Subchronic Intravenous (I.V.) Toxicity Study in Rabbits

SUMMARY

"Three 'SPF' (New Zealand albino) male rabbits received an intravenous infusion of Filmix, three times per week for 2.5 weeks, at a dosage of 0.48 ml/kg. After the initial 2.5 week period, Filmix (0.48 ml/kg) with added Gd-DTPA derivative (3-20 mg/kg) was continued at the same dosage for 2.5 months. An extensive serum chemistry profile, a hematology profile, and four coagulation tests were performed on blood samples taken: prior to injection, after 2.5 weeks, 7 weeks, and 11 weeks after the initial injection, and prior to necropsy. At the end of this period the animals were sacrificed, subjected to a gross autopsy, and tissues fixed for histological examination [by Dr. Stuart Wyand, Professor of Pathobiology, University of Connecticut]."

"The clinical pathology parameters for serum chemistry, hematology, and coagulation revealed no findings that could be related to the administration of the test material and were essentially within normal limits at each examination period. The microscopic pathology examination revealed no atheromati, mural thrombi, or emboli or any other findings that could be related to the administration of Filmix. Therefore, Filmix is further considered to be safe for single or 2 times administration in short-term clinical trials."

Robert West, Ph.D.
Consulting Pharmacologist/Toxicologist
FOOD, DRUG, CHEMICAL SERVICES, INC., Stamford, Connecticut 06906
November 28, 1989