Title
Safety evaluation of pectin-derived acidic oligosaccharides (pAOS): Genotoxicity and sub-chronic studies
Author
Garthoff, J.A.
Heemskerk, S.
Hempenius, R.A.
Lina, B.A.R.
Krul, C.A.M.
Koeman, J.H.
Speijers, G.J.A.
TNO Kwaliteit van Leven
Publication year
2010
Abstract
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 NH4Cl, 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.
Subject
Ames
Chromosomal aberration
In utero
Infant formulae
Medical foods
Micronucleus
Mouse lymphoma
Non-digestible carbohydrates
PAOS
To reference this document use:
http://resolver.tudelft.nl/uuid:c09d7581-89a3-4f3d-9591-32976adbccad
DOI
https://doi.org/10.1016/j.yrtph.2009.12.004
TNO identifier
352040
ISSN
0273-2300
Source
Regulatory toxicology and pharmacology, 57 (1), 31-42
Document type
article