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 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.
Keywords: Emollient; Exposure assessment; Menstrual hygiene; Menstrual pad; Polyacrylate; Polymeric foam; Quantitative risk assessment; Safety; Sanitary pad.
Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.