Odkaz na časť A prílohy k nariadeniu (EÚ) č. 283/2013 Skúšobné metódy (2) Usmerňovacie dokumenty (3)

1. IDENTITA ÚČINNEJ LÁTKY — 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. FYZIKÁLNE A CHEMICKÉ VLASTNOSTI ÚČINNEJ LÁTKY —

2.1. Bod topenia a bod varu 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. Tlak pary, prchavosť Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Vzhľad (fyzikálny stav, farba) — —

2.4. Spektrá (UV/VIS, IR, NMR, MS), molekulárna extinkcia pri relevantných vlnových dĺžkach, optická čistota OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Rozpustnosť v organických rozpúšťadlách CIPAC Method MT 181: Solubility in organic solvents —

2.7. Rozdeľovací 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 Ak je zlúčenina povrchovo aktívna (povrchové napätie podľa metódy A.5), možno použiť metódu trepačkovej banky opísanú v metóde A.8, ak je zo správy zrejmé, že sa nevyskytli žiadne problémy (napr. oddelenie fáz). Metódu HLCP opísanú v metóde A.8 nemožno použiť na povrchovo aktívne zlúčeniny. —

2.8. Disociácia vo vode OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Horľavosť a samovoľné vznietenie Horľavosť: 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) Samovoľné vznietenie: 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. Bod vzplanutia 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. Výbušnosť 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. Povrchové napätie Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oxidačné vlastnosti Pevné látky: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Kvapaliny: 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. Iné štúdie Skúšobné metódy uvedené v časti II prílohy I k nariadeniu (ES) č. 1272/2008 —

3. ĎALŠIE INFORMÁCIE O ÚČINNEJ LÁTKE EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Použitie účinnej látky — —

3.2. Funkcia — —

3.3. Účinky na škodlivé organizmy — —

3.4. Plánovaná oblasť použitia — —

3.5. Regulované škodlivé organizmy a chránené alebo ošetrované plodiny alebo produkty — —

3.6. Spôsob pôsobenia — —

3.7. Informácie o vzniku alebo možnom vzniku vývoja rezistencie a o vhodných stratégiách riadenia EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metódy a bezpečnostné opatrenia týkajúce sa manipulácie, skladovania, prepravy alebo požiaru — —

3.9. Postupy na zneškodnenie alebo dekontamináciu — —

3.10. Mimoriadne opatrenia v prípade nehody — —

4. ANALYTICKÉ METÓDY — Technický materiál a prípravky: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Rezíduá: 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. TOXIKOLOGICKÉ A METABOLICKÉ ŠTÚDIE — —

5.1. Štúdie absorpcie, distribúcie, metabolizmu a vylučovania u cicavcov — 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. Absorpcia, distribúcia, metabolizmus a vylučovanie po expozícii orálnou cestou Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorpcia, distribúcia, metabolizmus a vylučovanie po expozícii inými cestami Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Akútna toxicita — —

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

5.2.3. Inhalačná 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. Dráždenie 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. Dráždenie očí 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. Senzibilizácia 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. Fototoxicita 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. Krátkodobá toxicita — —

5.3.1. Orálna 28-dňová štúdia 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. Orálna 90-dňová štúdia 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. Iné cesty 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. Skúšanie génotoxicity — —

5.4.1. Štúdie 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. Štúdie in vivo v somatických bunkách 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. Štúdie in vivo v zárodočných bunkách 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. Dlhodobá toxicita a karcinogénnosť 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. Reprodukčná toxicita —

5.6.1. Viacgeneračné štúdie 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. Štúdie vývojovej toxicity 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. Štúdie neurotoxicity —

5.7.1. Štúdie neurotoxicity u hlodavcov 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. Štúdie oneskorenej polyneuropatie 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. Iné toxikologické štúdie — —

5.8.1. Štúdie toxicity 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. Doplňujúce štúdie týkajúce sa účinnej látky — 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. Vlastnosti narušujúce endokrinný systém 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. Lekárske údaje — —

6. REZÍDUÁ V OŠETRENÝCH PRODUKTOCH, POTRAVINÁCH A KRMIVÁCH ALEBO NA OŠETRENÝCH PRODUKTOCH, POTRAVINÁCH A KRMIVÁCH 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 Stabilita rezíduí počas skladovania OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Metabolizmus, distribúcia a vyjadrenie rezíduí — —

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

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

6.2.3. Prežúvavce produkujúce mlieko OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Ryby — —

6.3. Pokusy na rastlinách týkajúce sa množstva rezíduí 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. Skrmovacie štúdie — —

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

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

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

6.4.4. Ryby — —

6.5. Účinky spracovania — —

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

6.5.2. Distribúcia rezídua v nejedlej šupke a dužine OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Množstvo rezíduí v spracovaných komoditách 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. Rezíduá v následných plodinách — —

6.6.1. Metabolizmus v následných plodinách OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Množstvo rezíduí v následných plodinách OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Navrhnuté definície rezíduí a maximálne hladiny rezíduí — —

6.7.1. Navrhnuté definície rezíduí — 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. Navrhnuté maximálne hladiny rezíduí (maximum residue levels – MRLs) a odôvodnenie prijateľnosti navrhnutých hladín — 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. Navrhnuté maximálne hladiny rezíduí (MRL) a odôvodnenie prijateľnosti navrhnutých hladín v dovezených produktoch (tolerancia pri dovoze) — 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. Navrhované ochranné obdobia — 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. Odhad potenciálnej a skutočnej expozície prostredníctvom potravy a iných zdrojov — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Iné štúdie — —

