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Related Experiment Videos

Embryotoxicity and teratogenicity study with gamma-cyclodextrin in rabbits

D H Waalkens-Berendsen1, A E Smits van Prooije, A Bär

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

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

Dietary gamma-cyclodextrin (gamma-CD) up to 20% was well tolerated by pregnant rabbits. This study found no adverse effects on reproductive performance, embryotoxicity, fetotoxicity, or teratogenicity in rabbits administered gamma-CD.

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Area of Science:

  • Reproductive Toxicology
  • Developmental Toxicology
  • Pharmacology

Background:

  • Cyclodextrins are frequently used as excipients in pharmaceutical formulations.
  • Assessing the safety of excipients during pregnancy is crucial for drug development.

Purpose of the Study:

  • To evaluate the embryotoxic and teratogenic potential of dietary gamma-cyclodextrin (gamma-CD) in pregnant rabbits.
  • To determine the maternal and developmental toxicity of gamma-CD during gestation.

Main Methods:

  • New Zealand White rabbits were administered diets containing 0, 5, 10, or 20% gamma-CD from gestation day 0 to 29.
  • A control group received 20% lactose.
  • Maternal body weight, food intake, reproductive parameters, and fetal development (visceral and skeletal) were assessed.

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Main Results:

  • Gamma-CD was well tolerated, with transient diarrhea in some animals at higher doses.
  • No significant differences in maternal toxicity, reproductive performance, or fetal development were observed between gamma-CD treated groups and the control.
  • No embryotoxic, fetotoxic, or teratogenic effects were detected even at the highest dose (20%).

Conclusions:

  • Dietary gamma-CD is safe for pregnant rabbits at concentrations up to 20%.
  • Gamma-CD does not adversely affect reproductive performance or cause developmental toxicity in this model.
  • Gamma-CD can be considered safe as an excipient during pregnancy based on these findings.