9.18 - Ocular and Dermal Local Tissue Tolerance Studies

Abstract

Local tissue tolerance studies are designed to evaluate the adverse effects of exposure to a xenobiotic at the site of initial or primary exposure. Concentrations at these sites are the highest the body will experience, and adverse effects occurring are frequently due to physicochemical as well as true toxicity effects. Exposure of the eye and skin to man-made chemical substances is the most common route of exposure (and source of potential harm) in occupational, consumer product, and environmental settings, and is also a frequent occurrence with topically applied drugs cosmetics and personal care products. The traditional tests employed to evaluate the potential for such exposures to cause harm are among the oldest codified in regulatory settings. Though they have undergone significant modification in response to perceptions and concerns about animal welfare, modified forms remain in use and serve their intended purpose well. There are also in vitro alternatives, some with regulatory acceptance and most without.