Back to Search
Start Over
Assessment of the safety of hydrogenated resistant maltodextrin: reverse mutation assay, acute and 90-day subchronic repeated oral toxicity in rats, and acute no-effect level for diarrhea in humans
- Source :
- The Journal of Toxicological Sciences. 38:459-470
- Publication Year :
- 2013
- Publisher :
- Japanese Society of Toxicology, 2013.
-
Abstract
- A series of safety assessments were performed on hydrogenated resistant maltodextrin prepared by converting the reducing terminal glucose of resistant maltodextrin into sorbitol. The reverse mutation assay did not show mutagenicity. Acute and 90-day subchronic oral toxicity studies in rats showed no death was observed in any groups, including the group receiving the highest single dose of 10 g/kg body weight or the highest dose of 5 g/kg body weight per day for 90 days. Mucous or watery stools were observed in the hydrogenated resistant maltodextrin treatment group on the acute study, which were transient and were associated with the osmotic pressure caused by intake of the high concentrations. Subchronic study showed dose-dependent increases in the weights of cecum alone, cecal contents alone, and cecum with cecal contents as well as hypertrophy of the cecal mucosal epithelium, which are considered to be common physiological responses after intake of indigestible carbohydrates. These results indicated that the no observed adverse effect level (NOAEL) of hydrogenated resistant maltodextrin was 10 g/kg body weight or more on the acute oral toxicity study and 5.0 g/kg body weight/day or more on the 90-day subchronic repeated oral toxicity study in rats. Further study performed in healthy adult humans showed that the acute no-effect level of hydrogenated resistant maltodextrin for diarrhea was 0.8 g/kg body weight for men and more than 1.0 g/kg body weight for women. The results of the current safety assessment studies suggest that hydrogenated resistant maltodextrin is safe for human consumption.
- Subjects :
- Adult
Diarrhea
Male
Time Factors
No-observed-adverse-effect level
Administration, Ophthalmic
Pharmacology
Toxicology
Muscle hypertrophy
Rats, Sprague-Dawley
Young Adult
chemistry.chemical_compound
Cecum
Osmotic Pressure
Polysaccharides
medicine
Animals
Humans
Osmotic pressure
Intestinal Mucosa
No-Observed-Adverse-Effect Level
Dose-Response Relationship, Drug
Mutagenicity Tests
business.industry
food and beverages
Hypertrophy
Middle Aged
Gastrointestinal Contents
Acute toxicity
Rats
Dose–response relationship
medicine.anatomical_structure
chemistry
Biochemistry
Female
Sorbitol
Hydrogenation
medicine.symptom
business
Subjects
Details
- ISSN :
- 18803989 and 03881350
- Volume :
- 38
- Database :
- OpenAIRE
- Journal :
- The Journal of Toxicological Sciences
- Accession number :
- edsair.doi.dedup.....0bb031a4278ef20a771889b58657b851