Chemical characterization of menstrual and intimate care products: An extractables & leachables investigation

Menstrual and intimate care products (MICPs) such as tampons, menstrual pads, menstrual cups, and adult novelties are widely used worldwide for women's menstrual comfort or pleasure, respectively. However, growing consumer concerns regarding the presence of hazardous chemicals in these products have been raised.

The aim of this study was to obtain an accurate overview of potential hazardous chemicals (organic and inorganic) that are present in MICPs and to determine the quantities that might leach under typical in-use conditions. Hereto, we developed a workflow analogous to the biological evaluation of medical devices (ISO-10993), encompassing three steps: (1) Conducting extraction experiments under exaggerated conditions and developing analytical methods to identify all chemical constituents (extractables); (2) Prioritizing the extracted chemicals based on available regulatory hazard information, eventually supplemented with in silico toxicological data; (3) Performing migration studies using simulants of vaginal and menstrual fluids, followed by targeted quantification of the prioritized leachable chemicals using newly developed analytical methodologies. The established strategy was applied to 64 MICPs, including absorbent menstrual products (i.e. tampons (n = 9) and menstrual pads (n = 6)), adult novelties (n = 15), menstrual cups (n = 15), Kegel-exercise devices (n = 14) and menstrual sea sponges (n = 5), all products originating from EU, US and China.

(1) Extractables assessment revealed the presence of 55 unique chemicals, including phthalates, siloxanes, volatile organic compounds (VOCs), fragrances, and plastic additives. (2) A hazard-based prioritization step highlighted phthalates (DEHP, DiNP, DBP), styrene, and ethylbenzene as the top chemicals for further investigation. (3) The leaching simulation experiments revealed that 65 %, i.e. 36 of the 55 chemicals identified in the extractables assessment were not detected in the leachables assessment. The 19 leachable chemicals identified comprised 9 fragrances, 5 phthalates, 2 plastic additives and 3 VOCs. Their maximum levels quantified were 28.22 µg/g (heliotropine), 100 ppb (DEHP), 18 ppm (triethyl citrate), and 0.24 ppm (2-ethyl-1-hexanol), respectively. In addition to the analysis of organic chemicals, examination of metals and metalloids revealed that menstrual sea sponges had the highest levels of metals and metalloids leaching among all tested menstrual and intimate care product categories, with Nickel, Cadmium, Antimony, and Mercury reaching levels of 1850, 1.0, 0.3, and 0.6 ppm, respectively.

This study provides new insights into the chemical composition of MICPs. Furthermore, it demonstrates that the majority of hazardous chemicals present in the studied MICPs are not detected under realistic use conditions; however exposure to phthalates, fragrances and other chemical constituents remains possible.