Viide määruse (EL) nr 283/2013 lisa A osale Katsemeetodid (2) Juhenddokumendid (3)

1. TOIMEAINE NIMETUS — 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. TOIMEAINE FÜÜSIKALISED JA KEEMILISED OMADUSED —

2.1. Sulamistemperatuur ja keemistemperatuur 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. Aururõhk, lenduvus Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Välimus (füüsikaline olek, värvus) — —

2.4. Spektrid (UV/nähtav, IP, TMR, mass-spektromeetria), molaarne ekstinktsioon asjakohastel lainepikkustel, optiline puhtus OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Lahustuvus orgaanilistes lahustites CIPAC Method MT 181: Solubility in organic solvents —

2.7. Jaotuskoefitsient süsteemis n-oktanool-vesi Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method (Kui aine on pindaktiivne (vastavalt määratlusele, mis on esitatud meetodis A.5, Pindpinevus), võib kasutada meetodis A.8 kirjeldatud loksutusmeetodit, kui ülevaatest on selge, et ei teki probleeme (nt faaside eraldamisega). Meetodis A.8 kirjeldatud HPLC-meetod ei ole pindaktiivsete ainete korral kasutatav. —

2.8. Dissotsieerumine vees OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Süttivus ja isekuumenevus Süttivus: 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) Isekuumenevus: 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. Leekpunkt 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. Plahvatusohtlikkus 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. Pindpinevus Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oksüdeerimisvõime Tahked ained: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Vedelikud: 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. Muud uuringud Määruse (EÜ) nr 1272/2008 I lisa II osas esitatud katsemeetodid —

3. TÄIENDAV TEAVE TOIMEAINE KOHTA Euroopa ja Vahemere maade taimekaitseorganisatsiooni (EPPO) normdokumendiseeria PP1: Taimekaitsevahendite tõhususe hindamine (7) —

3.1. Toimeaine kasutamine — —

3.2. Otstarve — —

3.3. Toime kahjulikele organismidele — —

3.4. Kavandatud kasutusala — —

3.5. Tõrjutavad kahjulikud organismid ja kaitstavad või töödeldavad põllukultuurid või tooted — —

3.6. Toimeviis — —

3.7. Teave resistentsuse kujunemise või võimaliku kujunemise ja sobivate vastumeetmete kohta EPPO standard PP 1/213: Resistance risk analysis —

3.8. Meetodid ja ettevaatusabinõud käitlemisel, ladustamisel, veol või tulekahju korral — —

3.9. Hävitamise või saastusest puhastamise meetodid — —

3.10. Erakorralised meetmed õnnetusjuhtumi korral — —

4. ANALÜÜSIMEETODID — Tehnilised materjalid ja valmistised: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Jäägid: 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. TOKSIKOLOOGIA- JA METABOLISMI UURINGUD — —

5.1. Imendumise, jaotumise, metabolismi ja väljutamise uuringud imetajatel — 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. Imendumine, jaotumine, metabolism ja väljutamine pärast suukaudset kokkupuudet Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Imendumine, jaotumine, metabolism ja väljutamine pärast muul viisil kokkupuudet Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Äge mürgisus — —

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

5.2.3. Hingamisteede kaudu 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. Nahaärritus 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. Silmade ärritus 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. Naha sensibiliseerimine 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. Fototoksilisus 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. Lühiajaline mürgisus — —

5.3.1. 28-päevane suukaudse manustamise uuring 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. 90-päevane suukaudse manustamise uuring 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. Muud kokkupuuteviisid 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. Genotoksilisuse katse — —

5.4.1. In vitro uuringud 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 katsed somaatiliste rakkudega 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 katsed sugurakkudega 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. Pikaajaline mürgisus ja kantserogeensus 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. Reproduktiivtoksilisus —

5.6.1. Põlvkondade uuringud 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. Arengutoksilisuse uuringud 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. Neurotoksilisuse uuringud —

5.7.1. Neurotoksilisuse uuringud närilistel 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. Viivistoimega polüneuropaatia uuringud 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. Muud toksikoloogiauuringud — —

5.8.1. Metaboliitide toksilisuse uuringud 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. Täiendavad toimeaine uuringud — 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. Sisesekretsioonisüsteemi kahjustavad omadused 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. Meditsiiniandmed — —

6. JÄÄGID TÖÖDELDUD TOODETES, TOIDUS JA SÖÖDAS VÕI NENDE PINNAL 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 Jääkide stabiilsus säilitamisel OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Jääkide metabolism, jaotumine ja väljendumine — —

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

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

6.2.3. Mäletsejad laktatsiooniperioodil OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Kalad — —

6.3. Taimedes esinevate jääkide hulga määramise katsed 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. Söödauuringud — —

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

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

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

6.4.4. Kalad — —

6.5. Töötlemise mõjud — —

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

6.5.2. Jääkide jaotumine mittesöödavas koores ja viljalihas OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Töödeldud toodetes esinevate jääkide hulk 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. Jäägid külvikorrakultuurides — —

6.6.1. Metabolism külvikorrakultuurides OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Külvikorrakultuurides esinevate jääkide hulk OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Kavandatud jääkide määratlused ja jääkide piirnormid — —

6.7.1. Kavandatud jääkide määratlused — 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. Kavandatud jääkide piirnormid ja nende piirnormide vastuvõetavuse põhjendus — 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. Kavandatud jääkide piirnormid ja nende piirnormide vastuvõetavuse põhjendus imporditud toodete puhul (lubatavus impordi puhul) — 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. Kavandatud ohutusajad — 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. Toidu kaudu ja muul viisil toimuva võimaliku ja tegeliku kokkupuute hindamine — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Muud uuringud — —

