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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 stratified screening model of in vitro cell method for the surfactant irritation test. Methods The eye irritation of 20 kinds of surfactants was detected by three kinds of in vitro cell methods, NRU, RBCH and FLT. The test results were substituted into 4 fractions (FLT + NRU, FLT + RBCH, RBCH + NRU, NRU + RBCH). The graded results were compared with those of the Draize test (the indicators were Gamma coefficient, McNemar-Bowker coefficient, Kappa coefficient and grading agreement rate ), In order to evaluate the effectiveness of the four stratification screening models for surfactant detection. Results The four stratified screening models (FLT + NRU, FLT + RBCH, RBCH + NRU, NRU + RBCH) established in this study were compared with the Draize test grading results. The agreement rates were 90.0%, 80.0%, 80.0% 65.0%, Kappa values were 0.84,0.68,0.69,0.47 (all P <0.01), Gamma values were 1.00,1.00,0.93,0.88 (all P <0.01). Conclusion The hierarchical screening model composed of FLT (layer 1) and NRU (layer 2) has better detection performance than the other three models and is more suitable for the detection of eye irritation of surfactants.