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Mutation as a Toxicological Endpoint for Regulatory Decision-Making.
Environmental and Molecular Mutagenesis ( IF 2.8 ) Pub Date : 2019-10-23 , DOI: 10.1002/em.22338
Robert H Heflich 1 , George E Johnson 2 , Andreas Zeller 3 , Francesco Marchetti 4 , George R Douglas 4 , Kristine L Witt 5 , B Bhaskar Gollapudi 6 , Paul A White 4
Affiliation  

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.

中文翻译:

突变作为管理决策的毒理学终点。

在体细胞和生殖细胞中诱导的突变是造成多种人类疾病的原因,自20世纪初期以来,突变本身就被视为不利于健康的问题。尽管监管机构最常使用体外和体内体细胞突变数据来进行危害识别,即确定某种物质是否是潜在的诱变剂和致癌物,但定量诱变剂量反应数据正越来越多地用于风险评估中。 。当前正在努力改善突变的测量并改进用于评估突变数据的计算方法。我们建议继续开发这些方法,目的是就包括将突变本身的定量分析作为评估毒理学风险的必要终点的价值达成共识。环境。大声笑 诱变剂。2020年61:34-41。©2019 Wiley Periodicals,Inc.
更新日期:2019-11-01
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