title: Validation study of the Short Time Exposure (STE) test to assess the eye irritation potential of chemicals.
abstract: 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.
authors.affiliation: Kao Corporation, Safety Science Research Laboratories, 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi 321-3497, Japan. sakaguchi.hitoshi@kao.co.jp
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sakaguchi
authors.forename: Naoko
authors.initials: N
authors.lastname: Ota
authors.forename: Takashi
authors.initials: T
authors.lastname: Omori
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kuwahara
authors.forename: Takashi
authors.initials: T
authors.lastname: Sozu
authors.forename: Yumi
authors.initials: Y
authors.lastname: Takagi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Kouko
authors.initials: K
authors.lastname: Tanigawa
authors.forename: Miki
authors.initials: M
authors.lastname: Nakanishi
authors.forename: Tsuneaki
authors.initials: T
authors.lastname: Nakamura
authors.forename: Takashi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Shinobu
authors.initials: S
authors.lastname: Wakuri
authors.forename: Yuko
authors.initials: Y
authors.lastname: Okamoto
authors.forename: Mayumi
authors.initials: M
authors.lastname: Sakaguchi
authors.forename: Takumi
authors.initials: T
authors.lastname: Hayashi
authors.forename: Takayuki
authors.initials: T
authors.lastname: Hanji
authors.forename: Shinichi
authors.initials: S
authors.lastname: Watanabe
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D002460:Cell Line; D003315:Cornea / Q000187:drug effects*; D011136:Polysorbates / Q000633:toxicity; D011817:Rabbits; D015203:Reproducibility of Results; D012967:Sodium Dodecyl Sulfate / Q000633:toxicity; D013864:Thioglycolates / Q000633:toxicity; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D011136:Polysorbates; D013864:Thioglycolates; D012967:Sodium Dodecyl Sulfate; C017487:2-mercaptoacetate