Safety evaluation of pectin-derived acidic oligosaccharides (pAOS): Genotoxicity and sub-chronic studies

Regulatory Toxicology and Pharmacology

Volumn 57, Issue 1, 2010, Pages 31-42

  Garthoff, Jossie A ^a   Heemskerk, Suzanne ^a,b   Hempenius, Rixta A ^c   Lina, Ben A R ^d   Krul, Cyrille A M ^d   Koeman, Jan H ^e   Speijers, Gerrit J A ^f  

^a DANONE RESEARCH   (Netherlands)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c ENVIRON Netherlands BV   (Netherlands)

^d TNO   (Netherlands)

^e Emeritus Prof of Toxicology   (Netherlands)

^f General Health Effects Toxicology Safety Food (GETS)   (Netherlands)

Author keywords

Ames; Chromosomal aberration; In utero; Infant formulae; Medical foods; Micronucleus; Mouse lymphoma; Non digestible carbohydrates; PAOS

Indexed keywords

ACIDIC OLIGOSACCHARIDE; AMMONIUM CHLORIDE; OLIGOSACCHARIDE; PECTIN; SODIUM; UNCLASSIFIED DRUG;

AMES TEST; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; ARTIFICIAL MILK; BLADDER EPITHELIUM; CARBOHYDRATE ANALYSIS; CHROMOSOME ABERRATION; CONCENTRATION RESPONSE; CONTROLLED STUDY; ENVIRONMENTAL EXPOSURE; EPITHELIUM HYPERPLASIA; FEMALE; FOOD INTAKE; FOOD SAFETY; GENOTOXICITY; IN VIVO STUDY; LYMPHOMA; MALE; MOUSE; MUTATIONAL ANALYSIS; NONHUMAN; NUTRITIONAL ASSESSMENT; PRENATAL EXPOSURE; PRIORITY JOURNAL; RAT; RISK ASSESSMENT; SODIUM URINE LEVEL; TOXICITY TESTING; URINE PH;

ADMINISTRATION, ORAL; ANIMALS; ANIMALS, NEWBORN; BODY WEIGHT; CELL LINE, TUMOR; CHO CELLS; CHROMOSOME ABERRATIONS; CONSUMER PRODUCT SAFETY; CRICETINAE; CRICETULUS; DOSE-RESPONSE RELATIONSHIP, DRUG; ESCHERICHIA COLI; FEMALE; INFANT FORMULA; LACTATION; MALE; MATERNAL EXPOSURE; MICE; MITOTIC INDEX; MUTAGENICITY TESTS; OLIGOSACCHARIDES; ORGAN SIZE; PECTINS; PREGNANCY; RATS; RATS, WISTAR; SALMONELLA TYPHIMURIUM; TOXICITY TESTS, CHRONIC; URINARY BLADDER;

RATTUS;

EID: 77951976875     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.12.004     Document Type: Article

References (50)

