应用细胞方法建立表面活性剂眼刺激性分层筛选模型

Establishment of a tiered screening model for testing eye irritation of surfactants by in vitro methods

目的建立表面活性剂眼刺激性测试的体外细胞方法分层筛选模型。方法应用中性红摄取试验(NRU)、红细胞溶血试验(RBCH)及荧光素漏出试验(FLT)3种体外细胞方法对20种表面活性剂的眼刺激性进行检测,将检测结果代入4种分层筛选模型(FLT+NRU、FLT+RBCH、RBCH+NRU、NRU+RBCH),所得到的分级结果与Draize试验结果进行比较(指标为Gamma系数、Mc Nemar-Bowker系数、Kappa系数和分级一致率),以此来评价4种分层筛选模型对表面活性剂的检测效能。结果本研究建立的4种分层筛选模型(FLT+NRU、FLT+RBCH、RBCH+NRU、NRU+RBCH)与Draize试验分级结果进行比较,分级一致率分别为90.0%、80.0%、80.0%、65.0%,Kappa值分别为0.84、0.68、0.69、0.47(均P<0.01),Gamma值分别为1.00、1.00、0.93、0.88(均P<0.01)。结论以FLT(第1层)和NRU(第2层)组成的分层筛选模型较其他3种模型具有较好的检测效能,更适合应用于对表面活性剂的眼刺激性检测。

Objective To establish a tiered screening model for testing eye irritation of surfac- tants. Methods Twenty surfactants were tested with FLT, RBCH, and NRU methods, then the test results were plugged into four screening models （ FLT ＋ NRU, FLT ＋ RBCH, RBCH ＋ NRU, NRU ＋ RBCH） and compared the grading results with those of Draize test （ based on the indices of Gamma coefficient, Mc- Nemar-Bowker coefficient, Kappa coefficient, and concordance rate）. Finally, the predictive abilities of the four tiered screening models for eye irritation of surfactants were evaluated. Results Compared with the results of Draise test, the concordance rates of grading results of four screening models （ FLT ＋ NRU, FLT ＋ RBCH, RBCH ＋ NRU, NRU ＋ RBCH） evaluated in this study were 90.0% , 80.0%, 80.0% , and 65.0% , respectively; the Kappa values were 0.84, 0.68, 0.69, and 0. 47, respectively （P 〈 0. 01 for all） ; the Gamma values were 1.00, 1.00, 0. 93, and 0.88, respectively （P 〈 0.01 for all）. Conclusion The tiered screen model composed of FLT test （1st stage） and NRU test （2nd stage） has better detection performance than the other 3 models and is more suitable for the eye irritation detection of the surfactants.