Safety of micronized palmitoylethanolamide (microPEA): lack of toxicity and genotoxic potential

Area of Science:

• Biochemistry
• Toxicology
• Pharmacology

Background:

• Palmitoylethanolamide (PEA) is a naturally occurring fatty acid amide found in foods like egg yolk.
• MicroPEA, with a defined particle size, was the subject of this safety evaluation.

Purpose of the Study:

• To assess the mutagenicity of PEA in bacterial assays.
• To evaluate the clastogenicity and aneuploidy potential of PEA in human lymphocytes.
• To determine the acute and subchronic toxicity of PEA in rats.

Main Methods:

• Bacterial mutagenicity testing using Salmonella typhimurium strains (TA1535, TA97a, TA98, TA100, TA102) with and without metabolic activation.
• In vitro genotoxicity assays on cultured human lymphocytes.
• Acute oral toxicity study (OECD Acute Oral Up and Down Procedure) and a 90-day oral toxicity study in rats following OECD guidelines and GLP.

Main Results:

• PEA did not induce mutations in any of the Salmonella typhimurium strains tested.
• No genotoxic effects were observed in human lymphocytes under various treatment conditions.
• The LD50 of PEA was determined to be greater than 2000 mg/kg body weight.
• In the 90-day rat study, the No Effect Level (NOEL) was the highest dose tested (1000 mg/kg bw/day).

Conclusions:

• MicroPEA is not mutagenic or genotoxic.
• PEA exhibits a low toxicity profile, with no observed adverse effects at high doses in rodent studies.
• The safety profile supports the use of PEA in further investigations.