Public consultation on perfumery materials in the framework of Council Directive 76/768/EEC relative to cosmetic products

Background: Isoeugenol, an important fragrance allergen in consumers, has been restricted to 200 p.p.m. since 1998 according to guidelines issued by the fragrance industry. However, no decline in contact allergy to isoeugnol has been detected. It has been speculated that isoeugenol derivatives, especially isoeugenyl acetate, are used instead. Isoeugenyl acetate is probably metabolized in the skin to isoeugenol and gives positive patch test reactions in 1/3 of isoeugenol-sensitized individuals. Objectives: To investigate the content of isoeugenol, isoeugenyl acetate, and two isoeugenol ethers in perfumes/aftershaves. Materials and Methods: 29 international brand perfumes/aftershaves were analysed for the target fragrance ingredient by gas chromatography-mass spectrometery. All samples were analysed in duplicate at detection levels of 1-5 p.p.m. Results: 16 products (55%) contained isoeugenol. The maximum concentration was 202 p.p.m. 10 products (34%) contained isoeugenyl acetate, which in 9 cases occurred together with isoeugenol. The concentrations of isoeugenyl acetate ranged from 20 to 4689 p.p.m. 13 products (44%) contained 64.9-1755.0 p.p.m. isoeugenyl methyl ether. Isoeugenyl benzyl ether was not detected in any of the investigated products. Conclusions: Isoeugenyl acetate is present in perfumes/aftershaves, in some products in significant amounts. This may lead to elicitation of contact allergy in isoeugenol-sensitized individuals and may contribute to unchanged levels of isoeugenol sensitization.