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Mutation as a Toxicological Endpoint for Regulatory Decision‐Making
Author(s) -
Heflich Robert H.,
Johnson George E.,
Zeller Andreas,
Marchetti Francesco,
Douglas George R.,
Witt Kristine L.,
Gollapudi B. Bhaskar,
White Paul A.
Publication year - 2020
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.22338
Subject(s) - mutagen , germline mutation , mutation , somatic cell , point mutation , biology , risk assessment , genetics , computational biology , toxicology , carcinogen , bioinformatics , gene , computer science , computer security
Mutations induced in somatic cells and germ cells are responsible for a variety of human diseases, and mutation per se has been considered an adverse health concern since the early part of the 20th Century. Although in vitro and in vivo somatic cell mutation data are most commonly used by regulatory agencies for hazard identification, that is, determining whether or not a substance is a potential mutagen and carcinogen, quantitative mutagenicity dose–response data are being used increasingly for risk assessments. Efforts are currently underway to both improve the measurement of mutations and to refine the computational methods used for evaluating mutation data. We recommend continuing the development of these approaches with the objective of establishing consensus regarding the value of including the quantitative analysis of mutation per se as a required endpoint for comprehensive assessments of toxicological risk. Environ. Mol. Mutagen. 61:34–41, 2020. © 2019 Wiley Periodicals, Inc.