五种化妆品的皮肤刺激性:平皿法鸡胚试验评价

Assessment of the skin irritation hazard of 5 cosmetics using the shell-less hen's egg test chorioallantoic membrane assay

背景:评价化妆品皮肤刺激性,传统多采用兔皮肤刺激实验,即将化学物涂抹在动物背部去毛的皮肤上,观察其变化,这些方法费时,费力,且给动物带来很大痛苦。各国实验室都在寻找动物替代实验的方法。目的:采用平皿法鸡胚试验方法作为替代方法评价化妆品引起人体皮肤不良反应潜在可能的可行性。设计、时间及地点:动物替代实验,于2008-03/05在中国检验检疫科学研究院毒理学实验室完成。材料:无特定病原体级受精鸡卵,购于北京梅里亚通实验动物技术有限公司。方法:将鸡胚置于平皿中,孵育第8天用于试验,记录出现出血,血管裂解及凝血的鸡胚数目,得出刺激因子X,以判断待测物质是否具有人体皮肤不良反应潜在可能。并与人体斑贴试验结果进行比较。主要观察指标:刺激因子X。结果:5种化妆品中2种有人体皮肤不良反应潜在可能,刺激因子X>5。与人体斑贴试验结果经校正χ2检验比较,差异无显著性意义,其灵敏度、特异度、阳性预测价值、阴性预测价值均为1。结论:平皿法鸡胚试验和人体斑贴试验的结果一致,该方法可以用来评价化妆品的皮肤刺激性。

BACKGROUND： Rabbit skin irritation assay has been used to predict the skin irritation hazard of cosmetics, limiting by time-consuming, strenuous, and causing great pain for animals. At present, studies based on alternative models to replace this assay are in development. OBJECTIVE： To use the shell-less hen＇s egg test chorioallantoic membrane （HET-CAM） as alternative methods to test the skin irritation hazard of some sunscreen cosmetics. DESIGN, TIME AND SETTING： A alternative experiment was performed at the Laboratory of Toxicology, Chinese Academy of Inspection and Quarantine from March to May 2008. MATERIALS： Hen＇ eggs of SPF grade were provided from Beijing Material Vital Laboratory Animal Technology Co., Ltd. METHODS： The eggs were placed into petri dish to record the number of blooding, vessel lysis and coagulation in order to get the irritation factor X which was used to judge if the cosmetics had the skin irritation potential. And the results were compared with the human patch test. MAIN OUTCOME MEASURES： Irritation factor X. RESULTS： Two cosmetics had the skin irritation potential, and the irritation factor X was 〉5. Chi-square test indicated that there was no significant difference compared to human patch test. While, the sensitivity, specificity, positive predictive value, and negative predictive value were 1. CONCLUSION： Shell-less HET-CAM can get the same conclusion with the human patch test, and it has the potential to be used as an alternative method to test the skin irritation hazard of cosmetics in future.