摘要
A new fragrance mix (FM II), with 6 frequently used chemicals not present in the currently used fragrance mix (FM I), was evaluated in 6 dermatological centres in Europe, as previously reported. In this publication, test results with the individual constituents and after repeated open application test (ROAT) of FM II are described. Furthermore, cosmetic products which had caused a contact dermatitis in patients were analysed for the presence of the individual constituents. In 1701 patients, the individual constituents of the medium (14%) and the highest (28%) concentration of FM II were simultaneously applied with the new mix at 3 concentrations (break-down testing for the lowest concentration of FM II (2.8%) was performed only if the mix was positive). ROAT was performed with the concentration of the FM II which had produced a positive or doubtful (+or ?+) patch test reaction. Patients’products were ana-lysed for the 6 target compounds by gas chromatography-mass spectrometry (GC-MS). Results:50 patients (2.9%) showed a positive reaction to 14%FM II and 70 patients (4.1%) to 28%FM II. 24/50 (48%) produced a positive reaction to 1 or more of the individual constituents of 14%FM II and 38/70 (54.3%) to 28%FM II, respectively. If doubtful reactions to individual constituents are included, the break-down testing was positive in 74%and 70%, respectively. Patients with a positive reaction to 14%FM II showed a higher rate of reactions to the individual constituent of the 28%FM II:36/50 (72%). Positive reactions to individual constituents in pa-tients negative to FM II were exceedingly rare. If doubtful reactions are regarded as negative, the sensitivity, specificity, positive predictive value and negative predictive value for the medium concentration of FM II towards at least 1 individual constituent was 92.3%(exact 95%confidence interval 74.9-99.1%), 98.4%(97.7-99.0%), 48%(33.7-62.6%) and 99.9%(99.6-100.0%), respectively. For the high concentration, the figures were very similar. The frequency of positive reactions t
A new fragrance mix (FM II), with 6 frequently used chemicals not present in the currently used fragrance mix (FM I), was evaluated in 6 dermatological centres in Europe, as previously reported. In this publication, test results with the individual constituents and after repeated open application test (ROAT) of FM II are described. Furthermore, cosmetic products which had caused a contact dermatitis in patients were analysed for the presence of the individual constituents. In 1701 patients, the individual constituents of the medium (14%) and the highest (28%) concentration of FM II were simultaneously applied with the new mix at 3 concentrations (break-down testing for the lowest concentration of FM II (2.8%) was performed only if the mix was positive). ROAT was performed with the concentration of the FM II which had produced a positive or doubtful (+or ?+) patch test reaction. Patients'products were ana-lysed for the 6 target compounds by gas chromatography-mass spectrometry (GC-MS). Results:50 patients (2.9%) showed a positive reaction to 14%FM II and 70 patients (4.1%) to 28%FM II. 24/50 (48%) produced a positive reaction to 1 or more of the individual constituents of 14%FM II and 38/70 (54.3%) to 28%FM II, respectively. If doubtful reactions to individual constituents are included, the break-down testing was positive in 74%and 70%, respectively. Patients with a positive reaction to 14%FM II showed a higher rate of reactions to the individual constituent of the 28%FM II:36/50 (72%). Positive reactions to individual constituents in pa-tients negative to FM II were exceedingly rare. If doubtful reactions are regarded as negative, the sensitivity, specificity, positive predictive value and negative predictive value for the medium concentration of FM II towards at least 1 individual constituent was 92.3%(exact 95%confidence interval 74.9-99.1%), 98.4%(97.7-99.0%), 48%(33.7-62.6%) and 99.9%(99.6-100.0%), respectively. For the high concentration, the figures were very similar. The frequency of positive reactions to
