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Subchronic intravenous toxicity studies with gamma-cyclodextrin in rats
H H Donaubauer1, H Fuchs, K H Langer
1Drug Safety, Hoechst Marion Roussel Deutschland GmbH, Mainzerlandstrasse 500, Hattersheim am Main, D-65795, Germany.
Regulatory Toxicology and Pharmacology : RTP
|July 22, 1998
Summary
Gamma-cyclodextrin (gamma-CD) administered intravenously to rats was well tolerated at doses up to 200 mg/kg. Higher doses showed reversible effects on blood cells and organs, indicating no significant toxicity.
Area of Science:
- Toxicology
- Pharmacology
- Biochemistry
Background:
- Gamma-cyclodextrin (gamma-CD) is a cyclic polymer with potential applications in food and pharmaceuticals.
- Assessing the safety profile of gamma-CD is crucial for its intended uses.
Purpose of the Study:
- To evaluate the toxicity of gamma-cyclodextrin (gamma-CD) in rats following intravenous administration.
- To determine dose-dependent effects and reversibility of any observed changes.
Main Methods:
- Two toxicity studies (1-month and 3-month) were conducted in rats with intravenous gamma-CD administration.
- Dose levels ranged from 60 to 2000 mg/kg/day, with hematological, clinical, and histopathological examinations performed.
- Recovery groups were included to assess reversibility of effects.
Main Results:
- Gamma-CD was well tolerated at doses up to 200 mg/kg/day.
- Higher doses (≥600 mg/kg/day) caused reversible decreases in erythrocyte counts, hemoglobin, hematocrit, and thrombocyte counts, with increased spleen weight.
- Reversible renal tubular vacuolation and lung histiocytosis were observed at higher doses, while liver toxicity was not indicated.
Conclusions:
- Intravenous gamma-CD doses of 120-200 mg/kg/day are safe in rats.
- Adverse effects at higher doses were reversible and considered biochemical responses to transient high concentrations, not indicative of significant toxicological concern.