title: No evidence of toxicity or carcinogenicity of pentaerythritol tetranitrate given in the diet to F344 rats and B6C3F1 mice for up to two years.
abstract: Toxicology and carcinogenesis studies of pentaerythritol tetranitrate (PETN), an organic nitrate used in explosives and as a therapeutic agent for angina pectoris, were conducted by administering diets containing PETN,NF (National Formulary Grade, a 1:4 mixture of PETN and lactose) to both sexes of F344 rats and B6C3F1 mice in 14-day, 13-week and 2-year studies. PETN was found to be essentially non-toxic in 14-day and 13-week studies at dietary concentrations as high as 10,000 ppm; the weight gain of female rats was lower than that of controls at 5000 and 10,000 ppm in the 13-week study. In the 13-week studies, one in ten high-dose female rats had an adenoma of the Zymbal gland and one in ten high-dose female mice had a hepatocellular adenoma. Dietary concentrations chosen for the 2-year studies were 5000 and 10,000 ppm for male rats and male and female mice, and 1240 and 2500 ppm for female rats. In the 2-year studies, there were no adverse effects on survival or body weight gains in either sex of rats or mice. No neoplastic or non-neoplastic lesions were considered to be related clearly to PETN administration. Neoplasms of the Zymbal gland occurred at low incidences in PETN-exposed groups of both sexes of rats in the 2-year study.
authors: National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709.
authors: J R
authors: JR
authors: Bucher
authors: J
authors: J
authors: Huff
authors: J K
authors: JK
authors: Haseman
authors: S L
authors: SL
authors: Eustis
authors: H S
authors: HS
authors: Lilja
authors: A S
authors: AS
authors: Murthy
mesh_terms: D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002273:Carcinogens; D004032:Diet; D005260:Female; D008114:Liver Neoplasms, Experimental / Q000139:chemically induced / Q000473:pathology; D008297:Male; D051379:Mice; D008815:Mice, Inbred Strains; D010417:Pentaerythritol Tetranitrate / Q000633:toxicity*; D051381:Rats; D011916:Rats, Inbred F344; D012626:Sebaceous Gland Neoplasms / Q000139:chemically induced / Q000473:pathology; D013045:Species Specificity
chemical_list: D002273:Carcinogens; D010417:Pentaerythritol Tetranitrate