欧洲法规规定的 12 种非混合香料物质的斑贴试验浓度（mg/cm2 剂量）。
Patch test concentrations (doses in mg/cm2 ) for the 12 non-mix fragrance substances regulated by European legislation.
机构信息
Department of Occupational and Environmental Dermatology, Malmö University Hospital, Lund University, S-205 02 Lund, Sweden.
出版信息
Contact Dermatitis. 2012 Mar;66(3):131-6. doi: 10.1111/j.1600-0536.2011.02037.x.
BACKGROUND
According to EU legislation, 26 fragrance substance allergens must be labelled on cosmetic products. For 12 of them, the optimal patch test concentration/dose has not been evaluated.
OBJECTIVES
To establish the optimal patch test doses in mg/cm2 for the 12 fragrance substances that are not included in fragrance mix I or II in the European baseline patch test series.
MATERIALS AND METHODS
Patch testing with the 12 fragrance substances was performed in a stepwise manner encompassing up to five rounds in at least 100 dermatitis patients for each round. Before patch testing, an individual maximum concentration/dose was determined for each fragrance substance.
RESULTS
The predetermined maximum patch test concentrations/doses could be tested for all 12 fragrance substances, with no observable adverse reactions being noted.
CONCLUSIONS
For each fragrance substance investigated, it is recommended that half of the maximum patch test dose (mg/cm2) be used for aimed and screening patch testing.
背景
根据欧盟法规，必须在化妆品产品上标注 26 种香料过敏原。对于其中 12 种，尚未评估最佳斑贴试验浓度/剂量。
目的
确定未包含在欧洲基本斑贴试验系列中的 12 种香料混合物 I 或 II 中的 12 种香料物质的最佳斑贴试验剂量（mg/cm2）。
材料和方法
对 12 种香料物质进行逐步斑贴试验，每个轮次至少有 100 名皮炎患者进行多达五轮试验。在斑贴试验之前，为每种香料物质确定了个体最大浓度/剂量。
结果
可以对所有 12 种香料物质进行预定的最大斑贴试验浓度/剂量测试，没有观察到不良反应。
结论
对于所研究的每种香料物质，建议使用最大斑贴试验剂量（mg/cm2）的一半进行有针对性和筛选性斑贴试验。
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