title: Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification.
abstract: Short time exposure (STE) test using rabbit corneal cell line (SIRC) cells was developed as an alternative eye irritation test. STE test uses relative viability as the endpoint after cells are exposed to the test material at constant concentrations for 5 min. In this inter-laboratory study with 3 laboratories, 44 chemicals with a wide range of classes were evaluated for the transferability, between-lab reproducibility and predictive capacity of the STE test as an alternative eye irritation test. Globally harmonized system (GHS) classification based on Draize eye irritation test data was used as the comparative in vivo data. Transferability was assessed using standard chemicals (sodium lauryl sulfate, calcium thioglycolate, and Tween 80) and the coefficient variations (CVs) of relative viabilities between 3 labs were less than 0.13. The irritation category (Irritant or Non irritant) at each test concentration (5% and 0.05%) in STE test was the same in 3 laboratories for all 44 tested chemicals. The predictive capacity irritation category classification between STE test and GHS were compared, and a good correlation was confirmed (accuracy was 90.9% at all laboratories). In addition, the STE rankings of 1, 2, and 3 classified by the prediction model (PM) based on the relative viability at two concentrations (5% and 0.05%) were highly correlated with the GHS ranks of non-irritant, category 1, and category 2, respectively (accuracy was 75.0% at all laboratories). These results suggest that the STE test possessed easy transferability, reproducibility, good predictive performance.
authors: Safety Science Research Laboratories, Kao Corporation, Tochigi, Japan. takahashi.yutaka@kao.co.jp
authors: Yutaka
authors: Y
authors: Takahashi
authors: Takumi
authors: T
authors: Hayashi
authors: Shinichi
authors: S
authors: Watanabe
authors: Kazuhiko
authors: K
authors: Hayashi
authors: Mirei
authors: M
authors: Koike
authors: Noriko
authors: N
authors: Aisawa
authors: Shinya
authors: S
authors: Ebata
authors: Hitoshi
authors: H
authors: Sakaguchi
authors: Tsuneaki
authors: T
authors: Nakamura
authors: Hirofumi
authors: H
authors: Kuwahara
authors: Naohiro
authors: N
authors: Nishiyama
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D002460:Cell Line; D002470:Cell Survival / Q000187:drug effects; D003315:Cornea / Q000166:cytology* / Q000187:drug effects*; D007509:Irritants / Q000633:toxicity*; D007753:Laboratories; D011237:Predictive Value of Tests; D011817:Rabbits; D015203:Reproducibility of Results; D023382:Toxicity Tests, Acute / Q000379:methods*
chemical_list: D007509:Irritants