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Related Concept Videos

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The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
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Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
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Related Experiment Video

Updated: Mar 2, 2026

Construction of Vapor Chambers Used to Expose Mice to Alcohol During the Equivalent of all Three Trimesters of Human Development
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Prenatal Developmental Toxicity Study of Glycosides-based Standardized Fenugreek Seed Extract in Rats.

Pallavi O Deshpande1, Vishwaraman Mohan1, Mukul P Pore2

  • 1Department of Scientific affairs, Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, India.

Pharmacognosy Magazine
|May 9, 2017
PubMed
Summary

This study found that glycoside-based standardized fenugreek seed extract (SFSE-G) did not cause maternal or embryo-fetal toxicity in rats up to 1000 mg/kg. The no-observed-adverse-effect level (NOAEL) for prenatal exposure was determined to be 1000 mg/kg.

Keywords:
OECD No. 414Prenatal development toxicityglycosidesno-observed-adverse-effect levelratsstandardized fenugreek seed extract

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Area of Science:

  • Reproductive toxicology
  • Pharmacology
  • Natural product research

Background:

  • Glycoside-based standardized fenugreek seed extract (SFSE-G) shows potential in immune-inflammatory conditions.
  • Preclinical safety data is crucial for evaluating botanical extracts.

Purpose of the Study:

  • To evaluate the embryo-fetal development toxicity of SFSE-G in Wistar rats.
  • To determine the no-observed-adverse-effect level (NOAEL) for prenatal exposure to SFSE-G.

Main Methods:

  • Oral administration of SFSE-G (250, 500, 1000 mg/kg) or vehicle to pregnant Wistar rats from gestational day 5 to 19.
  • Monitoring of maternal parameters (body weight, food consumption, clinical signs).
  • Cesarean section on gestational day 20 with fetal examination for malformations and variations.

Main Results:

  • No maternal toxicity or embryo-fetal toxicity was observed at any SFSE-G dose.
  • Skeletal and visceral malformations were incidental and not treatment-related.
  • The no-observed-adverse-effect level (NOAEL) for prenatal oral exposure was established at 1000 mg/kg.

Conclusions:

  • SFSE-G is safe for prenatal oral exposure in rats at doses up to 1000 mg/kg.
  • The study supports the safety profile of SFSE-G for potential use during pregnancy.
  • The established NOAEL provides a critical benchmark for future safety assessments.