Current Research in Toxicology (Jan 2023)

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

Journal volume & issue
Vol. 4
p. 100100

Abstract

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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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