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Updated: Aug 18, 2026

Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment
Published on: April 22, 2019
A note on the role of background tumor incidence in risk assessment for carcinogens
R L Kodell1, J J Chen, D W Gaylor
1Food and Drug Administration, National Center for Toxicological Research, Jefferson, Arkansas 72079.
Abstract:
The extrapolation of animal bioassay data to humans for the purpose of estimating risk from food additives, drugs, pesticides, etc. is still the primary approach to carcinogenic risk assessment. When the extrapolation is based on tumor data with high background incidence (e.g., hepatocellular tumors in rodents), its direct relevance to the human situation is sometimes questioned. This paper suggests a method for adjusting the acceptable excess risk level for humans according to the background incidence of the tumor type used for extrapolating from animals to humans. Application of the suggested "fixed relative risk" extrapolation method in setting acceptable low-risk exposure levels for humans is illustrated for methylene chloride.
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