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

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

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.

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General Guidance on Endocrine Assessment: Assays and Endpoints

Section B of Guidance Document 150 provides general guidance on endocrine assessment, assays, and endpoints. The section also provides considerations for information collected at each level of the Conceptual Framework. In this section is a table of all endpoints in the assays included the Conceptual Framework, along identification of those endpoints that are relevant to the estrogen, androgen, thyroid, and steroidogenesis modalities of vertebrates and juvenile hormone of invertebrates are include for each assay. Guidance is also provided for cross-species extrapolation among the well conserved endocrine pathways of vertebrates, consideration of chemicals with potential multiple endocrine modes of action, and recognition that no single assay provides definitive evidence of endocrine disruption, but rather a weight of evidence approach is needed. A table describing evidence approaches for considering chemicals as endocrine disrupters is included, along with experiences using test methods for endocrine assessment of chemicals in a regulatory context.

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