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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 90-Day Oral Toxicity Study in Non-Rodents (OECD TG 409)

TG 409 is an OECD validated test providing information on health hazard likely to arise from short-term exposure to test chemical. The determination of sub-chronic oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained from acute or repeated dose 28-day toxicity tests. The method is based on the repeated oral administration of the chemical of interest over a prolonged period (one dose level daily during 90 days). This Test Guideline is intended primarily for use with non-rodents species. The commonly used non-rodent species is the dog (the beagle is frequently used). At least 8 animals (4 female and 4 male) should be used for each test group. At least three concentrations of test chemical should be used. The test chemical is administered in the diet or in the drinking water, by gavage or in capsules. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The results of this study include: measurements (body weight measured at least once a week, food/water consumption) and daily (preferably at the same time) and detailed observations (ophtalmological examination, haematology, clinical biochemistry and urinalysis), as well as gross necropsy and histopathology.

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