A developmental safety study in rats using DHA- and ARA-rich single-cell oils.

The long-chain omega-3 and omega-6 fatty acids, docosahexaenoic and arachidonic acids, are important in fetal development, but may be depleted from the mother during pregnancy as she transfers reserves to the developing fetus in utero and later to the infant through her breast milk. Pregnant women can increase their dietary intake of these nutrients to maintain adequate maternal reserves and ensure an optimal infant supply. DHASCO(R) and ARASCO(R) oils, concentrated sources of docosahexaenoic and arachidonic acids, respectively, have been tested in acute and subchronic studies without toxic effects. The present developmental toxicity study was undertaken to test for potential teratogenic activity of these oils to ensure their safe use during pregnancy. DHASCO and ARASCO oils were administered by oral gavage to pregnant rats at doses up to 1250 and 2500 mg/kg body weight/day, respectively, during the period of organogenesis. Caesarean sections and necropsies were performed on day 20 of gestation. Maternal reproductive outcomes were analyzed, and fetal external, soft and skeletal tissue were examined. Treatment with these oils did not produce overt maternal toxicity, nor did either oil result in changes in pre- or postimplantation losses, resorptions, live births or sex ratios. Neither oil caused fetal malformations. Increased frequencies of renal variations in development occurred in a non-dose-dependent manner and were not toxicologically significant. We conclude that these oils are not teratogenic at doses that represent a 100-fold safety factor over expected use levels.