Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8554012 | Toxicology in Vitro | 2018 | 8 Pages |
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.
Keywords
HClDPBSHCENICEATMBCOPGHSDMSOMTTEuropean Unionhydrochloric acidHuman corneal epitheliumBovine Corneal Opacity and PermeabilityDimethyl sulfoxideCAMGlobally harmonized system of classification and labelling of chemicalschorioallantoic membraneDulbecco's phosphate buffered salineFluorescein leakageisolated chicken eyeIce
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Authors
Takayuki Abo, Allison Hilberer, Christine Behle-Wagner, Mika Watanabe, David Cameron, Annette Kirst, Yuko Nukada, Takuo Yuki, Daisuke Araki, Hitoshi Sakaguchi, Hiroshi Itagaki,