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Food Science & Nutrition

Food Science & Nutrition

IF: 3.5
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Safety of micronized palmitoylethanolamide (microPEA): lack of toxicity and genotoxic potential

Published:15 June 2016 DOI: 10.1002/fsn3.392 PMID: 28265364
Earle R. Nestmann

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.

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