Abstract
Palmitoylethanolamide (PEA) is a natural fatty acid amide found in a variety of foods, which was initially identified in egg yolk. MicroPEA of defined particle size (0.5–10 μm) was evaluated for mutagenicity in Salmonella typhimurium, for clastogenicity/aneuploidy in cultured human lymphocytes, and for acute and subchronic rodent toxicity in the rat, following standard OECD test protocols, in accordance with Good Laboratory Practice (GLP). PEA did not induce mutations in the bacterial assay using strains TA1535, TA97a, TA98, TA100, and TA102, with or without metabolic activation, in either the plate incorporation or liquid preincubation methods. Similarly, PEA did not induce genotoxic effects in human cells treated for 3 or 24 h without metabolic activation, or for 3 h with metabolic activation. PEA was found to have an LD50 greater than the limit dose of 2000 mg/kg body weight (bw), using the OECD Acute Oral Up and Down Procedure. Doses for the 90‐day rat oral toxicity study were based on results from the preliminary 14‐day study, that is, 250, 500, and 1000 mg/kg bw/day. The No Effect Level (NOEL) in both subchronic studies was the highest dose tested.
Highlights
The history of PEA as a natural food ingredient with medicinal properties has been described by Masek and Raskova (1967)
The results of the new toxicological studies described in this study show that microPEA has a favorable safety profile for its use in health products intended for human and companion animal consumption, with a no effect level in repeated dose studies that is >1000 mg/kg bw
No deaths occurred in this acute toxicity study (Masek 1980)
Summary
The history of PEA as a natural food ingredient with medicinal properties has been described by Masek and Raskova (1967). The initial observation was in 1943 by Coburn et al (1943), as part of an epidemiological study focused on childhood rheumatic fever, the incidence of which was higher in those children consuming diets low in eggs. These investigators noted that occurrence was reduced in children fed egg yolk powder, and subsequently they demonstrated antianaphylactic properties in guinea pig with a lipid extract from egg yolk (Coburn et al 1954). A crystalline anti-inflammatory agent was isolated from egg yolk as well as from soybean lecithin (Kuehl et al 1957) They identified the chemical structure to be N-2 hydroxyethyl palmitamide, or PEA. It was later found that PEA is an endogenous compound, locally synthesized in animal and human tissues and body fluids, to protect against perturbing inflammation (Skaper et al 2013, 2014)
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