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
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.