Global regulatory requirements for mutagenicity assessment in the registration of industrial chemicals.

Abstract:

:Mutagenicity is an important toxicological endpoint that requires thorough evaluation during the industrial chemical registration process. Regulatory requirements for mutagenicity assessment in registration of industrial chemicals vary in geographic regions (and in some cases by intended application). Here we compile the mutagenicity testing requirements for registration of industrial chemicals from representative geographic regions (in alphabetical order), that is Australia, Brazil, Canada, China, European Union (EU), India, Japan, South Korea, Taiwan, and United States (US). We further discuss the challenges that industry is facing to meet global regulations, for example, different testing requirements among geographic regions, different strategies in follow-up tests to in vitro positive findings, no-observed-adverse-effect-levels in genetic toxicity testing, and human relevance of mutagenicity. Environ. Mol. Mutagen. 58:345-353, 2017. © 2017 Wiley Periodicals, Inc.

journal_name

Environ Mol Mutagen

authors

Ji Z,Ball NS,LeBaron MJ

doi

10.1002/em.22096

subject

Has Abstract

pub_date

2017-06-01 00:00:00

pages

345-353

issue

5

eissn

0893-6692

issn

1098-2280

journal_volume

58

pub_type

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