Referência à parte A do anexo ao Regulamento (UE) n.o 283/2013 Métodos de ensaio (2) Documentos de orientação (3)

1. IDENTIDADE DA SUBSTÂNCIA ATIVA — 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. PROPRIEDADES FÍSICAS E QUÍMICAS DA SUBSTÂNCIA ATIVA —

2.1. Ponto de fusão e ponto de ebulição 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. Pressão do vapor, volatilidade Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Aspeto (estado físico, cor) — —

2.4. Espetros (UV/VIS, IR, RMN, MS), extinção molar em comprimentos de onda relevantes, pureza ótica OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Solubilidade em solventes orgânicos CIPAC Method MT 181: Solubility in organic solvents —

2.7. Coeficiente de partição n octanol/água Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Se um componente for tensoativo (como definido pelo Método A.5 Tensão superficial), o método do frasco agitado descrito no método A.8 pode ser aplicado se o relatório indicar claramente que não ocorreram problemas (p. ex., separações de fases). O método HPLC descrito no Método A.8 não é aplicável aos compostos tensoativos. —

2.8. Dissociação em água OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Inflamabilidade e auto inflamabilidade Inflamabilidade: 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) Auto-inflamabilidade: 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. Ponto de inflamabilidade 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. Propriedades explosivas 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. Tensão superficial Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Propriedades oxidantes Sólidos: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Líquidos: 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. Outros estudos Métodos de ensaio referidos no anexo I, parte II, do Regulamento (CE) n.o 1272/2008 —

3. INFORMAÇÕES ADICIONAIS SOBRE A SUBSTÂNCIA ATIVA EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Utilização da substância ativa — —

3.2. Função — —

3.3. Efeitos sobre os organismos nocivos — —

3.4. Domínio de utilização previsto — —

3.5. Organismos nocivos controlados e culturas ou produtos protegidos ou tratados — —

3.6. Modo de ação — —

3.7. Informações sobre a ocorrência ou possível ocorrência de desenvolvimento de resistência e estratégias de gestão adequadas EPPO standard PP 1/213: Resistance risk analysis —

3.8. Métodos e precauções relativos ao manuseamento, armazenagem, transporte ou incêndio — —

3.9. Processos de destruição ou descontaminação — —

3.10. Medidas de emergência em caso de acidente — —

4. MÉTODOS DE ANÁLISE — Materiais técnicos e preparações: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Resíduos: 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. ESTUDOS TOXICOLÓGICOS E DE METABOLISMO — —

5.1. Estudos relativos à absorção, distribuição, metabolismo e excreção em mamíferos — 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. Absorção, distribuição, metabolismo e excreção após exposição por via oral Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorção, distribuição, metabolismo e excreção após exposição por outras vias Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Toxicidade aguda — —

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

5.2.3. Via inalatória 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. Irritação cutânea 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. Irritação ocular 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. Sensibilização cutânea 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. Fototoxicidade 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. Toxicidade a curto prazo — —

5.3.1. Estudo de toxicidade por via oral de 28 dias 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. Estudo de toxicidade por via oral de 90 dias 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. Outras vias 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. Ensaio de genotoxicidade — —

5.4.1. Estudos 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. Estudos in vivo em células somáticas 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. Estudos in vivo em células germinativas 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. Toxicidade e carcinogenicidade a longo prazo 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. Toxicidade para a reprodução —

5.6.1. Estudos geracionais 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. Estudos de toxicidade para o desenvolvimento 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. Estudos de neurotoxicidade —

5.7.1. Estudo de neurotoxicidade em roedores 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. Estudos de polineuropatia retardada 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. Outros estudos toxicológicos — —

5.8.1. Estudos de toxicidade dos metabolitos 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. Estudos complementares da substância ativa — 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. Propriedades perturbadoras do sistema endócrino 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. Dados médicos — —

6. RESÍDUOS NO INTERIOR E À SUPERFÍCIE DE PRODUTOS, GÉNEROS ALIMENTÍCIOS E ALIMENTOS PARA ANIMAIS, TRATADOS 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 Estabilidade dos resíduos na armazenagem OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Metabolismo, distribuição e expressão de resíduos — —

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

6.2.2. Aves de capoeira OECD Test Guideline 503: Metabolism in livestock —

6.2.3. Ruminantes lactantes OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Peixes — —

6.3. Ensaios da magnitude dos resíduos nos vegetais 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. Estudos alimentares com animais — —

6.4.1. Aves de capoeira OECD Test Guideline 505: Residues in livestock. —

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

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

6.4.4. Peixes — —

6.5. Efeitos da transformação — —

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

6.5.2. Distribuição do resíduo na casca não comestível e na polpa OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Magnitude dos resíduos em produtos transformados 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. Resíduos em culturas rotativas — —

6.6.1. Metabolismo em culturas rotativas OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Magnitude dos resíduos em culturas rotativas OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Definições de resíduos e limites máximos de resíduos propostos — —

6.7.1. Definições de resíduos propostas — 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. Limites máximos de resíduos (LMR) propostos e justificação da aceitabilidade dos limites propostos — 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. Limites máximos de resíduos (LMR) propostos e justificação da aceitabilidade dos limites propostos para produtos importados (tolerância de importação) — 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. Intervalos de segurança propostos — 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. Estimativa da exposição potencial e real através do regime alimentar e por outras fontes — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Outros estudos — —

