荧光素漏出试验检测化妆品眼刺激性的初步验证  

Primary validation of fluorescein leakage test on cosmetics ocular irritation assessment

作　　者：俞萍[1] 陆罗定[1] 杨明晶[1] 刘协[1] 奚清丽[1] 

机构地区：[1]江苏省疾病预防控制中心,南京210009

出　　处：《江苏预防医学》2013年第5期31-34,共4页Jiangsu Journal of Preventive Medicine

摘　　要：目的初步验证荧光素漏出试验(FLT)替代家兔眼刺激试验用于化妆品行政许可检验的可行性。方法用荧光素漏出试验对20份化妆品进行检测,以受试物处理后4h所引起荧光素漏出20%时受试物浓度(FL20H4)作为刺激分级标准,与《化妆品卫生规范》(2007年版)中家兔眼刺激试验分级标准进行相关性比较。结果 FLT能有效筛选出重度刺激物,FLT分级与规范要求做30s冲洗产品的家兔眼刺激试验分级有较好的一致性,两者间校正Spearman等级相关系数rs为0.694(P<0.05),Pearsonχ2值为16.343(P<0.01);对规范要求做4s冲洗的染发剂类产品,FLT法中仅20mg/mL FL20H4值与兔眼刺激试验结果有一定的相关性。结论荧光素漏出试验有望成为我国现行化妆品行政许可检验体外替代方法之一。Objective To validate the feasibility of fluorescein leakage test （FLT） as an alternative to rabbit ocular irritation test for administrative permission of cosmetics. Methods 20 cosmetic samples were tested by FLT. The FL20 H4 value （mg/ mL, concentration that results in 20% fluorescein leakage 4 hours after treatment） was used as stimulus grading standard to test ocular irritation of the sample. The results were compared with those from rabbit tests according to the Hygienic Standard for Cosmetics （2007） by Ministry of Health. Results Severe irritants could be idenfified efficiently by FLT. There was a good consistency between grading results of FLT and rabbit tests which require rinsing eyes 30s after exposure based on the national hygienic standard. The r＇s（corrected Spearman rank correlation coefficient） between FLT ranks and rabbit test ranks was 0. 694（P〈0.05） ,X2 = 16. 343（P〈0.01）. For the hair dye products requiring rinsing eyes 4s after exposure, only under concen tration of 20mg/mL, the results between the FL20 H4 and rabbit tests showed some consistency, r＇s=0. 866 （P〈0.05）. Con-clusion FLT could be one alternative test to rabbit ocular irritation test for administrative permission in China.

关 键 词：荧光素漏出试验 替代方法 化妆品 眼刺激试验 

分 类 号：R114[医药卫生—卫生毒理学]