Resorption, Metabolism and Toxicity Studies on the Peroral Application of beta‐Cyclodextrin

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Abstract
It is probable that only an insignificant amount of β‐cyclodextrin is absorbed in unchanged form from the intestinal tract. The oral administration of the conversion mixture (38% β‐cyclodextrin, 2.8% α‐cyclodextrin, the rest partially decomposed starch) to rats and dogs, as well as the crystalline β‐cyclodextrin (97%) at doses of 200, 400 and 600 mg/kg of bodyweight daily, according to the clinico‐biochemical tests has not caused significant changes. The pathological and histopathological studies performed after a 6 months treatment have not proved any observable changes. β‐Cyclodextrin proved not to be embryotoxic and teratogenic. The chromosoma test performed on rats treated for 6 months has not increased the incidence of spontaneous aberration and no change relating to mutation could be observed, either.

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