| Safety evaluation of pectin-derived acidic oligosaccharides (pAOS): genotoxicity and sub-chronic studies. | |
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MedLine Citation:
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PMID: 20026148 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Pectin-derived acidic oligosaccharides (pAOS) are non-digestible carbohydrates to be used in infant formulae and medical nutrition. To support its safety, the genotoxic potential of pAOS was evaluated. pAOS was not mutagenic in the Ames test. Positive results were obtained in the chromosome aberration test only at highly cytotoxic concentrations. The effects obtained in the mouse lymphoma test were equivocal; pAOS was not mutagenic in vivo. A sub-chronic dietary study, preceded by 4-week parental and in utero exposure phase, investigated general safety. Administration of pAOS did not affect parental health nor pup characteristics. No effects specific for acidic oligosaccharides were observed in the subsequent sub-chronic study. Slight diffuse hyperplasia of epithelial layer of the urinary bladder was noted to result from concurrently elevated urinary sodium, due to high sodium in pAOS, and elevated urinary pH. This phenomenon was confirmed in a mechanistic (sub-chronic) study. In contrast, in rats fed pAOS in combination with NH(4)Cl, an acidifying agent, the induced low urinary pH completely prevented the development of urothelial hyperplasia. Hyperplasia induced by this mechanism in rats is considered not relevant to man. Based on the current knowledge we consider pAOS safe for human consumption under its intended use. |
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Authors:
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Jossie A Garthoff; Suzanne Heemskerk; Rixta A Hempenius; Ben A R Lina; Cyrille A M Krul; Jan H Koeman; Gerrit J A Speijers |
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Publication Detail:
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Type: Journal Article Date: 2009-12-21 |
Journal Detail:
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Title: Regulatory toxicology and pharmacology : RTP Volume: 57 ISSN: 1096-0295 ISO Abbreviation: Regul. Toxicol. Pharmacol. Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-04-21 Completed Date: 2010-07-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8214983 Medline TA: Regul Toxicol Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 31-42 Citation Subset: IM |
Copyright Information:
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(c) 2009 Elsevier Inc. All rights reserved. |
Affiliation:
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Danone Research, Centre for Specialised Nutrition, Department Product Safety, Wageningen, The Netherlands. jossie.garthoff@danone.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Animals Animals, Newborn Body Weight / drug effects CHO Cells Cell Line, Tumor Chromosome Aberrations* / chemically induced Consumer Product Safety* Cricetinae Cricetulus Dose-Response Relationship, Drug Escherichia coli / drug effects, genetics Female Infant Formula / chemistry, standards* Lactation Male Maternal Exposure / adverse effects Mice Mitotic Index Mutagenicity Tests Oligosaccharides / chemistry, isolation & purification, toxicity* Organ Size / drug effects Pectins / chemistry* Pregnancy Rats Rats, Wistar Salmonella typhimurium / drug effects, genetics Toxicity Tests, Chronic Urinary Bladder / drug effects, pathology |
| Chemical | |
Reg. No./Substance:
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0/Oligosaccharides; 0/Pectins; 9000-69-5/pectin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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