Riferimento alla parte A dell'allegato del regolamento (UE) n. 283/2013 Metodi di prova (2) Documenti di orientamento (3)

1. IDENTITÀ DELLA SOSTANZA ATTIVA — 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. PROPRIETÀ FISICHE E CHIMICHE DELLA SOSTANZA ATTIVA —

2.1. Punto di fusione e punto di ebollizione 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. Tensione di vapore, volatilità Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Aspetto (stato fisico, colore) — —

2.4. Spettri (UV/VIS, IR, NMR, MS), estinzione molare a lunghezze d'onda rilevanti, purezza ottica OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Solubilità nei solventi organici CIPAC Method MT 181: Solubility in organic solvents —

2.7. Coefficiente di ripartizione n-ottanolo/acqua Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Se un composto è attivo in superficie (definiti dal metodo A.5 tensione superficiale) il metodo del dibattimento in pallone descritto nel metodo A.8 può essere applicabile se nella relazione è evidente che non si sono verificati problemi (ad esempio, separazioni di fase). Il metodo HPLC descritto nel metodo A.8 non è applicabile a composti attivi di superficie. —

2.8. Dissociazione in acqua OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Infiammabilità e autoinfiammabilità Infiammabilità 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) Autoinfiammabilità: 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. Punto di infiammabilità 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. Proprietà esplosive 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. Tensione superficiale Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Proprietà comburenti Solidi: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Liquidi: 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. Altri studi Metodi di prova riportati nell'allegato I, parte II del regolamento (CE) n. 1272/2008 —

3. ALTRE INFORMAZIONI SULLA SOSTANZA ATTIVA EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Impiego della sostanza attiva — —

3.2. Funzione — —

3.3. Effetti sugli organismi nocivi — —

3.4. Campo d'impiego previsto — —

3.5. Organismi nocivi controllati e piante o prodotti protetti o trattati — —

3.6. Meccanismo di azione — —

3.7. Informazioni sulla comparsa, o sull'eventuale comparsa, di resistenza, e strategie adeguate di gestione EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metodi e precauzioni per la manipolazione, l'immagazzinamento, il trasporto o in caso di incendio — —

3.9. Metodi di distruzione o di decontaminazione — —

3.10. Misure di emergenza in caso di incidente — —

4. METODI ANALITICI — Materiale tecnico e preparazioni: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Residui: 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. STUDI TOSSICOLOGICI E SUL METABOLISMO — —

5.1. Studi di assorbimento, distribuzione, metabolismo ed escrezione nei mammiferi — 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. Assorbimento, distribuzione, metabolismo ed escrezione in seguito ad esposizione per via orale Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Assorbimento, distribuzione, metabolismo ed escrezione in seguito ad esposizione per altre vie Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Tossicità acuta — —

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

5.2.3. Per inalazione 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. Irritazione cutanea 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. Irritazione degli occhi 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. Sensibilizzazione cutanea 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. Fototossicità 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. Tossicità a breve termine — —

5.3.1. Studio di tossicità orale a 28 giorni 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. Studio di tossicità orale a 90 giorni 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. Altre vie 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. Test di genotossicità — —

5.4.1. Analisi 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. Studi in vivo su cellule somatiche 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. Studi in vivo su cellule germinali 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. Tossicità a lungo termine e cancerogenesi 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. Tossicità per la riproduzione —

5.6.1. Studi generazionali 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. Studi di tossicità per lo sviluppo 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. Studi di neurotossicità —

5.7.1. Studi di neurotossicità nei roditori 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. Studi di polineuropatia ritardata 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. Altri studi tossicologici — —

5.8.1. Studi di tossicità dei metaboliti 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. Studi supplementari sulla sostanza attiva — 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. Proprietà di interferenza endocrina 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. Dati medici — —

6. RESIDUI IN O SU PRODOTTI, ALIMENTI PER L'UOMO E ALIMENTI PER GLI ANIMALI TRATTATI 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 Stabilità dei residui durante l'immagazzinamento OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Metabolismo, distribuzione ed espressione dei residui — —

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

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

6.2.3. Ruminanti da latte OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Pesci — —

6.3. Prove per la determinazione dell'entità dei residui nei vegetali 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. Studi sull'alimentazione — —

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

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

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

6.4.4. Pesci — —

6.5. Effetti della trasformazione — —

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

6.5.2. Distribuzione del residuo nella buccia non commestibile e nella polpa OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Entità dei residui nei prodotti trasformati 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. Residui nelle colture a rotazione — —

6.6.1. Metabolismo nelle colture a rotazione OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Entità dei residui nelle colture a rotazione OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Definizioni dei residui e livelli massimi di residui proposti — —

6.7.1. Definizioni dei residui proposte — 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. Livelli massimi di residui (LMR) proposti e giustificazione dell'accettabilità dei livelli proposti — 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. Livelli massimi di residui (LMR) proposti e giustificazione dell'accettabilità dei livelli proposti per i prodotti importati (tolleranza all'importazione) — 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. Intervalli di sicurezza proposti — 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. Stima dell'esposizione potenziale ed effettiva attraverso la dieta e altre vie — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Altri studi — —

6.10.1. Livelli dei residui nel polline e nei prodotti delle api — —

7. DESTINO E COMPORTAMENTO NELL'AMBIENTE — —

7.1. Destino e comportamento nel suolo 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 di degradazione nel suolo — —

