Toxicological assessment of a particulate yeast (1,3/1,6)-β-d-glucan in rats

Food and Chemical Toxicology

Volumn 45, Issue 9, 2007, Pages 1719-1730

  Babicek K ^a   Cechova I ^a   Simon, R R ^b   Harwood, M ^b   Cox, D J ^c  

^a Research Institute of Biopharmacy and Veterinary Drugs   (Czech Republic)

^b Cantox Health Sciences International   (Canada)

^c Biothera   (United States)

Author keywords

(1,3) d Glucan; NOAEL; Rat; Safety; Toxicity; Yeast

Indexed keywords

BETA 1,3 GLUCAN; BETA 1,6 GLUCAN; BETA GLUCAN; UNCLASSIFIED DRUG; WGP 3-6;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BLOOD ANALYSIS; CLINICAL CHEMISTRY; CONTROLLED STUDY; DOSE RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOOD COMPOSITION; MALE; MORTALITY; NONHUMAN; RAT; SINGLE DRUG DOSE; YEAST;

ACUTE TOXICITY TESTS; ANALYSIS OF VARIANCE; ANIMALS; BETA-GLUCANS; BLOOD CHEMICAL ANALYSIS; BODY WEIGHT; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEMATOLOGIC TESTS; INTUBATION, GASTROINTESTINAL; LETHAL DOSE 50; MALE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RANDOM ALLOCATION; RATS; RATS, INBRED F344; SACCHAROMYCES CEREVISIAE; TOXICITY TESTS, CHRONIC;

ANIMALIA; RATTUS;

EID: 34547127390     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2007.03.013     Document Type: Article

References (41)

