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Rodent bladder tumors do not always predict for humans

S M Cohen¹, T A Lawson

¹Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha 68198-3135, USA.

|June 29, 1995

Summary

Urinary calculi formation in rodents may artifactually inflate carcinogenic risk in humans. These non-genotoxic chemicals induce cancer via cell proliferation, not DNA damage, impacting human risk extrapolation.

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Area of Science:

Toxicology and Carcinogenesis
Urology and Nephrology

Background:

Dr. David Clayson's 20-year-old hypothesis questioned the relevance of rodent urinary calculi to human cancer risk.
Urinary calculi, microcrystalluria, and amorphous precipitates complicate the interpretation of rodent bioassays.

Purpose of the Study:

To review the role of urinary calculi in bladder carcinogenesis over the past 20 years.
To assess the impact of solid urinary materials on extrapolating rodent carcinogenicity data to humans.

Main Methods:

Literature review of studies on urinary calculi and bladder cancer in rodents.
Analysis of examples illustrating the formation and effects of urinary precipitates.
Examination of the mechanism of action for non-genotoxic chemicals causing calculi.

Main Results:

Chemicals inducing urinary calculi in rodents are non-genotoxic.
These substances promote cancer through increased cell proliferation, not direct DNA damage.
Calculi formation presents an artifactual concern for human carcinogenic risk extrapolation.

Conclusions:

The formation of urinary calculi and precipitates in rodents is a significant artifact in carcinogenicity studies.
The non-genotoxic mechanism involving cell proliferation highlights challenges in human risk assessment.
Further research is needed to refine the extrapolation of rodent bioassay findings to human health.

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