Abstract：
In recent years, mild baby cleansers have experienced ever-growing demand from caregivers. In the meantime, formulation developers are in practical need for a method(s) to screen mild formulations. In the present study, we aim to repurpose the HET-CAM and SkinEthic™ models to further classify in vivo nonirritant baby cleansing formulations into mild and less mild categories. Both methods were modified to best describe the samples\' irritation potential. The results showed that both models successfully classified the formulations into mild and less mild categories according to our customized criteria. For the HET-CAM, the medians of mean irritation scores (IS) were 3.0 for mild formulations (with 0 ≤ mean IS ≤4.5), and 5.0 for less mild formulations (with mean IS values all equaled 5), respectively. And for the SkinEthic™ model, the median relative viabilities were 69.46% for less mild formulations (with 46.80% ≤ mean relative viability ≤84.76%), and 99.96% for mild formulations (with 90.57% ≤ mean relative viability ≤124.58%). Thirty out of 35 formulations were predicted consistently between the HET-CAM and SkinEthic™ model. Statistical analysis of the agreement between predictions made by the two models demonstrated substantial agreement with a Cohen\'s kappa coefficient of 0.713 (P < 0.001). We conclude that the HET-CAM and SkinEthic™ models are promising in vitro alternatives for screening mild formulations.
摘要：
近年来,温和的婴儿清洁剂经历了照顾者不断增长的需求。同时,制剂开发者实际上需要一种或多种方法来筛选温和的制剂。在本研究中,我们的目标是重新调整HET-CAM和SkinEthic™模型，以进一步将体内无刺激性婴儿清洁配方分为温和和较不温和的类别。对两种方法进行了修改，以最好地描述样品的刺激潜力。结果显示,根据我们的定制标准,两种模型都成功地将制剂分类为温和和较不温和的类别。对于HET-CAM，温和制剂的平均刺激评分（IS）的中位数为3.0（0≤平均IS≤4.5），和5.0对于不太温和的配方(平均IS值均等于5)，分别。对于SkinEthic™模型，较温和的制剂的中位数相对活力为69.46%(46.80%≤平均相对活力≤84.76%)，轻度制剂为99.96%（90.57%≤平均相对生存力≤124.58%）。在HET-CAM和SkinEthic™模型之间一致地预测了35种制剂中的30种。通过两个模型进行的预测之间的一致性的统计分析表明，Cohen的kappa系数为0.713（P<0.001）。我们得出的结论是，HET-CAM和SkinEthic™模型是筛选温和制剂的有希望的体外替代品。
