A combined subchronic (90-day) toxicity and neurotoxicity study of a single-cell source of docosahexaenoic acid triglyceride (DHASCO oil).
Docosahexaenoic acid (DHA), a 22-carbon long-chain polyunsaturated fatty acid of the omega-3 family, is a major structural component of neural membranes and is a particularly important nutrient during infant development. New safe and well-defined sources of DHA are required for infant formula fortification and dietary supplementation. DHASCO oil is an algal-derived triglyceride containing 40-50% DHA. Previous studies have shown that DHASCO oil is neither mutagenic nor toxic in acute or 28-day subchronic tests. To further establish the safety of this oil, a 90-day subchronic toxicity study in rats which included haematology, clinical chemistry, pathology and ophthalmologic, neurobehavioural and neuropathological assessments, using doses of 0.5 and 1.25g/kg body weight/day was performed. There were no treatment-related adverse effects in any of the parameters measured at either dose. Based on these results, the no-adverse-effect level (NOAEL) for DHASCO oil under the conditions of this study corresponds to the highest dose level. The DHA in the DHASCO oil was bioavailable, resulting in significant elevations in the levels of this fatty acid in liver, heart and brain after 90 days of administration. In conclusion, this 90-day subchronic toxicity study provides additional evidence that DHASCO oil is a safe and bioavailable source of dietary DHA.
Arterburn
L M
LM
Martek Biosciences Corporation, 6480 Dobbin Road, Columbia, MD 21045, USA.
Boswell
K D
KD
Koskelo
E
E
Kassner
S L
SL
Kelly
C
C
Kyle
D J
DJ
D000818:Animals; D001682:Biological Availability; D004041:Dietary Fats; D004281:Docosahexaenoic Acids / Q000009:adverse effects* / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007225:Infant Food; D007231:Infant, Newborn; D008297:Male; D016296:Mutagenesis; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D018675:Toxicity Tests; D014280:Triglycerides / Q000009:adverse effects* / Q000493:pharmacokinetics
D004041:Dietary Fats; D014280:Triglycerides; D004281:Docosahexaenoic Acids