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Endocrine Disrupters – Developing criteria

image of Endocrine Disrupters – Developing criteria

During the 2010 Danish Presidency of the Nordic Council of Ministers environment and health was a prioritized subject. The aim was enhanced Nordic information exchange. To support this aim a number of Nordic workshops were held to strengthen the capacity building and discuss future regulatory aspects in the area of endocrine disruptors, combination effects, and soft regulatory measures and effective risk communication. One of the workshops held in November focused on developing criteria for endocrine disruptors. This report describes the workshop presentations, the ensuing discussions, and the outcome.

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Report from workshop sessions 1 and 2: Test methods and data intepretation

The human health group discussed what could be concluded on the basis of the test results from each specific test method at the various levels in the OECD conceptual framework. Summarizing the discussion, it was agreed that, in some cases, a substance can be categorized as an ED based on in-vitro tests (level 2) supported by weight of evidence and read across. Furthermore, considering level 2 of the conceptual framework (in-vitro data), the group was of the opinion that a negative in-vitro result cannot exclude ED effects and that it would be necessary to apply a broader panel of in-vitro tests and have good knowledge on toxicokinetics to make even preliminary conclusions at this level. Most participants agreed, however, that it would be possible to classify for ED properties on the basis of positive test results at level 3 (in-vivo data providing evidence of modulation of the endocrine system but where there is generally not agreement about whether/which types of effects should be regarded as adverse effects (AE)) although some participants felt more information would be needed. At level 4, most of the ED endpoints are optional and the mandatory endpoints do not allow a final conclusion on their own if only negative responses are obtained. It was noted that a negative result at this level (obtained with adult animals) cannot exclude ED effects during e.g. other developmental stages. The discussion of the level 5 focussed on the limitations of the methods, e.g. lack of sufficient endpoints and the risk of false positive results due to use of high dose levels. It was concluded that only the Extended One-Generation Reproductive Toxicity Study (EOGRTS) can be used to exclude ED effects if it is supported by other relevant data.

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