A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients.

Autor:	Kojima H; National Institute of Health Sciences, Japan., Nakada T; Showa University Fujigaoka Hospital, Japan., Yagami A; Fujita Health University School of Medicine, Japan., Todo H; Josai University, Japan., Nishimura J; Pharmaceuticals and Medical Devices Agency, Japan., Yagi M; Pharmaceuticals and Medical Devices Agency, Japan., Yamamoto K; Pharmaceuticals and Medical Devices Agency, Japan., Sugiyama M; Skin Safety Case Information Network, Japan., Ikarashi Y; National Institute of Health Sciences, Japan., Sakaguchi H; Japan Cosmetic Industry Association, Japan., Yamaguchi M; Japan Cosmetic Industry Association, Japan., Hirota M; Japan Cosmetic Industry Association, Japan., Aizawa S; Japan Cosmetic Industry Association, Japan., Nakagawa S; Japan Cosmetic Industry Association, Japan., Hagino S; Japan Cosmetic Industry Association, Japan., Hatao M; Japan Cosmetic Industry Association, Japan.
Jazyk:	angličtina
Zdroj:	Current research in toxicology [Curr Res Toxicol] 2022 Dec 23; Vol. 4, pp. 100100. Date of Electronic Publication: 2022 Dec 23 (Print Publication: 2023).
DOI:	10.1016/j.crtox.2022.100100
Abstrakt:	Animal testing of cosmetic ingredients and products has been banned in the European Union since 2013. However, in Japan, the application of new quasi-drugs requires the generation of data on acute oral toxicity through animal testing. A weight of evidence approach for assessing oral toxicity was challenged. This approach used a combination of safety data, including a neutral red uptake cytotoxicity assay using BALB/c3T3 cells (3T3-NRU cytotoxicity assay), which can assess the acute oral toxicity of quasi-drugs or cosmetic ingredients. We conclude that the step-by-step approach can be used to assess test substances that cause low acute oral toxicity, such as the median lethal dose (LD 50) > 2000 mg/kg, thereby avoiding animal testing. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2022 The Author(s).)
Databáze:	MEDLINE
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