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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 28-Day Oral Toxicity Study in Rodents (OECD TG 407)

TG 407 is an OECD validated method providing information on health hazard likely to arise from exposure to test chemical via oral administration. The method is based on the repeated oral administration of the chemical of interest during one limited period (one dose level daily during 28 days). This Guideline is intended primarily for use with rodents (rat preferably). At least 10 animals (5 female and 5 male) should be used for each dose level. Three tests groups, at least, should be used. The test chemical is administered by gavage or via the diet or drinking water. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The report of this study will include results from clinical and functional observations, body weight and food/water consumption measurements, hematology and clinical biochemistry; as well as gross necropsy and histopathology.

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