Doucet, O., M. Lanvin, and L. Zastrow. A New In Vitro Human Epithelial Model for Assessing the Eye Irritating Potential of Formulated Cosmetic Products. In Vitro & Molecular Toxicol. 1998. 11(4): 273-283.

This study investigated the potential of a new in vitro model to assess eye irritation. Three-dimensional human reconstituted epithelial cultures (REC), grown from a squamous cell carcinoma line (TR146), were used to quantify the irritating potential of cosmetic formulations. A mean cytotoxicity index (MCI), reflecting the time course of toxicity for products applied to the cultures, was used as an endpoint to quantify irritation. Forty cosmetic formulated products were tested in both the in vitro cytotoxicity test and the traditional Draize test. The MCI obtained with this new model correlated (p < 0.001, Rp =0.89) with a Draize modified maximum average score (MMAS). Across product categories tested, a simple linear correlation was found. In addition, it was possible to correctly identify 100% of the cosmetic test products into two classes: irritant or nonirritant by setting appropriate in vitro cut-off values. Despite the different types of formulae tested, high sensitivity, high specificity, and high concordance values were obtained using this in vitro model. Its performance assessed through a Kappa test gave a value of K=1.00. These preliminary results indicate the promise of this new three-dimensional human epithelial model for the in vitro assessment of eye irritation.