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.


Hershberger Bioassay in Rats (H assay) (OECD TG 441) (including OECD GD 115 on the Weanling Hershberger Bioassay)

TG 441 is a OECD validated in vivo short–term screening test to evaluate the ability of a chemical to elicit biological activities consistent with androgen agonists, antagonists or 5 alpha-reductase inhibition. Weights of five androgen-dependent tissues are measured in the castrate-peripubertal male rat: the ventral prostate, seminal vesicle (plus fluids and coagulating glands), levator ani-bulbocavernosus muscle, paired Cowper’s glands and the glans penis. The test substance is administered by gavage or subcutaneous injection daily for 10 consecutive days. To test for antiandrogens, the test substance is administered together with a reference androgen agonist. Each treated and control group should include a minimum of 6 animals. The animals are necropsied approximately 24 hours after the last administration of the test substance. The tissues are excised and their fresh weights determined. A statistically significant increase (androgenic) or decrease (antiandrogenic) in the weights of two of the five tissues indicates a positive response in this assay.


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