1.Prediction of ocular irritancy of 26 chemicals and 26 cosmetic products with isolated rabbit eye (IRE) test.
Xiang GUO ; Xing Fen YANG ; Ying YANG ; Raabe HANS ; Jing Heng CAI ; Jin Yu XUE ; Xiao Hua TAN ; Xiao Ping XIE ; Xi Kun XIONG ; Jun Ming HUANG
Biomedical and Environmental Sciences 2012;25(3):359-366
OBJECTIVEThis study aims to establish and evaluate the methodology of isolated rabbit eye (IRE) test.
METHODSIRE test was performed according to modifications of the in vitro toxicology (INVITTOX) Protocol No.85: Rabbit enucleated eye test by European Centre for the Validation of Alternative Methods (ECVAM), and then 26 chemicals and 26 cosmetic products were tested in both in vitro IRE and in vivo Draize tests. A statistical analysis was conducted to determine the relevance of the IRE test to the data generated in the Draize test.
RESULTSIRE test was established successfully in our laboratory. It was shown that ranking correlation and class concordance were fairly well between the IRE test and the Draize test for 26 reference chemicals (Fisher's Exact Test χ(2)=51.314, P<0.001; McNemar P=0.261; Gamma=0.960, P<0.001; Kappa=0.843, P<0.001) and 26 cosmetic products (Fisher's Exact Test χ(2)=15.522, P<0.001; McNemar P=0.311; Gamma=0.967, P<0.001; Kappa=0.611, P<0.001).
CONCLUSIONIRE test was established successfully for in vitro testing of eye irritation as an alternative to Draize test.
Animal Testing Alternatives ; Animals ; Cosmetics ; toxicity ; Eye ; drug effects ; Irritants ; toxicity ; Rabbits ; Toxicity Tests ; methods
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