Document Type
Article
Publication Date
9-1-2023
Identifier/URL
42416393 (Pure); 37442267 (PubMed)
Abstract
For decades, there has been increasing concern about the potential developmental neurotoxicity (DNT) associated with chemicals. Regulatory agencies have historically utilized standardized in vivo testing to evaluate DNT. Owing to considerations including higher-throughput screening for DNT, reduction in animal use, and potential cost efficiencies, the development of alternative new approach methods (NAMs) occurred; specifically, the advent of the DNT in vitro test battery (DNT IVB). SciPinion convened an expert panel to address specific questions related to the interpretation of in vitro DNT test data. The consensus of the expert panel was that the DNT IVB might be used during initial screening, but it is not presently a complete or surrogate approach to determine whether a chemical is a DNT in humans. By itself, the DNT IVB does not have the ability to capture nuances and complexity of the developing nervous system and associated outcomes including behavioral ontogeny, motor activity, sensory function, and learning/memory. Presently, such developmental landmarks cannot be adequately assessed in the DNT IVB or by other NAMs. The expert panel (all who serve as co-authors of this review) recommended that additional data generation and validation is required before the DNT IVB can be considered for application within global regulatory frameworks for decision-making.
Repository Citation
Juberg, D. R.,
Fox, D. A.,
Forcelli, P. A.,
Kacew, S.,
Lipscomb, J. C.,
Saghir, S. A.,
Sherwin, C. M.,
Koenig, C. M.,
Hays, S. M.,
& Kirman, C. R.
(2023). A Perspective on In Vitro Developmental Neurotoxicity Test Assay Results: An Expert Panel Review. Regulatory Toxicology and Pharmacology, 143.
https://corescholar.libraries.wright.edu/pediatrics/735
DOI
10.1016/j.yrtph.2023.105444
Comments
This work is licensed under CC BY 4.0
