TESTING WITH FRAGRANCE MIX - IS THE ADDITION OF SORBITAN SESQUIOLEATETO THE CONSTITUENTS USEFUL - RESULTS OF A MULTICENTER TRIAL OF THE EUROPEAN ENVIRONMENTAL AND CONTACT-DERMATITIS RESEARCH GROUP (EECDRG)

In a multicentre study, the value of adding sorbitan sesquioleate (SSO ) to the constituents of the 8% fragrance mix (FM) was investigated. I n 7 centres, 709 consecutive patients were tested with 2 types of FM f rom different sources, its 8 constituents with 1% SSO, its 8 constitue nts without SSO, and 20% SSO. 5 patients (0.71%) reacted to the emulsi fier SSO itself, read as definitely allergic on day 3/4. 53 patients r eacted to either one of the mixes with an allergic type of reaction. W hen tested with the constituents without SSO, 41.5% showed an allergic reaction versus 54.7% with SSO. If both types of reactions were consi dered (allergic and irritant) 38.3% of 73 patients showed a positive ' 'breakdown'' result without SSO, versus 54.8% with SSO. The difference s were statistically significant. Reactivity to FM constituents was ch anged in a specific pattern by addition of SSO- irritant reactions inc reased, particularly for cinnamic alcohol, eugenol, geraniol, oak moss and hydroxycitronellal, whereas others showed only a slight change. A llergic reactions were also increased by SSO, but the rank order of th e top 3 sensitizers (isoeugenol, oak moss and eugenol) did not change. Cinnamic alcohol was the only constituent with decreased reactivity a fter addition of SSO. A positive history of fragrance sensitivity (HFS ) was clearly associated with a positive allergic reaction to either t he mix or 1 of its constituents (51% versus 28.6% with a negative HFS) . Irritant reactions were linked to a negative HFS in a high proportio n (64.3%). In 17 patients, a repeated open application test (ROAT) was performed with a total of 43 patch-test-positive materials. The ROAT was positive in 20/31 (64.5%) tests in 11 patients with a positive HFS , but negative in all 6 patients with a negative HFS (0/12 tests). In conclusion, addition of SSO to the constituents of FM increases both i rritant and allergic reactions, though the difference from the results without SSO is not as high as previously reported. The ROAT is a valu able tool in validating such patch test results.