摘要
Objective This study aims to establish and evaluate the methodology of isolated rabbit eye （IRE） test. Methods IRE 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. Results IRE 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 X2=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 X^2=15.522, P〈0.O01; McNemar P=0.311; Gamma=0.967, P〈0.001; Kappa=0.611, P〈0.O01）. Conclusion IRE test was established successfully for in vitro testing of eye irritation as an alternative to Draize test.
Objective This study aims to establish and evaluate the methodology of isolated rabbit eye （IRE） test. Methods IRE 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. Results IRE 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 X2=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 X^2=15.522, P〈0.O01; McNemar P=0.311; Gamma=0.967, P〈0.001; Kappa=0.611, P〈0.O01）. Conclusion IRE test was established successfully for in vitro testing of eye irritation as an alternative to Draize test.
基金
supported by a grant from the Ministry of Health of the People's Republic of China for the Alternative to animals Testing project,200802080
