title: Acute and repeated dose (28 days) oral safety studies of an alkoxyglycerol extract from shark liver oil in rats.
abstract: 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).
authors.affiliation: Departamento de Toxicología y Farmacología, Facultad de Veterinaria, Universidad Complutense de Madrid, 28040 Madrid, Spain. anadon@vet.ucm.es
authors.forename: Arturo
authors.initials: A
authors.lastname: Anadón
authors.forename: Maria A
authors.initials: MA
authors.lastname: Martínez
authors.forename: Irma
authors.initials: I
authors.lastname: Ares
authors.forename: Eva
authors.initials: E
authors.lastname: Ramos
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Señoráns
authors.forename: Guillermo
authors.initials: G
authors.lastname: Reglero
authors.forename: Carlos
authors.initials: C
authors.lastname: Torres
mesh_terms: D000284:Administration, Oral; D000818:Animals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage / Q000009:adverse effects*; D005995:Glyceryl Ethers / Q000737:chemistry; D008099:Liver / Q000737:chemistry*; D008297:Male; D051381:Rats; D017208:Rats, Wistar; D012754:Sharks
chemical_list: D005395:Fish Oils; D005995:Glyceryl Ethers