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Title: The assessment and communication of genotoxicity test results: moving beyond binary
Authors: Omori, Takashi  kyouindb  KAKEN_id
Hayashi, Makoto
Author's alias: 大森, 崇
Keywords: Human health risk
Study interpretation
Uncertainty
Risk communication
Issue Date: Jan-2024
Publisher: Elsevier BV
Journal title: Mutation Research - Genetic Toxicology and Environmental Mutagenesis
Volume: 893
Thesis number: 503722
Abstract: Potential genotoxicity is one of the essential considerations in the safety assessment of chemicals to which humans may be exposed. Several endpoints are used to evaluate genotoxicity, but, in each case, a binary assessment (negative/positive) is demanded by regulators. The use of binary assessment has rarely been questioned, although we have pointed out some questions and difficulties with regard to the statistical methods used and the evaluation of biological significance, both of which inform the calls of negative/ positive. Here, we discuss these issues further, focusing on ambiguity and uncertainty in the binary paradigm, and we seek a new direction for genotoxicity assessment. To this end, we need to understand, acknowledge, and accept these ambiguities and study-related uncertainties and then to consider new strategies for safety assessment. We also discuss the communication of ambiguity and uncertainty in risk communication.
Rights: © 2023. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.
The full-text file will be made open to the public on 01 January 2025 in accordance with publisher's 'Terms and Conditions for Self-Archiving'.
This is not the published version. Please cite only the published version. この論文は出版社版でありません。引用の際には出版社版をご確認ご利用ください。
URI: http://hdl.handle.net/2433/287500
DOI(Published Version): 10.1016/j.mrgentox.2023.503722
PubMed ID: 38272631
Appears in Collections:Journal Articles

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