title: An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting eye irritation potential.
abstract: We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative eye irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative eye irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the eye irritation categories (irritants and nonirritants) were over 97% for each concentration tested, exhibiting high between-laboratory reproducibility. The correspondence rates for predicting eye irritation potential of undiluted raw materials and a diluted solution (10%) were over 85% at each laboratory for the 5% and 0.05% test concentrations in the STE. Lastly, the correspondence rate for the rank classification by the STE test prediction model at each laboratory was over 72%, and the correspondence rate became almost 90% when acids, amines, and alcohols were excluded from the analysis. From the above data, excellent transferability, high between-laboratory reproducibility, and high predictive capacity of the STE test were observed in the interlaboratory study by 2 laboratories.
authors.affiliation: Kao Corporation, Haga, Tochigi, Japan. takahashi.yutaka@kao.co.jp <takahashi.yutaka@kao.co.jp>
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Takumi
authors.initials: T
authors.lastname: Hayashi
authors.forename: Mirei
authors.initials: M
authors.lastname: Koike
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sakaguchi
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kuwahara
authors.forename: Naohiro
authors.initials: N
authors.lastname: Nishiyama
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D002460:Cell Line; D003315:Cornea / Q000473:pathology; D005128:Eye Diseases / Q000139:chemically induced* / Q000473:pathology; D007509:Irritants / Q000145:classification / Q000633:toxicity*; D011237:Predictive Value of Tests; D011817:Rabbits; D015203:Reproducibility of Results
chemical_list: D007509:Irritants