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

# PH 422-CV-001-90

SUMMARY

"Ten rabbits (five males and five females) were intravenously administered Filmix, Lot #12-29-89 at a dose level of 4.8 ml/kg. Signs observed during the study included increased respiration and decreased activity. None of the animals died during the study. Terminal necropsy revealed pale lungs in one animal. No other visible lesions were observed in any of the remaining animals at terminal necropsy."

"Based upon the observations made in the Acute Intravenous (I.V.) Toxicity Study in Rabbits, the estimated intravenous LD50 for Filmix, Lot #12-29-89, was determined to be greater than 4.8 ml/kg."

Victor T. Mallory, B.S., RLAT
Study Director
PHARMAKON RESEARCH INTERNATIONAL, INC., Waverly, Pennsylvania 18471
March 20, 1990