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Genotoxicity Studies of PolyGlycopleX (PGX)

A Novel Dietary Fiber

From the Eurofins Product Safety Laboratories, Dayton, New Jersey (PAM); Canadian Centre for Functional Medicine, Coquitlam, British Columbia, Canada (ML, SW); University of British Columbia, Vancouver (ML); Factors R & D Technologies, Calgary, Alberta, Canada (RG); and and BSL Bioservice Scientific Laboratories GmbH, Planegg, Germany (CD, HH-H).

Correspondence: Please address correspondence to Palma Ann Marone, Eurofins Product Safety Laboratories, 2394 US Highway 130, Suite E, Dayton, NJ 08810; E-mail:PamMarone{at}productsafetylabs.com.

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 µg/plate. No biologically relevant increases in revertant colonies of any of the 5 strains are observed at any concentration; however, a reduction at 100 µg/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.

Key Words: Ames test • dietary fiber • genotoxicity • mammalian erythrocyte micronucleus • PGX

International Journal of Toxicology, Vol. 28, No. 4, 318-331 (2009)
DOI: 10.1177/1091581809338955


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