Sklic na del A Priloge k Uredbi (EU) št. 283/2013 Preskusne metode (2) Smernice (3)

1. OPREDELITEV AKTIVNE SNOVI — 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. FIZIKALNE IN KEMIJSKE LASTNOSTI AKTIVNE SNOVI —

2.1. Tališče in vrelišče 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. Parni tlak, hlapnost Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Videz (agregatno stanje, barva) — —

2.4. Spektri (UV/VIS, IR, NMR, MS), molekulska ekstinkcija pri ustreznih valovnih dolžinah, optična čistost OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Topnost v organskih topilih CIPAC Method MT 181: Solubility in organic solvents —

2.7. Porazdelitveni koeficient n-oktanol/voda Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Če je sestavina površinsko aktivna (kakor je opredeljeno z metodo A.5 Surface tension), se lahko uporabi metoda „stresanja bučke“, opisana v metodi A.8, v kolikor je iz poročila jasno, da ni bilo težav (npr. fazne delitve). Metoda HPLC, opisana v metodi A.8, se ne uporablja za površinsko aktivne sestavine. —

2.8. Disociacija v vodi OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Vnetljivost in samosegrevanje Vnetljivost: 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) Samosegrevanje: 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. Plamenišče 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. Eksplozivne lastnosti 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. Površinska napetost Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oksidacijske lastnosti Trdne snovi: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Tekočine: 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. Druge študije Preskusne metode iz dela II Priloge I k Uredbi (ES) št. 1272/2008 —

3. DODATNE INFORMACIJE O AKTIVNI SNOVI EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Uporaba aktivne snovi — —

3.2. Delovanje — —

3.3. Vplivi na škodljive organizme — —

3.4. Predvideno področje uporabe — —

3.5. Škodljivi organizmi, ki se jih zatira, in kulture ali proizvodi, ki se varujejo ali tretirajo — —

3.6. Način delovanja — —

3.7. Podatki o pojavu ali možnem pojavu razvoja odpornosti in ustrezne strategije ravnanja EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metode in varnostni ukrepi v zvezi z ravnanjem, skladiščenjem, prevozom ali požarom — —

3.9. Postopki uničenja ali dekontaminacije — —

3.10. Nujni ukrepi v primeru nesreče — —

4. ANALITSKE METODE — Tehnični material in pripravki: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Ostanki: 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. TOKSIKOLOŠKE ŠTUDIJE IN ŠTUDIJE O PRESNOVI — —

5.1. Študije o absorpciji, porazdelitvi, presnovi in izločanju pri sesalcih — 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. Absorpcija, porazdelitev, presnova in izločanje po oralni izpostavljenosti Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorpcija, porazdelitev, presnova in izločanje po drugih načinih izpostavljenosti Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Akutna toksičnost — —

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

5.2.3. Inhalacijska 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. Draženje kože 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. Draženje oči 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. Preobčutljivost kože 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. Fototoksičnost 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. Kratkotrajna toksičnost — —

5.3.1. 28-dnevna oralna študija 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-dnevna oralna študija 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. Drugi načini 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. Preskušanje genotoksičnosti — —

5.4.1. Študije in vitro 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. Študije in vivo na somatskih celicah 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. Študije in vivo na kličnih celicah 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. Dolgotrajna toksičnost in rakotvornost 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. Reproduktivna toksičnost —

5.6.1. Generacijske študije 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. Študije o vplivu toksičnosti na razvoj potomcev 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. Študije nevrotoksičnosti —

5.7.1. Študije nevrotoksičnosti na glodalcih 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. Študije o zapozneli polinevropatiji 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. Druge toksikološke študije — —

5.8.1. Študije o toksičnosti metabolitov, 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. Dodatne študije o aktivni snovi — 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. Lastnosti, ki lahko povzročijo motnje endokrinega sistema 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. Zdravstveni podatki — —

6. OSTANKI V TRETIRANIH PROIZVODIH, ŽIVILIH IN KRMI ALI NA NJIH 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 Stabilnost ostankov med shranjevanjem OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Presnova, porazdelitev in izražanje ostankov — —

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

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

6.2.3. Molznice pri prežvekovalcih OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Ribe — —

6.3. Obseg poskusov za določitev ostankov pri rastlinah 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. Študije o krmljenju — —

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

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

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

6.4.4. Ribe — —

6.5. Učinki predelave — —

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

6.5.2. Porazdelitev ostankov v neužitni lupini in mesu OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Obseg ostankov v predelanih proizvodih 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. Ostanki v kulturah, ki sledijo v kolobarju — —

6.6.1. Presnova pri kulturah, ki sledijo v kolobarju OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Obseg ostankov v kulturah, ki sledijo v kolobarju OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Predlagane opredelitve ostankov in mejne vrednosti ostankov — —

6.7.1. Predlagane opredelitve ostankov — 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. Predlagane mejne vrednosti ostankov (MRL) in utemeljitev sprejemljivosti predlaganih vrednosti — 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. Predlagane mejne vrednosti ostankov (MRL) in utemeljitev sprejemljivosti predlaganih vrednosti za uvožene izdelke (uvozna toleranca) — 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. Predlagane karenčne dobe — 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. Ocene možne in dejanske izpostavljenosti prek prehrane in drugih virov — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Druge študije — —

6.10.1. Vrednost ostankov v pelodu in čebeljih proizvodih — —

7. KONČNO STANJE IN OBNAŠANJE V OKOLJU — —

7.1. Končno stanje in obnašanje v tleh 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. Pot razgradnje v tleh — —

7.1.1.1. Aerobna razgradnja OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaerobna razgradnja OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

