ABSTRACT
Both carcinogenesis and the broader realm of risk assessment (as it applies to toxicology) have in common that, based on experimental results in a nonhuman species at some relatively high dose or exposure level, an attempt is made to predict the level of impact in humans at much lower levels. In this chapter we will examine the assumptions involved in these undertakings, review the aspects of design and interpretation of animal carcinogenicity studies, take a critical look at low dose extrapolation models and methods, and present the framework on which risk assessment is based.
