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Toxicity of human recombinant interferon-gamma in rats and dogs
1Division of Antimalarial Drugs, Faculty of Basic Medicine, Second Military Medical University, Shanghai, China.
Aim:
To study the acute and chronic toxicities of human recombinant interferon-gamma (Hu-rIFN-gamma) in mice, rats, and dogs.
Method:
Twenty mice were administrated Hu-rIFN-gamma (i.m. or i.v.) 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 i.m. for 3 months, treatment-related changes were measured in the hematologic, chemical, urinalysis values, ECG and pathologic profile of organs and tissues.
Results:
The maximal tolerance dose (MTD) i.m. or i.v. 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.
Conclusion:
Human recombinant interferon-gamma did not produce toxic reaction in rats and dogs.