Safety evaluation of fructooligosaccharide (FOSSENCE<sup>TM</sup>): Acute, 14-day, and subchronic oral toxicity study in Wistar rats

Jain, Manish; Gote, Manoj; Dubey, Ashok Kumar; Narayanan, Sunilkumar Puthenpurackal; Krishnappa, H.; Kumar, DP Santhosh; Ravi, G.; Vijayasarathi, S. K.; Shankar, Sudha

doi:10.1177/2397847318787750

Cited by 5 publications

(6 citation statements)

References 18 publications

(23 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Fructo-oligosaccharides are general recognized as safe (GRAS) by Food and Drug Administration (FDA) [14], and by other worldwide regulatory agencies for food applications and pharmaceutical drugs formulations. In the European Union, fructo-oligosaccharides are approved for use in infant formulas in combination with galacto-oligosaccharide [15] and in the year 2013, Food Standards of Australia, and New Zealand concluded that no adverse effects on healthy infants fed fructo-oligosaccharides up to 3.0 grams per litre for periods ranging from one week to three months [16].…”

Section: Fructo-oligosaccharidesmentioning

confidence: 99%

Functional Oligosaccharide: Chemicals Structure, Manufacturing, Health Benefits, Applications and Regulations

Ibrahim¹

2018

J Food Chem Nanotechol

View full text Add to dashboard Cite

Functional oligosaccharides are carbohydrates that have two to ten monosaccharides units linked together with glycosidic bonds. The two linked monosaccharides (disaccharides) of maltose, sucrose, and lactose are digestible oligosaccharides by human gut enzymes. These, digestible disaccharides are sugars and are not classified as functional oligosaccharides. Functional oligosaccharides are non-digestible by human gut enzymes and providing health benefits as fibers and prebiotics [1]. The common known functional oligosaccharides are fructo-oligosaccharides, galacto-oligosaccharides, lacto-sucrose, malto-oligosaccharides, isomalto-oligosaccharides, trehalose, cyclodextrins, xylo-oligosaccharides, and soy-oligosaccharides. Two of these enzymatically produced functional oligosaccharides are cyclodextrins and trehalose. In addition, to their highlighted health benefits, both have an important pharmaceutical application in drugs delivery systems, in the case of cyclodextrins, and as cryoprotectants of biological materials, viable cells, and foods, in the case of trehalose.

show abstract

Section: Fructo-oligosaccharidesmentioning

confidence: 99%

Functional Oligosaccharide: Chemicals Structure, Manufacturing, Health Benefits, Applications and Regulations

Ibrahim¹

2018

J Food Chem Nanotechol

View full text Add to dashboard Cite

show abstract

“…1 The cecum enlargement is consistent with other reports for the same class of compounds; various studies had been reported that consumption of pectin and nondigestible oligosaccharides can cause histological changes in cecum in rats. 2,24 The cecum is an area of bacterial fermentation and growth. Cecal hypertrophy can occur due to trophic effects of short fatty acids which are produced during bacterial fermentation after an excessive amount of nonabsorbed carbohydrate and dietary fiber enter the cecum and colon.…”

Section: Discussionmentioning

confidence: 99%

“…Hence, these prebiotics are extensively added to dairy products, resulting in long-term consumption among pregnant mothers and young infants. 1,2 Galactooligosaccharides (GOS), also known as oligoglalactosyllactose, oligogalactose, oligolactose, or trans-galactooligosaccharides (TOS), belong to a group of prebiotics. Prebiotics, TOS, have been shown to increase bifidobacteria counts and decrease harmful pathogens like Escherichia coli and Clostridium lituseburense/Clostridium histolyticum in the gut of infants.…”

Section: Introductionmentioning

confidence: 99%

Juvenile toxicity study of Gossence™ (galactooligosaccharides) in Sprague Dawley rats

