Single- and 14-day repeat-dose toxicity of cross-linked β-cyclodextrin in rats.

The present study was carried out to investigate the oral single and repeat toxicity of cross-linked β-cyclodextrin (β-CD) made with adipic acid. Ten each of female and male rats were orally administered a 5000 mg/kg single dose. At this dose, mortality or macroscopic changes of internal organs were not observed. Dose levels 500, 1000, or 2000 mg/kg of β-CD were given daily to 5 each of female and male rats by oral gavage for 14 days. Body and organ weights were not significantly different during the study (P < .05). Hematology and clinical chemistry did not show any toxicity from the cross-linked β-CD. Macroscopic or microscopic changes were not observed between the controls and the treated rats. Based on these results, the cross-linked β-CD did not produce any signs of toxicity or other adverse effects at dose levels up to 2000 mg/kg per d for 14 days.