Mutation as a Toxicological Endpoint for Regulatory Decision‐Making
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...
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| Veröffentlicht in: | Environmental and molecular mutagenesis 2020-01, Vol.61 (1), p.34-41 |
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| container_title | Environmental and molecular mutagenesis |
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| creator | Heflich, Robert H. Johnson, George E. Zeller, Andreas Marchetti, Francesco Douglas, George R. Witt, Kristine L. Gollapudi, B. Bhaskar White, Paul A. |
| description | 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. |
| doi_str_mv | 10.1002/em.22338 |
| format | Article |
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Bhaskar ; White, Paul A.</creator><creatorcontrib>Heflich, Robert H. ; Johnson, George E. ; Zeller, Andreas ; Marchetti, Francesco ; Douglas, George R. ; Witt, Kristine L. ; Gollapudi, B. Bhaskar ; White, Paul A.</creatorcontrib><description>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. 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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. 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| language | eng |
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| source | Wiley-Blackwell Journals |
| subjects | Carcinogens Computer applications Decision making error‐corrected next‐generation sequencing germ cell mutation Germ cells Hazard identification Mutagenicity Mutation point of departure Quantitative analysis Regulatory agencies Risk assessment somatic cell mutation Somatic cells somatic mosaicism |
| title | Mutation as a Toxicological Endpoint for Regulatory Decision‐Making |
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