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Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes.
- Source :
-
Toxicology and applied pharmacology [Toxicol Appl Pharmacol] 2018 Sep 01; Vol. 354, pp. 3-6. Date of Electronic Publication: 2018 Feb 12. - Publication Year :
- 2018
-
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.<br /> (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Age Factors
Animal Testing Alternatives standards
Animals
Brain growth & development
Brain pathology
Consensus
Diffusion of Innovation
Humans
Neurons pathology
Neurotoxicity Syndromes pathology
Neurotoxicity Syndromes physiopathology
Policy Making
Reproducibility of Results
Risk Assessment
Stakeholder Participation
Toxicity Tests methods
Toxicology methods
Brain drug effects
Neurons drug effects
Neurotoxicity Syndromes etiology
Toxicity Tests standards
Toxicology standards
Subjects
Details
- Language :
- English
- ISSN :
- 1096-0333
- Volume :
- 354
- Database :
- MEDLINE
- Journal :
- Toxicology and applied pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 29447839
- Full Text :
- https://doi.org/10.1016/j.taap.2018.02.004