Mutagenicity evaluation for quantitative evaluation of carcinogenicity in the risk assessment I for human health: Reexamination of the existence or non-existence of carcinogenicity threshold

DOI
  • USHIDA Kazuo
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences
  • INOUE Kaoru
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences
  • KAI Kaoru
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences
  • YOSHIDA-YAMASHITA Lucia Satiko
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences
  • SUZUKI Hiroshi
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences
  • HIROSE Akihiko
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences

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Other Title
  • 化審法のリスク評価（一次）評価Ⅰでの発がん性定量的評価のために求められる変異原性評価のあり方：閾値の有無に関する再検討

Abstract

<p>In the Risk Assessment I (RA I) for human health under the Chemical Substances Control Law, a quantitative evaluation of the carcinogenicity of priority-assessment chemical substances is required, if possible. Since it is necessary to judge about the existence or non-existence of carcinogenicity threshold, results from genotoxicity studies have been used without detailed review (reliability verification) and mutagenicity was judged by a provisional rule consisted of a reported positive Ames test and / or positive in vivo test. In the present study, to increase the reliability of the judgement of carcinogenicity threshold, the available genotoxicity information for 8 substances provisionally judged as having no carcinogenicity threshold was reviewed carefully with especial attention to the plausibility of positive genetic toxicity. As a result, it was clarified that among them, 2 substances should be evaluated as having no mutagenicity. Since these substances contradicted the previous provisional judgments, it was found that the reliability of the tests and mechanisms of mutagenicity should be more accurately assessed in the RA I.</p>

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