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

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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.


Non-OECD non-mammalian screens and tests (Conceptual Framework Levels 3-5)

Specific guidance is provided for in vivo screens and tests using non-mammalian vertebrates and invertebrates for evaluating endocrine disrupting chemicals. The assays in this section have not been fully validated as OECD test guidelines, but have undergone partial validation (Androgenised Female Stickleback Screen (GD 148), Harpacticoid Copepod Development and Reproduction Test with Amphiascus (GD 201)); have been validated at the national level ( Fish Life Cycle Toxicity Test (FLCTT), Avian Two-Generation Toxicity Test in the Japanese Quail (ATGT)); are draft test guidelines in the OECD validation process (Short-Term Juvenile Hormone Activity Screening Assay using Daphnia magna, EASZY assay for detection of substances acting through estrogen receptors using zebrafish embryos, Juvenile Medaka Anti-Androgen Screening Assay, Xenopus Embryonic Thyroid Signalling Assay (XETA), Zebrafish Extended One-Generation Reproduction Test (ZEOGRT), RADAR: Rapid Androgen Disruption Adverse Outcome Reporter Assay); or are assays proposed as OECD test guidelines (Daphnia Multigeneration Test for Assessment of Endocrine-Active Chemicals (DMGT)) at the time of publication of this document.


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