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External Scientific Report on the Interpretation of Data from the Developmental Neurotoxicity In Vitro Testing Assays for Use in Integrated Approaches for Testing and Assessment

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Disclaimer: The present document has been produced and adopted by the bodies identified above as authors. This task has been carried out exclusively by the authors in the context of a contract between the European Food Safety Authority and the authors awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights view and position as regards the issues addressed and the conclusions reached in the present document without prejudice to the rights of the authors

Abstract

Developmentally neurotoxic chemicals are a diverse set of substances that have the potential to interfere with the normal development of the nervous system, which, if perturbed without compensation, may lead to adverse effects on the normal development of nervous system structures and/or functions. The current OECD test guideline (TG) 426 requires assessing the impact of fetal and postnatal maternal exposure on the development of: physical and developmental landmarks, clinical observations, and behavioural and neuropathological endpoints (OECD 2007). Use of the in vivo test guideline has been limited due to extensive time, resource costs and animal used. This limited testing, coupled with an increasing need to assess the hazards of hundreds of pesticides and thousands of industrial chemicals, has resulted in calls for the development and use of in vitro methods. International efforts have led to the development of the Developmental Neurotoxicity In Vitro Battery (DNT IVB). The purpose of the present document is to provide guidance on the interpretation of data developed with the DNT IVB for use in regulatory decisions. The major aims are to describe the assays that comprise the battery in terms of neurodevelopment, provide criteria that allows evaluation of the relevance of the data to developmental neurotoxicity, and to assist in the determination of the degree of certainty in any positive or negative findings to better inform use of DNT in vitro data in regulatory hazard determinations.

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