In vivo genotoxicity testing strategies: Report from the 8th International Workshop on Genotoxicity Testing (IWGT).

Carol Beevers¹, Yoshifumi Uno², Krista Meurer³, Shuichi Hamada⁴, Kiyohiro Hashimoto⁵, David Kirkland⁶, Matthew J LeBaron⁷, Frank Le Curieux⁸, Ludovic Le Hegarat⁹, Hans-Joerg Martus¹⁰, Kenichi Masumura¹¹, Wakako Ohyama¹², Daniel J Roberts¹³, Marie Vasquez¹⁴, James Whitwell¹⁵, Kristine L Witt¹⁶

¹Corteva Agriscience, Oxford, UK.

²LSI Medience Co., Tokyo, Japan.

³BASF SE, Limburgerhof, Germany.

⁴BoZo Research Center Inc., Tokyo, Japan.

⁵Takeda Pharmaceutical Co., Ltd., Tokyo, Japan.

⁶Kirkland Consulting, Tadcaster, UK.

⁷The Dow Chemical Company, Midland, Michigan, USA.

⁸European Chemicals Agency, Helsinki, Finland.

⁹ANSES, French Agency for Food, Environmental and Occupational Health and Safety, Fougères Laboratory, Toxicology of Contaminants Unit, Fougères, France.

¹⁰Preclinical Safety, Novartis Institutes for BioMedical Research, Basel, Switzerland.

¹¹National Institute of Health Sciences, Kawasaki, Kanagawa, Japan.

¹²Yakult Central Institute, Yakult Honsha Co., Ltd., Tokyo, Japan.

¹³Charles River Labs, Genetic & In Vitro Toxicology, Cook County, Illinois, USA.

¹⁴Helix3 Inc., Morrisville, North Carolina, USA.

¹⁵Labcorp Drug Development, Harrogate, UK.

¹⁶Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.

PubMed DOI

Abstract

The in vivo working group (WG) considered three topics: acceptable maximum doses for negative erythrocyte micronucleus (MN) tests, validation status of MN assays in non-hematopoietic tissues, and nuisance factors in the comet assay. The WG reached agreement on many issues, including: negative erythrocyte MN studies should be acceptable if dosing is conducted to Organisation for Economic Co-operati…

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Create Free Account Sign In

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.