Ra. Burns et al., Evaluation of single-cell sources of docosahexaenoic acid and arachidonic acid: 3-month rat oral safety study with an in utero phase, FOOD CHEM T, 37(1), 1999, pp. 23-36
Owing to the presence of the polyunsaturated fatty acids (PUFA) docosahexae
noic acid (DHA) and arachidonic acid (ARA) in human milk and their importan
t biological function, several authorities recommend that they be added to
infant formulas. This study assessed the safety of an algal oil rich in DHA
and a fungal oil rich in ARA, blended to provide a DHA to ARA ratio simila
r to human milk. The oil blend was incorporated into diets and fed to rats
such that they received 3, 11 and 22 times the anticipated infant exposure
to DHA and ARA. Low-fat and high-fat control groups received canola oil. Ra
ts received experimental diets over a premating interval and throughout mat
ing, gestation and lactation. Pups born during this period (F-1) consumed t
reatment diets from weaning for 3 months. Physical observations, ophthalmos
copic examinations, body weight, food intake, clinical chemistry, neurobeha
vioural evaluations and postmortem histopathology of selected tissues were
performed. No statistically significant, dose-dependent adverse effects wer
e seen in reproductive performance or fertility, nor in the neonates from b
irth to weaning. Mid- and high-dose treated F-1 animals exhibited increased
white cell count, neutrophil count and blood urea nitrogen; increased live
r and spleen weights (absolute and relative to body weight) also were obser
ved. There were no corresponding microscopic findings. The clinical patholo
gy and organ weight differences at these treatment levels represent physiol
ogical or metabolic responses to the test substance rather than adverse res
ponses. These single-cell oils produced no adverse effects in rats when adm
inistered in utero and for 90 days at dietary levels resulting in exposures
up to 22 or 66 times higher than those expected in infant formulas when ex
trapolated on the basis of diet composition (g/100 Cat) or intake (g/kg bod
y weight), respectively. (C) 1998 Elsevier Science Ltd. All rights reserved
.