鸡胚绒毛尿囊膜试验用于化妆品的体外眼刺激性评价

Hen's egg chorioallantoic membrane in vitro test for evaluating eye irritation of cosmetic products

采用鸡胚绒毛尿囊膜(HET-CAM)试验评价了66种不同品类化妆品筛选配方或终配方产品的眼刺激性,并与家兔眼刺激试验结果比较,考察HET-CAM试验的可靠性,并建立本实验室该方法的化妆品产品眼刺激性评价标准。家兔眼刺激试验结果表明,66个样品中有6个样品具有微刺激性,4个样品为轻刺激性,其余样品均无眼刺激性。按照国家质量监督检验检疫总局的行业标准分级,HET-CAM法共有38个样品为眼刺激阳性,假阳性率50.0%,假阴性率为0,灵敏度为100%,特异度为66.7%,如果采用≤4分为眼刺激阴性,>4分为眼刺激阳性的评价标准,则66个样品中有29个样品为眼刺激阳性,37个样品为眼刺激阴性,灵敏度为100%,特异度提高至74.7%,假阴性率为0,假阳性率降低至33.9%。结果显示,HET-CAM试验用于化妆品产品的体外眼刺激性评价时,可采用刺激积分≤4分为无眼刺激,>4分为眼刺激性阳性的判断标准。

Eye irritation of 66 cosmetic product samples were evaluated by hen＇ s egg chorioallantoic membrane （HET-CAM） test, an alternative method of in vivo Draize rabbit test. Furthermore, the reliability of HET-CAM test was examined and the criterion for the HET-CAM test was set up in the laboratory in this paper. The results of Draize rabbit test indicated that 10 of 66 samples were irritant to eye, but HET-CAM test＇ s results showed that 38 of 66 samples were positive with eye irritation according to the industry standard of ＂Cosmetics ocular irritant and corrosive HET-CAM test＂ issued by General Administration of Quality Supervision, Inspection and Quarantine of the People＇s Republic of China. Therefore, of HET-CAM test, the false negative rate was 0, false positive rate was 50 %, sensitivity was 100 % and the specificity was 66.7 %. As the grading standard was modified and the irritation score 〉 4 of the samples was classified as positive with eye irritation, the false negative rate, false positive rate, sensitivity and specificity of HET-CAM test were 0, 33.9 %, 100 % and 74.7 %, respectively. The results of this study suggested that HET-CAM test could be used to assess the eye irritation of cosmetic products; and the sample will be classified as positive with eye irritation when the irritation score is more than 4.