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Toxicol Appl Pharmacol. 2018 Sep 1;354:3-6. doi: 10.1016/j.taap.2018.02.004. Epub 2018 Feb 12.

Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes.

Author information

1
IUF - Leibniz Research Institute for Environmental Medicine, Duesseldorf, Germany.
2
University of Southern Denmark, Harvard T.H. Chan School of Public Health, USA.
3
Neurotoxicologist, Durham, NC, USA.
4
Albert Einstein College of Medicine Bronx, New York, USA.
5
Bloomberg School of Public Health, Founding Director (Emeritus) of Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, USA; Global Food Ethics, Johns Hopkins University, Baltimore, USA.
6
Finnish Centre for Alternative Methods (FICAM), University of Tampere, Tampere, Finland.
7
National Institute for Public Health and the Environment, RIVM Center for Health Protection, Bilthoven, Netherlands.
8
Centre for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Baltimore, USA.
9
The Danish Environmental Protection Agency (EPA), Copenhagen, Denmark.
10
Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, Davis, USA.
11
CAAT - Centre for Alternatives to Animal Testing, University of Konstanz, Konstanz, Germany.
12
Neurotoxicologist, Durham, USA.
13
Austrian National Coordinator of Testing Methods, Austria.
14
RIVM Center for Health Protection, Bilthoven and Institute for Risk Assessment Sciences, Utrecht University, Utrecht, Netherlands.
15
Organisation for Economic Co-operation and Development (OECD), Paris, France.
16
Bayer, Wuppertal, Germany.
17
Federal Institute for Risk Assessment (BfR), Berlin, Germany.
18
European Food Safety Authority (EFSA), Parma, Italy.
19
Department of Physiology, University of Lausanne and SCAHT, Switzerland.
20
SCAHT - Swiss Centre for Applied Human Toxicology, University of Basel, Basel, Switzerland.
21
VITO, Flemish Institute for Technological Research, Unit Environmental Risk and Health, Belgium.
22
European Commission -DG Joint Research Centre (JRC), Ispra, Italy. Electronic address: anna.price@ec.europa.eu.

Abstract

This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.

KEYWORDS:

Developmental neurotoxicity; In vitro testing; Regulatory purposes

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