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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


ABSTRACT: Graphical abstract Highlights • The step-by-step approach challenged in a weight of evidence assessment of acute oral toxicity.• A combination of safety data for acute oral toxicity, including a neutral red uptake cytotoxicity assay using BALB/c3T3 cells (3T3-NRU cytotoxicity assay).• Available to assess the acute oral toxicity of quasi-drugs or 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 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.

SUBMITTER: Kojima H 

PROVIDER: S-EPMC9816657 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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