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

Autor: Fritsche, Ellen, Grandjean, Philippe, Crofton, Kevin M, Aschner, Michael, Goldberg, Alan, Heinonen, Tuula, Hessel, Ellen V S, Hogberg, Helena T, Bennekou, Susanne Hougaard, Lein, Pamela J, Leist, Marcel, Mundy, William R, Paparella, Martin, Piersma, Aldert H, Sachana, Magdalini, Schmuck, Gabriele, Solecki, Roland, Terron, Andrea, Monnet-Tschudi, Florianne, Wilks, Martin F, Witters, Hilda, Zurich, Marie-Gabrielle, Bal-Price, Anna, Sub RIVM, dIRAS RA-1
Přispěvatelé: Sub RIVM, dIRAS RA-1
Jazyk: angličtina
Rok vydání: 2018
Předmět:
0301 basic medicine
Toxicity Tests/methods
Brain development
Consensus
Developmental neurotoxicity
In vitro testing
Regulatory purposes
Computer science
Policy making
Statement (logic)
Animal Testing Alternatives
Toxicology
Risk Assessment
Article
03 medical and health sciences
Stakeholder Participation
ddc:570
Toxicity Tests
Journal Article
Regulatory purposes
Animals
Humans
Policy Making
Pharmacology
Developmental neurotoxicity
Neurons
Brain/drug effects
Toxicology/methods
Age Factors
Brain
Reproducibility of Results
Neurotoxicity Syndromes/etiology
Pharmacology and Pharmaceutical Sciences
Neurons/drug effects
Variety (cybernetics)
030104 developmental biology
Risk analysis (engineering)
In vitro testing
Neurotoxicity Syndromes
Diffusion of Innovation
Animal Testing Alternatives/standards
Zdroj: Toxicology and Applied Pharmacology
Toxicology and Applied Pharmacology, 354, 3. Academic Press Inc.
Fritsche, Ellen; Grandjean, Philippe; Crofton, Kevin M; Aschner, Michael; Goldberg, Alan; Heinonen, Tuula; et al.(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. doi: 10.1016/j.taap.2018.02.004. UC Davis: Retrieved from: http://www.escholarship.org/uc/item/8g38c80h
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, Wilks, M F, Witters, H, Zurich, M-G & 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, vol. 354, pp. 3-6 . https://doi.org/10.1016/j.taap.2018.02.004
ISSN: 1096-0333
0041-008X
DOI: 10.1016/j.taap.2018.02.004.
Popis: 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.
Highlights • An increased prevalence of neurodevelopmental disorders in children is observed. • There is very limited information on neurodevelopmental toxicity (DNT) induced by environmental chemicals. • A new framework is required for assessment of chemicals with the potential to disrupt brain development. • In vitro DNT data together with in silico approaches should be used for regulatory purposes.
Databáze: OpenAIRE
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