Application of the margin of exposure (MoE) approach to substances in food that are genotoxic and carcinogenic: EXAMPLE 12: Sudan I (CAS No. 842-07-9).

Sudan I is generally considered mutagenic based on various in vitro and in vivo tests and is carcinogenic in the rat. Dose-response modelling of the data for hepatocellular adenomas in male rats gave a BMDL(10) of 7.3mg/kg-bw/day. Sudan I is an unauthorised substance that might be present in food intermittently. The great variability and uncertainties in the human exposure data which are country specific, depending on consumption patterns and methodology used, resulted in a large range of MOE values (from 30 to 2,000,000).