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Related Experiment Videos

Embryotoxicity and teratogenicity study with gamma-cyclodextrin in rats

D H Waalkens-Berendsen1, F J Verhagen, A Bär

  • 1TNO-Nutrition and Food Research Institute, Zeist, 3700 AJ, The Netherlands.

Regulatory Toxicology and Pharmacology : RTP
|July 22, 1998
PubMed
Summary

Gamma-cyclodextrin (gamma-CD) was tested for embryotoxicity and teratogenicity in rats. No adverse effects were observed, indicating gamma-CD is safe for prenatal development at high dietary levels.

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Area of Science:

  • Toxicology
  • Developmental Biology
  • Pharmacology

Background:

  • Cyclodextrins are widely used in pharmaceutical formulations.
  • Assessing the safety of cyclodextrins during pregnancy is crucial.

Purpose of the Study:

  • To evaluate the embryotoxic and teratogenic potential of gamma-cyclodextrin (gamma-CD).

Main Methods:

  • Pregnant Wistar rats were fed diets containing 0-20% gamma-CD from day 0 to 21 of gestation.
  • Reproductive parameters and fetal development were assessed.
  • A lactose control group was included.

Main Results:

  • Gamma-cyclodextrin was well tolerated with no treatment-related deaths.
  • No significant effects on maternal weight gain, food, or water intake were observed, except for slightly reduced food intake at 20% gamma-CD.

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  • Reproductive performance was unaffected.
  • No external, visceral, or skeletal abnormalities were found in fetuses.
  • Conclusions:

    • Gamma-cyclodextrin demonstrated no embryotoxic or teratogenic effects in rats up to 20% of the diet.
    • These findings support the safety of gamma-CD during pregnancy.