title: Safety evaluation of oleic-rich triglyceride oil produced by a heterotrophic microalgal fermentation process.
abstract: Numbers of macro- and microalgae have been used as food sources in various cultures for centuries. Several microalgae are currently being developed as modern food ingredients. The dietary safety of oleic-rich microalgal oil produced using a heterotrophic fermentation process was assessed in a 13-week feeding trial in rats with genotoxic potential evaluated using in vitro and in vivo assays. In the genotoxicity assays, the test oil was not mutagenic in Salmonella typhimurium or Escherichia coli tester strains (⩽5000μg/plate) with or without metabolic activation. Further, no clastogenic response occurred in chromosome aberration assays in the bone marrow of mice administered a single intraperitoneal dose (2000mg/kg). In the subchronic study, rats consumed feed containing 0, 25,000, 50,000 or 100,000ppm oleic-rich oil for 90days. No treatment-related mortalities or adverse effects occurred in general condition, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, gross pathology, organ weights or histopathology. Although several endpoints exhibited statistically significant effects, none were dose-related or considered adverse. Taking all studies into consideration, the NOAEL for the oleic-rich oil was 100,000ppm, the highest concentration tested and equivalent to dietary NOAELs of 5200mg/kg bw/day and 6419mg/kg bw/day in male and female rats, respectively.
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, FL 32814, United States. Electronic address: nszabo@burdockgroup.com.
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Szabo
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, FL 32814, United States.
authors.forename: Ray A
authors.initials: RA
authors.lastname: Matulka
authors.affiliation: Product Safety Laboratories, 2394 Highway 130, Dayton, NJ 08810, United States.
authors.forename: Palma Ann
authors.initials: PA
authors.lastname: Marone
authors.affiliation: Product Safety Laboratories, 2394 Highway 130, Dayton, NJ 08810, United States.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Bauter
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: Teresa
authors.initials: T
authors.lastname: Chan
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: Scott
authors.initials: S
authors.lastname: Franklin
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: John R
authors.initials: JR
authors.lastname: Carney
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: McQuaid
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: Walter
authors.initials: W
authors.lastname: Rakitsky
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: Richard
authors.initials: R
authors.lastname: Green
authors.affiliation: Solazyme, Inc., 225 Gateway Blvd., South San Francisco, CA 94080, United States.
authors.forename: Peter
authors.initials: P
authors.lastname: Licari
mesh_terms: D000818:Animals; D001835:Body Weight; D002869:Chromosome Aberrations; D004042:Dietary Fats, Unsaturated / Q000009:adverse effects / Q000032:analysis*; D005285:Fermentation; D058086:Microalgae / Q000378:metabolism*; D019301:Oleic Acid / Q000032:analysis*; D051381:Rats; D017207:Rats, Sprague-Dawley; D014280:Triglycerides / Q000737:chemistry*
chemical_list: D004042:Dietary Fats, Unsaturated; D014280:Triglycerides; D019301:Oleic Acid
keywords: Fermentation; Genotoxic; Microalgae; Mutagenic; Oleic-rich oil; Subchronic toxicity