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

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 cha...

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Autores principales: Kojima, Hajime, Nakada, Tokio, Yagami, Akiko, Todo, Hiroaki, Nishimura, Jihei, Yagi, Mio, Yamamoto, Keiko, Sugiyama, Mariko, Ikarashi, Yoshiaki, Sakaguchi, Hitoshi, Yamaguchi, Masahiko, Hirota, Morihiko, Aizawa, Sakiko, Nakagawa, Shota, Hagino, Shigenobu, Hatao, Masato
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9816657/
https://www.ncbi.nlm.nih.gov/pubmed/36619289
http://dx.doi.org/10.1016/j.crtox.2022.100100
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author Kojima, Hajime
Nakada, Tokio
Yagami, Akiko
Todo, Hiroaki
Nishimura, Jihei
Yagi, Mio
Yamamoto, Keiko
Sugiyama, Mariko
Ikarashi, Yoshiaki
Sakaguchi, Hitoshi
Yamaguchi, Masahiko
Hirota, Morihiko
Aizawa, Sakiko
Nakagawa, Shota
Hagino, Shigenobu
Hatao, Masato
author_facet Kojima, Hajime
Nakada, Tokio
Yagami, Akiko
Todo, Hiroaki
Nishimura, Jihei
Yagi, Mio
Yamamoto, Keiko
Sugiyama, Mariko
Ikarashi, Yoshiaki
Sakaguchi, Hitoshi
Yamaguchi, Masahiko
Hirota, Morihiko
Aizawa, Sakiko
Nakagawa, Shota
Hagino, Shigenobu
Hatao, Masato
author_sort Kojima, Hajime
collection PubMed
description 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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spelling pubmed-98166572023-01-07 A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients Kojima, Hajime Nakada, Tokio Yagami, Akiko Todo, Hiroaki Nishimura, Jihei Yagi, Mio Yamamoto, Keiko Sugiyama, Mariko Ikarashi, Yoshiaki Sakaguchi, Hitoshi Yamaguchi, Masahiko Hirota, Morihiko Aizawa, Sakiko Nakagawa, Shota Hagino, Shigenobu Hatao, Masato Curr Res Toxicol Article 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. Elsevier 2022-12-23 /pmc/articles/PMC9816657/ /pubmed/36619289 http://dx.doi.org/10.1016/j.crtox.2022.100100 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Kojima, Hajime
Nakada, Tokio
Yagami, Akiko
Todo, Hiroaki
Nishimura, Jihei
Yagi, Mio
Yamamoto, Keiko
Sugiyama, Mariko
Ikarashi, Yoshiaki
Sakaguchi, Hitoshi
Yamaguchi, Masahiko
Hirota, Morihiko
Aizawa, Sakiko
Nakagawa, Shota
Hagino, Shigenobu
Hatao, Masato
A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
title A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
title_full A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
title_fullStr A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
title_full_unstemmed A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
title_short A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
title_sort step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9816657/
https://www.ncbi.nlm.nih.gov/pubmed/36619289
http://dx.doi.org/10.1016/j.crtox.2022.100100
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