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

7.1.2. Stopnja razgradnje v tleh — 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. Laboratorijske študije 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. Terenske študije US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Tehnični vidiki za določitev stopnje razgradnje v tleh v terenskih študijah so na voljo v: 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. Adsorpcija in desorpcija v tleh — —

7.1.3.1. Adsorpcija in desorpcija 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. Stara sorpcija — FOCUS Ground Water

7.1.4. Mobilnost v tleh — —

7.1.4.1. Študije o izpiranju v kolonah OECD Test Guideline 312: Leaching in Soil Columns —

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

7.1.4.3. Terenske študije o izpiranju — FOCUS Ground Water

7.2. Končno stanje in obnašanje v vodi in usedlini — —

7.2.1. Pot in stopnja razgradnje v vodnih sistemih (kemijska in fotokemijska razgradnja) — —

7.2.1.1. Hidrolizna razgradnja OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Neposredna fotokemijska razgradnja OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Posredna fotokemijska razgradnja — —

7.2.2. Pot in stopnja biološke razgradnje v vodnih sistemih — —

7.2.2.1. „Hitra biorazgradljivost“ 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. Aerobna mineralizacija v površinskih vodah 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. Študija o vodi/usedlini OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Študija o obsevani vodi/usedlini OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Razgradnja v nasičenem območju — —

7.3. Končno stanje in obnašanje v zraku FOCUS Air

7.3.1. Pot in stopnja razgradnje v zraku — —

7.3.2. Prenos po zraku — —

7.3.3. Lokalni in globalni učinki — —

7.4. Opredelitev ostanka — —

7.4.1. Opredelitev ostanka za oceno tveganja — —

7.4.2. Opredelitev ostanka za spremljanje — —

7.5. Podatki o spremljanju — —

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

8.1. Učinki na ptice in druge kopenske vretenčarje — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Učinki na ptice — —

8.1.1.1. Akutna oralna toksičnost za ptice OECD Test Guideline No 223: Avian acute oral toxicity study ali US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Kratkotrajna toksičnost pri vnosu s hrano za ptice OECD Test Guideline 205: Avian Dietary Toxicity Test ali US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Subkronična in reproduktivna toksičnost za ptice OECD Test Guideline 206: Avian Reproduction Test ali US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Učinki na kopenske vretenčarje, razen ptic — —

8.1.2.1. Akutna oralna toksičnost za sesalce — —

8.1.2.2. Dolgotrajna in reproduktivna toksičnost za sesalce — —

8.1.3. Biokoncentracija aktivne snovi v plenu ptic in sesalcev — —

8.1.4. Učinki na prostoživeče kopenske vretenčarje (ptice, sesalce, plazilce in dvoživke) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Lastnosti, ki lahko povzročijo motnje endokrinega sistema — 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. Učinki na vodne organizme — 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. Akutna toksičnost za ribe 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. Dolgotrajna in kronična toksičnost za ribe — —

8.2.2.1. Preskus toksičnosti za ribe v zgodnji fazi življenja OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Preskus v celotnem življenjskem ciklu rib US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokoncentracija pri ribah — —

8.2.3. Lastnosti, ki lahko povzročijo motnje endokrinega sistema 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. Akutna toksičnost za vodne nevretenčarje — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Akutna toksičnost za vodno bolho (Daphnia magna) OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Akutna toksičnost za druge vrste vodnih nevretenčarjev US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Dolgotrajna in kronična toksičnost za vodne nevretenčarje — —

8.2.5.1. Reproduktivna in razvojna toksičnost za vodno bolho (Daphnia magna) OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reproduktivna in razvojna toksičnost za dodatne vrste vodnih nevretenčarjev US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Razvoj in pojav pri vrsti Chironomus riparius OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [Na splošno sistem denaturacije vode (i.e. OECD 219) bolje zajema načine izpostavljenosti, ki so tipični za fitofarmacevtska sredstva] —

8.2.5.4. Organizmi, ki živijo v usedlinah OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Učinki na rast alg — —

8.2.6.1. Učinki na rast zelenih alg OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Učinki na rast dodatnih vrst alg OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Učinki na vodne makrofite 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. Dodatni preskusi na vodnih organizmih — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Učinek na členonožce — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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

8.3.1.1. Akutna toksičnost za čebele —

8.3.1.1.1. Akutna oralna toksičnost 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. Akutna kontaktna toksičnost 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. Kronična toksičnost za čebele 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. Učinki na razvoj čebele in njene druge življenjske faze 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. Subletalni učinki 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. Učinki na neciljne členonožce, razen čebel 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. Učinki na vrsto 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. Učinki na vrsto 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. Učinki na neciljno mezofavno in makrofavno v tleh — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Deževniki – subletalni učinki OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Učinki na neciljno mezofavno in makrofavno v tleh (razen deževnikov) —

8.4.2.1. Preskusi na ravni vrste Za skočirepko (Collembola): OECD Test Guideline 232: Collembolan Reproduction Test in Soil Za plenilske pršice: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Učinki na transformacijo dušika v tleh OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Učinki na kopenske neciljne višje rastline — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Povzetek podatkov v zvezi s presejalnimi pregledi — —

8.6.2. Preskusi na neciljnih rastlinah Kalitev in rast sadik: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Preskus rastne moči zemeljskih rastlin: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Učinki na druge kopenske organizme (flora in favna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Učinki na biološke metode v postopkih čiščenja odplak OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. PODATKI IZ LITERATURE 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