Genotoxicity testing of esterified propoxylated glycerol (EPG)

Abstract

Four versions of esterified propoxylated glycerols (EPGs) were evaluated for potential genotoxicity using a range of in vitro and in vivo assays. H-EPG-05 HR/SO 9:1, H-EPG-05 soyate, and H-EPG-14 soyate were non-mutagenic in reverse mutation assays (maximum concentration 1000μg/plate) using Salmonella typhimurium and Escherichia coli. Heated and unheated H-EPG-05 HR/SO 9:1 and EPG-05 HR/ST 45:55 were likewise non-mutagenic in reverse mutation assays in S. typhimurium strains TA98 and TA100 (maximum concentration 5000μg/plate). H-EPG-05 HR/SO 9:1, H-EPG-05 soyate, and H-EPG-14 soyate, were devoid of mutagenic activity in a mouse lymphoma assay in L5178Y tk +/− cells (maximum concentration 200μg/plate for H-EPG-05 HR/SO 9:1; 100μg/plate for H-EPG-05 soyate and H-EPG-14 soyate), and a chromosomal aberration test using human lymphocytes (maximum concentration 50μg/plate for H-EPG-05 HR/SO 9:1 and H-EPG-05 soyate; 60μg/plate for H-EPG-14 soyate). All assays were conducted with and without metabolic activation. Additionally, H-EPG-05 HR/SO 9:1, H-EPG-05 soyate, and H-EPG-14 soyate were non-genotoxic in unscheduled DNA synthesis tests in rats (maximum dose 2000mg/kg). Based on the results of these assays it was concluded that these versions of EPG were not genotoxic under any of the conditions of the assays performed.