SETAC Europe 35th Annual Meeting

How to break the silos and strengthen the weight of evidence: an example

Abstract: In the context of the assessments for endocrine disruption for the environment, the weight of evidence is fundamental when trying to consider all the available data together and reach a robust conclusion on whether the criteria as laid down in the Regulation 605/2018 are met or not.
The strength of the weight of evidence often depends on the data richness on one side, and on the knowledge and gaps therein that may exist for specific cases on the other side.
The ED assessment of pesticide active substances is performed both for mammalian and non-mammalian species and two separate conclusions are normally drawn since one considers specific data on mammals and the other consider data on fish for Estrogen, Androgen and Steroidogenesis (EAS) modalities and amphibians for the Thyroid modality. Although the ECHA/EFSA Guidance on the hazard identification of endocrine disruptors suggest a holistic approach, this approach is rarely followed, especially for the identification of EDs in humans. In addition, although the endocrine system is known to be conserved across vertebrates, mammals and non-mammalian species may show different sensitivity and therefore a different outcome of the assessment may be possible.
The experience and knowledge gained from EFSA so far have shown, however, that in the case of substances suspected to be anti-androgens a conclusion for non-mammalian species may be challenging since the available study designs with fish do not allow to clearly detect anti-androgens. The use of mammalian and non-mammalian data in a holistic manner has resulted in strengthening the weight of evidence and has allowed to reach a conclusion for the environment which would have not been possible if data on non-mammalian species had not been considered.
The poster will show one case of a holistic approach where mammalian and non-mammalian data have been used together. The example will show how data for endocrine activity and adversity for mammalian and non-mammalian species have been assessed and consider together in the Mode of action analysis to strengthen the weight of evidence and conclude the substance under assessment was an endocrine disruptor.

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Author(s):

Maria Arena EFSA Italy This Author Is the Presenter

Simone Rizzuto EFSA Italy

Aude Kienzler EFSA Italy

Laura Villamar-Bouza EFSA Italy