Genotoxicity and subchronic toxicity studies of DHA-rich oil in rats.
Polyunsaturated fatty acids, including docosahexaenoic acid (DHA), are natural constituents of the human diet. DHA-algal oil is produced through the use of the non-toxigenic and non-pathogenic marine protist, Ulkenia sp. The safety of DHA-algal oil was assessed in a subchronic toxicity study and in genotoxicity studies. In a 90-day study, rats were orally administered water or DHA-algal oil at concentrations of 0, 500, 1000, and 2000 mg/kg in combination with 2000, 1500, 1000 or 0 mg/kg DHA-containing fish oil, respectively. Additional animals were administered water, 2000 mg/kg DHA-algal oil, or 2000 mg/kg fish oil for 90 days, followed by a 4-week recovery phase. No treatment-related effects were observed in clinical observations, food and water consumption, mortality, gross pathology, and histopathology. Increased body weights and liver weights in oil-treated groups were attributed to the large lipid load and were not regarded as toxicologically significant. Furthermore, no treatment-related differences in the measured parameters between the DHA-algal oil and fish oil groups were detected. In genotoxicity experiments, DHA-algal oil exerted no mutagenic activity in various bacterial strains, nor did it induce chromosomal aberrations in Chinese hamster fibroblast cells. These results support the safety of DHA-algal oil as a dietary source of DHA.
Blum
René
R
Lonza Group Ltd., Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland. rene.blum@lonza.com
Kiy
Thomas
T
Tanaka
Satohiro
S
Wong
Andrea W
AW
Roberts
Ashley
A
D000818:Animals; D049109:Cell Proliferation / Q000187:drug effects; D002869:Chromosome Aberrations / Q000187:drug effects; D006224:Cricetinae; D004281:Docosahexaenoic Acids / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D056890:Eukaryota / Q000737:chemistry; D005260:Female; D005347:Fibroblasts / Q000166:cytology / Q000187:drug effects / Q000378:metabolism; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008297:Male; D009152:Mutagenicity Tests / Q000379:methods; D009154:Mutation; D009821:Oils / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D009929:Organ Size / Q000187:drug effects; D011188:Potassium / Q000652:urine; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D012964:Sodium / Q000652:urine; D036401:Toxicity Tests, Chronic / Q000379:methods*; D015430:Weight Gain / Q000187:drug effects
D009821:Oils; D004281:Docosahexaenoic Acids; D012964:Sodium; D011188:Potassium