title: Genotoxicity studies of PolyGlycopleX (PGX): a novel dietary fiber.
abstract: PolyGlycopleX (PGX), a novel dietary fiber, produces no mutagenic effects in bacterial tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, and TA 1537 and Escherichia coli WP2 uvrA at concentrations of 0.316, 1.00, 3.16, 10.0, 31.6, and 100 microg/plate. No biologically relevant increases in revertant colonies of any of the 5 strains are observed at any concentration; however, a reduction at 100 microg/plate in TA 1537 is noted. PGX, analyzed for polychromatic erythrocyte micronuclei induction in mice following a single 1x, 0.5x, and 0.2x maximum tolerable dose intraperitoneal treatment, produces no biologically relevant increase in any dose group. Males at 1x maximum tolerable dose show a reduction of micronuclei-containing cells. High-dose animals show signs of systemic toxicity, including a reduction of spontaneous activity, rough fur, palpebral closure, prone position, and constricted abdomen. These genotoxicity studies show PGX to be nonmutagenic in both the Ames bacterial reverse mutation assay and the mammalian erythrocyte micronucleus test.
authors.affiliation: Eurofins Product Safety Laboratories, 2394 US Highway 130, Suite E, Dayton, NJ 08810, USA. PamMarone@productsafetylabs.com
authors.forename: Palma Ann
authors.initials: PA
authors.lastname: Marone
authors.forename: Michael
authors.initials: M
authors.lastname: Lyon
authors.forename: Roland
authors.initials: R
authors.lastname: Gahler
authors.forename: Claudia
authors.initials: C
authors.lastname: Donath
authors.forename: Hana
authors.initials: H
authors.lastname: Hofman-Hüther
authors.forename: Simon
authors.initials: S
authors.lastname: Wood
mesh_terms: D000464:Alginates / Q000633:toxicity*; D000818:Animals; D001711:Biotransformation; D004043:Dietary Fiber / Q000633:toxicity*; D004338:Drug Combinations; D004926:Escherichia coli / Q000187:drug effects; D051379:Mice; D009152:Mutagenicity Tests; D011135:Polysaccharides, Bacterial / Q000633:toxicity*; D012486:Salmonella typhimurium / Q000187:drug effects
chemical_list: D000464:Alginates; D004043:Dietary Fiber; D004338:Drug Combinations; C540519:PolyGlycoplex; D011135:Polysaccharides, Bacterial