PATCH TESTING WITH FRAGRANCES - RESULTS OF A MULTICENTER STUDY OF THEEUROPEAN ENVIRONMENTAL AND CONTACT-DERMATITIS RESEARCH GROUP WITH 48 FREQUENTLY USED CONSTITUENTS OF PERFUMES

The objective of this study was to determine the frequency of reactivi ty to a series of commonly used fragrances in dermatological patients. A total of 48 fragrances (FF) were chosen, based on the publication o f Fenn in 1989 in which the top 25 constituents of 3 types (1. perfume s, 2. household products, 3. soaps) of 400 commercial products on the US market had been determined. In a pilot study on a total of 1069 pat ients in 11 centres, the appropriate test concentration and vehicle we re examined. For most fragrances, 1% and 5% were chosen, and petrolatu m proved to be the best vehicle in comparison to isopropyl myristate a nd diethyl phthalate. In the main study, a set of 5 to 10 fragrances a t 2 concentrations was patch tested in each centre on a minimum of 100 consecutive patients seen in the patch test clinic. These patients we re also patch tested to a standard series with the 8% fragrance mix (F M) and its 8 constituents. In patients with a positive reaction to any of the 48 FF, a careful history with regard to past or present reacti ons to perfumed products was taken. A total of 1323 patients were test ed in 11 centres. The 8% FM was positive in 89 patients (8.3% of 1072 patients). Allergic reactions to the constituents were most frequent t o oak moss (24), isoeugenol (20), eugenol (13), cinnamic aldehyde (10) and geraniol(8). Reactions read as allergic on day 3/4 were observed only 10x to 7 materials of the new series (Iso E Super(R) (2), Lyral(R ) (3), Cyclacet(R) (1), DMBCA (1), Vertofix(R) (1), citronellol (1) an d amyl salicylate (1)). The remaining 41 fragrances were negative. 28 irritant or doubtful reactions on day 3/4 were observed to a total of 19 FF materials (more than 1 reaction: 5% citronellol (2), 1% amyl sal icylate (2), 1% isononyl acetate (3), 0.1% musk xylol (2), 1% citral ( 2), and 1% ionone beta (2)). Clinical relevance of positive reactions to any of the FF series was not proved in a single case. This included the 4 reactions in patients who were negative to the 8% FM. In conclu sion, the top 25 fragrances commonly found in various products caused few reactions in dermatological patients and these few appeared to be clinically irrelevant, with the possible exeption of Lyral(R). However , this data should be interpreted in the light of the relatively small number of patients tested (only 100 in most centres). (C) Munksgaard, 1995.