Subchronic oral toxicity studies with gamma-cyclodextrin in rats

Area of Science:

• Toxicology
• Food Science
• Biochemistry

Background:

• Gamma-cyclodextrin (gamma-CD) is a cyclic polymer with potential as a food ingredient.
• Assessing the safety and toxicity of novel food ingredients is crucial before market introduction.

Purpose of the Study:

• To evaluate the oral toxicity of gamma-cyclodextrin (gamma-CD) in Wistar rats.
• To determine the safety of gamma-CD for potential use as a food ingredient.

Main Methods:

• Two studies were conducted: a 2-week pilot study and a 13-week oral toxicity study in Wistar rats.
• Rats were administered dietary levels of gamma-CD ranging from 0% to 20%.
• Comprehensive assessments included clinical signs, body weight, food/water intake, hematology, urinalysis, organ weights, and histopathology.

Main Results:

• No treatment-related mortalities were observed in either study.
• Minor, transient soft stools were noted in high-dose gamma-CD groups and the lactose control group.
• No significant treatment-related changes were found in hematology, urinalysis, clinicochemistry, organ weights, or histopathology.

Conclusions:

• Oral administration of gamma-cyclodextrin (gamma-CD) up to 20% in the diet was well-tolerated in Wistar rats.
• Gamma-CD did not induce any signs of toxicity during the 13-week study.
• The results support the safety of gamma-CD for potential food ingredient applications.