NEW EPIDERMAL MODEL FOR DERMAL IRRITANCY TESTING
NEW EPIDERMAL MODEL FOR DERMAL IRRITANCY TESTING
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DOI：
10.1016/0887-2333(94)90095-7
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发表时间：
1994-08-01
影响因子：
3.2
通讯作者：
KLAUSNER, M
中科院分区：
文献类型：
--
作者：
CANNON, CL;NEAL, PJ;KLAUSNER, M
使用一系列阴离子和非离子表面活性剂和含表面活性剂的最终制剂对人表皮（EpiDerm）的新模型进行了实验室间比较。使用浓度（EC（50））和时间（ET（50））方案，通过MTT转化来估计材料的毒性。在MatTek和两个独立的检测实验室（美国微生物协会（MA）和英国苏格兰）储存1天和2天（运输后）后，对不同生产批次的EpiDerm进行了一系列16种化合物的检测。比较EC（50）和ET（50）值，并计算最小二乘拟合线和所得相关系数（r）。体外结果与人体临床腔室刺激和重复洗手试验的相关性得出r值范围为0.977 - 0.993，独立实验室与生产地点所得结果的比较良好（MA，USA，r = 0.84; MA，UK，r = 0.74）。该模型似乎可用于预测临床观察到的体外皮肤刺激，在不同实验室和跨大西洋运输后可重现，因此值得进一步研究。
An interlaboratory comparison of a new model of the human epidermis (EpiDerm) was conducted using a range of anionic and non-ionic surfactants and surfactant-containing final formulations. The toxicity of the materials was estimated by MTT conversion, using both concentration (EC(50)) and time (ET(50)) protocols. A range of 16 compounds was tested on different production lots of EpiDerm following storage periods of 1 and 2 days (after shipping) at MatTek and at two independent testing laboratories, Microbiological Associates (MA), USA and Scotland, UK. The EC(50) and ET(50) values were compared and the least squares fit lines with resulting correlation coefficients (r) calculated. Correlation of in vitro results to human clinical chamber irritation and repeat handwash testing gave r values ranging from 0.977 to 0.993 and comparison of the results obtained in the independent laboratories with the site of manufacture was good (MA, USA, r = 0.84; MA, UK, r = 0.74). The model appears to have utility in predicting clinically observed dermal irritation in vitro which is reproducible in different laboratories and after transatlantic shipping, such that it is worthy of further investigation.