| Title: | Two-stage bottom-up tiered approach combining several alternatives for identification of eye irritation potential of chemicals including insoluble or volatile substances |
| Author(s): | Hayashi K; Mori T; Abo T; Ooshima K; Hayashi T; Komano T; Takahashi Y; Sakaguchi H; Takatsu A; Nishiyama N; |
| Address: | "Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi 321-3497, Japan. hayashi.kazuhiko@kao.co.jp" |
| DOI: | 10.1016/j.tiv.2012.06.008 |
| ISSN/ISBN: | 1879-3177 (Electronic) 0887-2333 (Linking) |
| Abstract: | "For the assessment of eye irritation, one alternative test may not completely replace the rabbit Draize test. In the present study, we examined the predictive potential of a tiered approach analyzing the results from several alternatives (i.e., the Short Time Exposure (STE) test, the EpiOcular assay, the Hen's Egg Test-Chorioallantoic Membrane (HET-CAM) assay and the Bovine Corneal Opacity and Permeability (BCOP) assay) for assessing Globally Harmonized System (GHS) eye irritation categories. Fifty-six chemicals including alcohols, surfactants, and esters were selected with a balanced GHS category and a wide range of chemical classes. From a standpoint of both assessable sample numbers and predictive accuracy, the more favorable tiered approach was considered to be the two-stage bottom-up tiered approach combining the STE test, the EpiOcular assay followed by the BCOP assay (accuracy 69.6%, under prediction rate 8.9%). Moreover, a more favorable predictive capacity (accuracy 71.4%, under prediction rate 3.6%) was obtained when high volatile alcohols/esters with vapor pressures >6 kilopascal (kPa) at 25 degrees C were evaluated with EpiOcular assay instead of the STE test. From these results, the two-stage bottom-up tiered approach combining the STE test, the EpiOcular assay followed by the BCOP assay might be a promising method for the classification of GHS eye irritation category (Not classified (NC), Category 2 (Cat. 2), and Category 1 (Cat. 1)) for a wide range of test chemicals regardless of solubility" |
| Keywords: | *Animal Testing Alternatives Animals Cattle Cell Line Cell Survival/drug effects Chorioallantoic Membrane/drug effects/pathology Cornea/drug effects/pathology Corneal Opacity/chemically induced/pathology Eye/*drug effects Irritants/classification/*toxicit; |
| Notes: | "MedlineHayashi, Kazuhiko Mori, Taeko Abo, Takayuki Ooshima, Kenichi Hayashi, Takumi Komano, Tomoko Takahashi, Yutaka Sakaguchi, Hitoshi Takatsu, Akihiko Nishiyama, Naohiro eng England 2012/06/30 Toxicol In Vitro. 2012 Oct; 26(7):1199-208. doi: 10.1016/j.tiv.2012.06.008. Epub 2012 Jun 26" |