1. Amberg, A., Braun, K., Czich, A., Kauffmann H-M., Spirkl, H-P., Stammberger, I., Troschau, G., 2008. Positive genotoxicity results due to the formation of genotoxic reaction-products of the solvent DMSO with carboxylic/sulfonic acid halides. SOT 2008, abstract #2259.
2. Ben Amor, K., Gori, A., Rizzardini, G., Torti, C., Quirino T., Moroni, M., Kno, J., Bray, D., Vriesema, A., Clerici M, 2008. Disturbed gut microbiota in HAART-naïve HIV-positive adults: effects of intervention with a specific prebiotic oligosaccharide mixture. In: 15th CROI Conference, 3-6 Feb 2008, Boston, USA.
3. Boehm G., Moro G. Structural and functional aspects of prebiotics used in infant nutrition. J. Nutr. 2008, 138:18185-18285.
4. Brommage R., Binacua C., Antille S., Carrfie A. Intestinal calcium absorption in rats as stimulated by dietary lactulose and other resistant sugars. J. Nutr. 1993, 123:2186-2194.
5. Codex Alimentarius, 1981. Codex standard 72 on infant formula and formulas for special medical purposes intended for infants, pp. 1-21 (as amended).
6. Coppa G.V., Zampini L., Galeazzi T., Facinelli B., Ferrante L., Capretti R., Orazio G. Human milk oligosaccharides inhibit the adhesion to Caco-2 cells of diarrheal pathogens: Escherichia coli, Vibrio cholerae, and Salmonella fyris. Pediatr. Res. 2006, 59:377-382.
7. Cummings J.H., Edmons L.M., Magee E.A. Dietary carbohydrate and health: do we still need the fibre concept?. Clin. Nutr. Suppl. 2004, 1:5-17.
8. Doesburg J. Relation between the behaviour of pectin substances and changes in firmness of horticultural products during heating. Qual. Plant. et Mater. Veg. 1961, VIII:115-129.
9. EC Commission Directive 1999/21/EC, OJ L 91, 7.4.1999.
10. EC Commission Directive 2001/59/EC, OJ L 225, 21.8.2001.
11. EC Commission Directive 2006/141/EC, OJ L 401, 30.12.2006.
12. EC Council Directive 86/609/EEC, OJ L 358, 18.12.1986.
13. Eder E., Deininger C. The influence of the solvents DSMO and ethanol on the genotoxicity of alpha, beta-unsaturated aldehydes in the SOS chromotest. Mutat. Res. 2002, 516:81-89.
14. Fanaro S., Boehm G., Garssen J., Knol J., Mosca F., Stahl B., Vigi V. Galacto-oligosaccharides and long-chain fructo-oligosaccharides as prebiotics in infant formulas: a review. Acta Paediatr. Suppl. 2005, 94:22-26.
15. Fanaro S., Jelinek J., Stahl B., Boehm G., Kock R., Vigi V. Acidic oligosaccharides from pectin hydrolysate as new component for infant formulae: effect on intestinal flora, stool characteristics, and pH. J. Pediatr. Gastroenterol. Nutr. 2005, 41:186-190.
16. Flamm G., Glinsmann W., Kritchevsky W., Proski L., Roberfroid M. Inulin and oligofructose as dietary fiber: a review of the evidence. Crit. Rev. Food Sci. Nutr. 2001, 41:353-362.
17. Gebel T., Koenig A. Impact of dimethyl sulfoxide and examples of combined genotoxicity in the SOS chromotest. Mutat. Res. 1999, 444:405-411.
18. Gori, A., Rizzardine, G., Van't Land, B., Ben Amor, K., Van Schaik, J., Torti, C., Quirino, T., Tincati, C., Bandera, A., Knol, J., Benlhassan-chahour, K., Trabatloni, D., Bray, D., Vriesema, A., Welling G., Garssen, J., Clerici, M., submitted for publication. Specific prebiotics modulate gut microbiota and immune activation in HAART-native HIV infected adults. Results of the COPA pilot trial.
19. Govers M., Buco A., Hendrich T., Stahl B., Boehm G. Comparison of human milk oligosaccharides with oligosaccharides for use in infant nutrition on in vitro fermentation using faeces form breast-fed and formula-fed infants. J. Pediatr. Gastroenterol. Nutr. 2005, 40:PN1-23.
20. de Groot A.P., Feron V.J., Immel H.R. Induction of hyperplasia in the bladder epithelium of rats by a dietary excess of acid or base: implications for toxicity/carcinogenicity testing. Food Chem. Toxicol. 1988, 26:425-434.
21. Guggenbichler J., De Bettignies-Dutz A., Meissner P., Schellmoser S., Jurenitsch J. Acidic oligosaccharides from natural sources block adherence of Escherichia coli on uroepithelial cells. Pharm. Pharmacol. Lett. 1997, 1:35-38.
22. Harquindey S. Integrating fields of cancer research through pivotal mechanisms and synthetic final pathways: a unifying and creative overview. Med. Hypotheses 2002, 58:444-452.
23. Heusel J.W., Siggaard-Andersen O., Scott M.G. Physiology and disorders of water, electrolyte and acid-base metabolism. Tietz Textbook of Clinical Chemistry 1999, 1095-1124. W.B. Sounders Company, Philadelphia. C.A. Burtis, E. Ashwood (Eds.).
24. Hodkinson A., Davis D., Fourman J., Roberson W.G., Roe F.J.C. A comparison of the effect of lactose and of two chemically modified waxy maize starches on mineral metabolism in the rat. Food Chem. Toxicol. 1982, 20:371-382.
25. Kastner U., Glasl S., Follrich B., Guggenbichler J.P., Jurenitsch J. Acid oligosaccharides as the active principle of aqueous carrot extracts for prevention and therapy of gastrointestinal infections. Wien Med. Wochenschr. 2002, 152:379-381.
