Trimitere la partea A din anexa la Regulamentul (UE) nr. 283/2013 Metode de testare (2) Documente de orientare (3)

1. IDENTITATEA SUBSTANȚEI ACTIVE — 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. PROPRIETĂȚILE FIZICE ȘI CHIMICE ALE SUBSTANȚEI ACTIVE —

2.1. Punctul de topire și punctul de fierbere 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. Presiunea de vapori, volatilitatea Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Aspect (stare fizică, culoare) — —

2.4. Spectru (UV/VIS, IR, RMN, SM), extincție molară la lungimi de undă relevante, puritate optică OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Solubilitatea în solvenți organici CIPAC Method MT 181: Solubility in organic solvents —

2.7. Coeficientul de partiție n-octanol/apă Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Dacă un compus face parte din categoria substanțelor active de suprafață (astfel cum este definit de metoda A.5„tensiune superficială”), se poate aplica metoda agitării flaconului descrisă de metoda A.8 dacă din raport rezultă în mod clar că nu au apărut probleme (de exemplu, probleme de separare a fazelor). Metoda HPLC (cromatografie lichidă de înaltă performanță) descrisă de metoda A.8 nu se aplică compușilor activi de suprafață. —

2.8. Disociere în apă OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Inflamabilitate și autoîncălzire Inflamabilitate: 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) Autoîncălzire: 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. Punct de aprindere 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. Proprietăți explozive 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. Tensiunea superficială Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Proprietăți oxidante Solide: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Lichide: 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. Alte studii Metodele de testare prezentate în partea II din anexa I la Regulamentul (CE) nr. 1272/2008 —

3. INFORMAȚII SUPLIMENTARE PRIVIND SUBSTANȚA ACTIVĂ EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Utilizarea substanței active — —

3.2. Funcție — —

3.3. Efecte asupra organismelor dăunătoare — —

3.4. Domeniul de utilizare preconizat — —

3.5. Organisme dăunătoare combătute și culturi sau produse protejate sau tratate — —

3.6. Mod de acțiune — —

3.7. Informații privind apariția sau eventuala apariție a unei rezistențe și strategiile de gestionare adecvate EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metode și precauții în materie de manipulare, depozitare și transport sau în caz de incendiu — —

3.9. Proceduri de distrugere sau decontaminare — —

3.10. Măsuri de urgență în caz de accident — —

4. METODE ANALITICE — Material tehnic și preparate: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Reziduuri: 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. STUDII TOXICOLOGICE ȘI DE METABOLISM — —

5.1. Studii de absorbție, de distribuție, de metabolism și de excreție la mamifere — 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. Absorbția, distribuția, metabolismul și excreția după expunere pe cale orală Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorbția, distribuția, metabolismul și excreția după expunere pe alte căi Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Toxicitate acută — —

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

5.2.3. Prin inhalare 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. Iritație cutanată 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. Iritație oculară 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. Sensibilizare cutanată 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. Fototoxicitate 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. Toxicitate pe termen scurt — —

5.3.1. Studiu de 28 de zile pe cale orală 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. Studiu de 90 de zile pe cale orală 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. Alte căi 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. Studii de genotoxicitate — —

5.4.1. Studii 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. Studii in vivo pe celule somatice 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. Studii in vivo pe celule germinative 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. Toxicitate pe termen lung și carcinogenitate 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. Toxicitate pentru reproducere —

5.6.1. Studii pe generații 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. Studii de toxicitate pentru dezvoltare 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. Studii de neurotoxicitate —

5.7.1. Studii de neurotoxicitate pe rozătoare 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. Studii de polineuropatie tardivă 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. Alte studii toxicologice — —

5.8.1. Studii de toxicitate a metaboliților 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. Studii suplimentare privind substanța activă — 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. Proprietăți de perturbator endocrin 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. Date medicale — —

6. REZIDUURILE DIN SAU DE PE PRODUSELE, ALIMENTELE ȘI FURAJELE TRATATE 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 Stabilitatea la depozitare a reziduurilor OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Metabolismul, distribuția și exprimarea reziduurilor — —

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

6.2.2. Păsări de curte OECD Test Guideline 503: Metabolism in livestock —

6.2.3. Rumegătoare în lactație OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Pești — —

6.3. Magnitudinea studiilor privind reziduurile în plante 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. Studii de hrănire — —

6.4.1. Păsări de curte OECD Test Guideline 505: Residues in livestock. —

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

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

6.4.4. Pești — —

6.5. Efectele prelucrării — —

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

6.5.2. Distribuția reziduurilor în coaja necomestibilă și pulpă OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Magnitudinea reziduurilor în produsele prelucrate 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. Reziduurile din culturile de rotație — —

6.6.1. Metabolismul în culturile de rotație OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Magnitudinea reziduurilor în culturile de rotație OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Definițiile propuse pentru reziduuri și limitele maxime de reziduuri — —

6.7.1. Definițiile propuse pentru reziduuri — 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. Limitele maxime de reziduuri (LMR) propuse și justificarea acceptabilității limitelor propuse — 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. Limitele maxime de reziduuri (LMR) propuse și justificarea acceptabilității limitelor propuse pentru produsele importate (toleranță la import). — 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. Intervale de siguranță propuse — 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. Estimarea expunerii potențiale sau efective prin alimente sau alte surse — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Alte studii — —

6.10.1. Nivelul de reziduuri din polen și produse apicole — —

7. EVOLUȚIA ȘI COMPORTAMENTUL ÎN MEDIU — —

7.1. Evoluția și comportamentul în sol 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. Calea de degradare în sol — —

