Henvisning til del A i bilaget til forordning (EU) nr. 283/2013 Testmetoder (2) Vejledninger (3)

1. AKTIVSTOFFETS IDENTITET — 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. AKTIVSTOFFETS FYSISKE OG KEMISKE EGENSKABER —

2.1. Smeltepunkt og kogepunkt 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. Damptryk, flygtighed Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Udseende (fysisk tilstand, farve) — —

2.4. Spektre (UV/VIS, IR, NMR, MS), molær ekstinktion ved relevante bølgelængder, optisk renhed OECD Test Guideline 101: UV-VIS Absorption Spectra —

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

2.6. Opløselighed i organiske opløsningsmidler CIPAC Method MT 181: Solubility in organic solvents —

2.7. Fordelingskoefficient n-octanol/vand Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Hvis en forbindelse er overfladeaktiv (jf. Metode A.5 (Surface tension)), kan rystekolbemetoden, der er beskrevet i Metode A.8, finde anvendelse, hvis det fremgår af rapporten, at der ikke opstod problemer (f.eks. faseadskillelser). HPLC-metoden, der er beskrevet i Metode A.8, finder ikke anvendelse på overfladeaktive forbindelser. —

2.8. Dissociation i vand OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Antændelighed og selvopvarmning Antændelighed: 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) Selvopvarmning: 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. Flammepunkt 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. Eksplosive egenskaber 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. Overfladespænding Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oxiderende egenskaber Faste stoffer: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Væsker: 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. Andre undersøgelser Testmetoder, jf. del II i bilag I til forordning (EF) nr. 1272/2008 —

3. YDERLIGERE OPLYSNINGER OM AKTIVSTOFFET EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Anvendelse af aktivstoffet — —

3.2. Funktion — —

3.3. Virkninger på skadegørere — —

3.4. Påtænkt anvendelsesområde — —

3.5. Skadegørere, som skal bekæmpes, og afgrøder eller produkter, som ønskes beskyttet eller behandlet — —

3.6. Virkningsmekanisme — —

3.7. Oplysninger om forekomst eller mulig forekomst af resistensudvikling samt om forholdsregler i så fald EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metoder og forholdsregler med hensyn til håndtering, oplagring, transport eller brand — —

3.9. Procedurer for destruktion eller dekontaminering — —

3.10. Nødforanstaltninger i tilfælde af uheld — —

4. ANALYSEMETODER — Teknisk materiale og tekniske præparater: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Restkoncentrationer: 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. TOKSIKOLOGISKE UNDERSØGELSER OG METABOLISMEUNDERSØGELSER — —

5.1. Undersøgelser af absorption, fordeling, metabolisme og udskillelse hos pattedyr — 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. Absorption, fordeling, metabolisme og udskillelse efter oral eksponering Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorption, fordeling, metabolisme og udskillelse efter eksponering ad anden vej Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Akut toksicitet — —

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

5.2.3. Indånding 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. Hudirritation 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. Øjenirritation 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. Hudsensibilisering 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. Fototoksicitet 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. Korttidstoksicitet — —

5.3.1. Oral 28-dages-test 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. Oral 90-dages-test 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. Andre eksponeringsveje 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. Genotoksicitetstest — —

5.4.1. In vitro-test 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. In vivo-test i somatiske celler 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. In vivo-test i kønsceller 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. Langtidstoksicitet og karcinogenicitet 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. Reproduktionstoksicitet —

5.6.1. Flergenerationsundersøgelser 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. Udviklingstoksicitetstest 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. Neurotoksicitetstest —

5.7.1. Neurotoksicitetstest på gnavere 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. Test for forsinket polyneuropati 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. Andre toksikologiske undersøgelser — —

5.8.1. Toksicitetstest af metabolitter 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. Supplerende undersøgelser af aktivstoffet — 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. Hormonforstyrrende egenskaber 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. Medicinske data — —

6. RESTKONCENTRATIONER I ELLER PÅ BEHANDLEDE PRODUKTER, FØDEVARER OG FODERSTOFFER 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 Restkoncentrationernes stabilitet ved oplagring OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Metabolisme, fordeling og angivelse af restkoncentrationer — —

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

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

6.2.3. Lakterende drøvtyggere OECD Test Guideline 503: Metabolism in livestock —

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

6.2.5. Fisk — —

6.3. Forsøg til undersøgelse af omfanget af restkoncentrationer i planter 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. Fodringsforsøg — —

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

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

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

6.4.4. Fisk — —

6.5. Virkninger af forarbejdning — —

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

6.5.2. Restkoncentrationens fordeling i ikke-spiselig skal/skræl og frugtkød OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Omfanget af restkoncentrationer i forarbejdede produkter 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. Restkoncentrationer i efterfølgende afgrøder — —

6.6.1. Metabolisme i efterfølgende afgrøder OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Omfanget af restkoncentrationer i efterfølgende afgrøder OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Foreslåede restkoncentrationsdefinitioner og maksimalgrænseværdier — —

6.7.1. Foreslåede restkoncentrationsdefinitioner — 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. Foreslåede maksimalgrænseværdier for restkoncentrationer (MRL) og begrundelse for, at disse niveauer er acceptable — 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. Foreslåede maksimalgrænseværdier for restkoncentrationer (MRL) og begrundelse for, at disse niveauer er acceptable for importerede produkter (importtolerancer) — 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. Foreslåede sikkerhedsintervaller — 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. Skøn over potentiel og faktisk eksponering via føden og andre kilder — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Andre undersøgelser — —

