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EC number: 421-860-7 | CAS number: 156145-64-1
Histopathology: Treatment-related findings
Dose (mg/kg bw/day
Cortical tubules with hyaline droplets
Cortical tubular basophilia
Medullary tubular basophilia
Total number of kidneys examined
Total number of spleens examined
a-p<0.05, b-p<0.01 with Fisher’s Exact test, on total incidences only.
After oral administration of OS2200 to the rats for 13 weeks, changes were seen in the kidney and spleen. In the male kidney, cortical tubules with hyaline droplets and cortical tubular basophilia were identified with a severity and/or higher incidence in rats treated at 15 or 50 mg/kg/day OS2200. In the spleen, there were increased incidence and severity of extramedullary haemopoiesis in all treated groups of both sexes, compared with controls. Also increased incidence and severity of haemosiderosis were seen in animals treated at 50 mg/kg/day of OS2200 in both sexes, when compared with controls. In the recovery, all lesions of kidney and spleen had resolved.
A 13 week repeated dose toxicity test followed by a 4 week recovery period was performed to assess the systemic toxicity of OS 2200 under GLP conditions. The test was performed in rats by oral gavage, three groups, each comprising then male and ten female rats received OS2200 at dosages of 5, 15 or 50 mg/kg bodyweight/day. A similarly constituted group received the vehicle, corn oil, at the same volume-dosage. A further five male and five female rats were assigned to each of the groups, these animals were treated for 13 weeks, followed by a 4 week period without treatment to assess recovery from any treatment related effect. During the study, clinical condition, detailed physical and arena observations, sensory reactivity, grip strength, motor activity, bodyweight, food consumption, ophthalmic examination, haematology, blood chemistry, urinalysis, organ weight, macropathology and histopathology investigations were undertaken. It was concluded that the principal action of OS2200 was to affect the red blood cell rate of turnover occurring mainly among animals receiving 50 mg/kg/day, resulting in associated changes in the spleen. Due to the high incidence of medullary haemopoesis observed in the spleen in both sexes among all treated groups, a NOEL was not established for OS 2200 in this study. A dosage level of 15 mg/kg/day, however, was considered to be the highest NOAEL for OS 2200 on this study, as the changes observed at 5 and 15 mg/kg/day were considered to be minor in nature and had shown full recovery after 4 weeks without treatment.
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