甲基异噻唑啉酮在健康人群和化妆品接触性皮炎患者中引起皮肤反应的限量研究

目的甲基异噻唑啉酮(MI)是一类常见的容易引发接触性皮炎的化妆品防腐剂。本研究旨在探讨MI在中国健康人群和化妆品接触性皮炎患者中引起皮肤不良反应的限量阈值。方法通过梯度稀释不同浓度的MI,在124例健康人群和98例化妆品接触性皮炎患者背部进行人体皮肤斑贴试验。结果0.2%、0.02%和0.01%MI在健康志愿者中皮肤反应发生率分别为5.65%,2.42%和1.61%,在化妆品接触性皮炎患者中分别为44.90%、37.76%和33.67%,发生率均显著高于0.001%MI和蒸馏水。MI在化妆品接触性皮炎患者中引起的强阳性皮肤反应率呈剂量依赖递增。结论我国现行法规中对MI的限量浓度0.01%MI较易引起皮肤不良反应,而0.001%MI的剂量在健康人群和化妆品接触性皮炎患者中均较为安全。由于MI易引发化妆品接触性皮炎的特性,在化妆品不良反应监管中需要更为关注。

Limited Concentration of Methylisothiazolinone on Skin Reactions in Healthy Individuals and Patients with Cosmetic Contact Dermatitis

Objective Methylisothiazolinone(MI)is a common cosmetic preservative which can easily cause contact dermatitis.The purpose of this study is to investigate the threshold of adverse skin reactions induced by MI in healthy people and patients with cosmetic contact dermatitis.Methods Totally 124 healthy volunteers and 98 patients with cosmetic contact dermatitis were recruited to conduct the human skin patch test on the subjects'backs by gradient dilution of different concentrations of MI.Results The incidence of adverse skin reactions of 0.2%,0.02%and 0.01%MI were 5.65%,2.42%and 1.61%respectively in healthy volunteers,and 44.90%,37.76%and 33.67%respectively in patients with cosmetic contact dermatitis,which were significantly higher than 0.001%MI and distilled water.The strong reaction of four concentrations of MI in patients with cosmetic contact dermatitis showed dose-dependent increase pattern.Conclusion The limited concentration of 0.01%MI in national current regulations is more likely to cause adverse skin reactions in resident cosmetics,while the dose of 0.001%MI is relatively safe.The development of MI contact dermatitis of cosmetics should be monitored closely.