Entsprechender Abschnitt in Teil A des Anhangs der Verordnung (EU) Nr. 283/2013

Leitliniendokumente

Anmerkungen

Allgemeine Leitlinien

EFSA Guidance on the use of the benchmark dose approach in risk assessment (EFSA Journal 2017;15(1):4658)

Allgemeine Leitlinien

Commission Notice of 10.10.2017: Guidance on monitoring and surveying of impacts of pesticide use on human health and the environment under Article 7(3) of Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides (referred to as the Sustainable Use Directive)

Allgemeine Leitlinien

EFSA Guidance on Uncertainty Analysis in Scientific Assessments (EFSA Journal 2018;16(1):5123)

Allgemeine Leitlinien

EFSA Guidance on the assessment of the biological relevance of data in scientific assessment (EFSA Journal 2017;15(8):4970)

Allgemeine Leitlinien

EFSA Scientific Opinion on the guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971)

Allgemeine Leitlinien

OECD Consideration for assessing the risk of combined exposure to multiple chemicals. Series on Testing and Assessment No. 296

Allgemeine Leitlinien

EFSA Guidance on harmonised methods for human health, animal health and environmental risk assessment of combined exposure to multiple chemicals (EFSA Journal 2019;17(3):5634)

Allgemeine Leitlinien

OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) No. 260

Allgemeine Leitlinien

OECD Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No. 184

Allgemeine Leitlinien

OECD Guidance Document for Describing Non-Guideline In-vitro Test Methods. Series on Testing and Assessment, No. 211

Allgemeine Leitlinien

OECD Guidance document on the recognition, assessment, and use of clinical signs as human endpoints for experimental animals used in safety evaluation. Series on Testing and Assessment. No. 19.

Allgemeine Leitlinien

ECHA Guidance on the Application of the CLP Criteria

Allgemeine Leitlinien

Guidance document for environmental risk assessments of active substances used on rice in the EU for Annex 1 inclusion (SANCO/1090/2000)

Allgemeine Leitlinien

Guidance document on botanical active substances used in plant protection products (SANCO/11470/2012)

Allgemeine Leitlinien

Guidance document on semiochemical active substances used and plant protection products (SANTE/12815/2014)

Allgemeine Leitlinien

Guidance Document on the assessment of new substances falling into the group of Straight Chain Lepidopteran Pheromones (SCLPs) included in Annex I of Council Directive 91/414/EEC, (SANCO 5272/2009)

Allgemeine Leitlinien

Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers (SANTE/12278/2020)

Allgemeine Leitlinien

OECD Guidance Documents on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models. Series on Testing and Assessment, No. 69.

Allgemeine Leitlinien

ECHA Practical Guide – how to use and report (Q)SARs

Allgemeine Leitlinien

OECD Guidance on Grouping of Chemicals, Second Edition. Series on Testing and Assessment, No. 194

Allgemeine Leitlinien

OECD Guidance Document on Good In Vitro Method Practices (GIVIMP)

Allgemeine Leitlinien

OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests. Series on Testing & Assessment, No. 237.

Allgemeine Leitlinien

EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708)

Allgemeine Leitlinien

Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health. (EFSA Journal 2021; 19(8):6768)

Allgemeine Leitlinien

ECHA. Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN

WHO/FAO Pesticide Specifications. Manual on development and use of FAO and WHO specifications for chemical pesticides

EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No. 1107/2009 (SANCO/10597/2003)

ECHA Guidance on the Application of the CLP Criteria

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OECD Guidance Document for flammability testing of plant protection and biocidal products. Series on Testing and Assessment, No. 330

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Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 (the Renewal Regulation) (SANCO/2012/11251)

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EPPO Global Database on Crops and Pests (EPPO, 2017)

Die Datenbank ist online verfügbar: https://gd.eppo.int

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Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013 (SANCO/3030/99)

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632)

Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

OECD Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment, No. 72. Series on Pesticides, No. 39.

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE/2017/10632)

Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830)

OECD Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment, No. 72. Series on Pesticides, No. 39.

EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO/7531/2006)

EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (SANTE-10832-2015, EFSA Journal 2022;20(1):7032)

OECD Guidance for the Derivation of an Acute Reference Dose. Series on testing and assessment, No. 124

OECD Guidance document on the characterisation, validation and reporting of Physiologically Based Kinetic (PBK) models for regulatory purposes. Series on Testing and Assessment, No. 331

Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR panel) on testing and interpretation of comparative in vitro metabolism studies (EFSA Journal 2021;19(12):6970)

ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers Guidance for Industry, 2018

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OECD Guidance document on acute oral toxicity testing. Series on Testing and Assessment, No 24

OECD Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests. Series on Testing and Assessment, No. 129

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OECD Guidance Document for the Derivation of an Acute Reference Concentration (Arfc). Series on Testing and Assessment, No. 153

OECD Guidance document on inhalation toxicity studies. Series on testing and assessment, No. 39

OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation. Series on Testing and Assessment, No. 203

OECD Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation. Series on Testing and Assessment, No 263

OECD Guidance Document on the Bovine Corneal Opacity (BCOP) and Isolated Chicken Eye (ICE) Test Methods: Collection of Tissues for Histological Evaluation and Collection of Data on Non-severe Irritants. Series on Testing and Assessment, No. 160.

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ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals

OECD Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies. Series on Testing and Assessment, No. 32

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OECD Guidance Document on Histopathology for Inhalation Toxicity Studies, Supporting TG 412 (Subacute Inhalation Toxicity: 28-Day Study) and TG 413 (Subchronic Inhalation Toxicity: 90-Day Study). Series on Testing and Assessment, No. 125

EFSA Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. (EFSA Journal 2011; 9(9):2379)

EFSA Scientific Opinion, Clarification of some aspects related to genotoxicity assessment (EFSA Journal 2017;15(12):5113)

EFSA Guidance on aneugenicity assessment (PAFF-PPL-May22-Doc.A.07.02, EFSA Journal 2021;19(8):6770)

ICH Safety Guidelines S10 Photosafety Evaluation of Pharmacetuticals

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OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453

OECD Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453

OECD Guidance Document for Histologic Evaluation of Endocrine and Reproductive Tests in Rodents. Series on Testing and Assessment, No. 106

OECD Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment. Series on Testing and Assessment, No 43

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North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) Developmental Neurotoxicity Study Guidance Document

OECD Developmental Neurotoxicity Study (OECD TG 426), Chapter.3.8 in Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

OECD Guidance Document for Neurotoxicity Testing. Series on Testing and Assessment, No 20

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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)

OECD Guidance for conducting a single exposure toxicity study. IN: OECD (2010) Guidance for the Derivation of an Acute Reference Dose”. Series on testing and assessment, No. 124

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040)

Dieses Leitliniendokument sieht vor, dass die Identifizierung endokrinschädlicher Eigenschaften auf der Grundlage eines Verfahrens zur Ermittlung der Beweiskraft erfolgen sollte, bei dem alle verfügbaren Daten berücksichtigt werden, unabhängig davon, welche Taxa zur Generierung dieser Daten verwendet wurden.

OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.

Diese Leitlinie enthält Informationen über die einschlägigen Prüfmethoden und wird regelmäßig aktualisiert.

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OECD Guidance Document on Overview of Residue Chemistry Studies . Series on Testing and Assessment, No. 64 and Series on Pesticides, No. 32

Dieses Dokument ist teilweise veraltet.

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OECD Guidance Document on Crop Field Trials. Series on Testing and Assessment, No. 164 and Series on Pesticides, No. 66

Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolations of residue data on products from plant and animal origin (SANTE/2019/12752)

OECD Guidance Document on Residues in Livestock. Series on Pesticides, No. 73.

EFSA Estimation of animal intakes and HR, STMR and MRL calculations for products of animal origin

EFSA Spreadsheet for HR, STMR and MRL calculations for products of animal origin; EU Animal burden calculator - animals

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OECD Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment, No. 96.

OECD Guidance document on residues in rotational crops. Series on Pesticides, No. 97. and Series on Testing and Assessment, No. 279.

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OECD 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

Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolations of residue data on products from plant and animal origin (SANTE/2019/12752)

OECD MRL calculator : user guide

Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolations of residue data on products from plant and animal origin (SANTE/2019/12752)

OECD MRL calculator: user Guide

EU guidance document „Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals“ (SANCO 7039/VI/95)

Gilt nur für PHI-Klassen.

