SAFETY ESTIMATION METHOD (ALTERNATIVE TO ANIMAL EXPERIMENT)

摘要

PROBLEM TO BE SOLVED: To provide a new safety guarantee system of a cosmetic independent of an animal experiment.;SOLUTION: A method of calculating a safety guarantee density of a target substance in a safety guarantee estimation system consisting of a skin primary irritation test, a single dose toxicity test, a skin sensitization test, an eye irritation test, an optical toxicity test, an optical sensitization test, a heredity toxicity test, a repeat dose toxicity test, a reproduction generation toxicity test, and an exposure test is configured to include (a) a step of estimating a safety of the target substance by an in vitro and/or an in silico test and predicting a compound upper limit density; (b) a step of selecting a similar substance from a plurality of toxicity information databases and predicting the safety of the target substance from safety information of the similar substance showing the strongest toxicity based on a category classification relating to a toxicity development mechanism of the target substance; and (c) a step of setting a safety guarantee density of the target substance lower than the compound upper limit density predicted by the step (a) when the safety by the step (b) is lower than the safety by the step (a).;COPYRIGHT: (C)2015,JPO&INPIT