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Safety assessment of gamma-cyclodextrin
I C Munro1, P M Newberne, V R Young
1CanTox Inc., Consultants in Toxicology, Health and Environmental Sciences, 2233 Argentina Road, Suite 308, Mississauga, Ont., Canada L5N 2X7.
Regulatory Toxicology and Pharmacology : RTP
|July 22, 2004
Summary
Gamma-cyclodextrin (gamma-CD) is safe for food use, showing no toxic effects in extensive studies. It is rapidly digested, similar to starch, and does not impact nutrient absorption, earning it a GRAS status.
Area of Science:
- Food Science
- Toxicology
- Nutritional Science
Background:
- Gamma-cyclodextrin (gamma-CD) is an oligosaccharide used in food as a carrier and stabilizer.
- Its potential applications include encapsulating flavors, vitamins, and fatty acids.
- Estimated daily intake is up to 4.1g/person/day.
Purpose of the Study:
- To review and summarize safety data for gamma-cyclodextrin (gamma-CD) in food applications.
- To assess the toxicological profile and metabolic fate of gamma-CD.
- To determine the safety of gamma-CD for intended uses in the food industry.
Main Methods:
- Conducted standard genotoxicity tests.
- Performed subchronic (3-month) and chronic (1-year) oral toxicity studies in rats.
- Included subchronic toxicity studies in dogs and embryotoxicity/teratogenicity studies in rats and rabbits.
- Carried out metabolic studies in rats and a human gastrointestinal tolerance study.
Main Results:
- Gamma-CD demonstrated no toxicological effects across all oral and intravenous administration studies.
- Metabolic studies confirmed rapid digestion by amylase, similar to starch.
- Human studies showed no difference in gastrointestinal tolerance compared to maltodextrin.
- No adverse impact on the bioavailability of fat-soluble vitamins is expected.
Conclusions:
- Gamma-cyclodextrin (gamma-CD) is well-tolerated and safe for its intended food applications.
- Its metabolic profile supports its safety, closely resembling that of starch.
- Gamma-CD is concluded to be Generally Recognized As Safe (GRAS) for food use.
