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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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Palmitoylethanolamide: Prenatal Developmental Toxicity Study in Rats.

Narendra S Deshmukh1, Shailesh Gumaste1, Silma Subah2

  • 1INTOX Pvt. Ltd., Pune, Maharashtra, India.

International Journal of Toxicology
|February 12, 2021
PubMed
Summary

Palmitoylethanolamide (PEA) is safe for pregnant rats, showing no developmental toxicity even at high doses. This study confirms PEA

Keywords:
NOAELPEAdevelopmental toxicityembryotoxocityfetotoxicitymaternal toxicity

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Area of Science:

  • Pharmacology and Toxicology
  • Developmental Biology
  • Animal Science

Background:

  • Palmitoylethanolamide (PEA) is an endogenous compound with known protective roles.
  • Understanding the prenatal safety of PEA is crucial for its potential therapeutic applications.

Purpose of the Study:

  • To evaluate the prenatal developmental toxicity of Palmitoylethanolamide (PEA) in Wistar rats.
  • To determine the no-observed-adverse-effect level (NOAEL) for maternal and fetal toxicity.

Main Methods:

  • Oral administration of PEA at 250, 500, and 1,000 mg/kg to pregnant rats from day 0 to 19 of gestation.
  • Cesarean sections on day 20 to examine dams and fetuses for external, visceral, and skeletal abnormalities.
  • Assessment of maternal systemic toxicity, reproductive parameters, and fetal development according to OECD Test Guideline No. 414.

Main Results:

  • No treatment-related alterations were observed in maternal systemic toxicity parameters.
  • No adverse effects on reproductive parameters or fetal development, including external, visceral, and skeletal examinations.
  • The no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity was determined to be >1,000 mg/kg body weight/day.

Conclusions:

  • Palmitoylethanolamide (PEA) demonstrated a lack of prenatal developmental toxicity in rats.
  • PEA is well-tolerated and safe for pregnant rats, even at high doses.
  • This study supports a robust safety profile for PEA during prenatal development.