Determination of compound-specific acceptable daily intakes for 11 mutagenic carcinogens used in pharmaceutical synthesis

► All impurities were classified as DNA-reactive mutagenic carcinogens with linear dose-response. ► The ADIs ranged from 0.00357 to 257 μg/day. ► Three of 11 impurities had ADIs that were below the TTC. ► Three impurities had published exposure limits; two ADIs we derived were less conservative and one was similar. ► Selecting suitable bioassay data is challenging without knowledge of study design and limitations.