6.10.1. Jääkide tase õietolmus ja mesindustoodetes — —

7. SÄILIMINE JA KÄITUMINE KESKKONNAS — —

7.1. Säilimine ja käitumine mullas 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. Mullas lagunemise käik — —

7.1.1.1. Aeroobne lagunemine OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaeroobne lagunemine OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Fotolüüs mullas — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Mullas lagunemise kiirus — 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. Laboriuuringud 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. Väliuuringud US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Mullas lagunemise kiiruse määramise ja välikatsete tehnilised üksikasjad vt: 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. Adsorptsioon ja desorptsioon mullas — —

7.1.3.1. Adsorptsioon ja desorptsioon 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. Sorptsiooni suurenemine ajas — FOCUS Ground Water

7.1.4. Liikuvus mullas — —

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

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

7.1.4.3. Leostumise väliuuringud — FOCUS Ground Water

7.2. Säilimine ja käitumine vees ja setetes — —

7.2.1. Lagunemise käik ja -kiirus veesüsteemides (keemiline ja fotokeemiline lagunemine) — —

7.2.1.1. Hüdrolüütiline lagunemine OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Otsene fotokeemiline lagunemine OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Kaudne fotokeemiline lagunemine — —

7.2.2. Bioloogilise lagunemise käik ja kiirus veesüsteemides — —

7.2.2.1. Kiire biolagunevus 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. Aeroobne mineraliseerumine pinnavees 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. Vee-/setteuuringud OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Kiiritatud vee/sette uuringud OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Lagunemine küllastunud tsoonis — —

7.3. Säilimine ja käitumine õhus FOCUS Air

7.3.1. Õhus lagunemise käik ja kiirus — —

7.3.2. Edasikandumine õhu kaudu — —

7.3.3. Kohalik ja ülemaailmne mõju — —

7.4. Jääkide määratlus — —

7.4.1. Jääkide määratlus riskihindamiseks — —

7.4.2. Jääkide määratlus seire otstarbel — —

7.5. Seireandmed — —

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

8.1. Mõju lindudele ja muudele maismaaselgroogsetele — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Mõju lindudele — —

8.1.1.1. Äge suukaudne mürgisus lindudel OECD Test Guideline No 223: Avian acute oral toxicity study või US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Lühiajaline toidu kaudu mõjuv mürgisus lindudel OECD Test Guideline 205: Avian Dietary Toxicity Test või US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Subkrooniline ja reproduktiivtoksilisus lindudel OECD Test Guideline 206: Avian Reproduction Test või US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Mõju selgroogsetele maismaaloomadele, v.a lindudele — —

8.1.2.1. Äge suukaudne mürgisus imetajatel — —

8.1.2.2. Pikaajaline ja reproduktiivtoksilisus imetajatel — —

8.1.3. Toimeaine biokontsentreerumine lindude ja imetajate saakloomades — —

8.1.4. Mõju vabas looduses elavatele selgroogsetele maismaaloomadele (linnud, imetajad, roomajad ja kahepaiksed) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Sisesekretsioonisüsteemi kahjustavad omadused — 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. Mõju veeorganismidele — 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. Äge mürgisus kaladel OECD katsejuhend 203: Ägeda mürgisuse katse kaladel (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. Pikaajaline ja krooniline mürgisus kaladel — —

8.2.2.1. Mürgisuse katse varases elujärgus kaladega OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Kalade täiselutsükli katse US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokontsentreerumine kalades — —

8.2.3. Sisesekretsioonisüsteemi kahjustavad omadused 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. Äge mürgisus veeselgrootutel — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Äge mürgisus suurel kiivrikul (Daphnia magna) OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Äge mürgisus veel ühel veeselgrootute liigil US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Pikaajaline ja krooniline mürgisus veeselgrootutel — —

8.2.5.1. Reproduktiiv- ja arengutoksilisus suurel kiivrikul (Daphnia magna) OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reproduktiiv- ja arengutoksilisus veel ühel veeselgrootute liigil US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Areng ja valmikute koorumine liigi Chironomus riparius puhul OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [Üldiselt kirjeldab veega tembitud süsteem (st OECD 219) paremini tüüpilisi taimekaitsevahenditega kokkupuute teid] —

8.2.5.4. Setetes elavad organismid OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Mõju vetikate kasvule — —

8.2.6.1. Mõju rohevetikate kasvule OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Mõju veel ühe vetikaliigi kasvule OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Mõju makrofüütidele 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. Täiendavaid katsed veeorganismidel — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Mõju lülijalgsetele — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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

8.3.1.1. Äge mürgisus mesilastel —

8.3.1.1.1. Äge suukaudne mürgisus 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. Äge kokkupuutel mõjuv mürgisus 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. Krooniline mürgisus mesilastel 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. Mõju mesilaste arengule ja muudele mesilaste eluetappidele 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. Subletaalne mõju 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. Mõju mittesihtliikidesse kuuluvatele lülijalgsetele, v.a mesilastele 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. Mõju liigile 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. Mõju liigile 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. Mõju mulla meso- ja makrofauna mittesihtliikidele — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Subletaalne mõju vihmaussidele OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Mõju mulla meso- ja makrofauna mittesihtliikidele (v.a vihmaussid) —

8.4.2.1. Liigi tasandil katsetamine Collembola puhul: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Röövlestade puhul: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Mõju mulla lämmastiku muundumisele OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Mõju sihtliikidesse mittekuuluvatele kõrgematele maismaataimedele — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Sõeluuringute andmete kokkuvõte — —

8.6.2. Katsed mittesihtliikide taimedega Idanemine ja seemiku kasv: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Maismaataimede vegetatiivse elujõulisuseu uurimine: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Mõju muudele maismaaorganismidele (taimestik ja loomastik) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Mõju bioloogilistele reoveepuhastusmeetoditele OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. KIRJANDUSANDMED 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