Bio: Hajime Kojima, Ph.D., is a professor in the Department of Pharmaceutical Engineering, Faculty of Engineering in Sanyo-Onoda City University, an advisor in Hatano Research Institute (HRI), Food and Drug Safety Center (FDSC) and a visiting researcher, Division of Food Additives in National Institute of Health Sciences (NIHS). He was also a past secretary of Japanese Center for the Validation of Alternative methods (JaCVAM) and Center for Biological Safety and Research (CBSR) in NIHS contributing to the identification and evaluation of in vitro test methods for their potential validation, in the field of genotoxicity and local toxicity (skin & eye irritation and skin sensitisation). He holds several publications in refereed journals dealing with in vitro toxicity assay as well as validation study. He is a councilor the Japanese Society of Toxicology and a director of the Japanese Society for Alternatives to Animal Experiments. For public policy, he was a past vice-chair of the Working Group of the National Coordinators for the Test Guidelines Programme and is also an expert of skin and eye irritation, skin sensitisation, validation management group of non-animal for endocrine disrupter in OECD. Until now, he has contributed to be approved more than 20 OECD Test Guidelines and Guidance documents regarding alternative to animal testings.

Abstract: For safety evaluation of a cosmetic ingredient requires the generation of data on acute oral toxicity without animal testing, we developed the step-by-step approach for assessing the applicability of acute oral toxicity for cosmetic ingredients a few years ago. This approach was challenged in the Weight of Evidence (WoE) assessments of acute oral toxicity using a combination of safety data, including a neutral red uptake cytotoxicity assay using BALB/c3T3 cells (3T3-NRU cytotoxicity assay) that can assess the acute oral toxicity for additives of quasi-drugs or cosmetic ingredients. However, this approach doesn't seem to be gaining traction for regulatory use. Therefore, we have developed case studies to expand that the step-by-step approach can be used to assess test substances that cause low acute oral toxicity within this applicability domain, such as the median lethal dose (LD50) > 2000 mg/kg based on our proposal, thereby avoiding animal testing.