1. Babineau T.J., Marcello P., Swails W., Kenler A., Bistrian B., and Forse R.A. Randomized phase I/II trial of a macrophage-specific immunomodulator (PGG-glucan) in high-risk surgical patients. Ann. Surg. 220 (1994) 601-609
2. Babineau T.J., Hackford A., Kenler A., Bistrian B., Forse R.A., Fairchild P.G., Heard S., Keroack M., Caushaj P., and Benotti P. A phase II multicenter, double-blind, randomized, placebo-controlled study of three dosages of an immunomodulator (PGG-glucan) in high risk surgical patients. Arch. Surg. 129 (1994) 1204-1210
3. Bohn J.A., and BeMiller J.N. (1→3)-β-d-Glucans as biological response modifiers: A review of structure-functional activity relationships. Carbohydr. Polym. 28 (1995) 3-14
4. Bowers G.J., Patchen M.L., MacVittie T.J., Hirsch E.F., and Fink M.P. A comparative evaluation of particulate and soluble glucan in an endotoxin model. Int. J. Immunopharmacol. 8 (1986) 313-321
5. Breivik T., Opstad P.K., Engstad R., Gundersen G., Gjermo P., and Preus H. Soluble β-1,3/1,6-glucan from yeast inhibits experimental periodontal disease in Wistar rats. J. Clin. Periodontol. 32 (2005) 347-352
6. Browder W., Williams D., Pretus H., Olivero G., Enrichens F., Mao P., and Franchello A. Beneficial effect of enhanced macrophage function in the trauma patient. Ann. Surg. 211 (1990) 605-612 & discussion 612-613
7. Brown G. Hematology tests in toxicology: time for a re-think?. Comp. Hematol. Int. 2 (1992) 231-235
8. Brown G.D., Herre J., Williams D.L., Willment J.A., Marshall A.S., and Gordon S. Dectin-1 mediates the biological effects of β-glucans. J. Exp. Med. 197 (2003) 1119-1124
9. Cheung N.-K.V., Modak S., Vickers A., and Knuckles B. Orally administered β-glucans enhance anti-tumor effects of monoclonal antibodies. Cancer Immunol. Immunother. 51 (2002) 557-564
10. Cisneros R.L., Gibson F.C., and Tzianabos A.O. Passive transfer of poly-(1-6)-β-glucotriosyl-(1-3)-β-glucopyranose glucan protection against lethal infection in an animal model of intra-abdominal sepsis. Infect. Immun. 64 (1996) 2201-2205
11. Cramer D.E., Allendorf D.J., Baran J.T., Hansen R., Marroquin J., Li B., Ratajczak J., Ratajczak M.Z., and Yan J. β-glucan enhances complement-mediated hematopoietic recovery after bone marrow injury. Blood 107 (2006) 835-840
12. Dellinger E.P., Babineau T.J., Bleicher P., Kaiser A.B., Seibert G.B., Postier R.G., Vogel S.B., Norman J., Kaufman D., Galandiuk S., and Condon R.E. Effect of PGG-glucan on the rate of serious postoperative infection or death observed after high-risk gastrointestinal operations. (for the Betafectin Gastrointestinal Study Group). Arch. Surg. 134 (1999) 977-983
13. Descotes J. Importance of immunotoxicity in safety assessment: a medical toxicologist's perspective. Toxicol. Lett. 149 (2004) 103-108
14. Di Luzio N.R., Williams D.L., McNamee R.B., Edwards B.F., and Kitahama A. Comparative tumor inhibitory and antibacterial activity of soluble and particulate glucan. Int. J. Cancer 24 (1979) 773-779
15. Dillon S., Agrawal S., Banerjee K., Letterio J., Denning T.L., Oswald-Richter K., Kasprowicz D.J., Kellar K., Pare J., van Dyke T., Ziegler S., Unutmaz D., and Pulendran B. Yeast zymosan, a stimulus for TLR2 and dectin-1, induces regulatory antigen-presenting cells and immunological tolerance. J. Clin. Invest. 116 (2006) 916-928
16. Feletti F., De Bernardi di Valserra M., Contos S., Mattaboni P., and Germogli R. Chronic toxicity study on a new glucan extracted from Candida albicans in rats. Arzneimittelforschung 42 (1992) 1363-1367
17. Gantner B.N., Simmons R.M., Canavera S.J., Akira S., and Underhill D.M. Collaborative induction of inflammatory responses by dectin-1 and Toll-like receptor 2. J. Exp. Med. 197 (2003) 1107-1117
18. Gu Y.-H., Takagi Y., Nakamura T., Hasegawa T., Suzuki I., Oshima M., Tawaraya H., and Niwano Y. Enhancement of radioprotection and anti-tumor immunity by yeast-derived β-glucan in mice. J. Med. Food 8 (2005) 154-158
19. Herre J., Gordon S., and Brown G.D. Dectin-1 and its role in the recognition of β-glucans by macrophages. Mol. Immunol. 40 (2004) 869-876
20. Hong F., Yan J., Baran J.T., Allendorf D.J., Hansen R.D., Ostroff G.R., Xing P.X., Cheung N.-K.V., and Ross G.D. Mechanism by which orally administered β-1,3-glucans enhance the tumoricidal activity of antitumor monoclonal antibodies in murine tumor models. J. Immunol. 173 (2004) 797-806
