Show simple item record

dc.contributor.authorFritsche, Ellen
dc.contributor.authorGrandjean, Philippe
dc.contributor.authorCrofton, Kevin M
dc.contributor.authorAschner, Michael
dc.contributor.authorGoldberg, Alan
dc.contributor.authorHeinonen, Tuula
dc.contributor.authorHessel, Ellen V S
dc.contributor.authorHogberg, Helena
dc.contributor.authorBennekou, Susanne Hougaard
dc.contributor.authorLein, Pamela J
dc.contributor.authorLeist, Marcel
dc.contributor.authorMundy, William R
dc.contributor.authorPaparella, Martin
dc.contributor.authorPiersma, Aldert H
dc.contributor.authorSachana, Magdalini
dc.contributor.authorSchmuck, Gabriele
dc.contributor.authorSolecki, Roland
dc.contributor.authorTerron, Andrea
dc.contributor.authorMonnet-Tschudi, Florianne
dc.contributor.authorWilks, Martin F
dc.contributor.authorWitters, Hilda
dc.contributor.authorZurich, Marie-Gabrielle
dc.contributor.authorBal-Price, Anna
dc.date.accessioned2018-02-22T11:53:09Z
dc.date.available2018-02-22T11:53:09Z
dc.date.issued2018-02-12
dc.identifier.citationConsensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes. 2018 Toxicol. Appl. Pharmacol.en
dc.identifier.issn1096-0333
dc.identifier.pmid29447839
dc.identifier.doi10.1016/j.taap.2018.02.004
dc.identifier.urihttp://hdl.handle.net/10029/621427
dc.description.abstractThis 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.
dc.language.isoenen
dc.rightsArchived with thanks to Toxicology and applied pharmacologyen
dc.titleConsensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes.en
dc.typeArticleen
dc.identifier.journalToxicol Appl Pharmacol 2018; advance online publication (ahead of print)en
html.description.abstractThis 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.


Files in this item

Thumbnail
Name:
Publisher version

This item appears in the following Collection(s)

Show simple item record