化妆品及原料眼刺激性STE法评价  

Assessment on eye irritation of cosmetics raw materials and products with short time exposure in vitro test

作　　者：石莹[1] 阮鸿洁[1] 张宏伟[1] 王超[1] 宋瑞霞[1] SHI Ying;RUAN Hong-jie;ZHANG Hong-wei(Institute of Environmental Health and Related Product Safety,Chinese Center for Disease Control and Prevention,Beijing 100021,China)

机构地区：[1]中国疾病预防控制中心环境与健康相关产品安全所环境毒理室,北京100021

出　　处：《中国公共卫生》2020年第5期745-748,共4页Chinese Journal of Public Health

摘　　要：目的探讨兔角膜上皮细胞体外短时暴露试验方法(STE)用于化妆品原料及化妆品产品动物眼刺激试验替代的可行性及其适用范围。方法选择经济合作与发展组织(OECD)数据库中能涵盖无刺激性到重度眼刺激性的18种代表性化学物质以及20种市售化妆品产品,同时进行STE试验和兔眼刺激试验,通过Kappa分析比较2种试验方法结果的一致性。结果对于化妆品原料,经Kappa一致性检验,k=0.826,2种试验结果几乎完全一致(0.81~1.00)。对于化妆品产品,经Kappa一致性检验,k=0.370,2种方法分级结果一致性一般(0.21~0.40)。对于清洁类产品,经Kappa一致性检验,k=–0.333,2种方法分级结果一致性极低(<0.20),对于护肤类产品,k=0.796,2种方法的分级结果有高度的一致性(0.61~0.80)。结论STE试验适合于预测化妆品原料眼刺激性的分级标识。对于化妆品产品来说,面膜、眼霜和护发素等护肤类产品,预测效果好;清洁类产品和染发剂,假阳性率高,不太适用。Objective To explore the feasibility and application of the rabbit corneal epithelial cell line(SIRC)cell shortterm exposure test(STE test)for the replacement of eye-stimulation test(Draize test)for cosmetic raw materials and products.Methods We selected 18 representative chemical substances with various degree of eye irritation(ranging from not observed to severe irritation)from the database of Organization for Economic Co-operation and Development(OECD)and sampled 20 commercially available cosmetic products.SIRC STE test and Draize test were carried out on those substances and samples and consistencies between the results of the two tests were analyzed.Results For the samples of cosmetic raw materials,the Kappa coefficient was 0.826,indicating that the classification results of the two methods are almost perfect(0.81–1.00).For the samples of cosmetic products,the Kappa coefficient is 0.370,indicating that the results of the two methods are fair(0.21–0.4).For samples of cleaning products,the Kappa coefficient is–0.333,indicating that the consistency of the two methods is slight(<0.20).For samples of skin care products,the Kappa coefficient is 0.796(0.61–0.8),indicating that the consistency of the two methods is substantial.Conclusion SIRC STE test is suitable for the classification of eye irritation for cosmetic raw materials;for cosmetic products,SIRC STE test has good predictive results for skin care products such as masks,eye creams and conditioners.However SIRC STE test is not suitable for cleaning products and hair dyes due to a high false positive rate.

关 键 词：眼刺激性 兔角膜上皮细胞 体外短时暴露试验 兔眼刺激试验 

分 类 号：R99[医药卫生—毒理学]