Introduction: Allergenic fragrance ingredients are present in a wide range of products such as consumer products, cosmetics, and toys. However, they are not regulated in every industry to the same extent. The General Products Safety Directive (GPSD) states that consumer products must be safe in order to be marketed, but do not endorse disclosure or restriction of ingredients. Therefore, in consumer products such as absorbent hygiene products (AHPs) and lubricants, fragrances are used freely. Although 26 allergenic fragrances are documented as they are known to cause allergic contact dermatitis (ACD).
Aim: The aim is to develop a valid method to determine 24 allergenic fragrance ingredients in AHPs and lubricants by evaluating the packaging and labels. Thereupon, the fragrances present in the purchased samples were identified and quantified using GC-MS. The optimized and validated method was used to determine allergenic fragrances in different matrices such as tampons, sanitary towels, panty liners, and lubricants. Subsequently, samples were submitted to a real-life exposure scenario to gain a better understanding of the leaching of these fragrances. At last, a risk assessment was made using the estimated exposure and the toxicological data available.
Method: A liquid-liquid extraction was used as a sample ‘clean-up’ for lubricants. The sample was then injected using gas chromatography-flame ionization-mass spectrometry (GC-FID-MS). The AHPs were analyzed using a HS-GC-FID-MS method. The run time for lubricants and AHPs were respectively, 28 and 27 min. The matrix-effect of tampons was evaluated and confirmed, resulting in the need for optimization. The method validation included selectivity and specificity, linearity trueness, precision, and accuracy of the method. In addition, the homogeneity profile of scented tampons was evaluated.
Results: The validated GC-FID-MS was used to determine fragrances in lubricants using standard addition to correct for matrix effects. The established HS-GC-FID-MS method was optimized and validated. The observed matrix-effect in AHPs was reduced with the use of 1-fluoronapthalene as an internal standard (IS) and matrix-matched calibration for quantification purposes. A relative bias was set at 15%, that was met by each identified fragrance ingredient, illustrated in the acquired accuracy profiles.
Conclusion: It is concluded that the optimized and validated GC-FID-MS method works well for identification and quantification of scented lubricants. HS-GC-FID-MS provides good results for identification but needs further optimization in terms of quantification of scented AHPs, taking into account the heterogeneous distribution of fragrance ingredients in the samples. Furthermore, a more in-depth risk assessment of fragrance ingredients should be carried out on the scented samples, considering the leaching of fragrance ingredients in the vaginal environment.
