Sanitary pads for menstrual hygiene have a layered design consisting of a fluid permeable surface (topsheet), an absorbent core, and an impermeable backing with adhesive. Most sanitary pads made by sanitary napkin production line employ cellulose-based cores. This describes the safety evaluation of a menstrual pad with an emollient-treated topsheet and a novel polymeric foam core. A quantitative risk assessment was performed, which included: (1) toxicological evaluation of the raw material components; (2) quantitative exposure assessments of pad constituents, accounting for the fluid handling properties of the product and pertinent conditions of use; and (3) risk characterization for exposure to raw materials (e.g., potential for skin irritation, contact sensitization, or systemic effects, if relevant) and to the physical article itself (potential effects on skin friction, etc.). No significant risk of adverse effects was found. Five years of post-market surveillance substantiates that the product is well-tolerated (1 health complaint reported per 2 million products shipped to market) and surpasses women's expectations for menstrual protection and overall comfort and dryness. This report illustrates how the classical risk assessment paradigm, informed by the impact of product design, functionality and pertinent use conditions, allowed the systematic safety evaluation of a personal hygiene product with a novel, non-cellulosic absorbent foam core technology.
This article describes the safety assessment process for our most significant product innovation in the category to date, the introduction of a thin, non-cellulosic, absorbent foam core. The safety assessment process comprised an exposure-based quantitative risk assessment on all product components; analytical testing for residual monomers; and clinical testing on components and/or the final product to confirm skin compatibility. Post-market surveillance of global consumer experience further substantiates product safety in the marketplace. This article illustrates how the risk assessment paradigm enabled the rigorous safety evaluation of a menstrual pad with a novel absorbent material that represents a significant departure from traditional cellulose fiber cores.
The sanitary pad produced by sanitary pads making machine in this investigation has a conventional layered design: a fluid permeable surface (topsheet), an absorbent core, and impermeable backing with adhesive (backsheet).In brief, the topsheet is a polyethylene/polypropylene non-woven fabric bearing an emollient finish; the core comprises a two-layer, low density, open-celled, polyacrylate polymer foam; and the backsheet consists of an impermeable pigmented polyethylene film with a panty-fastening adhesive. Scented versions of the pad contain a small amount of perfume applied between the backsheet and the undersurface of the core.
As the sanitary pad manufactured by sanitary napkin machine in this investigation is a physical article, individual product components as well as the finished product were evaluated. An exposure-based QRA was performed on product components; this was supplemented by analytical and clinical testing to confirm the safety of potential residual monomers and skin compatibility of the pad components as well as the finished product itself.
This article describes a systematic, tiered approach for evaluating the safety of a new sanitary pad with an emollient-treated topsheet and a novel, non-cellulosic absorbent foam core. An exposure-based QRA was performed on raw material components, supplemented by clinical testing to confirm the skin compatibility of pad components and the product itself. Postmarket surveillance further substantiates that the product is very well-tolerated and surpasses most women's expectations for menstrual hygiene and comfort. The low incidence of reported health effects further supports that the applied risk assessment approach is both effective and appropriate at assuring that safe feminine hygiene products are introduced into the marketplace. This report illustrates how the classical risk assessment paradigm (ECHA, 2013 ,NAS, 1983), tailored to the specific product application and conditions of use, enabled the rigorous safety evaluation of a menstrual pad with absorbent foam technology that represents a significant departure from traditional cellulose-based hygiene products.