
Safety of micronized palmitoylethanolamide (microPEA): lack of toxicity and genotoxic potential
Author(s) -
Nestmann Earle R.
Publication year - 2017
Publication title -
food science and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.614
H-Index - 27
ISSN - 2048-7177
DOI - 10.1002/fsn3.392
Subject(s) - toxicity , palmitoylethanolamide , acute toxicity , genotoxicity , clastogen , pharmacology , chemistry , ames test , salmonella , bioassay , toxicology , food science , biology , biochemistry , bacteria , genetics , receptor , organic chemistry , cannabinoid receptor , agonist
Palmitoylethanolamide ( PEA ) is a natural fatty acid amide found in a variety of foods, which was initially identified in egg yolk. Micro PEA of defined particle size (0.5–10 μ m) 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 TA 1535, TA 97a, TA 98, TA 100, and TA 102, 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 LD 50 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.