Nuoroda į Reglamento (ES) Nr. 283/2013 priedo A dalį Bandymų metodai (2) Rekomendaciniai dokumentai (3)

1. VEIKLIOSIOS MEDŽIAGOS TAPATUMAS — 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. VEIKLIOSIOS MEDŽIAGOS FIZINĖS IR CHEMINĖS SAVYBĖS —

2.1. Lydymosi temperatūra ir virimo temperatūra 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. Garų slėgis, lakumas Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Pavidalas (fizinis būvis, spalva) — —

2.4. Spektras (UV/VIS, IR, NMR, MS), molinė ekstinkcija tam tikrame bangos ilgio diapazone, optinis grynumas OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Tirpumas organiniuose tirpikliuose CIPAC Method MT 181: Solubility in organic solvents —

2.7. N-oktanolio / vandens pasiskirstymo koeficientas Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Jei junginys yra paviršinio aktyvumo (kaip apibrėžta A.5 metode „Paviršiaus įtemptis“), galima taikyti A.8 metode aprašytą kratomos kolbos metodą, jei iš ataskaitos yra aišku, kad nekilo jokių problemų (pvz., fazių išskirstymo). A.8 metode aprašytas HPLC metodas paviršinio aktyvumo junginiams netaikomas. —

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

2.9. Degumas ir savaiminis kaitimas Degumas: 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) Savaiminis kaitimas: 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. Pliūpsnio temperatūra 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. Sprogumo savybės 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. Paviršiaus įtemptis Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oksidacijos savybės Kietosios medžiagos: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Skysčiai: 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. Kiti tyrimai Bandymų metodai pagal Reglamento (EB) Nr. 1272/2008 I priedo II dalį. —

3. KITA INFORMACIJA APIE VEIKLIĄJĄ MEDŽIAGĄ EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Veikliosios medžiagos naudojimo būdas — —

3.2. Funkcija — —

3.3. Poveikis kenksmingiesiems organizmams — —

3.4. Numatoma naudojimo sritis — —

3.5. Kontroliuojami kenksmingieji organizmai ir apsaugoti arba apdorojami kultūriniai augalai arba produktai — —

3.6. Veikimo būdas — —

3.7. Informacija apie atsparumo atsiradimą arba galimą atsparumo išsiugdymą bei atitinkamas valdymo strategijas EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metodai ir atsargumo priemonės, susiję su tvarkymu, laikymu, vežimu arba gaisru — —

3.9. Naikinimo arba nukenksminimo tvarka — —

3.10. Skubios pagalbos priemonės nelaimingo atsitikimo atveju — —

4. ANALIZĖS METODAI — Techninė medžiaga ir preparatai: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Likučiai: 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. TOKSIKOLOGINIAI IR METABOLIZMO TYRIMAI — —

5.1. Absorbcijos, pasiskirstymo, metabolizmo ir ekskrecijos žinduolių organizmuose tyrimai — 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. Absorbcija, pasiskirstymas, metabolizmas ir ekskrecija po sąlyčio oraliniu būdu Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorbcija, pasiskirstymas, metabolizmas ir ekskrecija po sąlyčio kitais būdais Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Ūmus toksiškumas — —

5.2.1 Oralinis toksiškumas 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. Toksiškumas susilietus su oda Method B.3 Acute toxicity (dermal) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 402: Acute Dermal Toxicity —

5.2.3. Inhaliacinis toksiškumas 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. Odos dirginimas 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. Akių dirginimas 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. Odos jautrinimas. 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. Fototoksiškumas 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. Trumpalaikis toksiškumas — —

5.3.1. 28 dienų trukmės oralinis tyrimas 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 dienų trukmės oralinis tyrimas 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. Kiti poveikio būdai 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. Genotoksiškumo bandymai — —

5.4.1. In vitro tyrimai 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. Somatinių ląstelių in vivo tyrimai 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. Embrioninių ląstelių in vivo tyrimai 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. Ilgalaikis toksiškumas ir kancerogeniškumas 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. Reprodukcinis toksiškumas —

5.6.1. Kartų tyrimai 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. Vystymosi toksiškumo tyrimai 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. Neurotoksiškumo tyrimai —