EFSA calculation model Pesticide Residue Intake Model „PRIMo“

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)

WHO Guidelines for drinking water quality

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EU guidance document „Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey“ (SANTE/11956/2016 )

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SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

EFSA guidance document on soil phototransformation products in groundwater – consideration, parameterisation and simulation in the exposure assessment of plant protection products (PAFF-PPL-Dec 22-Doc.A.07.02)

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Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on –among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014))

Die allgemeinen FOCUS-Leitlinien, die auf den einschlägigen, spezifischeren Leitliniendokumenten beruhen und regelmäßig aktualisiert werden, werden aufgelistet.

DG SANCO Working Document on „Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides“

Generic guidance for Tier 1 FOCUS Ground water assessments (based on -among others- the European Commission (2014) Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (SANCO/13144/2010); FOCUS (2000) „FOCUS groundwater scenarios in the EU review of active substances“ Report of the FOCUS Groundwater Scenarios Workgroup (Sanco/321/2000); Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil.(doi: 10.2903/j.efsa.2008.622); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); section 3.3.1 of European Food Safety Authority. Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (doi:10.2903/j.efsa.2017.4982); section 3.3 of Scientific report of EFSA on the „repair action“ of the FOCUS surface water scenarios (doi:10.2903/j.efsa.2020.6119))

Die allgemeinen FOCUS-Leitlinien, die auf den einschlägigen, spezifischeren Leitliniendokumenten beruhen und regelmäßig aktualisiert werden, werden aufgelistet.

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OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No. 82 / Series on Testing and Assessment, No. 232.

Generic guidance for Tier 1 FOCUS Ground water assessments (based on -among others- the European Commission (2014) Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (SANCO/13144/2010); FOCUS (2000) „FOCUS groundwater scenarios in the EU review of active substances“ Report of the FOCUS Groundwater Scenarios Workgroup (Sanco/321/2000); Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil.(doi: 10.2903/j.efsa.2008.622); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (SANCO/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014); section 3.3.1 of EFSA. Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (doi:10.2903/j.efsa.2017.4982); section 3.3 of Scientific report of EFSA on the „repair action“ of the FOCUS surface water scenarios (doi:10.2903/j.efsa.2020.6119))

Die allgemeinen FOCUS-Leitlinien, die auf den einschlägigen, spezifischeren Leitliniendokumenten beruhen und regelmäßig aktualisiert werden, werden aufgelistet.

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 (Koc) for a plant protection product active substance in the context of Council Directive 91/414/EEC

Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments EC Document Reference (SANTE/12586/2020)

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Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010)

Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010)

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DG SANCO Working Document on „Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides“

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Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on –among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (SANCO/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014))

Die allgemeinen FOCUS-Leitlinien, die auf den einschlägigen, spezifischeren Leitliniendokumenten beruhen und regelmäßig aktualisiert werden, werden aufgelistet.

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Pesticides in Air: Considerations for Exposure Assessment”. Report of the FOCUS Working Group on Pesticides in Air (SANCO/10553/2006)

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OECD Current approaches in the statistical analysis of ecotoxicity data: a guidance to application. Series of testing and assessment, No. 54

EFSA Risk assessment for birds and mammals (EFSA Journal 2009; 7(12):1438)

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Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040; EFSA Journal 2018; 16(6):5311).

Dieses Leitliniendokument sieht vor, dass die Identifizierung endokrinschädlicher Eigenschaften auf der Grundlage eines Verfahrens zur Ermittlung der Beweiskraft erfolgen sollte, bei dem alle verfügbaren Daten berücksichtigt werden, unabhängig davon, welche Taxa zur Generierung dieser Daten verwendet wurden.

OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.

Diese Leitlinie enthält Informationen über die einschlägigen Prüfmethoden und wird regelmäßig aktualisiert.

OECD Guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals. Testing and Assessment, No 23 (Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures)

OECD Short guidance on the threshold approach for acute fish toxicity. Series on Testing and Assessment, No. 126.

Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

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Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (C/2018/6040; EFSA Journal 2018; 16(6):5311).

Dieses Leitliniendokument sieht vor, dass die Identifizierung endokrinschädlicher Eigenschaften auf der Grundlage eines Verfahrens zur Ermittlung der Beweiskraft erfolgen sollte, bei dem alle verfügbaren Daten berücksichtigt werden, unabhängig davon, welche Taxa zur Generierung dieser Daten verwendet wurden.

OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

Diese Leitlinie enthält Informationen über die einschlägigen Prüfmethoden und wird regelmäßig aktualisiert.

Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

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Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

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Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

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Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters in the context of Regulation (EC) No 1107/2009 (SANTE-2015-00080)

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

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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

De Jong et al. (2010): Guidance for summarising and evaluating field studies with non-target arthropods

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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

De Jong et al (2006): Guidance for summarizing earthworm field studies. RIVM report No 601506006/2006

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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002)

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)

EFSA Application of systematic review methodology to food and feed safety assessments to support decision making (EFSA Journal 2010;8(6):1637)

ECHA Guidance on the Application of the CLP Criteria

Entsprechender Abschnitt in Teil A des Anhangs der Verordnung (EU) Nr. 283/2013

Prüfmethoden

Anmerkungen

Leitlinien für bestimmte Klassen von Stoffen

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OECD Test Guideline 102: Melting Point/ Melting Range

OECD Test Guideline 103: Boiling point

OECD Test Guideline 104: Vapour Pressure

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OECD Test Guideline 101: UV-VIS Absorption Spectra

OECD Test Guideline 105: Water Solubility

Method A.6 Water solubility, Part A of Commission Regulation (EC) No 440/2008

CIPAC Method MT 181: Solubility in organic solvents

CIPAC Method MT 157: Water solubility

kann unter bestimmten Umständen angepasst werden

OECD Test Guideline 105: Water Solubility

kann unter bestimmten Umständen angepasst werden

OECD Test Guideline 107: Partition coefficient, shake-flask method

Ist eine Verbindung oberflächenaktiv (gemäß OECD 115 Oberflächenspannung), kann die in OECD 107 beschriebene Schüttelmethode anwendbar sein, wenn aus dem Bericht eindeutig hervorgeht, dass keine Probleme aufgetreten sind (z. B. Phasentrennungen). Die in OECD 107 beschriebene HPLC-Methode ist nicht auf oberflächenaktive Verbindungen anwendbar.

OECD Test Guideline 117: Partition Coefficient (n-octanol/water), HPLC method

OECD Test Guideline 123: Partition coefficient (1-octanol/water): slow-stirring method

Method A.23 Partition coefficient (1-octanol/water): Slow stirring method, Part A of Regulation (EC) No. 440/2008

Method A.24 Partition coefficient (n-octanol/water), High performance liquid chromatography (HPLC) method, Part A of Regulation (EC) No 440/2008

OECD Test Guideline 112: Dissociation Constants in Water

Test N.1: test method for flammable solids, Part III of UN RTDG Manual of Tests and Criteria

Method A.15 Auto-ignition temperature (liquids and gases), Part A of Regulation (EC) No. 440/2008

Method A.16 Relative self-ignition temperature for solids, Part A of Regulation (EC) No. 440/2008

Method A.10 Flammability (Annex of Regulation (EC) No. 440/2008) for solids (solids)

Method A.11 Flammability (Annex of Regulation (EC) No. 440/2008) for gaseous materials

Method A.12 (Annex of Regulation (EC) No. 440/2008) for contact with water

Test methods according to Section 2.2.4.1. of Part 2 of Annex I to Regulation (EC) No. 1272/2008

Test L.2: sustained combustibility test, Part III of the UN RTDG Manual of Tests and Criteria

Test N.5: test method for substances which in contact with water emit flammable gases, Part III of the UN RTDG Manual of Tests and Criteria

Test N.4: test method for self-heating substances Part III of UN RTDG Manual of Tests and Criteria

Method A.15 (Annex of Regulation (EC) No. 440/2008) for liquids and Gases (liquids and gases)

Method A.16 (Annex of Regulation (EC) No. 440/2008) for solids (solids)

Test methods according to Table 2.6.3 of Part 2 of Annex I to Regulation (EC) No 1272/2008 (liquids)

Method A.9 Flash-point (Annex to Regulation (EC) No 440/2008)

Nur die „Closed cup“- Methoden sind zu verwenden.

Test methods according to Table 2.6.3 of Part 2 of Annex I to Regulation (EC) No 1272/2008 (liquids)

Test methods according to Test series 1-3, Part I of the UN RTDG Manual of Tests and Criteria

Method A.14 Explosive Properties (Annex of Regulation (EC) No. 440/2008)

OECD Test Guideline 115: Surface tension of aqueous solutions

Method A.5 Surface tension, Part A of Regulation (EC) No 440/2008

Test method according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008

Test O.2: Test for oxidizing liquids, Part III of UN RTDG Manual of Tests and Criteria

Test O.1: Test for oxidizing solids, Part III of UN RTDG Manual of Tests and Criteria

Test O.3: Gravimetric test for oxidising solids, Part III of UN RTDG Manual of Tests and Criteria

Method A.17 Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008)

Method A.21 Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008)

Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/.

