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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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Repeated Dose Dermal Toxicity: 21/28-Day Study (OECD TG 410)

TG 410 is an OECD valiated test to identify the health hazard of solid or liquid test substance following dermal application This method is composed of two tests: the main test and the limit test. This Test Guideline is intended for use with the adult rat, rabbit or guinea pig. At least 10 animals (5 female and 5 male) with healthy skin should be used for each of at least three dose levels. The highest dose level should result in toxic effects but not be fatal. The limit test corresponds to one dose level of at least 1000 mg/kg body weight. Test chemical is repeatedly applied for a limited time each day (several hours daily for 21/28 days). The test chemical should be applied over not less than 10 per cent of the body surface area. The results of this study include haematology, clinical biochemistry and urinalysis, gross necropsy and histopathology. A properly conducted 21-day or 28-day study should provide information on the effects of repeated inhalation exposure and can indicate the need for further longer term studies and provide information on the dose levels of the latter.

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