Improved performance of the SH test as an in vitro skin sensitization test with a new predictive model and decision tree

Noriyasu Imai; Midori Takeyoshi; Sakiko AizawaMika TsurumakiMasaharu KurosawaAkemi ToyodaMaki SugiyamaKaoru KasaharaShinichi OgataTakashi OmoriMorihiko Hirota

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Improved performance of the SH test as an in vitro skin sensitization test with a new predictive model and decision tree

机译：Improved performance of the SH test as an in vitro skin sensitization test with a new predictive model and decision tree

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Abstract Demands for the elimination and replacement of animal experiments for cosmetic safety assessment have increased in recent years. Evaluation of skin sensitization, however, is a critical issue in cosmetic safety assessment. The SH test is an in vitro skin sensitization test method that evaluates protein binding of chemical substances, which is an important event in skin sensitization. We previously verified the technical transferability and between‐laboratory reproducibility of the SH test, a domestic test method for which no scientific research has been conducted, and improved the protocol, but also noted some unresolved issues. Therefore, in the present study, we successfully improved the operational efficiency and clarity of the final judgment of the SH test by (i) developing a new decision‐making system that can make a final judgment without statistical processing, (ii) changing the statistical method, and (iii) evaluating and determining the maximum number of repetitions necessary for optimal efficiency. The improved SH test was verified by comparing it with existing test methods already adopted by the Organization for Economic Cooperation and Development. The results of this study demonstrated excellent performance of the improved SH test, with high reproducibility, reliable predictability, and good operational efficiency. The predictive performance of the improved method does not differ significantly from that of the conventional method, although it is clearer and more efficient. Therefore, the results of the present improved method are consistent with those obtained using the conventional method, with higher efficiency.

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来源
《Journal of applied toxicology》 |2022年第6期|1029-1043|共15页
作者
Noriyasu Imai; Midori Takeyoshi; Sakiko AizawaMika TsurumakiMasaharu KurosawaAkemi ToyodaMaki SugiyamaKaoru KasaharaShinichi OgataTakashi OmoriMorihiko Hirota;
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作者单位

Safety and Analytical Research Laboratories,KOSé Corporation;

Frontier Research Laboratories,POLA Chemical Industries, Inc.;

Graduate School of Environment and Information Sciences,Yokohama National UniversityDivision of Biostatistics Department of Social/Community Medicine and Health Science,KobeBrand Value R&D Institute,Shiseido Co., Ltd.;

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正文语种英语
中图分类毒物学（毒理学）;
关键词
95 confidence interval; alternative test method to animal experiment; between‐laboratory reproducibility; IATA for skin sensitization; in vitro skin sensitization test method; operational efficiency; prediction model; SH test; skin sensitization;

Improved performance of the SH test as an in vitro skin sensitization test with a new predictive model and decision tree

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