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ToxSci Advance Access originally published online on January 21, 2004
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Toxicological Sciences 78, 181-186 (2004)
Toxicological Sciences vol. 78 no. 2 © Society of Toxicology; all rights reserved.

Evaluating the Human Relevance of Chemically Induced Animal Tumors

Samuel M. Cohen*,1, James Klaunig{dagger}, M. Elizabeth Meek{ddagger}, Richard N. Hill§, Timothy Pastoor, Lois Lehman-McKeeman|, John Bucher||, David G. Longfellow, Jennifer Seed§, Vicki Dellarco§, Penelope Fenner-Crisp# and Dorothy Patton#

* ILSI RSI Steering Committee, University of Nebraska Medical Center, Omaha, Nebraska 68198-3135; {dagger} Indiana University School of Medicine, Indianapolis, Indiana 46202-5120; {ddagger} Health Canada, Ottawa, Ontario K1A 0L2 Canada; § U.S. Environmental Protection Agency, Washington, District of Columbia 20460; Syngenta Crop Protection, Greensboro, North Carolina 27419-8300; | Bristol-Myers-Squibb Company, Princeton, New Jersey 08543; || National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, 27709; National Cancer Institute, National Institutes of Health, Rockville, Maryland 20892-7638; and # International Life Sciences Institute (ILSI), Washington, District of Columbia 20005

Received December 23, 2003; accepted December 31, 2003

Defining the mode(s) of action by which chemicals induce tumors in laboratory animals has become a key to judgments about the relevance of such tumor data for human risk assessment. Frameworks for analyzing mode of action information appear in recent U.S. EPA and IPCS publications relating to cancer risk assessment. This FORUM paper emphasizes that mode of action analytical frameworks depend on both qualitative and quantitative evaluations of relevant data and information: (1) presenting key events in the animal mode of action, (2) developing a "concordance" table for side-by-side comparison of key events as defined in animal studies with comparable information from human systems, and (3) using data and information from mode of action analyses, as well as information on relative sensitivity and exposure, to make weight-of-evidence judgments about the relevance of animal tumors for human cancer assessments. The paper features a systematic analysis for using mode of action information from animal and human studies, based in part on case examples involving environmental chemicals and pharmaceuticals.

Key Words: carcinogenic mode of action; human relevance of animal tumors; risk assessment; PPAR{alpha} agonists.


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