A deep dive into historical Ames study data for N-nitrosamine compounds

• DOI: 10.1016/j.yrtph.2023.105460
• Publication Date: 2023-07-24T23:31:24Z
• Authors: Rachael E. Tennant; David J. Ponting; Andrew Thresher
• Keywords: Ames test; Nitrosamine

Mutagenicity data is a core component of the safety assessment required by regulatory agencies for acceptance new drug compounds, with OECD-471 bacterial reverse mutation (Ames) assay most widely used as primary screen to assess impurities potential mutagenic risk. N-Nitrosamines are highly potent carcinogens in rodent bioassays and their recent detection pharmaceutical products has sparked increased interest assessment. Previous literature reports indicated that Ames test might not be sensitive enough detect N-nitrosamines order accurately predict risk carcinogenicity. To explore this hypothesis, public carcinogenicity pertaining N-nitrosamine class compounds was collated analysis. Here we present how variations OECD 471-compliant test, including strain, metabolic activation, solvent type pre-incubation/plate incorporation methods, may impact predictive performance An understanding optimal conditions testing improve both accuracy confidence ability identify carcinogens.