7.1.1.1. Degradarea aerobă OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Degradarea anaerobă OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

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

7.1.2. Viteza de degradare în sol — 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. Studii de laborator 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. Studii de teren US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Aspectele tehnice ale determinării ratei de degradare în sol în studiile de teren pot fi găsite în: 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. Adsorbția și desorbția în/din sol — —

7.1.3.1. Adsorbția și desorbția 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. Adsorbție în funcție de timp — FOCUS Ground Water

7.1.4. Mobilitate în sol — —

7.1.4.1. Studii de percolare pe coloană OECD Test Guideline 312: Leaching in Soil Columns —

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

7.1.4.3. Studii de percolare în teren — FOCUS Ground Water

7.2. Evoluția și comportamentul în apă și sedimente — —

7.2.1. Calea și viteza de degradare în sistemele acvatice (degradare chimică și fotochimică) — —

7.2.1.1. Degradare hidrolitică OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Degradare fotochimică directă OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Degradare fotochimică indirectă — —

7.2.2. Calea și viteza de degradare biologică în sistemele acvatice — —

7.2.2.1. „Ușurința biodegradării” 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. Mineralizarea aerobă în apa de suprafață 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. Studiul sistemului apă-sediment OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Studiul sistemului apă-sediment iradiat OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Degradarea în zona saturată — —

7.3. Evoluția și comportamentul în aer FOCUS Air

7.3.1. Calea și viteza de degradare în aer — —

7.3.2. Transport prin aer — —

7.3.3. Efecte locale și globale — —

7.4. Definiția reziduurilor — —

7.4.1. Definiția reziduurilor pentru evaluarea riscurilor — —

7.4.2. Definiția reziduurilor în scopul monitorizării — —

7.5. Date de monitorizare — —

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

8.1. Efecte asupra păsărilor și a altor vertebrate terestre — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Efecte asupra păsărilor — —

8.1.1.1. Toxicitate orală acută la păsări OECD Test Guideline No 223: Avian acute oral toxicity study sau US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Toxicitate alimentară pe termen scurt la păsări OECD Test Guideline 205: Avian Dietary Toxicity Test sau US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Toxicitatea subcronică și toxicitatea pentru reproducere la păsări OECD Test Guideline 206: Avian Reproduction Test sau US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Efecte asupra vertebratelor terestre, altele decât păsările — —

8.1.2.1. Toxicitate orală acută la mamifere — —

8.1.2.2. Toxicitate pe termen lung și pentru reproducere la mamifere — —

8.1.3. Bioconcentrarea substanței active în prada păsărilor și a mamiferelor — —

8.1.4. Efecte asupra vertebratelor terestre sălbatice (păsări, mamifere, reptile și amfibieni) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Proprietăți de perturbator endocrin — 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. Efecte asupra organismelor acvatice — 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. Toxicitate acută la pești 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. Toxicitate pe termen lung și cronică la pești — —

8.2.2.1. Test de toxicitate la pești în primele stadii de viață OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Test asupra întregului ciclu de viață la pești US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Bioconcentrare în pești — —

8.2.3. Proprietăți de perturbator endocrin 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. Toxicitate acută la nevertebrate acvatice — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Toxicitate acută la Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Toxicitate acută la o specie nevertebrată acvatică suplimentară US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Toxicitate pe termen lung și cronică la nevertebrate acvatice — —

8.2.5.1. Toxicitate pentru reproducere și pentru dezvoltare la Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Toxicitate pentru reproducere și pentru dezvoltare la o specie nevertebrată acvatică suplimentară US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Dezvoltarea și emergența la Chironomus riparius Orientarea 219 a OCDE privind testarea: Test de toxicitate la Chironomus într-un sistem apă îmbogățită – sediment [în general, un sistem apă îmbogățită - sediment (a se vedea OCDE 219) acoperă mai bine căile de expunere specifice produselor de protecție a plantelor] —

8.2.5.4. Organisme care trăiesc în sedimente OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Efecte asupra creșterii algelor — —

8.2.6.1. Efecte asupra creșterii algelor verzi OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Efecte asupra creșterii unei specii de alge suplimentare OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Efecte asupra macrofitelor acvatice 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. Teste suplimentare asupra organismelor acvatice — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Efecte asupra artropodelor — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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

8.3.1.1. Toxicitate acută la albine —

8.3.1.1.1. Toxicitate orală acută 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. Toxicitate de contact acută 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. Toxicitate cronică la albine 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. Efectele asupra dezvoltării albinelor și asupra altor stadii de viață ale albinelor 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. Efecte subletale 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. Efecte asupra artropodelor nețintă, altele decât albinele 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. Efecte asupra 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. Efecte asupra 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. Efecte asupra mezofaunei și macrofaunei nețintă din sol — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Râme – efecte subletale OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Efecte asupra mezofaunei și macrofaunei nețintă din sol (altele decât râmele) —

8.4.2.1. Testări la nivel de specie Pentru Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Pentru acarieni prădători: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Efecte asupra transformării azotului în sol OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Efecte asupra plantelor superioare terestre nețintă — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Rezumatul datelor de screening — —

8.6.2. Testări la plante nețintă Apariția plantulelor și creșterea plantulelor: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Testarea vigorii vegetative a plantelor terestre: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Efecte asupra altor organisme terestre (floră și faună) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Efecte asupra metodelor biologice de tratare a apelor uzate OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. DATE DIN LITERATURA DE SPECIALITATE 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