Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Contact Dermatitis. 2009 Oct;61(4):217-23. doi: 10.1111/j.1600-0536.2009.01605.x.
Fragrance mix I (FM I) and fragrance mix II (FM II) in the European baseline series are used as screening tools for fragrance contact allergy. In 2005 the European Union (EU) required labelling of 26 fragrances when present in cosmetic products. INCI nomenclature is obligatory for such labelling.
To describe frequencies of contact allergy to these 26 fragrance substances, and to evaluate clinical relevance of these positive reactions.
Three hundred and twenty patients with eczema suspected of being contact allergy to fragrances or cosmetics were patch tested with the EU-declared fragrance chemicals, FM I and FM II.
There were 76 positive reactions in 33 patients. Most reactions were seen to [corrected] hydroxyisohexyl 3-cyclohexene carboxaldehyde in 3.1%, followed by Evernia furfuracea (2.5%) and cinnamyl alcohol (2.5%). Twelve reactions to FM I and II were not confirmed by separate ingredients. Clinical relevance of positive reactions to fragrances was certain in 20/33 (61%).
10.3% of the patients had positive patch tests in the EU-list. Hydroxyisohexyl 3-cyclohexene carboxaldehyde, a component of FM II, was the most frequent allergen, followed by Evernia furfuracea. Since Evernia furfuracea is not part of FM I or FM II, relevant reactions can be missed when only the European baseline series is used.
在欧洲基础系列中，混合香料 I（FM I）和混合香料 II（FM II）被用作香料接触过敏的筛选工具。2005 年，欧盟（EU）要求在化妆品中存在时对 26 种香料进行标签标注。INCI 命名法是此类标签标注的强制性要求。
描述对这 26 种香料物质的接触过敏频率，并评估这些阳性反应的临床相关性。
对 320 名患有湿疹的患者进行斑贴试验，怀疑他们对香料或化妆品有接触过敏，使用的是欧盟规定的香料化学物质、FM I 和 FM II。
在 33 名患者中，有 76 例出现阳性反应。最常见的反应是[修正]3-环己烯-1-羧酸-羟基异己基酯，占 3.1%，其次是糠醇（2.5%）和肉桂醇（2.5%）。FM I 和 II 中 12 例阳性反应无法通过单独的成分得到证实。33 例阳性反应中，有 20 例（61%）临床相关性确定。
在欧盟清单中，有 10.3%的患者斑贴试验呈阳性。FM II 的成分之一 3-环己烯-1-羧酸-羟基异己基酯是最常见的过敏原，其次是糠醇。由于糠醇不是 FM I 或 FM II 的一部分，因此仅使用欧洲基础系列可能会错过相关的反应。
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