The interpretation of equivocal or marginal animal carcinogenicity tests.
The interpretation of animal carcinogenicity tests traditionally rely almost exclusively upon a comparison of specific tumor rates in treated vs. matched and, perhaps, historical control animals. Yet, carcinogenicity tests yield much more biological and pathological data than simply final tumor rates. This additional data should also be considered as part of the total weight of evidence, particularly when analyzing a marginal or equivocal test result. If there are no positive findings among the data discussed here and listed in Table 1, it is unlikely that a marginal or equivocal increase in tumor incidence is actually treatment-related, irrespective of statistical analysis.
Squire
R A
RA
Division of Comparative Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
D000818:Animals; D015197:Carcinogenicity Tests / Q000706:statistics & numerical data*; D002273:Carcinogens / Q000633:toxicity; D002455:Cell Division / Q000187:drug effects; D004247:DNA / Q000096:biosynthesis; D004249:DNA Damage; D003627:Data Interpretation, Statistical; D004195:Disease Models, Animal; D006965:Hyperplasia / Q000139:chemically induced; D051379:Mice; D009369:Neoplasms / Q000139:chemically induced / Q000473:pathology; D009857:Oncogenes / Q000502:physiology; D051381:Rats
D002273:Carcinogens; D004247:DNA