Jain

Kaur

Tiwari

et al. 2020

Toxicology Research and Application

Self Cite

View full text Add to dashboard Cite

Gossence™ (galactooligosaccharide; GOS) is a prebiotics and used as one of the major constituents in infant milk formulas that act as a functional food. Gossence is manufactured by Tata Chemicals Ltd, India, through a patented process of biotransformation of lactose. A toxicology study in juvenile rats was carried out to assess the safety profile of Gossence intended for pediatric population. The objective of this study is to assess the potential systemic toxicity of Gossence when administered through gavage at dose levels of 1000, 2000, or 5000/3000 mg/kg/day (equivalent to 1347, 2694, and 6735/4041 mg/kg/day of GOS, respectively) to juvenile Sprague Dawley rats from postnatal day (PND) 4 to PND 52 (i.e. total 49 days of dosing period). A separate group of animals were treated with vehicle (purified Milli Q water) for a similar duration. The following parameters were evaluated during the study period: morbidity/mortality check, clinical signs, body weights, body weight changes, food consumption, functional observational battery, motor activity, postnatal developmental observations, hematology, clinical chemistry, urinalysis, organ weight, gross pathology, and histopathology. During dosing phase, the high-dose group, 5000 mg/kg/day, was reduced to 3000 mg/kg/day (equivalent to 4041 mg/kg/day dose of GOS) from day 16 (PND 19) onward, due to clinical signs of watery feces and yellow color stains at urogenital region and mortality in two animals on day 15 (PND 18) of the study. Time-weighted average dose for 5000 mg/kg/day was equivalent to 3600 mg/kg/day. No further deaths or clinical signs were noticed in animals at 3000 mg/kg/day from day 18 (PND 21) of dosing phase to until terminal euthanization. At the terminal euthanization, there were no test item-related gross changes observed in all surviving rats except for, an increased cecum size in some of the rats at 5000/3000 mg/kg/day, which correlated with the increased weights of cecum with contents during organ weight recording, but this had no correlating light microscopic changes during histological examination. The cecal enlargement was completely recovered following the 14-day recovery period. The no-observedadverse-effect level is 3000 mg/kg/day for Gossence, which is equivalent to 4041 mg/kg/day of GOS in both sexes.

show abstract

“…2 These findings in the cecum were consistent with earlier reports for compounds of similar class. [20][21][22][23] Cecal enlargement along with mucosal hypertrophy has been observed as an adaptive response in several rodent species to other food ingredient such as modified starches, polyols, some fibers and lactose, and these ingredients share the feature of being poorly absorbed and osmotically active. 21 Studies have demonstrated that consumption of pectin and nondigestible oligosaccharides can cause histological changes in cecum in rats.…”

Section: Discussionmentioning

confidence: 99%

“…2 These findings in the cecum were consistent with earlier reports for compounds of similar class. 20 –23…”

Section: Discussionmentioning

confidence: 99%

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

Jain

Narayanan

Tiwari

et al. 2019

Toxicology Research and Application

Self Cite

View full text Add to dashboard Cite

Galactooligosaccharides (GOS) used as prebiotics are one of the major constituents of the infant milk formulas. GOS (Gossence™) is produced by a patented process of biotransformation of lactose; hence toxicology studies were carried out to assess its safety. The objective of the present study was to evaluate the general and genetic toxicity of Gossence™. In 14-day and subchronic (90-day) oral toxicity studies in Sprague Dawley rats, daily administration of GOS at dose levels of 1000, 2000, or 5000 mg/kg (equivalent to 1347, 2694, and 6735 mg/kg/day of Gossence™, respectively) did not cause any mortality, or clinical signs, and changes in body weights, feed consumption, hematology, clinical chemistry, and urinalysis. In 90-day study, no changes in ophthalmological and neurological findings were observed. Significant increases in the cecum weights (with and/or without content) at dose levels of ≥2000 mg/kg were observed in both 14-day and 90-day studies. Based on the results of 90-day study, the no-observed-adverse-effect-level for GOS is 5000 mg/kg/day which is equivalent to 6735 mg Gossence™/kg/day. In the bacterial reverse mutation test, there was no significant increase in the mean numbers of revertants at the tested concentrations. Gossence™ was not mutagenic up to 5000 µg/plate. In chromosomal aberration test, there was no statistically significant increase in the number of percent aberrant metaphase for the Gossence™. Gossence™ is non-clastogenic (negative) in the in vitro chromosomal aberration test using human peripheral blood lymphocyte during short and prolonged treatment.

show abstract

Safety evaluation of fructooligosaccharide (FOSSENCE^TM): Acute, 14-day, and subchronic oral toxicity study in Wistar rats

Cited by 5 publications

References 18 publications

Functional Oligosaccharide: Chemicals Structure, Manufacturing, Health Benefits, Applications and Regulations

Functional Oligosaccharide: Chemicals Structure, Manufacturing, Health Benefits, Applications and Regulations

Juvenile toxicity study of Gossence™ (galactooligosaccharides) in Sprague Dawley rats

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

Contact Info

Product

Resources

About

Safety evaluation of fructooligosaccharide (FOSSENCETM): Acute, 14-day, and subchronic oral toxicity study in Wistar rats

Cited by 5 publications

References 18 publications

Functional Oligosaccharide: Chemicals Structure, Manufacturing, Health Benefits, Applications and Regulations

Functional Oligosaccharide: Chemicals Structure, Manufacturing, Health Benefits, Applications and Regulations

Juvenile toxicity study of Gossence™ (galactooligosaccharides) in Sprague Dawley rats

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

Contact Info

Product

Resources

About

Safety evaluation of fructooligosaccharide (FOSSENCE^TM): Acute, 14-day, and subchronic oral toxicity study in Wistar rats