期刊
REGULATORY TOXICOLOGY AND PHARMACOLOGY
卷 66, 期 1, 页码 109-115出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2013.03.009
关键词
4-Methylimidazole; Rodent cancer bioassay; Mouse lung tumors; National Toxicology Program; Categories of evidence of carcinogenic activity; Technical Reports
资金
- American Beverage Association
The potential carcinogenicity of 4-methylimidazole (4-MEI) was evaluated in a National Toxicology Program (NTP) rodent cancer bioassay in Fischer 344 rats and B6C3F1 mice (NTP, 2007; Chan et al., 2008). The NTP concluded that there was clear evidence of carcinogenic activity in male and female mice, based on an increased incidence of lung tumors. The category of evidence that the NTP assigns to a rodent cancer bioassay outcome can have significant regulatory implications. This is especially important for 4-MEI, which forms in caramel colorings and other foods during cooking, with potential widespread human exposure in a broad spectrum of food and beverage products. A detailed analysis of all NTP mouse-lung-tumor-only carcinogens reveals that the proper call for lung tumors in the 4-MEI study should have been some evidence rather than clear evidence of carcinogenic activity for both male and female mice in order to be consistent with the NTP's interpretation of other mouse lung carcinogens showing a similar strength of response. Suggestions are given as to measures the NTP should consider in the preparation of some or all future Technical Reports in order to enhance consistency of interpretation of experimental results. (C) 2013 Elsevier Inc. All rights reserved.
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