Basic Toxicological Issues in Product‐Safety Evaluations

Abstract

Product safety has become a keystone in the market success and longevity of many different types of products, such as pharmaceuticals, medical devices and a wide diversity of consumer products, including toys, health products, cosmetics, toys, food products and so on. Toxicologic testing for some types of products is required for registration by various international agencies, for example, pharmaceuticals, pesticides, medical devices and bulk chemicals. Other products, while not having strict registration testing requirements, should be evaluated for safety due to the potential for liability and loss of market share, as well as branding, should the product prove to have toxicologic issues while in routine consumer use. Toxicologists with appropriate training and experience, and the product-safety programmes they develop can, therefore, can have a significant impact on the success and longevity of a wide variety of products, if they are involved throughout the product life cycle, from the design of the product, through development and manufacturing, then on into the marketplace in postmarket surveillance. Basic toxicological issues to be addressed in a complete product-safety programme include the gathering of information to aid in product design, the development of specific toxicological tests and the design of toxicological-testing programmes, as well as postmarket vigilance activities. Keywords: product; safety; toxicology; testing; evaluation; nanotechnology; nanomaterials; US FDA; OECD; US EPA; consumer products; REACH; industrial chemicals; QSAR; alternative methods