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beta-Cyclodextrin: 52-week toxicity studies in the rat and dog
M E Bellringer1, T G Smith, R Read
1Huntingdon Research Centre Ltd., Cambridgeshire, UK.
Summary
Beta-cyclodextrin, a starch derivative, showed target organ toxicity in rats at high doses. However, beagle dogs tolerated beta-cyclodextrin well, indicating a safe profile for this molecular inclusion agent.
Area of Science:
- Toxicology
- Pharmacology
- Biochemistry
Background:
- Beta-cyclodextrin is a starch derivative utilized as a molecular inclusion agent.
- Dietary administration studies are crucial for assessing the safety of food additives and pharmaceutical excipients.
Purpose of the Study:
- To evaluate the subchronic toxicity of beta-cyclodextrin in Sprague-Dawley rats and beagle dogs.
- To determine the non-toxic effect level (NTEL) of beta-cyclodextrin through dietary administration.
Main Methods:
- A 52-week dietary toxicity study was conducted in rats and dogs.
- Histopathological examination, plasma liver enzyme assays, and triglyceride level analysis were performed.
- Urinalysis and biochemical parameters were monitored in dogs.
Main Results:
- Rats exhibited liver and kidney toxicity at 25,000 and 50,000 ppm, linked to elevated liver enzymes and reduced triglycerides.
- Dogs showed no systemic toxicity, with only minor, non-toxicological urinalysis and biochemical changes.
- The NTEL was established at 12,500 ppm for rats and 50,000 ppm for dogs.
Conclusions:
- Beta-cyclodextrin demonstrates target organ toxicity in rats at higher dietary concentrations.
- Beagle dogs tolerated beta-cyclodextrin well, with no significant adverse effects observed.
- The established non-toxic effect levels provide crucial data for risk assessment of beta-cyclodextrin.