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Chemical Characterization of Feminine Intimate Products an Extractables & Leachables Investigation

Marcelis, Quinten
Tie, Yaxin
Rogiers, Vera
Vanhaecke, Tamara
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Abstract

Feminine intimate products (FIPs), including tampons, sanitary napkins, menstrual cups, and adult novelties, are widely used for women’s hygiene and comfort. However, growing concerns about hazardous chemicals in these products have emerged.This study provides an accurate overview of potential hazardous chemicals (both organic and inorganic) in FIPs and to determine the quantities that may leach under typical in-use conditions. We developed a workflow akin to ISO-10993 for evaluating medical devices, consisting of three steps: (1) conducting extraction experiments under exaggerated conditions to identify all chemical constituents (extractables); (2) prioritizing these chemicals based on regulatory hazard information, supplemented by in silico toxicological data; and (3) performing migration studies using simulants of vaginal and menstrual fluids, followed by targeted quantification of the prioritized leachable chemicals. This strategy is applied to 64 FIPs, including absorbent hygiene products (tampons (n=9), sanitary napkins (n=6)), adult novelties (n=15), menstrual cups (n=15), Kegel devices (n=14), and menstrual sea sponges (n=5), sourced from the EU, US, and China.Extractables assessment revealed 55 unique chemicals, including phthalates, volatile organic compounds (VOCs), fragrances, and plastic additives. A hazard-based prioritization highlighted phthalates (DEHP, DiNP, DBP) and styrene as top chemicals for further investigation. Notably, leaching simulations showed that 65% (36 of 55) of the identified chemicals were not confirmed as leachables. The 19 leachable chemicals included 9 fragrances, 5 phthalates, 2 plastic additives, and 3 VOCs, with maximum levels of 28.22 µg/g (heliotropine), 100 ppb (DEHP), and 18 ppm (triethyl citrate). Additionally, menstrual sea sponges exhibited the highest levels of leaching metal(loid)s, with Nickel, Antimony, and Mercury reaching levels of 1850, 0.3, and 0.6 ppb, respectively.This study provides new insights into the chemical composition of FIPs, demonstrating that most hazardous chemicals present do not leach under realistic use conditions; however, exposure to phthalates, fragrances, and other constituents remains possible.

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2024-10-18
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Peer reviewed scientific article
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heavy metal #22519#
Medical device #22086#
Related project
FEMINA #1000019#
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