Test methods reported in Annex I, Part II to Regulation (EC) No 1272/2008

EPPO standard series PP1: Efficacy evaluation of plant protection products

Bitte nur diejenigen Verwendungen in Betracht ziehen, die gemäß der Verordnung (EG) Nr. 1107/2009 als relevant gelten, und nicht diejenigen in EPPO PP1/248, die sich auf Angaben über Biostimulanzien im Sinne der Verordnung (EU) 2019/1009 und im Sinne der technischen Spezifikationen CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4 und CEN/TS 17700-5 beziehen, auch wenn diese Biostimulanzien in EPPO PP 1/248 als Pflanzenwachstumsregulatoren ausgewiesen sind.

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EPPO Global Database on Crops and Pests (EPPO, 2017)

Die Datenbank ist online verfügbar: https://gd.eppo.int

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EPPO standard PP1/213: Resistance risk analysis

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OECD Test Guideline 417: Toxicokinetics

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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

nur zulässig, wenn die Prüfung vor Dezember 2002 durchgeführt wurden

OECD Test Guideline 402: Acute Dermal Toxicity

OECD Test Guideline 433: Acute Inhalation Toxicity: Fixed Concentration Procedure

OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method

OECD Test Guideline 403: Acute Inhalation Toxicity

Die aktuell verwendeten Prüfungen sind akzeptabel, bei der Durchführung einer neuen Prüfung sollte jedoch die OECD-Prüfrichtlinie 433 bevorzugt werden, da weniger Versuchstiere benötigt werden und/oder diese Methode mit weniger schwerem Leiden für die Versuchstiere verbunden ist.

OECD Test Guideline 431: In vitro Skin Corrosion: reconstructed human epidermis (RHE) test methodt

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

OECD Test Guideline 430: In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER)

OECD Test Guideline 404: Acute Dermal Irritation/Corrosion

OECD Test Guideline 492B. Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification

OECD Test Guideline 467. Defined Approaches for Serious Eye Damage and Eye Irritation

OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

OECD Test Guideline 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants

OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

OECD Test Guideline 405: Acute eye irritation/corrosion

OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA

OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay

OECD Test Guideline 406: Skin sensitisation

Angesichts der höheren Sensibilität des Maximierungstests wird häufig die Entscheidung für diesen Test anstelle des Bühler-Tests getroffen.

OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA

OECD Test Guideline 101: UV-VIS Absorption Spectra

OECD Test Guideline 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity

OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test

OECD Test Guideline 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method

OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test

ECHA. Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, 2012, ECHA-2010-G-19-EN

OECD Test Guideline 407: Repeated dose 28-day oral toxicity study in rodents

Gemäß der Verordnung (EU) Nr. 283/2013 in Verbindung mit Artikel 62 Absatz 1 der Verordnung (EG) Nr. 1107/2009 ist diese Studie nicht für einen Antrag zu erstellen, sondern nur einzureichen, wenn sie vorliegt.

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

OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study

Gemäß der Verordnung (EU) Nr. 283/2013 in Verbindung mit Artikel 62 Absatz 1 der Verordnung (EG) Nr. 1107/2009 ist diese Studie nur vorzulegen, wenn Sachverständige dies für erforderlich halten.

OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study

OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study

Gemäß der Verordnung (EU) Nr. 283/2013 in Verbindung mit Artikel 62 Absatz 1 der Verordnung (EG) Nr. 1107/2009 ist diese Studie nicht für einen Antrag zu erstellen, sondern nur einzureichen, wenn sie vorliegt.

OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study

Gemäß der Verordnung (EU) Nr. 283/2013 in Verbindung mit Artikel 62 Absatz 1 der Verordnung (EG) Nr. 1107/2009 ist diese Studie nur vorzulegen, wenn Sachverständige dies für erforderlich halten.