6.10.1. Restkoncentrationsmængden i pollen og biavlsprodukter — —

7. SKÆBNE OG OPFØRSEL I MILJØET — —

7.1. Skæbne og opførsel i jord 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. Nedbrydningsvej i jord — —

7.1.1.1. Aerob nedbrydning OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaerob nedbrydning OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

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

7.1.2. Nedbrydningshastighed i jord — 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. Laboratorietest 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. Felttest US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Tekniske aspekter med henblik på at fastlægge nedbrydningshastigheder i jord i felttest findes i: 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. Adsorption og desorption i jord — —

7.1.3.1. Adsorption og desorption 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. Tidsafhængig sorption (aged sorption) — FOCUS Ground Water

7.1.4. Mobilitet i jord — —

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

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

7.1.4.3. Nedvaskningstest i felten — FOCUS Ground Water

7.2. Skæbne og opførsel i vand og sediment — —

7.2.1. Nedbrydningsvej og -hastighed i akvatiske systemer (kemisk og fotokemisk nedbrydning) — —

7.2.1.1. Nedbrydning ved hydrolyse OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Direkte fotokemisk nedbrydning OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Indirekte fotokemisk nedbrydning — —

7.2.2. Nedbrydningsvej og –hastighed for biologisk nedbrydning i akvatiske systemer — —

7.2.2.1. "Let bionedbrydelighed" 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. Aerob mineralisering i overfladevand 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. Vand/sedimenttest OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Vand/sedimenttest under påvirkning af lys/mørke OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Nedbrydning i den mættede zone — —

7.3. Skæbne og opførsel i luft FOCUS Air

7.3.1. Nedbrydningsvej og -hastighed i luft — —

7.3.2. Transport via luften — —

7.3.3. Lokale og globale virkninger — —

7.4. Definition af restkoncentrationen — —

7.4.1. Definition af restkoncentrationen til risikovurderingsformål — —

7.4.2. Definition af restkoncentrationen til overvågningsformål — —

7.5. Overvågningsdata — —

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

8.1. Virkninger på fugle og andre hvirveldyr, der lever på land — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Virkninger på fugle — —

8.1.1.1. Akut oral toksicitet for fugle OECD Test Guideline No 223: Avian acute oral toxicity study eller US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Korttidstoksicitet for fugle via føden OECD Test Guideline 205: Avian Dietary Toxicity Test eller US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Subkronisk toksicitet og reproduktionstoksicitet for fugle OECD Test Guideline 206: Avian Reproduction Test eller US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Virkninger på hvirveldyr, der lever på land, bortset fra fugle — —

8.1.2.1. Akut oral toksicitet for pattedyr — —

8.1.2.2. Langtidstoksicitet og reproduktionstoksicitet for pattedyr — —

8.1.3. Aktivstoffets biokoncentration i bytte for fugle og pattedyr — —

8.1.4. Virkninger på vildtlevende hvirveldyr, der lever på land (fugle, pattedyr, krybdyr og padder) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Hormonforstyrrende egenskaber — 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. Virkninger på vandorganismer — 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. Akut toksicitet for fisk 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. Langtidstoksicitet og kronisk toksicitet for fisk — —

8.2.2.1. Toksicitetstest for fisk i de tidlige udviklingsstadier OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Fuld livscyklustest for fisk US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokoncentration i fisk — —

8.2.3. Hormonforstyrrende egenskaber 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. Akut toksicitet for hvirvelløse vanddyr — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Akut toksicitet for Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Akut toksicitet for yderligere en art af hvirvelløse vanddyr US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Langtidstoksicitet og kronisk toksicitet for hvirvelløse vanddyr — —

8.2.5.1. Reproduktions- og udviklingstoksicitet for Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reproduktions- og udviklingstoksicitet for yderligere en art af hvirvelløse vanddyr US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Udvikling og klækning hos Chironomus riparius OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [Generelt dækker et vandspiket system (dvs. OECD 219) bedre typiske eksponeringsveje for plantebeskyttelsesmidler] —

8.2.5.4. Organismer, der lever i sediment OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Virkninger på algevækst — —

8.2.6.1. Virkninger på grønalgers vækst OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Virkninger på væksten hos yderligere en algeart OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Virkninger på akvatiske makrofytter 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. Yderligere undersøgelser på vandorganismer — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Virkninger på leddyr — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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

8.3.1.1. Akut toksicitet for bier —

8.3.1.1.1. Akut oral toksicitet 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. Akut kontakttoksicitet 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. Kronisk toksicitet for bier 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. Virkninger på honningbiers udvikling og andre stadier i biernes livscyklus 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. Subletale virkninger 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. Virkninger på andre leddyr, der ikke er målarter, end bier 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. Virkninger på 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. Virkninger på 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. Virkninger på jordlevende meso- og makrofauna, der ikke er målarter — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Regnorme - subletale virkninger OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Virkninger på jordlevende meso- og makrofauna, der ikke er målarter (bortset fra regnorme) —

8.4.2.1. Testning på artsniveau For Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil For rovmider: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Virkninger på kvælstofomdannelsen i jord OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Virkninger på højerestående landplanter, der ikke er målarter — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Sammenfatning af screeningsdata — —

8.6.2. Testning på planter, der ikke er målarter Frøplantespiring og -vækst: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Testning af landplanters vækst: OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Virkninger på andre landorganismer (flora og fauna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Virkninger på biologiske metoder til spildevandsrensning OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. LITTERATUR 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