A 90-day oral toxicity study of glycolipids from Dacryopinax spathularia in Beagle dogs. (November 2017)

• Record Type: Journal Article
• Authors: Bitzer, Jens; Henkel, Thomas; Nikiforov, Andrey I.; Rihner, Marisa O.; Henderson, Kim A.
• Is Part Of: Food and chemical toxicology. Volume 109:Part 1(2017)
• Page Start: 544
• Page End: 551
• Publication Date: 2017-11
• Subjects: Oral -- Subchronic toxicity -- Dog -- Jelly mushroom glycolipids -- Natural preservative; ALT Alanine aminotransferase -- ALP alkaline phosphatase -- ANOVA analysis of variance -- AST aspartate aminotransferase -- FOB functional observation battery -- GGT gamma glutamyltransferase -- HCD historical control data -- HCT hematocrit -- HGB hemoglobin -- LCFA long chain fatty acid -- MCV mean corpuscular volume -- MCHC mean corpuscular hemoglobin concentration -- HDW mean hemoglobin distribution width -- NOAEL no-observed-adverse-effect level -- OECD Organisation for Economic Co-operation and Development -- RBC red blood cell -- RDW red cell distribution width -- SOPs standard operating procedures -- FDA U.S. Food and Drug Administration; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2017.07.026
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: The subchronic toxicity of glycolipids from Dacryopinax spathularia (herein referred to as "AM-1") was studied in male and female Beagle dogs administered AM-1 by oral capsule at doses of 150, 500 or 1000 mg/kg/day for 90 days. AM-1 was well tolerated at all dosages and there were no test article-related effects on survival, clinical observations, neurological screening (functional observational battery) parameters, clinical pathology parameters, organ weights, macroscopic or microscopic evaluations. Test article-related changes were limited to minimal effects on food consumption and body weight changes in the 1000 mg/kg/day group females. Therefore, the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day, the highest dosage level tested. These results add to the safety database for these naturally derived jelly mushroom glycolipids with potential for use as a food ingredient. Highlights: Oral administration of jelly mushroom glycolipids (AM-1) up to 1000 mg/kg/day for 90 days was well tolerated in Beagle dogs. Minimal test-article related effects on food consumption and body weight changes were noted in females given 1000 mg/kg/day. There were no test article-related effects on remaining endpoints and parameters evaluated. The no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day, the highest dosage level tested.