ABSTRACT
Allergic contact dermatitis (ACD) is a relatively common disorder in man, particularly in an occupational setting (Coenraads and Smit, 1995). It is instructive to consider why this is the case. Clinical ACD requires that humans be exposed sufficiently to contact allergens in the absence of appropriate risk management procedures, in other words, where there is a combination of a contact allergenic hazard with inadequately controlled exposure. However, it is evident from a wealth of published literature (e.g. Wahlberg and Boman, 1985; Botham et al., 1991a; Cronin and Basketter, 1994; Kimber et al., 1994, together with Chapters 7 and 8 in this present volume) that adequate methods have existed for some time which enable toxicologists to identify chemicals that present a contact allergenic hazard. Thus it is reasonable to speculate that the current prevalence of ACD arises, at least in part, from a continuing failure adequately to understand and/or implement risk assessment/management procedures when there is a reasonable possibility of skin exposure to potential contact allergens. In this chapter, it is our aim to provide detailed guidance on the processes of risk assessment that should be applied in such cases. Risk assessment is of fundamental importance-skin sensitization tests in general only evaluate hazards, and to some extent their potency. The risk assessment process enables these abstract hazards to be placed in a practical context and, where appropriate, permit risk management measures to be defined. Manufacturers of consumer and health care products, that come into direct contact with the skin, have a major responsibility to the consumer and to the worker to ensure that products will not cause allergic contact dermatitis. Product and
ingredient safety assessment should consider all types of human exposure situations. This includes the manufacture and distribution of the product as well as consumer use and reasonably foreseeable misuse. The guidance presented herein is based on our many years of experience of making risk assessments for large companies which manufacture a wide range of products which come into contact with the skin of billions of consumers.
