Subchronic Toxicity of Orally Administered Beta-Cyclodextrin in Rats

Beta-cyclodextrin (BCD) was administered in the diet to male and female OFA rats derived from a Sprague-Dawley strain. Rats were fed a standard semisynthetic diet, UAR 210, containing 1.25% BCD, 2.5% BCD, 5% BCD, 10% BCD, and 10% lactose. Twenty animals/sex/group were dosed for 90 consecutive days. One animal died in the course of the study, but there was no indication that the death was compound-related. There were no dose-related adverse effects pertaining to hematology, blood, or urine chemistry. A small fraction of BCD was recovered in the urine of animals fed 5% or 10% BCD, amounting to 0.1–0.3% of the highest administered dose. The absolute and relative filled cecal weights of the rats that were fed BCD or lactose were increased in both the males and females, which is common in rats receiving slowly digestible fermentable carbohydrates due to incomplete digestion in the small intestine. No treatment-related effects indicative of a toxicologic response were found from the histopathologic examination. Based on these findings, BCD appears to lack toxicologic activity.