化妆品安全性评价中鸡胚绒毛膜尿囊膜试验应用研究

目的 建立确定适用我国国情的化学物质和化妆品安全性分级标准和适用范围。方法同时采用HET—CAM法和动物试验对32种化学物、187种不同种类化妆品进行检验，以4种不同分级标准对检验结果进行分析比较。结果四种分级标准中第三种分级标准（0～6无/微刺激性、6．1～12轻刺激性、12．1～16刺激性、16．1～21腐蚀性）与动物试验的分级标准具有较高的等级相关性及一致性，且面膜类和眼部护肤类产品的结果一致性为最好。结论HET—CAM试验的分级标准采用第三种标准比较合适。面膜类和眼部护肤类产品可用HET—CAM法完全替代动物试验而对于洗面奶类、染发类、烫发类和洗发类的产品，只适宜作为筛选试验。

Application of Hen's egg-chorioallantoic membrane assay in safety evaluation of cosmetics

Objective To establish suitable classification standards and application scope of hen＇s egg-chorioallantoic membrane assay（HET,CAM） corresponding with our condition. Methods HET-CAM and in vivo eye irritation test were carried out on 32 chemicals and 187 cosmetic products. Four different classification standards were applied for evaluation of eye irritation. In Vitro test compareing with in vivo test was analyzed with SPSS software. Results When a third classification standard was applied, which included four categories： non/we ak-irritant （0.0-6.0）, slightly irritant （ 6.1 - 12.0 ）, irritant （12.1-16.0） and corrosive potential （16.1-21.0）,a good concordance was observed between HET-CAM and in vivo test for all substances,especially for masque and eye care formulations. Conclusion The third standard is more suitable for safety evaluation of cosmetics. For masque and eye care products,HET-CAM can be used as an alternative method for animal test. For cleansing foam, hair-dye, hair-curling and shampoos formulations, HET-CAM can only be used for screening.