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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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Introduction

Section A of Guidance Document 150 provides background and history, defines terms used in the document, and describes the objectives, scope and limitations. Guidance Document 150 was developed to be a resource for regulators and because of substantial regional differences in the regulatory policies on endocrine disrupters, the document offers guidance for identifying hazard of chemicals that may interact with the endocrine system but does not consider exposure herein. A table of all endocrine disrupter screens and tests for which guidance is provided, and includes the standardised test methods that are available at the international and national levels, as well as those under development. This section also describes the Conceptual Framework for Testing and Assessment of Endocrine Disrupting chemicals. The Conceptual framework includes five levels that increase in biological complexity. Level 1 of the framework is existing and non-test data; Level 2 covers mechanistic in vitro assays; Level 3 covers in vivo assays that provide limited data regarding select endocrine mechanisms or pathways; Level 4 covers in vivo assays providing limited data on adverse effects; and Level 5 covers in vivo assays which provide more complete data on adverse effects and an organism’s life cycle.

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