7.1.1.1. Degradazione aerobica OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Degradazione anaerobica OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Fotolisi nel suolo — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Tasso di degradazione nel suolo — 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. Studi di laboratorio 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. Studi sul campo US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Gli aspetti tecnici per determinare i tassi di degradazione nel suolo negli studi sul campo si possono trovare nei seguenti testi: 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. Adsorbimento e desorbimento nel suolo — —

7.1.3.1. Adsorbimento e desorbimento 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. Assorbimento in funzione del tempo — FOCUS Ground Water

7.1.4. Mobilità nel suolo — —

7.1.4.1. Studi di lisciviazione su colonna OECD Test Guideline 312: Leaching in Soil Columns —

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

7.1.4.3. Studi di lisciviazione sul campo — FOCUS Ground Water

7.2. Destino e comportamento nell'acqua e nei sedimenti — —

7.2.1. Via e percentuale di degradazione nei sistemi acquatici (degradazione chimica e fotochimica) — —

7.2.1.1. Degradazione idrolitica OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Degradazione fotochimica diretta OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Degradazione fotochimica indiretta — —

7.2.2. Via e percentuale di degradazione biologica nei sistemi acquatici — —

7.2.2.1. Biodegradabilità rapida 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. Mineralizzazione aerobica nelle acque di superficie 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. Studio su acque/sedimenti OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Studio su acque/sedimenti irradiati OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Degradazione nella zona di saturazione — —

7.3. Destino e comportamento nell'aria FOCUS Air

7.3.1. Via e percentuale di degradazione nell'aria — —

7.3.2. Propagazione atmosferica — —

7.3.3. Effetti locali e globali — —

7.4. Definizione di residuo — —

7.4.1. Definizione di residuo per la valutazione del rischio — —

7.4.2. Definizione del residuo ai fini del monitoraggio — —

7.5. Dati di monitoraggio — —

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

8.1. Effetti sugli uccelli e altri vertebrati terrestri — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Effetti sugli uccelli — —

8.1.1.1. Tossicità orale acuta per gli uccelli OECD Test Guideline No 223: Avian acute oral toxicity study oppure US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Tossicità alimentare a breve termine per gli uccelli OECD Test Guideline 205: Avian Dietary Toxicity Test oppure US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Tossicità subcronica e tossicità per la riproduzione degli uccelli OECD Test Guideline 206: Avian Reproduction Test oppure US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Effetti su vertebrati terrestri diversi dagli uccelli — —

8.1.2.1. Tossicità orale acuta per i mammiferi — —

8.1.2.2. Tossicità a lungo termine e per la riproduzione dei mammiferi — —

8.1.3. Effetti della bioconcentrazione della sostanza attiva nelle prede di uccelli e mammiferi — —

8.1.4. Effetti sui vertebrati selvatici terrestri (uccelli, mammiferi, rettili e anfibi) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Proprietà di interferenza endocrina — 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. Effetti sugli organismi acquatici — 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. Tossicità acuta per i pesci 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. Tossicità a lungo termine e cronica per i pesci — —

8.2.2.1. Prova di tossicità per i pesci nelle prime fasi di vita OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Test sull'intero ciclo di vita dei pesci US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Bioconcentrazione nei pesci — —

8.2.3. Proprietà di interferenza endocrina 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. Tossicità acuta per gli invertebrati acquatici — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Tossicità acuta nella Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Tossicità acuta per un'ulteriore specie di invertebrati acquatici US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Tossicità a lungo termine e cronica per gli invertebrati acquatici — —

8.2.5.1. Tossicità per la riproduzione e lo sviluppo della Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Tossicità per la riproduzione e lo sviluppo di un'ulteriore specie di invertebrati acquatici US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Sviluppo e comparsa della specie Chironomus riparius OECD Test Guideline 219: [in generale un sistema con acqua aggiunta (ossia OCSE 219) copre meglio le vie di esposizione tipiche dei prodotti fitosanitari] —

8.2.5.4. Organismi nei sedimenti OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Effetti sulla crescita delle alghe — —

8.2.6.1. Effetti sulla crescita delle alghe verdi OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Effetti sulla crescita di un'ulteriore specie di alghe OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Effetti sulle macrofite acquatiche 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. Test ulteriori sugli organismi acquatici — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Effetti sugli artropodi — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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

8.3.1.1. Tossicità acuta per le api —

8.3.1.1.1. Tossicità orale acuta 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. Tossicità acuta per contatto 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. Tossicità cronica per le api 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. Effetti sullo sviluppo delle api da miele e su altre fasi di vita delle api da miele 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. Effetti subletali 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. Effetti su artropodi non bersaglio diversi dalle api 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. Effetti sull'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. Effetti sul 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. Effetti sulla meso- e macrofauna non bersaglio del suolo — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Lombrichi - effetti subletali OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Effetti sulla meso- e macrofauna non bersaglio del suolo (diversa dai lombrichi) —

8.4.2.1. Test a livello di specie Per Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Per gli acari predatori: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Effetti sul suolo in termini di trasformazione dell'azoto OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Effetti sulle piante superiori terrestri non bersaglio — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Sintesi dei dati di screening — —

8.6.2. Test sulle piante non bersaglio Emergenza delle plantule e crescita delle plantule: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Prova del vigore vegetativo delle piante terrestri: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Effetti su altri organismi terrestri (flora e fauna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Effetti su metodi biologici di trattamento della acque reflue OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. DATI TRATTI DALLA LETTERATURA SCIENTIFICA 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