Best practices for developmental toxicity assessment for classification and labeling.

2.50
Hdl Handle:
http://hdl.handle.net/10029/621958
Title:
Best practices for developmental toxicity assessment for classification and labeling.
Authors:
Daston, George; Piersma, Aldert; Attias, Leonello; Beekhuijzen, Manon; Chen, Connie; Foreman, Jennifer; Hallmark, Nina; Leconte, Isabelle
Abstract:
Many chemicals are going through a hazard-based classification and labeling process in Europe. Because of the significant public health implications, the best science must be applied in assessing developmental toxicity data. The European Teratology Society and Health and Environmental Sciences Institute co-organized a workshop to consider best practices, including data quality and consistency, interpretation of developmental effects in the presence of maternal toxicity, human relevance of animal data, and limits of chemical classes. Recommendations included larger historical control databases, more pharmacokinetic studies in pregnant animals for dose setting and study interpretation, generation of mechanistic data to resolve questions about whether maternal toxicity is causative of developmental toxicity, and more rigorous specifications for what constitutes a chemical class. It is our hope that these recommendations will form the basis for subsequent consensus workshops and other scientific activities designed to improve the scientific robustness of data interpretation for classification and labeling.
Citation:
Best practices for developmental toxicity assessment for classification and labeling. 2018 Reprod. Toxicol.
Journal:
Reprod Toxicol 2018; advance online publication (ahead of print)
Issue Date:
14-May-2018
URI:
http://hdl.handle.net/10029/621958
DOI:
10.1016/j.reprotox.2018.05.001
PubMed ID:
29753929
Type:
Article
Language:
en
ISSN:
1873-1708
Appears in Collections:
Miscellaneous

Full metadata record

DC FieldValue Language
dc.contributor.authorDaston, Georgeen
dc.contributor.authorPiersma, Alderten
dc.contributor.authorAttias, Leonelloen
dc.contributor.authorBeekhuijzen, Manonen
dc.contributor.authorChen, Connieen
dc.contributor.authorForeman, Jenniferen
dc.contributor.authorHallmark, Ninaen
dc.contributor.authorLeconte, Isabelleen
dc.date.accessioned2018-05-27T13:16:43Z-
dc.date.available2018-05-27T13:16:43Z-
dc.date.issued2018-05-14-
dc.identifier.citationBest practices for developmental toxicity assessment for classification and labeling. 2018 Reprod. Toxicol.en
dc.identifier.issn1873-1708-
dc.identifier.pmid29753929-
dc.identifier.doi10.1016/j.reprotox.2018.05.001-
dc.identifier.urihttp://hdl.handle.net/10029/621958-
dc.description.abstractMany chemicals are going through a hazard-based classification and labeling process in Europe. Because of the significant public health implications, the best science must be applied in assessing developmental toxicity data. The European Teratology Society and Health and Environmental Sciences Institute co-organized a workshop to consider best practices, including data quality and consistency, interpretation of developmental effects in the presence of maternal toxicity, human relevance of animal data, and limits of chemical classes. Recommendations included larger historical control databases, more pharmacokinetic studies in pregnant animals for dose setting and study interpretation, generation of mechanistic data to resolve questions about whether maternal toxicity is causative of developmental toxicity, and more rigorous specifications for what constitutes a chemical class. It is our hope that these recommendations will form the basis for subsequent consensus workshops and other scientific activities designed to improve the scientific robustness of data interpretation for classification and labeling.en
dc.language.isoenen
dc.rightsinfo:eu-repo/semantics/closedAccessen
dc.titleBest practices for developmental toxicity assessment for classification and labeling.en
dc.typeArticleen
dc.identifier.journalReprod Toxicol 2018; advance online publication (ahead of print)en

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