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

Hajime Kojima; Tokio Nakada; Akiko Yagami; Hiroaki Todo; Jihei Nishimura; Mio Yagi; Keiko Yamamoto; Mariko Sugiyama; Yoshiaki Ikarashi; Hitoshi Sakaguchi; Masahiko Yamaguchi; Morihiko Hirota; Sakiko Aizawa; Shota Nakagawa; Shigenobu Hagino; Masato Hatao

doi:10.1016/j.crtox.2022.100100

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

Hajime Kojima, Tokio Nakada, Akiko Yagami, Hiroaki Todo, Jihei Nishimura, Mio Yagi, Keiko Yamamoto, Mariko Sugiyama, Yoshiaki Ikarashi, Hitoshi Sakaguchi, Masahiko Yamaguchi, Morihiko Hirota, Sakiko Aizawa, Shota Nakagawa, Shigenobu Hagino, Masato Hatao

Allergology

Research output: Contribution to journal › Review article › peer-review

4 Citations (Scopus)

Abstract

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.

Original language	English
Article number	100100
Journal	Current Research in Toxicology
Volume	4
DOIs	https://doi.org/10.1016/j.crtox.2022.100100
Publication status	Published - 01-2023

All Science Journal Classification (ASJC) codes

Applied Microbiology and Biotechnology
Toxicology
Health, Toxicology and Mutagenesis

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10.1016/j.crtox.2022.100100

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Kojima, H., Nakada, T., Yagami, A., Todo, H., Nishimura, J., Yagi, M., Yamamoto, K., Sugiyama, M., Ikarashi, Y., Sakaguchi, H., Yamaguchi, M., Hirota, M., Aizawa, S., Nakagawa, S., Hagino, S., & Hatao, M. (2023). A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients. Current Research in Toxicology, 4, Article 100100. https://doi.org/10.1016/j.crtox.2022.100100

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

abstract = "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.",

author = "Hajime Kojima and Tokio Nakada and Akiko Yagami and Hiroaki Todo and Jihei Nishimura and Mio Yagi and Keiko Yamamoto and Mariko Sugiyama and Yoshiaki Ikarashi and Hitoshi Sakaguchi and Masahiko Yamaguchi and Morihiko Hirota and Sakiko Aizawa and Shota Nakagawa and Shigenobu Hagino and Masato Hatao",

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year = "2023",

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doi = "10.1016/j.crtox.2022.100100",

language = "English",

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Kojima, H, Nakada, T, Yagami, A, Todo, H, Nishimura, J, Yagi, M, Yamamoto, K, Sugiyama, M, Ikarashi, Y, Sakaguchi, H, Yamaguchi, M, Hirota, M, Aizawa, S, Nakagawa, S, Hagino, S & Hatao, M 2023, 'A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients', Current Research in Toxicology, vol. 4, 100100. https://doi.org/10.1016/j.crtox.2022.100100

TY - JOUR

T1 - A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients

AU - Kojima, Hajime

AU - Nakada, Tokio

AU - Yagami, Akiko

AU - Todo, Hiroaki

AU - Nishimura, Jihei

AU - Yagi, Mio

AU - Yamamoto, Keiko

AU - Sugiyama, Mariko

AU - Ikarashi, Yoshiaki

AU - Sakaguchi, Hitoshi

AU - Yamaguchi, Masahiko

AU - Hirota, Morihiko

AU - Aizawa, Sakiko

AU - Nakagawa, Shota

AU - Hagino, Shigenobu

AU - Hatao, Masato

PY - 2023/1

Y1 - 2023/1

N2 - 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.

AB - 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.

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DO - 10.1016/j.crtox.2022.100100

M3 - Review article

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JO - Current Research in Toxicology

JF - Current Research in Toxicology

M1 - 100100

ER -

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

Abstract

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