1887

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.

English

Introduction to specific guidelines

Section C of Guidance Document 150 provides guidance on all assays covered in the document, including OECD validated test guidelines, test guidelines that have been validated at a national level, test guidelines described in other OECD guidance documents, and test methods that have been proposed as OECD guidelines or are currently in the OECD validation process. Description of each assay includes a discussion of the basis for the assay, special considerations, limitations, when the assay is likely to be used, and guidance for interpretation for positive, negative, and equivocal results. For each specific guideline, a table illustrating a variety of data scenarios is also included, as is guidance for a next testing step if a conclusion cannot be drawn from existing data.

English

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error