FS06.7 The new fragrance mix II – test results of a multicentre European Study

Abstract

A new fragrance mix (FM II) with 6 frequently used chemicals was evaluated in consecutive patients patch tested in 6 dermatological centres in Europe. 28% FM II contained 5% Lyral, 1% citral, 5% farnesol, 5% coumarin, 1% citronellol and 10% alpha‐hexyl cinnamic aldehyde (AHCA); in 14% FM II the single constituents’ concentrations was lowered to 50% and in 2.8% FM II to 10%. Each patient was classified regarding a history of adverse reactions to fragrances: certain, probable, questionable and none. The frequency of positive reactions to the currently used 8% fragrance mix (FM I) and the new mix in 1703 patients was as follows: FM I, 6.6%; 2.8% FM II, 1.3%; 14% FM II, 2.9%; 28% FM II, 4.1%. The number of doubtful/irritant reactions was 7.2% for FM I and ranged from 1.8% to 10.6% for FM II.8.7% of tested patients had a certain fragrance history. Of these 25.2% were positive to FM I, reactivity to FM II was dose‐dependent and ranged from 8.1% to 17.6% in this subgroup. Comparing 2 groups of history – certain and none – values for sensitivity (sens) and specificity (spec) were calculated. Sens: FM I, 27.2%; 2.8% FM II, 8.7%; 14% FM II, 15.9%; 28% FM II, 21.5%. Spec: FM I, 96.3%; 2.8% FM II, 99.5%; 14% FM II, 98.7%; 28% FM II, 97.9%. 31/70 (44.3%) patients positive to 28% FM II were negative to FM I. In the group of patients with a certain history a total of 6 patients was found reacting only to FM II. Simultaneous break‐down testing with the single constituents produced positive reactions in 54.3% for 28% FM II and 48% for 14% FM II. Lyral was the dominating single constituent with positive reactions (37.1% for 28% FM II, 36% for 14% FM II), followed by citral, farnesol, citronellol, AHCA and coumarin. Chemical analysis for the 6 constituents of FM II was performed on 25 products used by 12 patients being patch test positive to FM II. Lyral was detected in 76% of these products, citral in 16% and AHCA in 8%. In conclusion, the new FM II detects additional patients with contact allergy to fragrances missed by the currently used FM I. The medium concentration, 14% FM II, is probably the most useful one for diagnostic screening.