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OECD Test Guideline 471: Bacterial Reverse Mutation Test

OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test

OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test

OECD Test Guideline 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes

OECD Test Guideline 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene

OECD 470 Test Guideline on the Mammalian Erythrocyte Pig-a Gene Mutation Assay

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo

Die Ergebnisse eines UDS-Tests können nur bei positiven Ergebnissen als geeignet für die Bewertung des genotoxischen Potenzials angesehen werden.

Die aktuell verwendeten Prüfungen sind zulässig, aber es werden keine neuen Prüfungen gemäß dieser Leitlinie empfohlen – EFSA-Stellungnahme des Wissenschaftlichen Ausschusses (2017).

OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 489: In Vivo Mammalian Alkaline Comet Assay

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 478: Rodent Dominant Lethal Test

Es sollte die Möglichkeit geprüft werden, In-vivo-Gentoxizitätstests mit Studien zur Toxizität bei wiederholter Verabreichung zu verbinden, um die Zahl der getesteten Tiere zu verringern.

OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies

OECD Test Guideline 451: Carcinogenicity Studies

OECD Test Guideline 452: Chronic Toxicity Studies

OECD Series on Testing and Assessment Nr. 151. Guidance document supporting OECD test guideline 443 on the extended one-generation reproductive toxicity test

OECD Test Guideline 443: Extended One-generation Reproductive Toxicity

Bereits vorliegende Untersuchungen, die gemäß OECD TG 416 (angenommen 2001 oder später) durchgeführt wurden, oder gleichwertige Informationen werden als geeignet angesehen, um diese Informationsanforderung zu erfüllen. Wenn jedoch neue Prüfungen durchgeführt werden sollen, sollte der erweiterten Eingenerationen-Prüfung auf Reproduktionstoxizität (OECD TG 443) der Vorzug gegeben werden.

Erweiterte Eingenerationen-Prüfung auf Reproduktionstoxizität (OECD TG 443) mit den Kohorten 1A und 1B und Erweiterung der Kohorte 1B auf die F2-Generation bis auf 20 Würfe pro Dosisgruppe. F2-Jungtiere sind bis zum Absetzen zu beobachten und ähnlich zu untersuchen wie F1-Jungtiere. Bevorzugte Tierart ist die Ratte, die orale Verabreichung ist zu bevorzugen

Die höchste Dosis sollte sich nach der Toxizität richten und so gewählt werden, dass eine Reproduktions- und/oder sonstige systemische Toxizität induziert wird.

OECD Test Guideline 416: Two-Generation Reproduction Toxicity

Sie wurde nur aufgeführt, da sie in der Vergangenheit verwendet wurde. Der erweiterten Eingenerationen-Prüfung auf Reproduktionstoxizität sollte der Vorzug gegeben werden.

OECD Test Guideline 414: Prenatal developmental toxicity study

OECD Test Guideline 426: Developmental neurotoxicity study

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OECD Test Guideline 424: Neurotoxicity study in rodents

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

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Health Effects Test Guidelines: OPPTS 870.7800 Immunotoxicity [EPA 712–C–98–351]

Bedingte Anforderung: nur, wenn die Wirkungen auf ein immuntoxikologisches Potenzial hindeuten, das in toxikologischen und metabolischen Studien beobachtet wurde

ICH Safety Guidelines S8 Immunotoxicity Studies for Human Pharmacetuticals

Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption. Some of these test guidelines (OECD 407,408,409,414,443,416,426, 451-3) are already requested under 5.3.1; 5.3.2; 5.6.1; 5.6.2; 5.5

Es sollten gegebenenfalls Tests durchgeführt werden, um eine mögliche endokrine Wirkungsweise gemäß den EFSA/ECHA-Leitlinien zu klären.

Wenn hinreichende Beweise für die Feststellung des Vorhandenseins oder des Nichtvorhandenseins einer bestimmten Wirkungsweise einer endokrinen Störung vorliegen, ist Folgendes zu beachten:

Für OECD 443 die Anforderungen in den Anmerkungen in 5.6.1. „Untersuchungen über mehrere Generationen“ prüfen.

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OECD Test Guideline 506: Stability of Pesticide Residues in Stored Commodities

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OECD Test Guideline 501: Metabolism in crops

OECD Test Guideline 503: Metabolism in livestock

OECD Test Guideline 503: Metabolism in livestock

OECD Test Guideline 503: Metabolism in livestock

OECD Test Guideline 509: Crop field trials

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OECD Test Guideline 505: Residues in livestock.

