Safety of micronized palmitoylethanolamide (microPEA): lack of toxicity and genotoxic potential
Laboratory studyHumansOther animals
- Design
- Laboratory study
- Subjects
- Salmonella typhimurium strains, cultured human lymphocytes, and rats (acute and 90-day oral toxicity studies)
- Dose used in the study
- MicroPEA 250, 500 and 1000 mg/kg body weight/day in the 90-day rat study; up to 2000 mg/kg in the acute study
- Duration
- 14-day preliminary study, then a 90-day subchronic rat oral toxicity study
- What was measured
- Bacterial mutagenicity (Ames test), genotoxicity in human lymphocytes, and acute and subchronic oral toxicity in rats
What the authors reported
MicroPEA caused no mutations in five Salmonella strains and no genotoxic effects in human lymphocytes, with or without metabolic activation. The oral LD50 exceeded the 2000 mg/kg limit dose, and the No Effect Level in both subchronic rat studies was the highest dose tested, 1000 mg/kg/day.
Limits of this study
A standard OECD/GLP toxicology study in bacteria, cultured human cells and rats; it does not test PEA's effects on any disease and cannot show effect in people using it therapeutically. Funding and conflicts not stated in the abstract.
Source
PubMed 28265364 · doi:10.1002/fsn3.392
Entry checked against the abstract on PubMed on 2026-09-22. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.