på vattenlevande organismer — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4) OECD (2000). Guidance document on aquatic toxicity testing of difficult substances and mixtures. OECD series on testing and assessment Number 23.

8.2.1. Akut toxicitet för fisk OECD Test Guideline 203: Fish, Acute Toxicity Test (13) OECD. Series on testing and assessment No 126. Short guidance on the threshold approach for acute fish toxicity. ENV/JM/MONO(2010)17

8.2.2. Långtidstoxicitet och kronisk toxicitet för fisk — —

8.2.2.1. Test av toxicitet för fisk i tidiga levnadsstadier OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Livscykeltest på fisk US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokoncentration i fisk — —

8.2.3. Hormonstörande egenskaper OECD Test Guideline 229: Fish Short Term Reproduction Assay OECD Test Guideline 230: 21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition OECD Test Guideline 231: Amphibian Metamorphosis Assay OECD Test Guideline 234 Fish Sexual Development Test Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010.

8.2.4. Akut toxicitet för vattenlevande ryggradslösa djur — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Akut toxicitet för Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Akut toxicitet för en annan art av vattenlevande ryggradslösa djur US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Långtidstoxicitet och kronisk toxicitet för vattenlevande ryggradslösa djur — —

8.2.5.1. Reproduktions- och utvecklingstoxicitet för Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reproduktions- och utvecklingstoxicitet för en annan art av vattenlevande ryggradslösa djur US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Utveckling och kläckning hos Chironomus riparius OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [I allmänhet täcker ett system med spikat vatten (dvs. OECD 219) bättre typiska exponeringsvägar för växtskyddsmedel] —

8.2.5.4. Sedimentlevande organismer OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Effekter på algtillväxt — —

8.2.6.1. Effekter på tillväxt hos grönalger OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Effekter på tillväxt hos en annan algart OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Effekter på vattenlevande makrofyter OECD Test Guideline 221: Lemna sp. Growth Inhibition Test ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov Development of a proposed test method for the rooted aquatic macrophyte Myriophyllum sp. In: Maltby L, Arnold D, Arts G, et al (2010). Aquatic Macrophyte Risk Assessment for pesticides (AMRAP). SETAC Press & CRC Press, Taylor & -Francis Group, Boca Raton, London, New York, p. 46-56.

8.2.8. Ytterligare tester på vattenlevande organismer — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Effekter på leddjur — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.3.1. Effekter på bin — EPPO Standard PP 3/10 (3) Environmental risk assessment scheme for plant protection products. Chapter 10: honeybees.

8.3.1.1. Akut toxicitet för bin —

8.3.1.1.1. Akut oral toxicitet EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees. OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test

8.3.1.1.2. Akut kontakttoxicitet EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees. OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test

8.3.1.2. Kronisk toxicitet för bin Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90 Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.

8.3.1.3. Effekter på honungsbins utveckling och levnadsstadier Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90

8.3.1.4. Subletala effekter Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.

8.3.2. Effekter på övriga leddjur som inte är målarter Candolfi et al (2001). Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing). SETAC press, pp 46. ISBN 1-880611-52-x.

8.3.2.1. Effekter på Aphidius rhopalosiphi M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067-129-7.

8.3.2.2. Effekter på Typhlodromus pyri M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067-129-7

8.4. Effekter på marklevande meso- och makrofauna som inte är målarter — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Subletala effekter på daggmask OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Effekter på övrig marklevande meso- och makrofauna som inte är målarter —

8.4.2.1. Tester på artnivå För Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil För rovkvalster: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Effekter på kväveomsättning i mark OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Effekter på landlevande högre växter som inte är målarter — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Sammanfattning av screeningdata — —

8.6.2. Tester på växter som inte är målarter Utveckling av groddplantor och tillväxt av groddplantor: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Testning av landväxters växtkraft: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Effekter på andra landlevande organismer (flora och fauna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Effekter på biologiska metoder för avloppsvattenrening OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. LITTERATURUPPGIFTER EFSA (2011). Guidance of EFSA - Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011; 9(2):209