Evaluation of the EYTEX system as a screening method for ocular tolerance: application to raw materials and finished products

By Courtellemont, P. - Hebert, P. - Redziniak, G.

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.