The general approach taken by the document is primarily:
- to provide guidance on how test results might be interpreted in the light of data that may already be available from other in vitro or in vivo assays. The key questions addressed concern likely mechanisms of endocrine action and any resulting apical effects that can be attributed to such action.
- to provide advice on the next step in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios.
The GD only covers the same endocrine modalities as the Conceptual Framework i.e.:
- Estrogen receptor mediated
- Androgen receptor mediated
- Thyroid hormone mediated
- Steroidogenesis interference
For each standardised assay, the guidance document provides:
- a background to the assay,
- a table including:
- possible scenarios,
- other existing lines of evidence,
- possible conclusions,
- the next step that could be taken to increase evidence, and
- other useful considerations.
The OECD Test Guidelines Programme has been active for several years in the area of endocrine disrupters testing and assessment.
This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Assessment). The guidance document was developed by two consultants in close cooperation with an advisory group on testing and assessment of endocrine disrupters (EDTA AG). The guidance document was approved by the Working Group of the National Coordinators of the Test Guidelines Programme, representing regulatory authorities. It is published in the OECD Series on Testing and Assessment, which is a collection of guidance documents, review papers, analytical reports and workshop reports on chemical testing and non-testing methods and hazard assessment. These publications are part of the OECD work on chemical safety.
A series of case studies on example chemicals has also been published (see document No.181 published in the Series on Testing and Assessment) to illustrate how the guidance can be applied using concrete cases.