Menstrual hygiene products (MHPs) like tampons, sanitary towels and panty liners are widely used by girls and women of reproductive age to manage their menstruation. While the main goal of the products of interest is to absorb fluids and prevent leakage, some brands also aim to address aesthetical properties like odour, by the deliberate addition of fragrances. However, many of the perfumes are known to be skin sensitizers and/or irri-tants, possibly causing allergic or irritant contact dermatitis. Moreover, due to the lack of specific regulation in the EU, these fragrances can be used freely in the production of MHPs. In previous work, 11 sensitizing and/or irritating chemicals were found to be present in MHPs. This dissertation aims to assess the actual leaching of these compounds out of MHPs into the vulvovaginal environment, hereby possibly putting the consumer at risk of sensi-tization. To assess the leaching of these chemicals, firstly a menstrual fluid simulant (MFS) that emulates pH, osmolarity and protein binding was developed. This MFS was subsequently used in an experimental setup, representing in-use conditions of MHPs, for identification and quantification of the targeted compounds. For sample clean-up, a protein precipitation step and a salting-out assisted liquid-liquid extraction procedure were developed and op-timized. An ultra performance liquid chromatography – triple quad mass spectrometry (UPLC-TQMS) method with a run time of 12 minutes was developed and optimized for both identification and quantification of the leachables. Matrix effects were corrected by using matrix-matched calibration and methyl cinnamate was included as internal standard. Validation of the UPLC-TQMS method addressed selectivity, linearity, precision, trueness and accuracy. Out of the 15 investigated MHPs, 6 were found to leak 5 sensitizing and irritating com-pounds, with concentrations of up to 30 μg/g being detected after 8 hours of exposure: -isomethyl ionone, benzyl salicylate, hexyl cinnamaldehyde, linalool and piperonal. For every compound, the Acceptable Exposure Level (AEL) and Daily Exposure Dose (DED) were calculated and compared to each other in the context of a quantitative health risk assessment (QHRA) for sensitization. The DED did not exceed the AEL in any of the cases, suggesting that the consumer is not at risk of sensitization by the investigated products. In conclusion, we managed to develop and validate a UPLC-TQMS method with adequate sample clean-up procedure for the identification and quantification of leachables in the developed MFS. Although the QHRA indicated that there is no risk for sensitization, it does not include the risk for priorly sensitized consumers, neither does it cover the risk for individuals susceptible to irritant contact dermatitis. Consequently, the overall risk for this group of consumers is possibly underestimated by the approach followed.
