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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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Non-OECD mammalian screens and tests (Concptual Framework Levels 3-5)

Specific guidance is provided for in vivo screening assays validated at the national level by the US Environmental Protection Agency (the Pubertal Development and Thyroid Function Assay in Male Rats and the Pubertal Development and Thyroid Function Assay in Female Rats). These relatively short (31 days in the male, 21 days in the female) in vivo assays provide information on test chemical interaction with the sex steroid and thyroid hormone signalling pathways following administration of test chemical by oral gavage during the sensitive peri-pubertal period. Assay endpoints include the timing of reproductive advance (preputial separation or vaginal opening), organ weights, histopathology of reproductive and thyroid tissues, and thyroid hormone levels.

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