Validation activities in Japan: A report

Abstract

Japanese activities in the validation of alternative test methods are reviewed. The validation of the Limulus endotoxin test as an alternative method to the rabbit pyrogen test was initiated by the Japanese Pharmacopoeia Society, and was successfully conducted under the direction of the National Institute of Health Sciences (NIHS), with the participation of many pharmaceutical company laboratories. The validation of in vitro alternatives to the Draize eye test for cosmetics were carried out by the NIHS and cosmetic company laboratories. Research on alternatives in Japan has been promoted by the Japanese Society of Alternatives to Animal Experiments (JSAAE) since 1989. Validation studies on alternatives were also attempted by the JSAAE. Interlaboratory reproducibility studies were carried out by the JSAAE on five different cytotoxicity tests. The JSAAE is planning the validation of in vitro alternatives to a local irritation test for intramuscular injection. Cell transformation assays have been carried out in Japan as adjuncts to the in vivo carcinogenicity test.