6.10.1. Resíduos no pólen e produtos apícolas — —

7. DESTINO E COMPORTAMENTO NO AMBIENTE — —

7.1. Destino e comportamento no solo 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. Via de degradação no solo — —

7.1.1.1. Degradação aeróbia OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Degradação anaeróbia OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Fotólise no solo — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Taxa de degradação no solo — 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. Estudos laboratoriais 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. Estudos de campo US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Os aspetos técnicos que servem para determinar a taxa de degradação no solo nos estudos de campo podem ser consultados em: 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. Adsorção e dessorção no solo — —

7.1.3.1. Adsorção e dessorção 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. Sorção a prazo — FOCUS Ground Water

7.1.4. Mobilidade no solo — —

7.1.4.1. Estudos de lixiviação em coluna OECD Test Guideline 312: Leaching in Soil Columns —

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

7.1.4.3. Estudos de lixiviação no campo — FOCUS Ground Water

7.2. Destino e comportamento na água e no sedimento — —

7.2.1. Via e taxa de degradação em sistemas aquáticos (degradação química e fotoquímica) — —

7.2.1.1. Degradação hidrolítica OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Degradação fotoquímica direta OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Degradação fotoquímica indireta — —

7.2.2. Via e taxa de degradação biológica em sistemas aquáticos — —

7.2.2.1. Biodegradabilidade imediata 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. Mineralização aeróbia nas águas superficiais 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. Estudo água/sedimento OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Estudo água/sedimento irradiados OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Degradação na zona saturada — —

7.3. Destino e comportamento no ar FOCUS Air

7.3.1. Via e taxa de degradação no ar — —

7.3.2. Transporte através do ar — —

7.3.3. Efeitos locais e globais — —

7.4. Definição de resíduo — —

7.4.1. Definição de resíduos para efeitos de avaliação do risco — —

7.4.2. Definição de resíduos para efeitos de monitorização — —

7.5. Dados de monitorização — —

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

8.1. Efeitos em aves e outros vertebrados terrestres — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Efeitos em aves — —

8.1.1.1. Toxicidade aguda por via oral para aves OECD Test Guideline No 223: Avian acute oral toxicity study ou US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Toxicidade alimentar a curto prazo para aves OECD Test Guideline 205: Avian Dietary Toxicity Test ou US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Toxicidade subcrónica e reprodutiva para aves OECD Test Guideline 206: Avian Reproduction Test ou US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Efeitos em vertebrados terrestres, excluindo as aves — —

8.1.2.1. Toxicidade aguda por via oral para mamíferos — —

8.1.2.2. Toxicidade a longo prazo e reprodutiva para mamíferos — —

8.1.3. Bioconcentração da substância ativa em presas de aves e mamíferos — —

8.1.4. Efeitos em vertebrados terrestres selvagens (aves, mamíferos, répteis e anfíbios) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Propriedades perturbadoras do sistema endócrino — 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. Efeitos em organismos aquáticos — 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. Toxicidade aguda em peixes 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. Toxicidade a longo prazo e crónica para peixes — —

8.2.2.1. Ensaios de toxicidade nas primeiras fases da vida dos peixes OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Ensaio do ciclo de vida completo dos peixes US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Bioconcentração em peixes — —

8.2.3. Propriedades perturbadoras do sistema endócrino 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. Toxicidade aguda em invertebrados aquáticos — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Toxicidade aguda para Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Toxicidade aguda para uma outra espécie de invertebrados aquáticos US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Toxicidade a longo prazo e crónica para invertebrados aquáticos — —

8.2.5.1. Toxicidade reprodutiva e de desenvolvimento para Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Toxicidade reprodutiva e de desenvolvimento para uma outra espécie de invertebrados aquáticos US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Desenvolvimento e emergência em Chironomus riparius OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [Em geral, um sistema água enriquecida-sedimento (ver OCDE 219) cobre melhor as vias de exposição características dos produtos fitofarmacêuticos] —

8.2.5.4. Organismos dos sedimentos OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Efeitos sobre o crescimento das algas — —

8.2.6.1. Efeitos sobre o crescimento de algas verdes OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Efeitos sobre o crescimento de uma outra espécie de algas OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Efeitos sobre os macrófitos aquáticos 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. Outros ensaios em organismos aquáticos — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Efeitos em artrópodes — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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

8.3.1.1. Toxicidade aguda em abelhas —

8.3.1.1.1. Toxicidade aguda por via oral 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. Toxicidade aguda por contacto 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. Toxicidade crónica para abelhas 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. Efeitos sobre o desenvolvimento das abelhas e outras fases da vida das abelhas 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. Efeitos subletais 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. Efeitos em artrópodes não visados, excluindo as abelhas 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. Efeitos sobre 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. Efeitos sobre 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. Efeitos na mesofauna e na macrofauna do solo não visada — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Minhocas – efeitos subletais OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Efeitos na mesofauna e na macrofauna do solo não visada (exceto minhocas) —

8.4.2.1. Ensaio a nível da espécie Na Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Nos ácaros predatores: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Efeitos na transformação do azoto do solo OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Efeitos em plantas terrestres mais avançadas não visadas — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Resumo dos dados da triagem — —

8.6.2. Ensaios em plantas não visadas Emergência de plântulas e crescimento de plântulas: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Ensaio do vigor vegetativo dos vegetais terrestres: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Efeitos noutros organismos terrestres (flora e fauna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Efeitos nos métodos biológicos de tratamento das águas residuais OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. DADOS RELATIVOS À LITERATURA 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