First-phase validation of the in vitro eye irritation tests for cosmetic ingredients

Twelve alternative methods to Draize eye irritation tests were preliminarily validated using 9 coded surfactants and physiological saline solution by 20 laboratories including a national institute, universities, kit suppliers, and cosmetics companies. The results indicated that intra- and interlaboratory variances were small as a whole except for the case of hemolysis by Tween 20; rank order of the cytotoxicity potentials of Triton X-100 among samples by cultured cell methods with serum differed greatly from those without serum; correlation coefficient between in vitro methods and in vivo Draize scores is higher than 0.8 in HET-CAM-trypan blue staining method, and cultured cell methods with serum and rank order correlation coefficients were higher than 0.9; correlation among cultured cell methods using serum was also high (r = 0.92-0.99).