Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method. (April 2018)

• Record Type: Journal Article
• Authors: Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi
• Is Part Of: Toxicology in vitro. Volume 48(2018)
• Page Start: 78
• Page End: 85
• Publication Date: 2018-04
• Subjects: BCOP Bovine Corneal Opacity and Permeability -- CAM chorioallantoic membrane -- CT calcium thioglycolate -- DMSO dimethyl sulfoxide -- DPBS Dulbecco's phosphate buffered saline -- EU European Union -- FL Fluorescein Leakage -- GHS Globally Harmonized System of Classification and Labelling of Chemicals -- HCE human corneal epithelium -- HCl hydrochloric acid -- ICE Isolated Chicken Eye -- MTT methylthiazolydiphenyl-tetrazolium bromide -- NC No Category -- NICEATM National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods -- OECD Organisation for Economic Co-operation and Development -- RhCE Reconstructed human Cornea-like Epithelium -- SIRC Statens Seruminstitut Rabbit Cornea -- SLS sodium lauryl sulfate -- STE Short Time Exposure -- TG test guideline -- TW80 Tween 80 -- UN United Nations; STE -- Eye irritation -- Alternative method -- Oil-soluble mixtures -- Personal care products -- Inter-laboratory reproducibility; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2017.12.018
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: The Short Time Exposure (STE) test method is an alternative method for assessing eye irritation potential using Statens Seruminstitut Rabbit Cornea cells and has been adopted as test guideline 491 by the Organisation for Economic Co-operation and Development. Its good predictive performance in identifying the Globally Harmonized System (GHS) No Category (NC) or Irritant Category has been demonstrated in evaluations of water-soluble substances, oil-soluble substances, and water-soluble mixtures. However, the predictive performance for oil-soluble mixtures was not evaluated. Twenty-four oil-soluble mixtures were evaluated using the STE test method. The GHS NC or Irritant Category of 22 oil-soluble mixtures were consistent with that of a Reconstructed human Cornea-like Epithelium (RhCE) test method. Inter-laboratory reproducibility was then confirmed using 20 water- and oil-soluble mixtures blind-coded. The concordance in GHS NC or Irritant Category among four laboratories was 90%–100%. In conclusion, the concordance in comparison with the results of RhCE test method using 24 oil-soluble mixtures and inter-laboratory reproducibility using 20 water- and oil-soluble mixtures blind-coded were good, indicating that the STE test method is a suitable alternative for predicting the eye irritation potential of both substances and mixtures. Highlights: The STE test method is an alternative for assessing eye irritation. The STE test method can classify GHS No Category and Irritant. Good concordance was obtained for oil-soluble mixtures with the GHS classification. Good inter-laboratory reproducibility was confirmed for several mixtures. The STE test method can be applied to several substances and mixtures.