TOXICITY OF HUMAN RECOMBINANT INTERFERON-GAMMA IN RATS AND DOGS

AIM: To study the acute and chronic toxicities of human recombinant in terferon-gamma (Hu-rIFN-gamma) in mice, rats, and dogs. METHOD: Twenty mice were administrated Hu-rIFN-gamma (im or iv) 4.4 X 10(9) IU m(-2) to observe the acute toxicity. In chronic studies, 1 X 10(7), 5 X 10( 7), 1 X 10(8) IU m(-2) d(-1) were given to 80 rats and 5 X 10(5), 5 X 10(7) IU m(-2) d(-1) were injected to 14 dogs im for 3 months, treatme nt-related changes were measured in the hematologic, chemical, urinaly sis values, ECG and pathologic profile of organs and tissues. RESULTS: The maximal tolerance dose (MTD) im or iv in mice was 4.4 X 10(9) IU m(-2), 4400 times the recommended clinical dosage (1 X 10(6) IU m(-2)) . No adverse effects were found in chronic toxicity studies. CONCLUSIO N: Human recombinant interferon-gamma did not produce toxic reaction i n rats and dogs.