TABLE 7.

Definitions of Adverse Effect

Definition	Source
“Adverse effect: A biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”	IRIS, 2007
“Adverse effect: Change in the morphology, physiology, growth, development or life span of an organism, system or (sub) population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other external influences.”	Renwick et al., 2003
“Adverse effects are changes that are undesirable because they alter valued structural or functional attributes of the entities of interest …. The nature and intensity of effects help distinguish adverse changes from normal … variability or those resulting in little or no significant change.”	Sergeant, 2002
“The spectrum of undesired effects of chemicals is broad. Some effects are deleterious and others are not …. [Regarding drugs], some side effects … are never desirable and are deleterious to the well-being of humans. These are referred to as the adverse, deleterious, or toxic effects of the drug.”	Klaassen & Eaton, 1991
“All chemicals produce their toxic effects via alterations in normal cellular biochemistry and physiology …. It should also be recognized that most organs have a capacity for function that exceeds that required for normal homeostasis, sometimes referred to as functional reserve capacity.”	Klaassen & Eaton, 1991