High
dose used in
chronic toxicity testing that is expected on the basis of an adequate subchronic study to produce
limited
toxicity when administered for the duration of the test period. It should not induce: (a)
overt
toxicity, for example appreciable death of cells or organ dysfunction, or (b) toxic manifestations
that are predicted materially to reduce the life span of the animals except as the
result of neoplastic development or (c) 10% or greater retardation of body
weight gain as compared with control animals. In some studies,
toxicity that could interfere with a carcinogenic effect is specifically excluded from consideration.
Source:
PAC, 1993, 65, 2003
(Glossary for chemists of terms used in toxicology (IUPAC Recommendations 1993))
on page 2068