Schnuch Axel, Uter Wolfgang, Dickel Heinrich, Szliska Christiane, Schliemann Sibylle, Eben Ricarda, Ruëff Franziska, Gimenez-Arnau Ana, Löffler Harald, Aberer Werner, Frambach Yvonne, Worm Margitta, Niebuhr Margarete, Hillen Uwe, Martin Vera, Jappe Uta, Frosch Peter J, Mahler Vera
Information Network of Departments of Dermatology, University of Göttingen, Göttingen/Germany.
Contact Dermatitis. 2009 Sep;61(3):152-62. doi: 10.1111/j.1600-0536.2009.01601.x.
To identify the concentration of the fragrance compound hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI) (HICC) that is sufficiently low not to cause an allergic reaction in patients with proven sensitization.
Repeated open application testing (ROAT) in 64 subjects with 2 preparations (perfume and cream) in different concentration (0.005-2.5%). Confirmatory patch testing with four preparations in two different concentrations (2.5% and 5%).
The concentrations of HICC being tolerated by 90% of those sensitized to HICC are estimated as <88.2 ppm (cream) and <270 ppm (perfume) equivalent to 1.2 microg/cm(2) (perfume) and 4.9 microg/cm(2) (cream). Patch test preparations differed with regard to sensitivity (88.5-98.1%) and specificity (37.5-87.5%) against the ROAT result as external criterion. ROAT concentrations and the reaction strength in patch testing were inversely correlated (Kendall's tau-b: 0.69), both indicating the existence of different degrees of susceptibility.
To protect 90% (50%) of people sensitized, the use concentration should be in the range of 0.009-0.027% (0.18-0.34%), depending on the product type. Taking into account these results, excessive concentrations should be avoided, as this would continue to sensitize people. Close monitoring is indispensable to prove the efficacy of any recommendations aiming to prevent induction.
确定香料化合物羟基异己基 3 - 环己烯甲醛（国际化妆品原料命名，HICC）的浓度，该浓度要足够低，以免在已证实致敏的患者中引起过敏反应。
对64名受试者进行重复开放涂抹试验（ROAT），使用两种不同浓度（0.005 - 2.5%）的制剂（香水和乳膏）。用两种不同浓度（2.5%和5%）的四种制剂进行验证性斑贴试验。
估计对HICC致敏的人群中，90%能耐受的HICC浓度为乳膏中<88.2 ppm，香水中<270 ppm，相当于香水中1.2微克/平方厘米，乳膏中4.9微克/平方厘米。以ROAT结果作为外部标准，斑贴试验制剂在敏感性（88.5 - 98.1%）和特异性（37.5 - 87.5%）方面存在差异。ROAT浓度与斑贴试验中的反应强度呈负相关（肯德尔tau - b系数：0.69），两者均表明存在不同程度的易感性。
为保护90%（50%）的致敏人群，使用浓度应根据产品类型在0.009 - 0.027%（0.18 - 0.34%）范围内。考虑到这些结果，应避免过高浓度，因为这会持续使人群致敏。密切监测对于证明任何旨在预防诱导的建议的有效性是必不可少的。
