ABSTRACT
In toxicological safety evaluation processes, one of the ever-present problems is that presented by the need to extrapolate from information derived from non-human models in order to make judgements on human safety. Whilst professionals in this field have many sources of support for such extrapolations, nevertheless the most fundamental of these often arises from those occasions when, however unfortunately, there is detailed human experience of adverse toxic effects. However, there are certain areas in a toxicologist’s safety evaluation work where it is possible to generate data in human volunteers which provides valuable, if not essential, information effectively using the species of concern and the end-point of concern. One of these end-points is skin irritation and it is this which forms the central theme of this chapter. However, it is also possible actively to generate human data which have direct relevance for safety evaluation processes concerning eye irritation, skin sensitisation and skin penetration/metabolism.
