Daniel S. Marsman

Safety evaluation of superabsorbent baby diapers.

Superabsorbent disposable baby diapers are sophisticated, well-engineered products that provide many benefits including convenience, comfort, exceptional leakage protection, improved hygiene and skin care benefits compared with cloth diapers. Safety assurance is an integral part of the diaper development process at Procter & Gamble, with the goal of ensuring safety for both caregivers and babies. A systematic, stepwise approach to safety assessment starts with a thorough evaluation of new design features and materials, using the principles of general risk assessment including, as appropriate, controlled trials to assess clinical endpoints or independent scientific review of safety data. The majority of the diaper materials are polymers that are safe and do not have inherent toxicity issues. Trace amounts of non-polymeric materials, such as colorants, are assessed based on their skin contact potential. New materials or design features are introduced in marketed products only if they have been shown to be safe under the conditions of recommended or foreseeable use. The product safety continues to be confirmed after launch by means of in-market monitoring. This article provides a broad overview of human safety exposure-based risk assessment used at Procter & Gamble for absorbent hygiene products.

Animal Welfare Considerations in Biomedical Research and Testing

Abstract Animals serve a vital role as models for important biomedical research to understand and discover treatments for a wide range of human and animal diseases. Animals also serve an important role in determining the efficacy and safety of vaccines, medicines, consumer products, and a wide range of other substances. However, the welfare of animals used in research and testing may be adversely impacted by the pain and distress resulting from the induction of disease or toxicity. Animal welfare laws and policies mandate that such pain and distress should be avoided, or if not avoidable, should be limited to only that which is necessary in order to attain study objectives. Best practice strategies for minimizing or avoiding pain and distress include the use of pain-relieving drugs, humane endpoints, supportive veterinary care and husbandry, acclimatization, and consideration of replacement and reduction alternatives. Consideration and appropriate use of these best practices can help assure optimal welfare for animals used in biomedical research and testing. Objective: To discuss adverse animal welfare impacts that may result from biomedical research and testing studies, and to discuss current best practices for minimizing or avoiding these adverse impacts based on published guidelines and peer reviewed literature. The main focus will be on refinement: to discuss common research and testing models that involve pain and distress, and to discuss ways to avoid or minimize this pain and distress. Where replacement and reduction alternatives are available and applicable that can reduce the number of animals that will experience pain and/or distress, these will also be briefly discussed.

Safety Evaluation of Disposable Baby Diapers Using Principles of Quantitative Risk Assessment

Baby diapers are complex products consisting of multiple layers of materials, most of which are not in direct contact with the skin. The safety profile of a diaper is determined by the biological properties of individual components and the extent to which the baby is exposed to each component during use. Rigorous evaluation of the toxicological profile and realistic exposure conditions of each material is important to ensure the overall safety of the diaper under normal and foreseeable use conditions. Quantitative risk assessment (QRA) principles may be applied to the safety assessment of diapers and similar products. Exposure to component materials is determined by (1) considering the conditions of product use, (2) the degree to which individual layers of the product are in contact with the skin during use, and (3) the extent to which some components may be extracted by urine and delivered to skin. This assessment of potential exposure is then combined with data from standard safety assessments of components to determine the margin of safety (MOS). This study examined the application of QRA to the safety evaluation of baby diapers, including risk assessments for some diaper ingredient chemicals for which establishment of acceptable and safe exposure levels were demonstrated.