A genotoxic carcinogen, N-nitrosodimethylamine (NDMA), was detected as a synthesis impurity in some valsartan drugs 2018, and other N-nitrosamines, such N-nitrosodiethylamine (NDEA), were later sartan products. N-nitrosamines are pro-mutagens that can react with DNA following metabolism to produce adducts, O6-alkyl-guanine. The adducts result replication miscoding errors leading GC>AT mutations...

The primary routes of potential human exposure to N-nitrosodiethylamine (NDEA) are ingestion, inhalation, and dermal contact. Air, diet and smoking contribute to potential human exposure at levels of a few μg of NDEA/day. Potential exposure depends on the ability of the nitrosamines to migrate from the product into the body. The first step in the metabolic degradation of NDEA by cytochrome oxid...

Cancer is particularly alarming in developing countries like India where life expectancy is increasing rapidly. Over the past 25 years the incidence and mortality rates of Hepatocellular carcinoma (HCC) are expected to double over the next 10–20 years.HCC is a transformation process of normal liver cell into a cancerous cell which involves initiation, promotion and progression stages.HCC was in...

Methyl tertiary butyl ether (MTBE) is an additive in some formulations of unleaded gasoline (UG) that enhances octane and reduces carbon monoxide emissions from motor vehicles. MTBE in CD-1 mice and UG in B6C3F1 mice increased the incidence of liver tumors selectively in female mice in their chronic bioassays. Both agents were negative in in vitro tests of genotoxicity, and exhibit similar hepa...

Tumors of the liver, kidneys, and lungs have been induced in rats by the feeding of dimethyl nitrosamine (DMN) and diethylnitrosamine (DENA) (1, 11, 12, 18). Dontenwill et al. (3, 4) reported that squamous-cell carcinoma of the trachea and lung of Syrian hamsters followed ad ministration of DENA by each of three ap proaches—tube feeding, inhalation, and subcu taneous injection. They observed ...