Regulatory requirements for genotoxicity assessment of plant protection product active ingredients, impurities, and metabolites.
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.
Department of Toxicology and Health Sciences, Syngenta Ltd, Jealott's Hill International Research Centre, Bracknell, Berkshire, United Kingdom.
Ewan D
ED
Booth
Department of Toxicology and Health Sciences, Syngenta Ltd, Jealott's Hill International Research Centre, Bracknell, Berkshire, United Kingdom.
Paul J
PJ
Rawlinson
Department of Product Safety, Syngenta Protecao de Cultivos Ltda, Sao Paulo, SP, 04795-900, Brazil.
Priscila
P
Maria Fagundes
Department of Toxicology and Health Sciences, Syngenta Crop Protection LLC, Research Triangle Park, North Carolina.
Kevin A
KA
Leiner
D016573:Agrochemicals / Q000633:toxicity*; D000818:Animals; D020552:Comet Assay; D006801:Humans; D009152:Mutagenicity Tests / Q000379:methods*
D016573:Agrochemicals
biological; groundwater; impurity; metabolite; microbial