26. Kirkland D., Pfuhler S., Tweats D., Aardema M., Corvi R., Darroudi F., Elhajouji A., Glatt H., Hastwell P., Hayashi M., Kasper P., Kirchner S., Lynch A., Marzin D., Maurici D., Meunier J.R., Muller L., Nohynek G., Parry J., Parry E., Thybaud V., Tice R., van Benthem J., Vanparys P., White P. How to reduce false positive results when undertaking in vitro genotoxicity testing and thus avoid unnecessary follow-up animal tests: report of an ECVAM workshop. Mutat. Res. 2007, 628:31-55.
27. Kunz C., Rudolff S., Baie W., Klein N., Strobel S. Oligosaccharides in human milk: structural, functional and metabolic aspects. Ann. Rev. Nutr. 2000, 20:699-722.
28. Lee K.B., Lee Y.C. Transfer of modified sialic acids by Trypanosoma cruzi trans-sialidase for attachment of functional groups to oligosaccharides. Anal. Biochem. 1994, 216:358-364.
29. Lemann J.L., Litzow J.R., Lennon E.J. Studies on the mechanism by which metabolic acidosis augments urinary calcium excretion in man. J. Clin. Invest. 1967, 46:1318-1328.
30. Lina B.A.R., Woutersen R.A. Effects of urinary potassium and sodium ions concentrations and pH on N-butyl-N-(4-hyrdroxybutyl) nitrosamine-induced urinary bladder carcinogenesis in rats. Carcinogenesis 1989, 10:1733-1736.
31. Lina B.A., Hollanders V.M., Kuijpers M.H. The role of alkalizing and neutral potassium salts in urinary bladder carcinogenesis in rats. Carcinogenesis 1994, 15:523-527.
32. Lina B.A.R. Diet-induced Modification of the Acid-base Balance in Rats. Toxicological Implications 2004, Utrecht University, Utrecht, pp. 128.
33. Marlett J.A. Content and composition of dietary fiber in 117 frequently consumed foods. J. Am. Diet. Assoc. 1992, 92:175-186.
34. McCormick C.P., Rauch A.L., Buckalew V.M. Differential effect of dietary salt on renal growth in Dahl salt-sensitive and salt-resistant rats. Hypertension 1989, 13:122-127.
35. Moro G.E., Stahl B., Fanaro S., Jelinek J., Boehm G., Coppa G.V. Dietary prebiotic oligosaccharides are detectable in the faeces of formula-fed infants. Acta Paediatr. Suppl. 2005, 94:27-30.
36. Moundras C., Behr S.R., Demigné D.C., Mazur A., Rémésy C. Fermentable polysaccharides that enhance fecal bile acid excretion lower plasma cholesterol and apolipoprotein E-rich HDL in rats. J. Nutr. 1994, 124:2179-2188.
37. Ng A., Waldron K.W. Effect of cooking and pre-cooking on cell-wall chemistry in relation to firmness of carrot tissues. J. Sci. Food Agric. 1997, 73:503-512.
38. OECD, 1997. Organisation for Economic Co-operation and Development. OECD Guideline for Testing of Chemicals Nos. 471, 473, 474 and 476. Genetic Toxicology, Paris.
39. OECD, 1998. Organisation for Economic Co-operation and Development. OECD guideline for Testing of Chemicals No. 408. Repeated Dose 90-day Oral Toxicity in Rodents, Paris.
40. Roberfroid M. Dietary fibre, inulin and oligofructose: a review comparing their physiological effects. Crit. Rev. Food Sci. Nutr. 1993, 33:103-148.
41. Rolin C., Nielsen B.U., Glahn P.E. Pectin 1998, Marcel Dekker Inc., New York, pp. 377.
42. Salminen S.J., Gueimonde M., Isolauri E. Probiotics that modify disease risk. J. Nutr. 2005, 135:1294-1298.
43. Stahl B., Thurl S., Zeng J., Karas M., Hillenkamp F., Steup M., Sawatzki G. Oligosaccharides from human milk as revealed by matrix-assisted laser desorption/ionization mass spectrometry. Anal. Biochem. 1994, 223:218-226.
44. Vaisman N., Boehm G., Jelinek J., Stahl B., Coppa G. Pectin hydrolysate is resistant against digestion during small intestinal passage in ileostomic patients. J. Pediatr. Gastroenterol. Nutr. 2004, 39:S486.
45. Van't Land, B., Benlhassan-Chahour, K., Rizzardini, G., Vriesema, A., Garssen, J., Trabattoni, D., Bray, D., Gori, A., Clerici, M., COPA Study Team, 2008. A specific mixture of prebiotic oligosaccharides reduces hyper-immune activation and improves NK cell cytolytic activity in HAART-naïve HIV positive adults. In: 15th CROI Conference, 3-6 February 2008, Boston, USA.
46. Vos A.P., Haarman M., van Ginkel J.W., Knol J., Garssen J., Stahl B., Boehm G., M'Rabet L. Dietary supplementation of neutral and acidic oligosaccharides enhances Th1-dependent vaccination responses in mice. Pediatr. Allergy Immunol. 2007, 18:304-312.
47. Vos A.P., van Esch B.C., Stahl B., M'Rabet L., Folkerts G., Nijkamp F.P., Garssen J. Dietary supplementation with specific oligosaccharide mixtures decreases parameters of allergic asthma in mice. Int. Immunopharmacol. 2007, 7:1582-1587.
48. WHO (World Health Organisation) Principles for the safety assessment of food additives and contaminants in food. Environ. Health Criteria 1987, 70:39-59.
49. WHO (World Health Organisation), 2007. Evaluation of Certain Food Additives and Contaminants (Sixty-seventh Report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series 940.
50. Younes H., Garleb K., Behr S., Rémésy C., Demigné C. Fermentable fibers or oligosaccharides reduce urinary nitrogen excretion by increasing urea disposal in the rat cecum. J. Nutr. 1995, 125:1010-1016.