Safety of a novel galacto-oligosaccharide: Genotoxicity and repeated oral dose studies

Abstract

<jats:p> A series of safety tests were undertaken on a novel galacto-oligosaccharide (GOS) produced from lactose by a two-step enzymatic process involving Sporobolomyces singularis and Kluyveromyces lactis. Bacterial reverse mutation and chromosomal aberration tests, with or without metabolic activation, were performed. These tests showed no mutagenesis in the Ames assay or in Escherichia coli WP2uvrA, and no chromosomal aberrations in cultured fibroblast cells from Chinese hamster lungs (CHL/IU). Micronuclei were not induced in the reticulocytes of mouse peripheral blood following oral administration of GOS. In a 90-day repeated oral dose toxicity study in rats, GOS was administered at 0, 500, 1000 and 2000 mg/kg to male and female Sprague-Dawley rats. There were no GOS-related changes in clinical signs, body weight, water intake, feed intake, urinalysis, ophthalmology, haematology, blood chemistry, organ weights, gross pathology or histopathology in any of the treatment groups compared to the control group. The no observed adverse effect level (NOAEL) of GOS was at least 2000 mg/kg/day in both males and females. </jats:p>

Influence of coffee (Coffea arabica) and galacto-oligosaccharide consumption on intestinal microbiota and the host responses

“…The GOS was a commercial product of Oligomate (Yakult, Tokyo, Japan) and was prepared with Kobayashi et al . 's () method.…”

“…The present study used galacto-oligosaccharide (GOS), a commercial product (Yakult, Tokyo, Japan), for its prebiotic testing (Kobayashi et al, 2009). Consuming GOS may relieve the symptoms of constipation (Nittynen et al, 2007).…”

Development of hypoallergenic galacto-oligosaccharides on the basis of allergen analysis

“…24) With regard to the safety of GOS, general toxicity and genetic toxicity studies have raised no safety concerns. 25,26) GOS products supplied by three manufacturers were approved in the GRAS Notice Inventory of the US FDA (GRAS Notice Nos. GRN 236, 285 and 286, 334).…”

Safety assessment of Gossence™ (galactooligosaccharides): Genotoxicity and general toxicity studies in Sprague Dawley rats

“…In this study, Gossence™ (GOS) was found to be non-genotoxic in both Ames test and in vitro chromosomal aberration test with HPBL, which is consistent with published reports with similar class of compounds. 11 In vivo micronucleus test was negative with GOS at a doable maximum dose. 2 The results of the current study and published literature suggest that GOS do not have genotoxic potential.…”

“…GOS is mainly added to infant formula as it is able to stimulate growth of beneficial intestinal microflora such as bifidobacterium and reinforce microbiota similar to that of in breastfed infants. [11][12][13] Gossence™ is a GOS containing product manufactured by the action of enzymes from whole microbial cells (Sporobolomyces singularis MTCC5491) in a manner like other GOS products in the market. In this report, the safety of Gossence™ (GOS) was demonstrated by repeat dose oral toxicity study for 90-days followed by 28-day recovery period in Sprague Dawley rats and by assessing for its genotoxicity potential.…”