Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (11) EYTEX (TM)

EYTEXTM is an in vitro test system for predicting the ocular irritation pot ential of chemicals and formulations. This method was evaluated as an alter native method to the Draize eye irritation test (Draize test) for the eye i rritation potential of several cosmetic ingredients in a three-phase valida tion study conducted at five to seven laboratories. Thirty-nine test substa nces were used as coded samples. The test procedures were controlled under the same standard operating procedure (SOP) at all participating laboratori es. The interlaboratory coefficient of variation (CV) was 20.8%. The correl ation coefficient between EYTEX scores and the maximal average Draize total score (MAS) was 0.313. Irritancy classifications were established based on the results of 54 EYTEX tests and the EYTEX/Draize equivalent was calculat ed. Thirty-eight EYTEX test results concurred with the results of the Draiz e test, substantial equivalence was 70.4%. These results indicate that EYTE X provides a rough method of classification rather than providing absolute values. The present results also indicate that EYTEX has the following char acteristics: (1) intensely coloured substance may not be compatible; (2) so me cationic surfactants may be underestimated; (3) EYTEX can be applied to most test substances under the same conditions as the in vivo tests. (C) 19 99 Elsevier Science Ltd. All rights reserved.