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

Details

Serval ID
serval:BIB_0F4E2D75CCBF
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes.
Journal
Toxicology and applied pharmacology
Author(s)
Fritsche E., Grandjean P., Crofton K.M., Aschner M., Goldberg A., Heinonen T., Hessel EVS, 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., Wilks M.F., Witters H., Zurich M.G., Bal-Price A.
ISSN
1096-0333 (Electronic)
ISSN-L
0041-008X
Publication state
Published
Issued date
01/09/2018
Peer-reviewed
Oui
Volume
354
Pages
3-6
Language
english
Notes
Publication types: Guideline ; Journal Article
Publication Status: ppublish
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
Age Factors, Animal Testing Alternatives/standards, Animals, Brain/drug effects, Brain/growth & development, Brain/pathology, Consensus, Diffusion of Innovation, Humans, Neurons/drug effects, Neurons/pathology, Neurotoxicity Syndromes/etiology, Neurotoxicity Syndromes/pathology, Neurotoxicity Syndromes/physiopathology, Policy Making, Reproducibility of Results, Risk Assessment, Stakeholder Participation, Toxicity Tests/methods, Toxicity Tests/standards, Toxicology/methods, Toxicology/standards, Developmental neurotoxicity, In vitro testing, Regulatory purposes
Pubmed
Web of science
Create date
01/03/2018 20:55
Last modification date
08/02/2020 6:17
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