biostudies-literatureSeo JECenter for Drug Evaluation and ResearchIntramural FDA HHS111538https://www.ebi.ac.uk/biostudies/studies/S-EPMC12441990biostudies-literatureUnknown416N-nitrosamines have been increasingly detected in human drugs, raising serious safety concerns due to their potential mutagenicity and carcinogenicity. In order to expand upon the human data available on these drug impurities, we previously used metabolically competent HepaRG human hepatoma cells to evaluate the genotoxicity of eight small-molecule nitrosamines [N-cyclopentyl-4-nitrosopiperazine (CPNP), N-nitrosodibutylamine (NDBA), N-nitrosodiethylamine (NDEA), N-nitrosodimethylamine (NDMA), N-nitrosodiisopropylamine (NDIPA), N-nitrosoethylisopropylamine (NEIPA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), and N-nitrosomethylphenylamine (NMPA)]. In this study, we used the comet assay to further investigate the DNA damage induced by the eight nitrosamines in primary human hepatocytes (PChemico-biological interactionsComparative DNA damage induced by eight nitrosamines in primary human and macaque hepatocytes.PMC12441990FD999999McGovern TJBryant MAtrakchi AHGuo XHe XSeo JEHeflich RHDavis Bruno KLfalseComparative DNA damage induced by eight nitrosamines in primary human and macaque hepatocytes.N-nitrosamines have been increasingly detected in human drugs, raising serious safety concerns due to their potential mutagenicity and carcinogenicity. In order to expand upon the human data available on these drug impurities, we previously used metabolically competent HepaRG human hepatoma cells to evaluate the genotoxicity of eight small-molecule nitrosamines [N-cyclopentyl-4-nitrosopiperazine (CPNP), N-nitrosodibutylamine (NDBA), N-nitrosodiethylamine (NDEA), N-nitrosodimethylamine (NDMA), N-nitrosodiisopropylamine (NDIPA), N-nitrosoethylisopropylamine (NEIPA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), and N-nitrosomethylphenylamine (NMPA)]. In this study, we used the comet assay to further investigate the DNA damage induced by the eight nitrosamines in primary human hepatocytes (P2025-01-01T00:00:00Z2025 Aug2026-06-03T11:21:20.133Z2026-05-29T03:06:07.637ZS-EPMC124419904031999810.1016/j.cbi.2025.111538