Acute and Repeated Dose (28 Days) Oral Safety Studies of an Alkoxyglycerol Extract from Shark Liver Oil in Rats

• Published in: Journal of agricultural and food chemistry Vol. 58; no. 3; pp. 2040 - 2046
• Main Authors: Anadón, Arturo, Martínez, Maria A, Ares, Irma, Ramos, Eva, Señoráns, Francisco J, Reglero, Guillermo, Torres, Carlos
• Format: Journal Article
• Language: English
• Published: Washington, DC American Chemical Society 10.02.2010
• Subjects: acute course; Administration, Oral; alkoxyglycerol extract; animal models; Animals; Biological and medical sciences; dosage; dose response; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Evaluation, Preclinical; Drug-Related Side Effects and Adverse Reactions; experimental diets; extracts; Fat industries; Female; fish oils; Fish Oils - administration & dosage; Fish Oils - adverse effects; Food industries; Fundamental and applied biological sciences. Psychology; General aspects; Glyceryl Ethers - chemistry; Hygiene and safety; liver; Liver - chemistry; Male; oral administration; Rats; Rats, Wistar; safety testing; shark liver oil; Sharks; Toxicology in Agriculture and Food; toxicity; Alkoxyglycerols; rats; Edible fish; Rat; Digestive system; Toxicity; Acute; Liver; Rodentia; Shark; Extract; Vertebrata; Mammalia; Oil; Safety; Day
• ISSN: 0021-8561; 1520-5118
• DOI: 10.1021/jf903384c

Shark liver oil has been used for over 50 years as both a therapeutic and preventive agent. The active ingredients in shark liver oil have been found to be a group of ether-linked glycerols known as alkoxyglycerols. Despite its popularity, there is little published toxicology data on alkoxyglycerols. The toxicity of a supercritical fluid extract of shark liver oil (AKG-1 extract) has been evaluated in acute and repeated dose (28 days) oral toxicity studies in rats at doses of 200 and 100 times the maximum recommended dose by supplement manufacturers in humans, respectively. The AKG-1 extract administered in a single oral gavage dose of 2000 mg kg−1 of body weight resulted in no adverse events or mortality. The AKG-1 extract administered as a daily dose of 1000 mg kg−1 of body weight for 28 days by gavage resulted in no adverse effects or mortality. For both studies, no abnormal clinical signs, behavioral changes, body weight changes, or change in food and water consumption occurred. There were no changes in hematological and serum chemistry values, organ weights, or gross or histological characteristics. It is concluded that the AKG-1 extract is well tolerated in rats at an acute dose of 2000 mg kg−1 and at a subchronic (28 days) dose of 1000 mg kg−1.