5.7.1. Neurotoksiško poveikio graužikams tyrimas 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. Uždelstos polineuropatijos tyrimai 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. Kiti toksikologiniai tyrimai — —

5.8.1. Metabolitų toksiškumo tyrimai 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. Papildomi veikliosios medžiagos tyrimai — 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. Poveikis, galintis sutrikdyti endokrininės sistemos veiklą 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. Medicininiai duomenys — —

6. LIKUČIAI APDOROTUOSE PRODUKTUOSE, MAISTO PRODUKTUOSE IR PAŠARUOSE ARBA ANT JŲ 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 Likučių laikymo trukmė OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Likučių metabolizmas, pasiskirstymas ir išraiška — —

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

6.2.2. Naminiai paukščiai OECD Test Guideline 503: Metabolism in livestock —

6.2.3. Laktuojantys atrajotojai OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Žuvys — —

6.3. Likučių masto augaluose bandymai 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. Pašarų tyrimai — —

6.4.1. Naminiai paukščiai OECD Test Guideline 505: Residues in livestock. —

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

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

6.4.4. Žuvys — —

6.5. Apdorojimo poveikis — —

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

6.5.2. Likučių pasiskirstymas nevalgomoje žievėje ir minkštime OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Likučių mastas apdorotuose produktuose 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. Likučiai sėjomainos būdu auginamuose kultūriniuose augaluose — —

6.6.1. Metabolizmas sėjomainos būdu auginamuose kultūriniuose augaluose OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Likučių mastas sėjomainos būdu auginamuose kultūriniuose augaluose OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Siūlomos likučių apibrėžtys ir didžiausios leidžiamosios likučių koncentracijos — —

6.7.1. Siūlomos likučių apibrėžtys — 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. Siūlomos didžiausios leidžiamosios koncentracijos (DLK) ir šių koncentracijų priimtinumo pagrindimas — 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. Siūlomos didžiausios leidžiamosios koncentracijos (DLK) ir importuojamiems produktams siūlomų šių koncentracijų priimtinumo pagrindimas (toleruojamos importuojamų produktų vertės) — 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. Siūlomi saugos laikotarpiai — 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. Galimo ir faktinio sąlyčio per maistą ir kitų šaltinių poveikio apskaičiavimas — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Kiti tyrimai — —

6.10.1. Poveikis likučių koncentracijai žiedadulkėse ir bičių produktuose — —

7. IŠLIKIMAS IR VEIKIMAS APLINKOJE — —

7.1. Išlikimas ir veikimas dirvožemyje 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. Skilimo dirvožemyje kelias — —

7.1.1.1. Aerobinis skilimas OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaerobinis skilimas OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

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

7.1.2. Skilimo dirvožemyje greitis — 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. Laboratoriniai tyrimai 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. Lauko tyrimai US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Techninius aspektus, kuriais remiantis galima nustatyti skaidymo greitį dirvožemyje atliekant lauko tyrimus, galima rasti: 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. Adsorbcija ir desorbcija dirvožemyje — —

7.1.3.1. Adsorbcija ir desorbcija 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. Ilgalaikė sorbcija — FOCUS Ground Water

7.1.4. Judumas dirvožemyje — —

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

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

7.1.4.3. Išplovimo lauke tyrimai — FOCUS Ground Water

7.2. Išlikimas ir veikimas vandenyje ir nuosėdose — —

7.2.1. Skilimo kelias ir greitis vandens sistemose (cheminis ir fotocheminis skilimas) — —

7.2.1.1. Hidrolitinis skilimas OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Tiesioginis fotocheminis skilimas OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Netiesioginis fotocheminis skilimas — —

7.2.2. Biologinio skilimo kelias ir greitis vandens sistemose — —

7.2.2.1. Greitasis biologinis skaidumas 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. Aerobinė paviršinio vandens mineralizacija 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. Vandens (nuosėdų) tyrimai OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Apšvitinto vandens (nuosėdų) tyrimas OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Skilimas prisotintoje zonoje — —

7.3. Išlikimas ir veikimas ore FOCUS Air

7.3.1. Skilimo ore kelias ir greitis — —

7.3.2. Pernešimas oru — —

7.3.3. Vietos ir globalus poveikis — —

7.4. Likučių apibrėžtis — —

7.4.1. Likučių apibrėžtis rizikos vertinimo požiūriu — —

7.4.2. Likučių apibrėžtis stebėsenos požiūriu — —

7.5. Stebėsenos duomenys — —

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

8.1. Poveikis paukščiams ir kitiems sausumos stuburiniams gyvūnams — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Poveikis paukščiams — —