21. Johnson K.J., Glovsk M., and Schrier D. Pulmonary granulomatous vasculitis. Pulmonary granulomatous vasculitis induced in rats by treatment with glucan. Am. J. Pathol. 114 (1984) 515-516
22. Kernodle D.S., Gates H., and Kaiser A.B. Prophylactic anti-infective activity of poly-[1-6]-β-d-glucopyranosyl-[1-3]-β-d-glucopryanose glucan in a guinea pig model of staphylococcal wound infection. Antimicrob. Agents Chemother. 42 (1998) 545-549
23. Ko Y.T., and Lin Y.L. 1,3-β-Glucan quantification by a fluorescence microassay and analysis of its distribution in foods. J. Agric. Food Chem. 52 (2004) 3313-3318
24. Li J., Xing J., Li D., Wang X., Zhao L., Lv S., and Huang D. Effects of β-glucan extracted from Saccharomyces cerevisiae on humoral and cellular immunity in weaned piglets. Arch. Anim. Nutr. 59 (2005) 303-312
25. Li B., Allendorf D.J., Hansen R., Marroquin J., Ding C., Cramer D.E., and Yan J. Yeast beta-glucan amplifies phagocyte killing of iC3b-opsonized tumor cells via complement receptor 3-Syk-phosphatidylinositol 3-kinase pathway. J. Immunol. 177 (2006) 1661-1669
26. Miura N.N., Adachi Y., Yodomae T., Tamura S.T., and Ohno N. Structure and biological activities of β-glucans from yeast and mycelial forms of Canida albicans. Microbiol. Immunol. 47 (2003) 173-182
27. Mueller A., Raptis J., Rice P.J., Kalbfleisch J.H., Stout R.D., Ensley H.E., Browder W., and Williams D.L. The influence of glucan polymer structure and solution conformation on binding to (1→3)-β-d-glucan receptors in a human monocyte-like cell line. Glycobiology 10 (2000) 339-346
28. Nicolosi R., Bell S.J., Bistrian B.R., Greenberg I., Forse R.A., and Blackburn G.L. Plasma lipid changes after supplementation with β-glucan fiber from yeast. Am. J. Clin. Nutr. 70 (1999) 208-212
29. OECD, 2001. Acute oral toxicity - Fixed dose procedure. In: OECD Guidelines for the Testing of Chemicals. Organization for Economic Co-operation and Development (OECD), Paris, Guideline Test No. 420.
30. Ohno N., Suzuki T., Saito K., and Yadomae T. Enhancement of clot formation of human plasma by β-glucans. J. Pharmacobiodyn. 13 (1990) 525-532
31. Onderdonk A.B., Cisneros R.L., Hinkson P., and Ostroff G. Anti-infective effect of poly-β1-6-glucotriosyl-β1-3-glucopyranose glucan in vivo. Infect. Immun. 60 (1992) 1642-1647
32. Patchen M.L., and MacVittie T.J. Hemopoietic effects of intravenous soluble glucan administration. J. Immunopharmacol. 8 (1986) 407-425
33. Riggi S.J., and Di Luzio N.R. Identification of a reticuloendothelial stimulating agent in zymosan. Am. J. Physiol. 200 (1961) 297-300
34. Saitô H., Yoshioka Y., Uehara N., Aketagawa J., Tanaka S., and Shibata Y. Relationship between conformation and biological response for (1→3)-β-d-glucans in the activation of coagulation factor G from limulus amebocyte lysate and host-mediated antitumor activity. Demonstration of single-helix conformation as a stimulant. Carbohydr. Res. 217 (1991) 181-190
35. Seljelid R., Bögwald J., and Lundwall Å. Glycan stimulation of macrophages in vitro. Exp. Cell Res. 131 (1981) 121-129
36. US FDA, 2006. Part 172-Food additives permitted for direct addition to food for human consumption. §172.898-Bakers yeast glycan. In: Code of Federal Regulations (CFR). Title 21-Food and Drugs (US Food and Drug Administration). US Government Printing Office (GPO), Washington, DC, p. 119.
37. Vetvicka V., Terayama K., Mandeville R., Brousseau P., Kournikakis B., and Ostroff G. Pilot study: orally-administered yeast β1,3-glucan prophylactically protects against anthrax infection and cancer in mice. J. Am. Nutraceut. Assoc. 5 (2002) 1-5
38. WHO, 1987. Toxicological versus physiological responses. In: Principles for the Safety Assessment of Food Additives and Contaminants in Food. World Health Organization (WHO), International Programme on Chemical Safety (IPCS), Geneva. Environmental Health Criteria, No. 70, p. 82.
39. Williams D.L., Sherwood E.R., Browder I.W., McNamee R.B., Jones E.L., and Di Luzio N.R. Pre-clinical safety evaluation of soluble glucan. Int. J. Immunopharmacol. 10 (1988) 405-414
40. Willment J.A., Gordon S., and Brown G.D. Characterization of the human β-glucan receptor and its alternatively spliced isoforms. J. Biol. Chem. 276 (2001) 43818-44323
41. Xia Y., Větvička V., Yan J., Hanikýřová M., Mayadas T., and Ross G.D. The β-glucan-binding lectin site of mouse CR3 (CD11b/CD18) and its function in generating a primed state of the receptor that mediates cytotoxic activation in response to iC3b-opsonized target cells. J. Immunol. 162 (1999) 2281-2290