Food and Chemical Toxicology. 2006;44(10):1613-1635
This paper was elaborated by an Expert Group commissioned by the ILSI Europe Risk Assessment of Genotoxic Carcinogens in Food Task Force. The Expert Group examined the particular difficulties presented by low levels of food-borne DNA-reactive genotoxic carcinogens and proposes a structured approach for the evaluation of such compounds. The analysis of different approaches (ALARA, TTC, Low-dose extrapolation of bioassay data, Margin of Exposure) lead to the overall conclusion that the Margin of Exposure (MOE) is the most appropriate default approach because it combines information on potency and exposure, without the generation of numerical risk estimates of unknown reliability.
The extensive appendix of the paper lists MOEs calculated from T25 and BMDL10 values for selected carcinogens and selected human exposure data for six examples (Acrylamide, Aflatoxin B1, Benzo(a)pyrene, Dimethylnitrosamine, Ethyl carbamate, PhIP).
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The draft of this paper was discussed in the EFSA/WHO International Conference with support of ILSI Europe on “Risk Assessment of Compounds that are both Genotoxic and Carcinogenic: New Approaches” in November 2005. The summary report of the conference was published in the same issue of Food and Chemical Toxicology and is available here.
A supplementary document “Introduction to Genetic Toxicology” can be downloaded here.