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J Toxicol Sci

Title:		Expansion of the applicability domain for highly volatile substances on the Short Time Exposure test method and the predictive performance in assessing eye irritation potential
Author(s):		Abo T; Yuki T; Xu R; Araki D; Takahashi Y; Sakaguchi H; Itagaki H;
Address:		"Kao Corporation, Safety Science Research Laboratories. Faculty of Engineering, Department of Materials Science and Engineering, Yokohama National University"
Journal Title:		J Toxicol Sci
Year:		2018
Volume:		43
Issue:		7
Page Number:		407 - 422
DOI:		10.2131/jts.43.407
ISSN/ISBN:		1880-3989 (Electronic) 0388-1350 (Linking)
Abstract:		"The Short Time Exposure (STE) test method is an in vitro method for assessing the eye irritation potential of chemicals and is used to classify the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Category 1 and No Category (NC). The method has been adopted by the Organisation for Economic Co-operation and Development (OECD) as test guideline (TG) 491 since 2015. While this method can be used to classify GHS NC, it is not suitable for testing highly volatile substances and solids other than surfactants. Here we evaluated highly volatile substances to expand the applicability domain. According to TG 491, acetone, ethanol, iso-propanol, and methyl acetate as highly volatile substances resulted in false negatives. Saline was selected as a solvent of these false negatives. In this study, mineral oil was used as the solvent, because these false negatives were amphiphilic. Based on this change, four highly volatile substances were correctly evaluated. The predictive performance for classifying GHS NC was then verified using a substance dataset constructed in reference to the Draize eye test Reference Database and STE Summary Review Document. The accuracy and false-negative rate were 86.6% (194/224) and 3.8% (3/80), respectively. Collectively, the applicability domain was expanded by changing the solvent to mineral oil for highly volatile substances, and the predictive performance for the new applicability domain including highly volatile substances was excellent. The STE test method is suitable to classify GHS NC, indicating its applicability as a test method in a bottom-up approach"
Keywords:		"2-Propanol/toxicity Acetates/toxicity Acetone/toxicity Animal Testing Alternatives/*methods Animals Cell Survival/*drug effects Cells, Cultured Cornea/cytology/*drug effects Ethanol/toxicity False Negative Reactions Irritants/*toxicity Mineral Oil Rabbits;"
Notes:		"MedlineAbo, Takayuki Yuki, Takuo Xu, Rui Araki, Daisuke Takahashi, Yutaka Sakaguchi, Hitoshi Itagaki, Hiroshi eng Japan 2018/07/06 J Toxicol Sci. 2018; 43(7):407-422. doi: 10.2131/jts.43.407"