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

Ellen Fritsche, Philippe Grandjean, Kevin M Crofton, Michael Aschner, Alan Goldberg, Tuula Heinonen, Ellen V S Hessel, Helena T Hogberg, Susanne Hougaard Bennekou, Pamela J Lein, Marcel Leist, William R Mundy, Martin Paparella, Aldert H Piersma, Magdalini Sachana, Gabriele Schmuck, Roland Solecki, Andrea Terron, Florianne Monnet-Tschudi, Martin F WilksHilda Witters, Marie-Gabrielle Zurich, Anna Bal-Price

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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.

Original languageEnglish
JournalToxicology and Applied Pharmacology
Volume354
Pages (from-to)3-6
ISSN0041-008X
DOIs
Publication statusPublished - Sep 2018

Keywords

  • Journal Article
  • In vitro testing
  • Developmental neurotoxicity
  • Regulatory purposes
  • Reproducibility of Results
  • Age Factors
  • Risk Assessment
  • Humans
  • Neurons/drug effects
  • Toxicity Tests/methods
  • Neurotoxicity Syndromes/etiology
  • Consensus
  • Animal Testing Alternatives/standards
  • Stakeholder Participation
  • Brain/drug effects
  • Animals
  • Toxicology/methods
  • Policy Making
  • Diffusion of Innovation

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  • Cite this

    Fritsche, E., Grandjean, P., Crofton, K. M., Aschner, M., Goldberg, A., Heinonen, T., Hessel, E. V. S., Hogberg, H. T., Bennekou, S. H., Lein, P. J., Leist, M., Mundy, W. R., Paparella, M., Piersma, A. H., Sachana, M., Schmuck, G., Solecki, R., Terron, A., Monnet-Tschudi, F., ... Bal-Price, A. (2018). Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes. Toxicology and Applied Pharmacology, 354, 3-6. https://doi.org/10.1016/j.taap.2018.02.004