6.10.1. Hladina rezíduí v peli a včelích produktov — —

7. OSUD A SPRÁVANIE V ŽIVOTNOM PROSTREDÍ — —

7.1. Osud a správanie v pôde 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. Spôsob degradácie v pôde — —

7.1.1.1. Aeróbna degradácia OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaeróbna degradácia OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Fotolýza v pôde — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Rýchlosť degradácie v pôde — 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. Laboratórne štúdie 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. Poľné štúdie US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Technické aspekty na určenie rýchlosti degradácie v pôde v štúdiách vykonaných v teréne môžete nájsť v týchto dokumentoch: 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. Adsorpcia a desorpcia v pôde — —

7.1.3.1. Adsorpcia a desorpcia 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. Sorpcia vystarnutých rezíduí — FOCUS Ground Water

7.1.4. Mobilita v pôde — —

7.1.4.1. Štúdie vyplavovania na kolónach OECD Test Guideline 312: Leaching in Soil Columns —

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

7.1.4.3. Poľné štúdie priesaku — FOCUS Ground Water

7.2. Osud a správanie vo vode a v sedimente — —

7.2.1. Cesta a rýchlosť degradácie vo vodných systémoch (chemická a fotochemická degradácia) — —

7.2.1.1. Hydrolytická degradácia OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Priama fotochemická degradácia OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Nepriama fotochemická degradácia — —

7.2.2. Cesta a rýchlosť biologickej degradácie vo vodných systémoch — —

7.2.2.1. „Ľahká biologická odbúrateľnosť“ 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. Aeróbna mineralizácia v povrchových vodách 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. Štúdia vody/sedimentu OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Štúdia ožiarená voda/sediment OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Degradácia v nasýtenej zóne — —

7.3. Osud a správanie v ovzduší FOCUS Air

7.3.1. Spôsob a rýchlosť degradácie v ovzduší — —

7.3.2. Prenos vzduchom — —

7.3.3. Lokálne a globálne účinky — —

7.4. Definícia rezídua — —

7.4.1. Definícia rezídua na účely hodnotenia rizika — —

7.4.2. Definícia rezídua na monitorovanie — —

7.5. Údaje získané monitorovaním — —

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

8.1. Účinky na vtáctvo a iné suchozemské stavovce — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Účinky na vtáky — —

8.1.1.1. Akútna orálna toxicita pre vtáky OECD Test Guideline No 223: Avian acute oral toxicity study alebo US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Krátkodobá toxicita pre vtáky pri prijatí v potrave OECD Test Guideline 205: Avian Dietary Toxicity Test alebo US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Subchronická a reprodukčná toxicita pre vtáky OECD Test Guideline 206: Avian Reproduction Test alebo US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Účinky na suchozemské stavovce okrem vtákov — —

8.1.2.1. Akútna orálna toxicita pre cicavce — —

8.1.2.2. Dlhodobá a reprodukčná toxicita pre cicavce — —

8.1.3. Biokoncentrácia účinnej látky v koristi vtákov a cicavcov — —

8.1.4. Účinky na voľne žijúce suchozemské stavovce (vtáky, cicavce, plazy a obojživelníky) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Vlastnosti narušujúce endokrinný systém — 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. Účinky na vodné organizmy — 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. Akútna toxicita pre ryby 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. Dlhodobá a chronická toxicita pre ryby — —

8.2.2.1. Skúška toxicity v ranom štádiu života rýb OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Skúška počas celého životného cyklu rýb US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokoncentrácia u rýb — —

8.2.3. Vlastnosti narušujúce endokrinný systém 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. Akútna toxicita pre vodné bezstavovce. — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Akútna toxicita pre Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Akútna toxicita pre ďalší druh vodných bezstavovcov US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Dlhodobá a chronická toxicita pre vodné bezstavovce — —

8.2.5.1. Reprodukčná a vývojová toxicita pre Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reprodukčná a vývojová toxicita pre ďalšie druhy vodných bezstavovcov US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Vývoj a liahnutie v druhoch Chironomus riparius OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [Vo všeobecnosti systém použitia vodného roztoku (t. j. OECD 219) lepšie pokrýva spôsoby vystavenia typické pre prípravky na ochranu rastlín] —

8.2.5.4. Organizmy sedimentov OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Účinky na rast rias — —

8.2.6.1. Účinky na rast zelených rias OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Účinky na rast ďalších druhov rias OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Účinky na vodné makrofyty 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. Ďalšie skúšky na vodných organizmoch — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

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

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

8.3.1.1. Akútna toxicita pre včely —

8.3.1.1.1. Akútna orálna toxicita 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. Akútna kontaktná toxicita 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. Chronická toxicita pre včely 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. Účinky na vývoj včiel medonosných a ďalšie štádiá života včiel medonosných 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. Subletálne účinky 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. Účinky na necieľové článkonožce iné ako včely 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. Účinky na 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. Účinky na 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. Účinky na necieľovú pôdnu mezofaunu a makrofaunu — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Subletálne účinky na dážďovky OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Účinky na necieľovú pôdnu mezofaunu a makrofaunu (okrem dážďoviek) —

8.4.2.1. Skúšanie na úrovni druhov Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Predátorské roztoče: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Účinky na transformáciu dusíka v pôde OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Účinky na suchozemské necieľové vyššie rastliny — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Zhrnutie údajov zo skríningu — —

8.6.2. Skúšanie na necieľových rastlinách Rast sadeníc: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Testovanie vegetatívnej aktivity suchozemských rastlín: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Účinky na ďalšie suchozemské organizmy (flóra a fauna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Účinky na biologické metódy čistenia odpadových vôd OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. ÚDAJE Z LITERATÚRY 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