Validation study of the Short Time Exposure (STE) test to assess the eye irritation potential of chemicals

By Hitoshi Sakaguchi - Naoko Ota - Takashi Omori - Hirofumi Kuwahara - Takashi Sozu - Yumi Takagi - Yutaka Takahashi - Kouko Tanigawa - Miki Nakanishi - Tsuneaki Nakamura - Takashi Morimoto - Shinobu Wakuri - Yuko Okamoto - Mayumi Sakaguchi - Takumi Hayashi - Takayuki Hanji - Shinichi Watanabe

Short Time Exposure (STE) test is a cytotoxicity test in SIRC cells (rabbit corneal cell line) that assesses eye irritation potential following a 5-min chemical exposure. This validation study assessed transferability, intra- and inter-laboratory reproducibility, and predictive capacity of STE test in five laboratories (supported by Japanese Society for Alternatives to Animal Experiments). Sodium lauryl sulfate, calcium thioglycolate, and Tween 80 were evaluated, in triplicate, using 5%, 0.5%, and 0.05% concentrations in physiological saline, to confirm transferability. Good transferability was noted when similar mean relative viabilities and rank classifications were obtained in all five laboratories and were comparable to data from test method developing laboratory. Good intra- and inter-laboratory reproducibility was obtained with four assay controls (three solvents and one positive control), and four assay controls and 25 chemicals, respectively. STE irritation category based on relative viability of a 5% solution of 25 blinded test chemicals showed good correlation with Globally Harmonized System (GHS) categories (NI; I: Cat. 1 and 2). The STE prediction model, using relative viability of the 5% and 0.05% solutions, provided an irritation rank (1, 2, or 3) that had a good correlation (above 80%), or predictive capacity, with GHS irritation ranks in all laboratories. Based on these findings, the STE test is a promising alternative eye irritation test that could be easily standardized.