title: Toxicological evaluation of arachidonic acid (ARA)-rich oil and docosahexaenoic acid (DHA)-rich oil.
abstract: The safety of DHA-rich oil from Schizochytrium sp. and ARA-rich oil from Mortierella alpina was separately evaluated by testing for gene mutations, clastogenicity, and aneugenicity, and by conducting 28-day and 90-day dietary studies in Wistar rats. The results of all genotoxicity tests were negative. The 28-day and 90-day studies involved dietary exposure to 1000, 2500, and 5000 mg per kg bw of the DHA-rich and ARA-rich oils and two control diets: water and corn oil (vehicle control). There were no treatment-related effects of either the DHA-rich or ARA-rich oils on clinical observations, body weight, food consumption, behavior, hematology, clinical chemistry, coagulation, urinalysis parameters, or necropsy findings. Increases in cholesterol and triglyceride levels were considered related to a high oil diet and non-adverse. The no observable adverse effect level (NOAEL) for both the DHA-rich and ARA-rich oils was 5000 mg per kg bw, the highest dose tested. The results confirm that these oils possess toxicity profiles similar to those of other currently marketed oils and support the safety of DHA-rich oil from Schizochytrium sp. and ARA-rich oil from Mortierella alpina for their proposed uses in food.
authors.affiliation: LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD 20854, USA.
authors.forename: Kara D
authors.initials: KD
authors.lastname: Lewis
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd., Zhao'an County, Zhangzhou City, Fujian Province China.
authors.forename: Weifeng
authors.initials: W
authors.lastname: Huang
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd., Zhao'an County, Zhangzhou City, Fujian Province China.
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Zheng
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd., Zhao'an County, Zhangzhou City, Fujian Province China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD 20854, USA.
authors.forename: Robin S
authors.initials: RS
authors.lastname: Feldman
authors.affiliation: LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD 20854, USA. Electronic address: falkm@lsro.org.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Falk
mesh_terms: D000818:Animals; D016718:Arachidonic Acid / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects*; D002869:Chromosome Aberrations / Q000187:drug effects*; D004281:Docosahexaenoic Acids / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D004912:Erythrocytes / Q000187:drug effects*; D005260:Female; D005395:Fish Oils / Q000633:toxicity*; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D017208:Rats, Wistar
chemical_list: D005395:Fish Oils; D004281:Docosahexaenoic Acids; D016718:Arachidonic Acid
keywords: Arachidonic acid; Docosahexaenoic acid; Mortierella alpina; Schizochytrium sp.; Toxicity