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.


OECD in vitro screens (Conceptual Framework Level 2)

Specific guidance is provided for validated OECD in vitro screens, including the Performance-based Test Guideline (TG 493) for Human Recombinant Estrogen Receptor (hrER) assay to detect chemicals that bind the estrogen receptor (ER), the Performance-based Test Guideline (TG 455) for ER capable of detecting estrogen agonsits and antagonists, the Androgen Receptor (AR) Transactivation Assay (TG 458) capable of detecting androgen agonists and antagonists, and the H295R Steroidogenesis Assay (TG 456) to screen for chemicals that interfere with the synthesis of androgens and estrogens. For each assay, background, considerations, limitations, and when the assay might be used are discussed. Scenarios for interpreting positive, negative, and equivocal results, along with other endocrine test guideline data are also provided.


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