title: Safety assessment of EPA-rich polar lipid oil produced from the microalgae Nannochloropsis oculata.
abstract: Almega PL is an eicosapentaenoic acid-rich ω-3 oil that is isolated from Nannochloropsis oculata algae and developed as a dietary supplement. The safety of the algal oil was evaluated in 14- and 90-day studies in Sprague-Dawley rats by oral gavage at dose levels of 0, 250, 500, and 2500 mg/kg/d and 0, 200, 400, and 2000 mg/kg/d, respectively. No mortalities occurred and no signs of toxicity were observed during the studies. No treatment-related effects were seen for body weight, food consumption, ophthalmology, neurological effects, urinalysis, clinical pathology, gross pathology, organ weights, or histopathology. Although statistically significant effects were noted for some end points, none were considered to be of toxicological significance. The no observed adverse effect level for Almega PL was 2000 mg/kg/d. Additionally, Almega PL was not mutagenic in Salmonella typhimurium or Escherichia coli, did not induce chromosome aberrations in Chinese hamster ovary cells, and did not induce genotoxic effects in vivo in rat bone marrow erythrocytes.
authors.affiliation: Qualitas Health Ltd, Jerusalem, Israel mkagan@qualitas-health.com.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Kagan
authors.affiliation: Gad Consulting Services, Cary, North Carolina, USA.
authors.forename: Dexter W
authors.initials: DW
authors.lastname: Sullivan
authors.affiliation: Gad Consulting Services, Cary, North Carolina, USA.
authors.forename: Shayne C
authors.initials: SC
authors.lastname: Gad
authors.affiliation: Gad Consulting Services, Cary, North Carolina, USA.
authors.forename: Corey M
authors.initials: CM
authors.lastname: Ballou
mesh_terms: D000818:Animals; D016466:CHO Cells; D002869:Chromosome Aberrations; D003412:Cricetulus; D015118:Eicosapentaenoic Acid / Q000633:toxicity*; D004912:Erythrocytes / Q000187:drug effects; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D005260:Female; D008297:Male; D020714:Maximum Tolerated Dose; D058086:Microalgae; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D009821:Oils / Q000633:toxicity*; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D058009:Stramenopiles; D059551:Toxicity Tests, Subacute; D059550:Toxicity Tests, Subchronic
chemical_list: D009821:Oils; D015118:Eicosapentaenoic Acid
keywords: DHA; EPA; Nannochloropsis oculata; algae; dietary supplement; docosahexaneoic acid; eicosapentaenoic acid; genotoxicity; toxicity; ω-3