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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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Fish Short-Term Reproduction Assay (FSTRA) (OECD TG 229)

TG 229 is an OECD validated in vivo screening assay for fish reproduction where sexually mature male and spawning female fish are held together and exposed to a chemical during a limited part of their life-cycle (21 days). The short term reproduction assay was validated in the fathead minnow (Pimephales promelas) and this is the recommended species. The assay is run with three test chemical concentrations and the necessary controls, including a carrier control if necessary. For the fathead minnow, four replicate test vessels are used for each treatment level and control(s). During the conduct of the assay, the egg production is measured quantitatively daily in each test vessel. At termination of the 21-day exposure period, two biomarker endpoints are measured in males and females separately, as indicators of endocrine activity of the test chemical; these endpoints are vitellogenin and secondary sexual characteristics. Gonads of both sexes are also preserved and histopathology may be evaluated to assess the reproductive fitness of the test animals and to add to the weight of evidence of other endpoints.

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