Subacute toxicity of a Pseudomonas vaccine prepared from outer membrane fraction of Pseudomonas aeruginosa in beagle dogs.
CFC-101, a Pseudomonas vaccine, was administered to beagle dogs by intramuscular injection for 4 weeks (5 days/week) at 0.05, 0.15 and 0.45 mg/kg/d. Clinical signs considered to be related to treatment were restricted to swelling at the injection sites, being apparent 1-2 h after treatment. There was no effect on body weight, food consumption, ophthalmoscopy, electrocardiography, hematology, biochemical and urinary parameters. The histopathological examination revealed treatment-related changes at the injection sites at all dosages, particularly in the hindlimbs where both perivascular and intramuscular aggregations of inflammatory cells were seen. Thus, the only treatment-related changes seen in this study were local reactions to the test substance at the injection sites; furthermore these changes seem to represent a pharmacological response to the test material. Because no evidence of any systemic toxicity was observed at any dosage level, it is concluded that dosages of CFC-101 up to and including 0.45 mg/kg/d were well tolerated over a period of 4 weeks in the beagle dog.
Kim
D H
DH
R&D Center, Cheil Jedang Corp., Kyonggi-do, Korea.
Baek
N J
NJ
Park
K H
KH
Park
W J
WJ
Ahn
D H
DH
Sim
H S
HS
Harling
R J
RJ
Ryle
P R
PR
McPherson
S M
SM
D000818:Animals; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology / Q000633:toxicity*; D001428:Bacterial Vaccines / Q000633:toxicity*; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D001853:Bone Marrow / Q000187:drug effects / Q000473:pathology; D004285:Dogs; D004435:Eating / Q000187:drug effects; D004562:Electrocardiography / Q000187:drug effects; D005128:Eye Diseases / Q000473:pathology; D005260:Female; D008297:Male; D011549:Pseudomonas / Q000276:immunology; D016482:Urinalysis
D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines