化妆品原料眼刺激性替代方法分层筛选模型的建立

发布时间：2019-01-11 14:03

【摘要】：目的建立化妆品原料眼刺激性的体外替代方法分层筛选模型。方法应用鸡胚绒毛膜尿囊膜试验(HET-CAM)、鸡胚绒毛膜尿囊膜-台盼蓝染色试验(CAM-TBS)、中性红摄取试验(NRU)、红细胞溶血试验(RBCH)、荧光素漏出试验(FLT)及离体兔眼试验(IRET)6种体外替代方法对30种化妆品原料的眼刺激性进行检测,将检测结果与Draize试验结果进行比对(指标为灵敏度、特异度和ROC曲线下面积),根据6种替代方法分别在区分有无刺激性、有无腐蚀性两个级别的效能设计、建立分层筛选模型,并对模型进行评价。结果 6种方法区分有无刺激性的效能为NRUHET-CAMIRETCAM-TBSRBCH,区分有无腐蚀性的效能为IRETFLTRBCHNRUHET-CAMCAM-TBS。本研究建立并评价的4种模型中,以NRU(第一层)和FLT(第二层)组成的分层筛选模型具有最好的检测效能[Mc Nemar-Bowker检验,W=3.0(P=0.392),Gamma=0.85(P0.001),Kappa=0.76(P0.001),分级一致率为83.3%]。结论鉴于由NRU和FLT组成的分层筛选模型与Draize试验分级结果比较具有很高的相关性和分级一致性,检测效能明显优于单一替代方法,因此更适合检测化妆品原料的眼刺激性。
[Abstract]:Objective to establish a stratified screening model for the irritation of cosmetic raw materials in vitro. Methods Chorioallantoic membrane test (HET-CAM), chicken embryo chorioallantoic membrane trypan blue staining (CAM-TBS) and neutral red uptake test (NRU), erythrocyte hemolysis test (RBCH),) were used. Fluorescein leakage test (FLT) and rabbit eye test in vitro (IRET) were used to detect the eye irritation of 30 cosmetic materials. The results were compared with the results of Draize test (sensitivity, sensitivity). Specificity and area under the ROC curve), according to the six alternative methods, the effectiveness design of the two levels of irritation and corrosiveness was distinguished, and a hierarchical screening model was established and evaluated. Results the effectiveness of the six methods for distinguishing irritation from irritation was that of NRUHET-CAMIRETCAM-TBSRBCH, and that of causticity was IRETFLTRBCHNRUHET-CAMCAM-TBS.. Among the four models established and evaluated in this study, the hierarchical screening model composed of NRU (first layer) and FLT (second layer) has the best detection efficiency [Mc Nemar-Bowker test, W3. 0 (P0. 392), Gamma=0.85 (P0. 001)]. Kappa=0.76 (P0. 001), the grading consistency rate was 83. 3%. Conclusion because the stratified screening model composed of NRU and FLT has a high correlation and consistency with the result of Draize test classification, and the detection efficiency is obviously superior to the single alternative method, it is more suitable for the detection of eye irritation of cosmetic raw materials.
【作者单位】：中山大学公共卫生学院;广东省疾病预防控制中心;深圳市职业病防治院;浙江省象山县疾病预防控制中心;东莞市疾病预防控制中心;
【分类号】：R965

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