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Quaternary silsesquioxane: a developmental toxicity study in rats

W H Siddiqui1, R G York

  • 1Dow Corning Corporation, Toxicology Laboratory, Midland, Michigan 48640.

Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology
|July 1, 1993
PubMed
Summary

Quaternary Silsesquioxane, an antimicrobial agent, showed no developmental toxicity in rats. High doses did not cause birth defects, indicating its safety for fetal development in this study.

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Biodisposition of dibromoacetic acid (DBA) and bromodichloromethane (BDCM) administered to rats and rabbits in drinking water during range-finding reproduction and developmental toxicity studies.

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Area of Science:

  • Toxicology
  • Developmental Biology
  • Organosilicon Chemistry

Background:

  • Antimicrobial organosilicon quaternary ammonium chloride compounds are increasingly utilized.
  • Assessing the developmental toxicity of novel chemical agents is crucial for regulatory approval and public safety.

Purpose of the Study:

  • To evaluate the developmental toxicity and teratogenicity of Quaternary Silsesquioxane (Quat-Silsesquioxane) in pregnant rats.
  • To determine the maternal and fetal effects following oral administration of Quat-Silsesquioxane during gestation.

Main Methods:

  • Pregnant CD rats were administered varying doses (100, 300, 1000 mg/kg/day) of Quat-Silsesquioxane or a vehicle control daily from gestation day 6 to 15.
  • Maternal animals were examined on gestation day 20, and fetuses were evaluated for teratogenicity, including external, visceral, and skeletal examinations.

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Main Results:

  • Maternal toxicity was observed as a slight increase in relative liver weights at the highest dose (1000 mg/kg/day), establishing a maternal no observable adverse effect level (NOAEL) at 300 mg/kg/day.
  • No significant differences were found in reproductive parameters (corpora lutea, implantation sites, resorptions) or fetal growth metrics (body weight, crown-rump length) between treated and control groups.
  • The incidence of external, internal soft tissue, and skeletal malformations or variations in fetuses was not statistically different from the control group.

Conclusions:

  • Oral administration of Quat-Silsesquioxane up to 1000 mg/kg/day did not induce teratogenicity or other developmental toxicities in rat fetuses.
  • The study suggests a lack of significant risk to fetal development from Quat-Silsesquioxane exposure under the tested conditions.