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Regulatory requirements for genotoxicity assessment of plant protection product active ingredients, impurities, and metabolites
Author(s) -
Booth Ewan D.,
Rawlinson Paul J.,
Maria Fagundes Priscila,
Leiner Kevin A.
Publication year - 2017
Publication title -
environmental and molecular mutagenesis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1
H-Index - 87
eISSN - 1098-2280
pISSN - 0893-6692
DOI - 10.1002/em.22084
Subject(s) - genotoxicity , micronucleus test , active ingredient , comet assay , microbiology and biotechnology , toxicology , biology , chemistry , dna damage , pharmacology , biochemistry , toxicity , dna , organic chemistry
Active ingredients in plant protection products are subject to rigorous safety assessment during their development, including assessment of genotoxicity. Plant protection products are used for agriculture in multiple regions and for the registration of active ingredients it is necessary to satisfy the data requirements of these different regions. There are no overarching global agreements on which genotoxicity studies need to be conducted to satisfy the majority of regulatory authorities. The implementation of new OECD guidelines for the in vitro micronucleus, transgenic rodent somatic and germ cell gene mutation and in vivo comet assays, as well as the revision of a number of other OECD test guidelines has resulted in some changes to data requirements. This review describes the genotoxicity data requirements for chemical active ingredients as well as biologicals, microbials, ground water metabolites, metabolites, and impurities in a number of regions. Similarities and differences are highlighted. Environ. Mol. Mutagen. 58:325–344, 2017. © 2017 Wiley Periodicals, Inc.