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目的:建立BALB/c-3T3中性红摄取细胞毒性试验并初步探讨其在化妆品原料皮肤刺激毒性评价中的适用性。方法:运用22种已知皮肤刺激性的化妆品原料进行BALB/c-3T3中性红摄取细胞毒性试验,根据判断标准划分皮肤刺激性等级,并与体内试验结果进行比较,分析3T3-中性红摄取细胞毒性实验的预测能力和重现性。结果:3T3-NRU细胞毒性试验与动物实验结果比较呈现较好的等级相关性及分级一致性;三次重复试验分析结果显示体外试验结果间的差别无统计学意义(χ2=0.245,P=0.984),Spearman等级相关系数rs=0.914,P<0.001;说明3T3-NRU细胞毒性试验具有良好的可重复性和稳定性。结论:与Draize试验比较,3T3-NRU试验对参照化学物质具有较好的预测能力和重复性,作为皮肤刺激性化妆品原料评价的筛选方法可进行进一步研究。
OBJECTIVE: To establish a BALB / c-3T3 neutral red cytotoxicity test and to investigate its applicability in the skin irritation of cosmetic raw materials. Methods: Cytotoxicity test of BALB / c-3T3 neutral erythrocytes was conducted by using 22 kinds of known skin-irritating cosmetic raw materials. The skin irritation grade was divided according to the judgment criteria and compared with the in vivo test results. The 3T3-neutral red Predictability and reproducibility of uptake cytotoxicity experiments. Results: The cytotoxicity of 3T3-NRU showed better rank correlation and grading consistency than that of animal experiment. The results of three replicates showed no significant difference between in vitro test results (χ2 = 0.245, P = 0.984) , Spearman rank correlation coefficient rs = 0.914, P <0.001; 3T3-NRU cytotoxicity test with good repeatability and stability. Conclusion: Compared with the Draize test, the 3T3-NRU test has good predictive ability and repeatability for the reference chemical substances and can be further studied as a screening method for the evaluation of skin irritation cosmetic materials.