The reproductive and developmental toxicity profile of beta-cyclodextrin in rodents.
A 3-generation study with two mating phases per generation and a teratology phase was performed in the rat to assess the reproductive and developmental toxicity of beta-cyclodextrin (beta-CD) in the diet. Transient neonatal growth retardation occurred with 5% beta-CD: a similar, but equivocal, effect was also observed with 2.5%. No permanent defects or other indications of developmental toxicity were found. There was no significant maternal toxicity. The dietary level of 1.25% was found to be a NOAEL for developmental toxicity. Further investigations showed the growth retardation to be specific to dietary administration during lactation: it was not produced by parenteral (i.p.) administration and was not influenced by treatment of the dams or litters during gestation. Slight maternal nutritional deficiency, caused by physico-chemical interactions of beta-CD with nutrients in the gut is proposed as the mechanism of action. No difference in milk composition was found.
D000818:Animals; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D003505:Cyclodextrins / Q000493:pharmacokinetics / Q000633:toxicity*; D004032:Diet; D004435:Eating / Q000187:drug effects; D004622:Embryo, Mammalian / Q000187:drug effects; D005260:Female; D005503:Food Additives / Q000493:pharmacokinetics / Q000633:toxicity*; D007774:Lactation / Q000187:drug effects; D008297:Male; D008425:Maternal Behavior / Q000187:drug effects; D008892:Milk / Q000737:chemistry; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects*; D012726:Sexual Behavior, Animal / Q000187:drug effects; D013723:Teratogens / Q000633:toxicity*; D014801:Vitamin A / Q000494:pharmacology; D014807:Vitamin D / Q000494:pharmacology; D047392:beta-Cyclodextrins
D003505:Cyclodextrins; D005503:Food Additives; D013723:Teratogens; D047392:beta-Cyclodextrins; D014801:Vitamin A; D014807:Vitamin D; C031215:betadex