1981 Volume 6 Issue Supplement Pages 121-140
The percutaneous subacute toxicity of 0.1% and 0.5% hydrocortisone 17-butyrate 21-propionate ointment (0.1% HBP, 0.5% HBP) were studied in beagle dogs for 3 months at the daily dose level of 200 mg per kilogram of body weight, using 0.1% and 0.5% hydrocortisone 17-buyrate ointment (0.1% HB, 0.5% HB), 0.12% and 0.5% betamethasone 17-butyrate ointment (0.12% BV, 0.5% BV) as the reference drugs. The results in this study were as follows : 1) In the sites applied HBP, HB and BV, acne-like changes and inhibition of hair growth wore found. 2) Body weight, food and water consumptions increased in the groups of 0.5% ointment, and in these dogs obesity by accumlation of subcutaneous fat was observed. 3) In hematological examination, biochemical examination and urinalysis, decrease in the number of lymphocytes and eosinophils, and increase in total cholesterol, triglyceride, urine-volume and urine-potassium were observed at 0.5% ointment groups. 4) In autopsy, dose-induced weight loss of thymus and adrenals, and hemorrhage of gastromucosa were found in dogs applied HBP, HB and BV. 5) In histopathological examination, the atrophy of adrenal cortex, lymphatic tissues, bone marrow, prostate, uterus and skin were found in dogs applied HBP, HB and BV. Further more, enlargement of hepatocytes was found. The above changes common other corticosteroids, which have been already reported, returned to normal after I month recovery period at 0.1% or 0.12% ointment groups. The percutaneous toxicity study of HBP compared with HB and BV was perfofmed. As the result, HBP and HB were almost samely toxic, but slightly less toxic than BV.
