title: Safety assessment of the commensal strain Bacteroides xylanisolvens DSM 23964.
abstract: We recently isolated and characterized the new strain Bacteroides xylanisolvens DSM 23964 and presented it as potential candidate for the first natural probiotic strain of the genus Bacteroides. In order to evaluate the safety of this strain for use in food, the following standard toxicity assays were conducted with this strain in both viable and pasteurized form: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration assay, and 90day subchronic repeated oral toxicity studies in mice. No mutagenic, clastogenic, or toxic effects were detected even at extremely high doses. In addition, no clinical, hematological, ophthalmological, or histopathological abnormality could be observed after necropsy at any of the doses tested. Hence, the NOAEL could be estimated to be greater than 2.3×10(11) CFUs, and 2.3×10(14) for pasteurized bacteria calculated as equivalent for an average 70kg human being. In addition, the absence of any in vivo pathogenic properties of viable B. xylanisolvens DSM 23964 cells was confirmed by means of an intraperitoneal abscess formation model in mice which also demonstrated that the bacteria are easily eradicated by the host's immune system. The obtained results support the assumed safety of B. xylanisolvens DSM 23964 for use in food.
authors.affiliation: Glycotope GmbH, Robert-Roessle-Str. 10, 13125 Berlin, Germany. philippe.ulsemer@glycotope.com
authors.forename: Philippe
authors.initials: P
authors.lastname: Ulsemer
authors.forename: Kawe
authors.initials: K
authors.lastname: Toutounian
authors.forename: Jens
authors.initials: J
authors.lastname: Schmidt
authors.forename: Jost
authors.initials: J
authors.lastname: Leuschner
authors.forename: Uwe
authors.initials: U
authors.lastname: Karsten
authors.forename: Steffen
authors.initials: S
authors.lastname: Goletz
mesh_terms: D000818:Animals; D001439:Bacteroides / Q000472:pathogenicity*; D005260:Female; D008297:Male; D051379:Mice; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D019936:Probiotics; D051381:Rats; D018570:Risk Assessment