Autoimmunity and risk assessment

Among the issues dealing with identifying potential adverse immunologic eff ects (i.e.. suppression. hypersensitivity, or autoimmunity) associated with xenobiotic exposure, general agreement exists among the regulatory and pha rmaceutical communities that predictive tests for autoimmunity are in most need of development in order to improve risk assessment. The estimation of risk (i.e., the probability of a deleterious effect resulting from exposure ) involves both the qualitative evaluation of whether a hazard exists and t he quantitative evaluation for determining an acceptable level of exposure in humans. Unless adequate human data are available, which is uncommon, thi s is based on animal studies. Although animal models exist to study autoimm une processes, these models do not readily lend themselves to interpretatio n in the risk assessment process due, for the most part. to the complexity of autoimmune disease(s), as they are multifactorial and exhibit genetic he terogeneity in humans. To improve the risk assessment process, researchers must develop and validate animal models that not only incorporate mechanist ic information into the assessment process but also allow for consideration of potent genetic, physiologic, and environmental influences.