OECD Test Guideline 505: Residues in livestock.

OECD Test Guideline 505: Residues in livestock.

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

OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities.

OECD Test Guideline 509: Crop field trials.

OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities.

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OECD Test Guideline 502: Metabolism in rotational crops.

OECD Test Guideline 504: Residues in rotational crops (limited field studies)

OECD Test Guideline 509: Crop field trials.

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EU guidance document „Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey“ (SANTE/11956/2016 )

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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

Eine Prüfung, die bis zum Datum der Veröffentlichung dieser Mitteilung durchgeführt wurde, ist noch gültig. Neue Prüfungen sind jedoch nach ISO 18400 durchzuführen.

ISO 18400-102:2017

ISO 18400-104:2018

ISO 18400-105:2017

ISO 18400-206:2018

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OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

US EPA Test Guideline OPPTS 835.2410 Photodegradation on Soil. EPA 712-C-08-015, October 2008

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OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

OECD Guidance Document for Conducting Pesticide Terrestrial Field Dissipation Studies. Series on Pesticides, No. 82, Series on Testing and Assessment, No. 232.

US EPA OCSPP 835.6100: Terrestrial field dissipation

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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)

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OECD Test Guideline 312: Leaching in Soil Columns

OECD Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies. Series on Testing and Assessment, No. 22

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OECD Test Guideline 111: Hydrolysis as a Function of pH

OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis

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OECD Guideline Test 301: Ready Biodegradability (301 A - F)

OECD Test Guideline 310: Ready Biodegradability - CO2 in sealed vessels (Headspace Test)

OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems

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OECD Test Guideline 223: Avian Acute oral toxicity study

US EPA OCSPP 850.2100: Avian oral toxicity test

OECD Test Guideline 205: Avian Dietary Toxicity Test

US EPA OCSPP 850.2200: Avian dietary toxicity test.

OECD Test Guideline 206: Avian Reproduction Test

US EPA OCSPP 850.2300: Avian Reproduction Test

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Please, refer to 5.2.1

Please, refer to 5.3.1; 5.3.2; 5.6.1 and 5.6.2.

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OECD Test Guideline 248: Xenopus Eleutheroembryonic Thyroid Assay (XETA)

OECD Test Guideline 231: Amphibian Metamorphosis Assay

OECD Test Guideline 241: Larval Amphibian Growth and Development Test

Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.

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OECD Test Guideline 203: Fish, Acute Toxicity Test

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OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test

OECD Test Guideline No. 234: Fish Sexual Development Test

US EPA protocol OCSPP 850.1500 Fish life cycle toxicity.

OECD Test Guideline 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure

Test guidelines are listed in OECD Revised Guidance Document No. 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.

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OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test

OECD Test Guideline 235: Chironomus sp., Acute Immobilisation Test

Nur eine der drei Arten muss getestet werden.

US EPA OCSPP 850.1035 Mysid Acute Toxicity Test

Nur eine der drei Arten muss getestet werden.

US EPA 850.1025 (Oyster acute toxicity test)

Nur eine der drei Arten muss getestet werden.

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OECD Test Guideline 211: Daphnia magna Reproduction Test

US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test

Nur eine der drei Arten muss getestet werden

OECD Test Guideline 242: Potamopyrgus antipodarum Reproduction Test

Nur eine der drei Arten muss getestet werden.

OECD Test Guideline 243: Lymnaea stagnalis Reproduction Test

Nur eine der drei Arten muss getestet werden.

OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water

OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment

OECD Test Guideline 233: Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment

OECD Test Guideline 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment

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OECD Test Guideline 201: Algae growth inhibition test

OECD Test Guideline 201: Algae growth inhibition test.

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

Eine Prüfung, die bis zum Datum der Veröffentlichung dieser Mitteilung durchgeführt wurde, ist noch gültig. Neue Prüfungen sind jedoch nach OECD 238 und 239 durchzuführen.

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, pp. 46-56.

Eine Prüfung, die bis zum Datum der Veröffentlichung dieser Mitteilung durchgeführt wurde, ist noch gültig. Neue Prüfungen sind jedoch nach OECD 238 und 239 durchzuführen.

OECD Test Guideline 238: Sediment-Free Myriophyllum Spicatum Toxicity Test