Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity.

Détails

ID Serval
serval:BIB_866FEC6DF239
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity.
Périodique
ALTEX
Auteur(s)
Bal-Price A., Hogberg H.T., Crofton K.M., Daneshian M., FitzGerald R.E., Fritsche E., Heinonen T., Hougaard Bennekou S., Klima S., Piersma A.H., Sachana M., Shafer T.J., Terron A., Monnet-Tschudi F., Viviani B., Waldmann T., Westerink RHS, Wilks M.F., Witters H., Zurich M.G., Leist M.
ISSN
1868-596X (Print)
ISSN-L
1868-596X
Statut éditorial
Publié
Date de publication
2018
Peer-reviewed
Oui
Volume
35
Numéro
3
Pages
306-352
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
Multiple non-animal-based test methods have never been formally validated. In order to use such new approach methods (NAMs) in a regulatory context, criteria to define their readiness are necessary. The field of developmental neurotoxicity (DNT) testing is used to exemplify the application of readiness criteria. The costs and number of untested chemicals are overwhelming for in vivo DNT testing. Thus, there is a need for inexpensive, high-throughput NAMs, to obtain initial information on potential hazards, and to allow prioritization for further testing. A background on the regulatory and scientific status of DNT testing is provided showing different types of test readiness levels, depending on the intended use of data from NAMs. Readiness criteria, compiled during a stakeholder workshop, uniting scientists from academia, industry and regulatory authorities are presented. An important step beyond the listing of criteria, was the suggestion for a preliminary scoring scheme. On this basis a (semi)-quantitative analysis process was assembled on test readiness of 17 NAMs with respect to various uses (e.g. prioritization/screening, risk assessment). The scoring results suggest that several assays are currently at high readiness levels. Therefore, suggestions are made on how DNT NAMs may be assembled into an integrated approach to testing and assessment (IATA). In parallel, the testing state in these assays was compiled for more than 1000 compounds. Finally, a vision is presented on how further NAM development may be guided by knowledge of signaling pathways necessary for brain development, DNT pathophysiology, and relevant adverse outcome pathways (AOP).
Mots-clé
Animal Testing Alternatives, Animals, Education, Guidelines as Topic, Humans, Neurotoxicity Syndromes/etiology, Risk Assessment, Toxicity Tests/methods, Toxicity Tests/trends, developmental in vitro neurotoxicity testing, quality assurance, regulatory toxicology, toxicity screening
Pubmed
Web of science
Open Access
Oui
Création de la notice
03/03/2018 14:38
Dernière modification de la notice
21/08/2019 6:36
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