8.1.1.1. Ūmus oralinis toksiškumas paukščiams OECD Test Guideline No 223: Avian acute oral toxicity study arba US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Trumpalaikio poveikio toksinės medžiagos, patenkančios į paukščių organizmą per lesalą OECD Test Guideline 205: Avian Dietary Toxicity Test arba US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Pusiau lėtinis toksiškumas ir reprodukcinis toksiškumas paukščiams OECD Test Guideline 206: Avian Reproduction Test arba US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Poveikis sausumos stuburiniams gyvūnams, išskyrus paukščius — —

8.1.2.1. Ūmus oralinis toksiškumas žinduoliams — —

8.1.2.2. Ilgalaikis arba reprodukcinis toksiškumas žinduoliams — —

8.1.3. Veikliosios medžiagos biokoncentracijos paukščių ir žinduolių grobyje — —

8.1.4. Poveikis stuburiniams laukiniams sausumos gyvūnams (paukščiams, žinduoliams, ropliams ir amfibijoms) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Poveikis, galintis sutrikdyti endokrininės sistemos veiklą — 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. Poveikis vandens organizmams — 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. Ūmus toksiškumas žuvims 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. Ilgalaikis arba lėtinis toksiškumas žuvims — —

8.2.2.1. Toksiškumo žuvims ankstyvajame jų gyvavimo etape bandymas OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Viso žuvų gyvavimo ciklo bandymas US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokoncentracija žuvyse — —

8.2.3. Poveikis, galintis sutrikdyti endokrininės sistemos veiklą 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. Ūmus toksiškumas vandens bestuburiams gyvūnams — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Ūmus toksiškumas Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Ūmus toksiškumas papildomai vandens bestuburių rūšiai US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Ilgalaikis arba lėtinis toksiškumas vandens bestuburiams — —

8.2.5.1. Reprodukcinis ir vystymosi toksiškumas Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reprodukcinis ir vystymosi toksiškumas papildomai vandens bestuburių rūšiai US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Chironomus riparius vystymasis ir išsinėrimas OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [apskritai, taikant praturtinto vandens sistemą (t.y. OECD 219), geriau apimami augalų apsaugos produktams būdingi sąlyčio būdai] —

8.2.5.4. Nuosėdose gyvenantys organizmai OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Poveikis dumblių augimui — —

8.2.6.1. Poveikis žaliadumblių augimui OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Poveikis papildomos rūšies dumblių augimui OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Poveikis vandens makrofitams 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. Tolesnis vandens organizmų tyrimas — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

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

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

8.3.1.1. Ūmus toksiškumas bitėms —

8.3.1.1.1. Ūmus oralinis toksiškumas 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. Ūmus sąlyčio toksiškumas 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. Lėtinis toksiškumas bitėms 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. Poveikis bičių vystymuisi ir kitiems bičių gyvavimo etapams 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. Beveik mirtinas poveikis 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. Poveikis atsitiktinai paveiktiems nariuotakojams, išskyrus bites 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. Poveikis 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. Poveikis 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. Poveikis atsitiktinai paveiktai dirvožemio mezofaunai ir makrofaunai — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Beveik mirtinas poveikis sliekams OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Poveikis atsitiktinai paveiktai dirvožemio mezofaunai ir makrofaunai (išskyrus sliekus) —

8.4.2.1. Rūšies lygmens bandymas Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Grobuoniškosioms erkėms: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Poveikis dirvožemio azoto virsmui OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Poveikis atsitiktinai paveiktiems aukštesniesiems sausumos augalams — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Patikros duomenų santrauka — —

8.6.2. Su atsitiktinai paveiktais augalais atliekami bandymai Daigų dygimas ir daigų augimas: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Sausumos augalų augimo spartos bandymai: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Poveikis kitiems sausumos organizmams (florai ir faunai) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Poveikis biologiniams nuotekų valymo metodams OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. LITERATŪROJE PATEIKIAMI DUOMENYS 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