The Threshold of Toxicological Concern (TTC) is a concept that is intended to establish an acceptable level of intake for an unstudied chemical that poses a negligible risk of carcinogenicity or toxic effects. It is a conservative estimate where the TD50, or dose that causes 50% tumor incidence, is extrapolated to a dose that would be expected to cause a 1 in 106 incidence using available data. Certain structural groups have been identified to be of such high mutagenic potency that the TTC approach is not justified for these compounds. This group is comprised of aflatoxin-like-, N-nitroso, and alkyl-azoxy compounds and is referred to as the Cohort of Concern (CoC). This white paper explores these groups of compounds and the associated regulatory guidance.
E&L testing helps us achieve the goal of this project, to demonstrate the detection of…