Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

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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.


Fish Sexual Development Test (FSDT) (OECD TG 234)

TG 234 is an OECD validated assay that assesses early life-stage effects and potential adverse consequences of putative endocrine disrupting chemicals (e.g. oestrogens, androgens and steroidogenesis inhibitors) on fish sexual development. In the test, fish are exposed, from newly fertilized egg until the completion of sexual differentiation at about 60 days post hatch, to at least three concentrations of the test substance dissolved in water. In each treatment level and control(s) group(s), a minimum of four replicates is recommended. At termination of the test, two core endpoints are measured in each fish: vitellogenin concentration from head and tail or from blood sampling, and proportion of males, females, intersex and undifferentiated fish through gonadal histology. In fish species possessing a genetic sex marker, the genetic sex is identified to determine sex reversal in individual fish. The combination of the two core endocrine endpoints, vitellogenin concentration and phenotypic (and possibly genotypic) sex ratio, enable the test to indicate the mode of action of the test chemical.


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