Horita Kotomi, Horita Daisuke, Tomita Hiroyuki, Yasoshima Mitsue, Yagami Akiko, Matsunaga Kayoko
Research Laboratory, Ikedamohando Co., Ltd., Jinden, Kamiichi-machi, Nakaniikawa, Toyama 930-0394, Japan.
Research Laboratory, Ikedamohando Co., Ltd., Jinden, Kamiichi-machi, Nakaniikawa, Toyama 930-0394, Japan.
Toxicology. 2017 May 1;382:10-15. doi: 10.1016/j.tox.2017.03.003. Epub 2017 Mar 6.
Animal testing for cosmetics was banned in the European Union (EU) in 2013; therefore, human tests to predict and ensure skin safety such as the patch test or usage test are now in demand in Japan as well as in the EU. In order to investigate the effects of different bases on the findings of tests to predict skin irritation, we performed patch testing (PT) and the repeated application test (RAT) using sodium lauryl sulfate (SLS), a well-known irritant, dissolved in 6 different base agents to examine the effects of these bases on skin irritation by SLS. The bases for PT were distilled water, 50% ethanol, 100% ethanol, a gel containing 50% ethanol, white petrolatum, and hydrophilic cream. The concentrations of SLS were 0.2% and 0.5%. Twelve different base combinations were applied to the normal back skin of 19 individuals for 24h. RAT was performed with distilled water, 50% ethanol, 100% ethanol, a gel containing 50% ethanol, white petrolatum, and hydrophilic cream containing SLS at concentrations of 0.2%, 2%, and 5%, being applied to the arms of the same PT subjects. The test preparation of each base was applied at the same site, with 0.2% SLS being used in the first week, 2% SLS in the following week, and 5% SLS in the final week. The results of PT revealed that skin irritation scores varied when SLS at the same concentration was dissolved in a different base. The results of RAT showed that although skin irritation appeared with every base at a concentration of 5%, the positive rate was approximately the same. In conclusion, our results suggest that skin irritation elicited in PT depends on the base, while in RAT, it does not depend on the type of base employed.
2013年，欧盟（EU）禁止了化妆品的动物试验；因此，如今在日本和欧盟，像斑贴试验或使用试验这样用于预测和确保皮肤安全性的人体试验都很有必要。为了研究不同基质对预测皮肤刺激性试验结果的影响，我们使用十二烷基硫酸钠（SLS，一种知名的刺激物）进行了斑贴试验（PT）和重复涂抹试验（RAT），将其溶解在6种不同的基质中，以检验这些基质对SLS引起的皮肤刺激的影响。PT的基质为蒸馏水、50%乙醇、100%乙醇、含50%乙醇的凝胶、白凡士林和亲水性乳膏。SLS的浓度为0.2%和0.5%。将12种不同的基质组合涂抹于19名个体的正常背部皮肤24小时。RAT是将含有浓度为0.2%、2%和5% SLS的蒸馏水、50%乙醇、100%乙醇、含50%乙醇的凝胶、白凡士林和亲水性乳膏涂抹于相同PT受试者的手臂上进行的。每种基质的试验制剂都涂抹在同一部位，第一周使用0.2%的SLS，第二周使用2%的SLS，最后一周使用5%的SLS。PT结果显示，相同浓度的SLS溶解在不同基质中时，皮肤刺激评分有所不同。RAT结果表明，虽然每种基质在浓度为5%时都会出现皮肤刺激，但阳性率大致相同。总之，我们的结果表明，PT中引发的皮肤刺激取决于基质，而在RAT中，它不取决于所用基质的类型。
