title: The toxicity of behenyl alcohol. I. Genotoxicity and subchronic toxicity in rats and dogs.
abstract: The genotoxic potential of behenyl alcohol, a saturated long-chain (C22:0) fatty alcohol, was examined in the Ames Salmonella typhimurium reverse mutation assay, the gene mutation, and chromosome aberrations assays in Chinese hamster V79 cells, and the micronucleus assay in NMRI mice. Behenyl alcohol did not increase the number of revertants per plate compared to controls in the S. typhimurium assay, with or without metabolic activation. No significant increases in the number of mutant colonies or in structural chromosome aberrations were observed in Chinese hamster V79 cells. In addition, behenyl alcohol did not increase the frequency of bone marrow polychromatic erythrocyte (PCE) micronuclei in mice in vivo. In two subchronic toxicity studies, CD rats and beagle dogs were administered behenyl alcohol by oral gavage for at least 26 weeks at doses of 0, 10, 100, or 1000 mg behenyl alcohol/kg body weight/day for rats and 0, 20, 200, or 2000 mg behenyl alcohol/kg body weight/day for dogs. Adverse effects were not observed following gross and histopathological evaluations of dosed rats. Compound-related effects in dogs were limited to observations of pale feces, indicative of unabsorbed behenyl alcohol, at doses of 2000 mg/kg body weight/day. There were no histopathological changes observed in dogs dosed with behenyl alcohol. The no-observed-adverse-effect-level (NOAEL) for behenyl alcohol was 1000 mg/kg body weight/day for rats, and 2000 mg/kg body weight/day for dogs, the highest doses used in these studies.
authors.affiliation: Cantox Health Sciences International, Inc 2233 Argentia Road, Suite 308, Mississauga, Ontario, L5N 2X7, Canada.
authors.forename: Guadalupe
authors.initials: G
authors.lastname: Iglesias
authors.forename: Jason  J
authors.initials: J
authors.lastname: Hlywka
authors.forename: James E
authors.initials: JE
authors.lastname: Berg
authors.forename: M H
authors.initials: MH
authors.lastname: Khalil
authors.forename: Laura E
authors.initials: LE
authors.lastname: Pope
authors.forename: Dov
authors.initials: D
authors.lastname: Tamarkin
mesh_terms: D000284:Administration, Oral; D000818:Animals; D019540:Area Under Curve; D016466:CHO Cells / Q000187:drug effects; D006224:Cricetinae; D003412:Cricetulus; D004285:Dogs; D004305:Dose-Response Relationship, Drug; D005233:Fatty Alcohols / Q000097:blood / Q000633:toxicity*; D005243:Feces; D005260:Female; D008297:Male; D051379:Mice; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D011916:Rats, Inbred F344; D012486:Salmonella typhimurium / Q000187:drug effects; D036401:Toxicity Tests, Chronic
chemical_list: D005233:Fatty Alcohols; C529236:docosanol