Odkaz na část A přílohy nařízení (EU) č. 283/2013

Metodické dokumenty

Poznámky

Obecné pokyny

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

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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)

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

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

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

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

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

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

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

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

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

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ECHA Guidance on the Application of the CLP Criteria

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

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

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

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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)

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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)

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

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

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

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

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

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

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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)

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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)

Databáze je k dispozici online: 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)

Tyto pokyny stanoví, že identifikace endokrinně disruptivních vlastností by měla být prováděna na základě přístupu založeného na průkaznosti důkazů s přihlédnutím ke všem dostupným údajům bez ohledu na taxony použité k získání těchto údajů.

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

Tyto pokyny obsahují informace o relevantních zkušebních metodách a jsou pravidelně aktualizovány.

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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

Tento dokument je částečně zastaralý.

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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)

Použije se pouze pro třídy intervalů před sklizní

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))

Jsou uvedeny obecné pokyny FOCUS, které jsou založeny na příslušných, konkrétnějších pokynech a jsou pravidelně aktualizovány.

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))

Jsou uvedeny obecné pokyny FOCUS, které jsou založeny na příslušných, konkrétnějších pokynech a jsou pravidelně aktualizovány.

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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))

Jsou uvedeny obecné pokyny FOCUS, které jsou založeny na příslušných, konkrétnějších pokynech a jsou pravidelně aktualizovány.

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))

Jsou uvedeny obecné pokyny FOCUS, které jsou založeny na příslušných, konkrétnějších pokynech a jsou pravidelně aktualizovány.

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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)

Tyto pokyny stanoví, že identifikace endokrinně disruptivních vlastností by měla být prováděna na základě přístupu založeného na průkaznosti důkazů s přihlédnutím ke všem dostupným údajům bez ohledu na taxony použité k získání těchto údajů.

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

Tyto pokyny obsahují informace o relevantních zkušebních metodách a jsou pravidelně aktualizovány.

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)

Tyto pokyny stanoví, že identifikace endokrinně disruptivních vlastností by měla být prováděna na základě přístupu založeného na průkaznosti důkazů s přihlédnutím ke všem dostupným údajům bez ohledu na taxony použité k získání těchto údajů.

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

Tyto pokyny obsahují informace o relevantních zkušebních metodách a jsou pravidelně aktualizovány.

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

Odkaz na část A přílohy nařízení (EU) č. 283/2013

Zkušební metody

Poznámky

Pokyny pro určité třídy látek

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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 Regulation (EC) No 440/2008

CIPAC Method MT 181: Solubility in organic solvents

CIPAC Method MT 157: Water solubility

lze za určitých okolností upravit

OECD Test Guideline 105: Water Solubility

lze za určitých okolností upravit

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

Je-li sloučenina povrchově aktivní (podle definice OECD 115 Povrchové napětí), lze použít metodu třepací láhve popsanou v OECD 107, je-li ve zprávě zřejmé, že nedošlo k žádným problémům (např. separace jednotlivých fází). Metoda HPLC popsaná v OECD 107 není pro povrchově aktivní sloučeniny použitelná.

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 Commission 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 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)

Měly by být použity pouze metody uzavřeného kelímku.

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 Commission 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 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

Zohledněte pouze ta použití, která jsou považována za relevantní v rámci nařízení (ES) č. 1107/2009, a nikoli ta použití, která jsou uvedena v dokumentu EPPO PP1/248, jež se týkají tvrzení o biostimulantech podle definice v rámci nařízení (EU) 2019/1009 a v rámci technických specifikací CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4 a CEN/TS 17700-5, a to i v případech, kdy jsou tyto biostimulanty v dokumentu EPPO PP1/248 označeny jako regulátory růstu rostlin.

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

Databáze je k dispozici online: 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

přijatelné pouze tehdy, pokud bylo provedeno před prosincem 2002

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

Stávající zkoušky jsou přijatelné, ale má-li být provedena nová zkouška, měly by být upřednostněny pokyny OECD ke zkoušce č. 433, protože je zapotřebí méně pokusných zvířat a/nebo je tato metoda spojena s méně závažným utrpením pokusných zvířat.

