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The objectives of this paper are to (1) reexamine the data that were used to support the conclusion of a threshold effect for 2-amino-3,8-dimethylimidazo[4,5-f] quinoxaline (MeIQx)-induced initiation and carcinogenicity at low doses in the rat liver, and (2) discuss issues and uncertainties about assessing cancer risk at low doses. Our analysis is part of an effort to understand proper interpretation and modeling of data related to cancer mechanisms and is not an effort to develop a risk assessment for this compound. The data reanalysis presented herein shows that the low-dose initiation activity of MeIQx, which can be found in cooked meat, cannot be dismissed. It is argued that the threshold effect for carcinogenic agents cannot be determined by statistical non-significance alone; more relevant biological information is required. A biologically motivated procedure is proposed for data analyses. The concept and procedure that are appropriate for analyzing MeIQx data are equally applicable to other compounds with comparable data.

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