Toxicity of human recombinant interferon-gamma in rats and dogs.
OBJECTIVE
To study the acute and chronic toxicities of human recombinant interferon-gamma (Hu-rIFN-gamma) in mice, rats, and dogs.


METHODS
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.


CONCLUSIONS
Human recombinant interferon-gamma did not produce toxic reaction in rats and dogs.
Yuan
B J
BJ
Division of Antimalarial Drugs, Faculty of Basic Medicine, Second Military Medical University, Shanghai, China.
Fang
Y Q
YQ
Liu
J P
JP
Lu
G C
GC
Yang
Y M
YM
Zhou
G X
GX
D000818:Animals; D004285:Dogs; D005260:Female; D007371:Interferon-gamma / Q000633:toxicity*; D008099:Liver / Q000187:drug effects; D008297:Male; D051379:Mice; D051381:Rats; D017208:Rats, Wistar; D011994:Recombinant Proteins; D013045:Species Specificity
D011994:Recombinant Proteins; D007371:Interferon-gamma