title: Genetic and acute toxicological evaluation of an algal oil containing eicosapentaenoic acid (EPA) and palmitoleic acid.
abstract: Algal strains of Nannochloropsis sp. were developed, optimized, cultivated and harvested to produce a unique composition of algal oil ethyl esters (Algal-EE) that are naturally high in eicosapentaenoic acid (EPA, 23-30%) and palmitoleic acid (20-25%), and contain no docosahexaenoic acid (DHA). Algal-EE was evaluated for mutagenic activity (Ames bacterial reverse mutation, in vitro mammalian chromosome aberration, in vivo micronucleus test) and for acute oral toxicity in Sprague-Dawley rats. In the acute toxicity study, rats received a single oral gavaged dose of Algal-EE (2000 mg/kg body weight). Clinical observations were made for 14 days before sacrifice on Day 15. Macroscopic evaluation involved the examination of all organs in the cranial, thoracic, and abdominal cavities. Algal-EE showed no evidence of mutagenicity, did not produce an increase in the frequency of structural chromosome aberrations, and did not cause an increase in the induction of micronucleated polychromatic erythrocytes. There were no macroscopic abnormalities. Algal-EE up to 2000 mg/kg body weight did not affect body weight, organ appearance or produce any toxic-related signs of morbidity. The acute median lethal dose (LD50) of Algal-EE was >2000 mg/kg body weight. Based on these assays, Algal-EE does not appear to have any genetic or acute oral toxicity.
authors: Aurora Algae, Inc., 3325 Investment Blvd, Hayward, CA 94545, United States. Electronic address: mcollins@aurorainc.com.
authors: M L
authors: ML
authors: Collins
authors: Intertek Scientific & Regulatory Consultancy, 2233 Argentia Rd, Mississauga, ON L5N 2X7, Canada. Electronic address: barry.lynch@intertek.com.
authors: B
authors: B
authors: Lynch
authors: Huntingdon Life Sciences, Eye Research Center, Eye, Suffolk IP23 7PX, United Kingdom. Electronic address: barfielw@ukorg.huntingdon.com.
authors: W
authors: W
authors: Barfield
authors: Huntingdon Life Sciences, Eye Research Center, Eye, Suffolk IP23 7PX, United Kingdom. Electronic address: bulla@ukorg.huntingdon.com.
authors: A
authors: A
authors: Bull
authors: Aurora Algae, Inc., 3325 Investment Blvd, Hayward, CA 94545, United States. Electronic address: aryan@aurorainc.com.
authors: A S
authors: AS
authors: Ryan
authors: Aurora Algae, Inc., 3325 Investment Blvd, Hayward, CA 94545, United States. Electronic address: jastwood@aurorainc.com.
authors: J D
authors: JD
authors: Astwood
mesh_terms: D000818:Animals; D001835:Body Weight; D004281:Docosahexaenoic Acids / Q000032:analysis; D004305:Dose-Response Relationship, Drug; D015118:Eicosapentaenoic Acid / Q000032:analysis*; D005229:Fatty Acids, Monounsaturated / Q000032:analysis*; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D051379:Mice; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects; D058009:Stramenopiles / Q000737:chemistry*; D023382:Toxicity Tests, Acute
chemical_list: D005229:Fatty Acids, Monounsaturated; C008757:palmitoleic acid; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid
keywords: Algae; Eicosapentaenoic acid; Nannochloropsis sp.; Omega-3; Omega-7; Palmitoleic acid