Peer-Reviewed Publication

Environ Mol Mutagen2025;66 Suppl 2(Suppl 2):144-165.December 1, 2025Journal Article

Assessing the quality and making appropriate use of historical negative control data: A report of the International Workshop on Genotoxicity Testing (IWGT).

Stephen D Dertinger¹, Dingzhou Li², Carol Beevers³, George R Douglas⁴, Robert H Heflich⁵, David P Lovell⁶, Daniel J Roberts⁷, Robert Smith⁸, Yoshifumi Uno⁹, Andrew Williams⁴, Kristine L Witt¹⁰, Andreas Zeller¹¹, Changhui Zhou¹²

¹Litron Laboratories, Rochester, New York, USA.

²Pfizer, Groton, Connecticut, USA.

³Corteva Agriscience, Oxford, UK.

⁴Environmental Health Science and Research Bureau, Health Canada, Ottawa, Canada.

⁵U.S. Food and Drug Administration/National Center for Toxicological Research, Jefferson, Arkansas, USA.

⁶St. George's Medical School, University of London, London, UK.

⁷Charles River Labs, Genetic & In Vitro Toxicology, Skokie, Illinois, USA.

⁸Labcorp Drug Development, Harrogate, UK.

⁹LSI Medience, Co., Tokyo, Japan.

¹⁰Division of Translational Toxicology, National Institute of Environmental Health Sciences/National Institutes of Health, Research Triangle Park, North Carolina, USA.

¹¹F. Hoffmann-La Roche, Ltd., Pharmaceutical Sciences, pRED Innovation Center Basel, Basel, Switzerland.

¹²Shanghai Innostar Bio-tech, Co., Ltd., China State Institute of Pharmaceutical Industry, Shanghai, China.

PubMed PMC DOI PDF

Abstract

Historical negative control data (HCD) have played an increasingly important role in interpreting the results of genotoxicity tests. In particular, Organisation for Economic Co-operation and Development (OECD) genetic toxicology test guidelines recommend comparing responses produced by exposure to test substances with the distribution of HCD as one of three criteria for evaluating and interpreting…

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