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From the 1996 FDA Science Forum
Abstract # G-04
Fish Oil Toxicity In Rats. P.I. Rabbani, H. Alam and S. Chirtel. CFSAN, FDA, Laurel, MD
The possible toxic side effects of high-dose long-term consumption of fish oil concentrates (FOC) were
investigated. Male (120) and female (120) Sprague Dawley rats were administered 5 mL/kg/day of corn oil(CO),
Menhaden Oil(MO) MaxEPA or mixtures of corn oil with Menhaden oil by gavage every day for 13 weeks.
Relative liver and spleen weights increased significantly in both sexes with the high dose of fish oil concentrates.
In female rats, serum iron, cholesterol, HDL and Vitamin. E were significantly reduced with high dosages of fish
oil concentrates. Treatment-related histological aberrations in the small intestine and in the mesenteric lymph
nodes were also observed in both sexes. FDA concluded that long-term high dosages of feeding fish oil
concentrates to rats can reduce serum Fe, HDL and Vitamin. E levels in females and may also cause
histological lesions in the small intestine and in the mesenteric lymph nodes of both sexes.