title: 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 1000 μg/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 5000 μg/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 200 μg/plate for H-EPG-05 HR/SO 9:1; 100 μg/plate for H-EPG-05 soyate and H-EPG-14 soyate), and a chromosomal aberration test using human lymphocytes (maximum concentration 50 μg/plate for H-EPG-05 HR/SO 9:1 and H-EPG-05 soyate; 60 μg/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 2000 mg/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.
authors.affiliation: Best Foods, Division of CPC International, 150 Pierce St., Somerset, NJ 08873, USA. Electronic address: david.bechtel@intertek.com.
authors.forename: David H
authors.initials: DH
authors.lastname: Bechtel
mesh_terms: D000818:Animals; D045744:Cell Line, Tumor; D002478:Cells, Cultured; D004247:DNA / Q000378:metabolism; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D019358:Fat Substitutes / Q000633:toxicity*; D005260:Female; D005989:Glycerides / Q000633:toxicity*; D022781:Hepatocytes / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D008214:Lymphocytes / Q000187:drug effects; D008297:Male; D051379:Mice; D009152:Mutagenicity Tests; D009154:Mutation; D017208:Rats, Wistar; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D013937:Thymidine Kinase / Q000235:genetics
chemical_list: D019358:Fat Substitutes; D005989:Glycerides; D004247:DNA; D013937:Thymidine Kinase
keywords: EPG; Esterified propoxylated glycerol; Fat substitute; Genotoxicity; Mutagenicity