The Effects of Intravenous Administration of 10% Travamulsion Fat Emulsion to Beagle Dogs for 91 Consecutive Days

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Abstract
The tolerance of 10% Travamulsion Intravenous Fat Emulsion (Travenol Laboratories, Inc., Deerfield, IL) was studied using beagle dogs. Physiological (0.9%) saline, USP, was used as the control, and Intralipid 10% Fat Emulsion (Vitrum, Sweden) as the reference article. The emulsions were administered intravenously to each of 10 animals for 91 days at a dosage of 40 ml (approximately 4 g)/kg of body weight/day. The saline was administered to 10 animals at 40 ml/kg/day. On day 92, 7 of the 10 animals in each group were necropsied. The remainder were observed and necropsied at approximately day 160. Toxicity was assessed on the basis of animal survival; changes in body weight, hematology, and serum chemistry; gross pathology; and histopathology. The results obtained for the Travenol emulsion correlated well with those for the Vitrum emulsion. The emulsions were well tolerated and they did not produce any major clinical signs of toxicity. All animals survived and gained weight. The Travenol emulsion administered provided about 45% of the total caloric requirement of the dog which is equal to an often used clinical dose. However, the emulsion was infused at six times the indicated clinical rate. Thus, in addition to demonstrating the similarity of Travenol and Vitrum emulsions, the results of this study indicate that the Travenol emulsion is safe for prolonged administration.