A critical appraisal of the value of the mouse cancer bioassay in safety assessment.

Abstract:

:Substantial progress in understanding nongenotoxic or secondary mechanisms of tumorigenesis has been made over the past decade. However, the methods used in regulated studies for assessment of carcinogenic potential in chemicals in development have not evolved significantly. Based on the experience of over 30 yr of testing and the societal need to control costs, reevaluation of standard cancer rodent bioassay protocols is being done. Expert consensus after evaluating the results of full-scale rodent bioassays of both sexes in 2 species is that a reduced protocol is acceptable. After review of relevant data, it is our opinion that cancer hazard assessment in male and female rats only would be sufficient and that, in the future, mouse bioassays will not add significant value on a routine basis. We are unable to find an example of a mouse tumorigenic finding that predicts a confirmed or probable human response with negative findings in a rat bioassay. The savings realized by eliminating mouse testing from routine protocols would be substantial and better spent in expanding short-term studies to add to our understanding of chemical carcinogenesis.

journal_name

Toxicol Pathol

journal_title

Toxicologic pathology

authors

Alden CL,Smith PF,Piper CE,Brej L

doi

10.1177/019262339602400610

subject

Has Abstract

pub_date

1996-11-01 00:00:00

pages

722-5

issue

6

eissn

0192-6233

issn

1533-1601

journal_volume

24

pub_type

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