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 No. 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

Vzhledem k tomu, že Buehlerův test je považován za méně citlivý než maximalizační zkouška, upřednostňuje se maximalizační zkouška.

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

OECD Test Guideline 101: UV-VIS Absorption Spectra

OECD Test No. 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity

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

OECD Test No. 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

Podle nařízení (EU) č. 283/2013 ve spojení s čl. 62 odst. 1 nařízení (ES) č. 1107/2009 tato studie se nevypracovává pro účely žádosti, ale měla by být předložena pouze tehdy, je-li k dispozici.

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

Podle nařízení (EU) č. 283/2013 ve spojení s čl. 62 odst. 1 nařízení (ES) č. 1107/2009 se tato studie předloží pouze v případě, že to odborníci považují za nezbytné.

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

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

Podle nařízení (EU) č. 283/2013 ve spojení s čl. 62 odst. 1 nařízení (ES) č. 1107/2009 se tato studie nevypracovává pro účely žádosti, ale měla by být předložena pouze tehdy, je-li k dispozici.

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

Podle nařízení (EU) č. 283/2013 ve spojení s čl. 62 odst. 1 nařízení (ES) č. 1107/2009 se tato studie předloží pouze v případě, že to odborníci považují za nezbytné.

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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

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

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

Výsledky zkoušky UDS lze považovat za dostatečné pro posouzení genotoxického potenciálu pouze v případě pozitivních výsledků.

Stávající zkoušky jsou přijatelné, ale nedoporučuje se žádná nová zkouška provedená podle těchto pokynů – stanovisko vědeckého výboru EFSA (2017).

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

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

OECD test guideline 489: In Vivo Mammalian Alkaline Comet Assay

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

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

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

OECD Test Guideline 478: Rodent Dominant Lethal Test

Měla by být prozkoumána možnost integrace zkoušek genotoxicity in vivo se studiemi toxicity po opakovaných dávkách, aby se snížil počet pokusných zvířat.

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 No. 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

Stávající studie provedené v souladu s pokynem OECD TG 416 (přijatým v roce 2001 nebo později) nebo rovnocenné informace se považují za vhodné pro splnění tohoto požadavku na informace. Má-li však být provedena nová zkouška, měla by být upřednostněna rozšířená jednogenerační studie reprodukční toxicity (OECD TG 443).

Rozšířená jednogenerační studie reprodukční toxicity (OECD TG 443) s kohortami 1A a 1B a rozšíření kohorty 1B o generaci F2 s cílem vyprodukovat 20 vrhů na každou exponovanou skupinu. Mláďata generace F2 musí být sledována až do odstavení a zkoumána podobně jako mláďata generace F1. Upřednostňovaným druhem je potkan a upřednostňovanou cestou podání je orální cesta.

Nejvyšší úroveň dávky by měla vycházet z toxicity a měla by se zvolit tak, aby vyvolala reprodukční a/nebo jinou systémovou toxicitu.

OECD Test Guideline 416: Two-Generation Reproduction Toxicity

Uvedeno na seznamu pouze proto, že bylo používáno v minulosti. Přednost by měla být dána rozšířené jednogenerační studii reprodukční toxicity.

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]

Podmíněný požadavek: pouze pokud účinky naznačují imunotoxikologický potenciál pozorovaný v toxikologických studiích a studiích metabolismu

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

Podle potřeby by měly být provedeny zkoušky s cílem objasnit možný endokrinní způsob účinku podle pokynů EFSA/ECHA.

Jsou-li k dispozici dostatečně přesvědčivé důkazy pro učinění závěru o existenci nebo neexistenci konkrétního způsobu účinku narušujícího činnost endokrinního systému:

U OECD 443 zkontrolujte požadavky podle poznámek v bodě 5.6.1.Generační studie

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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

Zkouška provedená přede dnem zveřejnění tohoto sdělení je stále platná, avšak nová zkouška musí být provedena v souladu s normou ISO 18400.

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