Cosmetic Safety: Proposal for the Replacement of In Vivo (Draize) by In Vitro Test

The procedures described by Draize have been criticized for ethical reasons. Thus, a comparative study was performed between ocular and cutaneous irritation tests, using rabbits and in vitro test through agar diffusion with the use of NCTC clone 929, FPC-IAL and SIRC cell lines. The results obtained revealed that the agar diffusion test positive sam- ples, which presented up to degree 3 reactivity rate, according to USP 31, did not provoke ocular or cutaneous irritation. The samples which presented reactivity grade 4 also showed different degrees of ocular and cutaneous irritation, with the exception of two units of liquid soap for children use. According to the data, the diffusion agar method, using the Ameri- can Pharmacopeia graduation, can be adopted as a sorting procedure in the evaluation of cosmetics. This is a result of its capacity of predicting irritation, what largely contributes for a decrease in the use of animals in tests.