Evaluation of the EYTEX™ System as a Screening Method for Ocular Tolerance: Application to Raw Materials and Finished Products

Abstract

In vitro evaluation of ocular irritation requires the use of a battery of tests, for example cell culture assays and the HET-CAM test. In order to check the field applications of the different methods and their complementation, we have studied the EYTEX™ physicochemical model in an internal validation study.

In this study, we compared the EYTEX™ results with the in vitro ocular irritation potencies of 52 formulations and 49 chemicals. The in vivo/in vitro correlation was highly significant, p < 0.01%, K = 0.8 (Kappa method). On the other hand, the concordance, sensitivity and specificity of this method were, 85%, 89% and 83% respectively. The compatability of 98% obtained showed the kit to be applicable to cosmetic formulations.

The EYTEX™ system has also been evaluated during a comparative study of EYTEX™ human clinical tests, performed on 12 finished products; we have observed a concordance equal to 92%, indicating an excellent correlation between the two methodologies.

These results suggest that the EYTEX™ test could be a reliable in vitro prescreening system for determining the eye irritation potential of cosmetic formulations, and that it should be accepted as a component of our battery of alternative methods.

Keywords

ocular irritation alternative methods complementation EYTEX™human clinical test prescreening system

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