Article
Quantitative genotoxicity assessment of N-nitrosodimethylamine in mice by error-corrected next-generation sequencing and DNA methylation quantification for toxicity threshold determination.
Archives of toxicology - 1 Nov 2025
You Xinyue, Sun Chen, Cao Yiyi, Xi Jing, Liu Weiying, Wu Jiaying, Zheng Jiang, Luan Yang
Abstract excerpt
The contamination of N-nitrosamines (N-NAs) in pharmaceuticals has raised global concerns, due to potential carcinogenic risks. N-nitrosodimethylamine (NDMA) is a rodent carcinogen and the most prevalent N-NAs impurity in drug products. Current acceptable intake of NDMA (96 ng/day) is a simple li...
Topics
- Animals
- Dimethylnitrosamine
- Mice
- DNA Adducts
- High-Throughput Nucleotide Sequencing
- DNA Methylation
- Dose-Response Relationship, Drug
- Male
- Mutagenicity Tests
- Liver
- Mutation
- Tandem Mass Spectrometry
- Carcinogens
- Female
- Risk Assessment