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Chemical safety and biosafety

Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

In series:OECD Series on Testing and Assessmentview more titles

Published on September 03, 2018

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This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide guidance for evaluating chemical using standardised test guidelines. Specific objectives include providing a description of the OECD conceptual framework for evaluating chemicals for endocrine disruption, background on the standardised test methods used, and guidance for interpreting the outcome of individual tests. The general approach taken by the document is primarily to provide guidance on how test results might be interpreted based on the outcome of standardised assays. Key questions addressed in the document concern likely mechanisms of endocrine action and any resulting apical effects that can be attributed to such action. The document is not proscriptive but provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios. The guidance document is focused primarily on endocrine modalities included in the conceptual framework; estrogen, androgen, and thyroid mediated endocrine disruption and chemicals that interfer with steroidogenesis.

TABLE OF CONTENTS

Introduction
General Guidance on Endocrine Assessment: Assays and Endpoints
Specific guidance for the test guidelines addressed3 chapters available
Introduction to specific guidelines
OECD in vitro screens (Conceptual Framework Level 2)
Non-OECD in vitro screens (Conceptual Framework Level 2)
OECD non-mammalian screens and tests (Conceptual Framework Levels 3-5)14 chapters available
Fish Short-Term Reproduction Assay (FSTRA) (OECD TG 229)
21-Day Fish Assay (OECD TG 230)
Amphibian Metamorphosis Assay (AMA) (OECD TG 231)
Potamopyrgus antipodarum Reproduction Test (OECD TG 242)
Lymnaea stagnalis Reproduction Test (OECD TG 243)
Chironomid Toxicity Test Using Spiked Sediment (OECD TG 218) or Spiked Water (OECD TG 219)
Daphnia magna Reproduction Test (OECD TG 211)
Fish, Early-Life Stage (FELS) Toxicity Test (OECD TG 210)
Fish Sexual Development Test (FSDT) (OECD TG 234)
Larval Amphibian Growth and Development Assay (LAGDA) (OECD TG 241)
Avian Reproduction Test (OECD TG 206)
Sediment-Water Chironomid Life-Cycle Toxicity Test (OECD TG 233)
Medaka Extended One-Generation Reproduction Test (MEOGRT) (OECD TG 240)
Non-OECD non-mammalian screens and tests (Conceptual Framework Levels 3-5)
OECD mammalian screens and tests (Conceptual Framework Levels 3-5)16 chapters available
Uterotrophic Bioassay in Rodents (UT assay) (OECD TG 440) (including OECD GD 71 on the procedure to test for anti-estrogenicity)
Hershberger Bioassay in Rats (H assay) (OECD TG 441) (including OECD GD 115 on the Weanling Hershberger Bioassay)
Repeated Dose 28-Day Oral Toxicity Study in Rodents (OECD TG 407)
Repeated Dose 90-Day Oral Toxicity Study in Rodents (OECD TG 408)
Combined Chronic Toxicity/Carcinogenicity Studies (OECD TG 451-3)
Reproduction/Developmental Toxicity Screening Test (OECD TG 421) and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD TG 422)
Prenatal Developmental Toxicity Study (OECD TG 414)
Developmental Neurotoxicity Study (OECD TG 426)
Repeated Dose Dermal Toxicity: 21/28-Day Study (OECD TG 410)
Subchronic Dermal Toxicity: 90-Day Study (OECD TG 411)
28-Day (Subacute) Inhalation Toxicity Study (OECD TG 412)
Subchronic Inhalation Toxicity: 90-Day Study (OECD TG 413)
Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents (OECD TG 409)
Two-Generation Reproduction Toxicity Study (OECD TG 416)
Extended One-Generation Reproductive Toxicity Study (EOGRTS) (OECD TG 443)
Non-OECD mammalian screens and tests (Concptual Framework Levels 3-5)
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