摘要
采用体外培养的兔角膜上皮细胞30 s暴露中性红摄取(SIRC-NRU)试验评价了75个化妆品产品的眼刺激性,并与家兔眼刺激试验结果进行比较,以考察其替代整体动物试验评价化妆品眼刺激性的可行性,初步建立了本实验室用于化妆品产品眼刺激性的评价标准。家兔眼刺激试验结果表明,75个样品中,有10个样品具有轻、微眼刺激性,其余样品均无眼刺激性。SIRC-NRU试验结果表明,LC50>3%的共65个,其余10个受试样品的LC50<3%,样品的动物试验眼损伤积分与LC50的相关系数rs=-0.570 9,P<0.001;按照LC50≥3%为眼刺激阴性的分级标准,有65个样品被分级为无眼刺激性,10个样品被分级为眼刺激性阳性。如以动物试验结果为标准,SIRC-NRU试验对样品眼刺激性分级的灵敏度为83.3%,特异度为97.0%,准确度为94.7%,假阳性率为3.1%,假阴性率为20.0%。以上结论表明SIRC-NRU可以作为化妆品动物眼刺激试验的替代方法,对眼刺激性的分级标准可以采用LC50<3%为眼刺激性阳性,LC50≥3%为无眼刺激性。
We tested the eye irritation of 75 cosmetic products by the rabbit corneal epithelial cells （SIRC） overshort time exposure neutral red uptake （SIRC-NRU） test, and compared the results with that of in vivo Draize rabbit eye irritation test as well to evaluate the possibility of SIRC-NRU test as an alterative method to latter; and set the passing criterion for SIRC-NRU test. In the in vivo Draize rabbit eye irritation test, 10 out of 75 were evaluated as mild eye irritation, while the left 65 as non-irritation. In SIRC-NRU test, the number of samples with LC50 （50% lethal concentration） 〉 3% was 65, as the LC50 of the rest 10 samples were all 〈 3%. The correlation coefficient between LCso and irritation score was rs= -0.570 9 （P 〈 0.001）. Based on the criterion of LC50〉13% as eye irritation negative level, 10 was rated as positive, and 65 as non-irritation. The sensitivity, specificity, accuracy, false positive rate and false negative rate of this test was 83.3%, 97.0%, 94.7%, 3.1% and 20.0%, respectively. The results indicated that SIRC-NRU test can be used as an alterative method for evaluation of cosmetic eye irritation; and the sample may be rated as positive in eye irritation at LC50 〈 3%.
出处
《日用化学品科学》
CAS
2014年第4期25-31,共7页
Detergent & Cosmetics
