title: Acute and twenty-eight days repeated oral dose toxicity study of besifloxacin in Wistar albino rats.
abstract: The purpose of this study was to investigate the potential acute and 28-day repeated oral toxicities of besifloxacin (BAF) in Wistar albino rats. In oral acute and repeated dose study, BAF was administered to both sex of rats, at dose levels of 0, 300, 600, 900 mg/kg/day and 0, 100, 200, 500 mg/kg/day, respectively. In the acute study, total white blood cell (WBC) (male, 43.74%; female, 42.60%) and total bilirubin (T-BIL) (male, 80%; female, 60%) were significantly increase, total protein (TP) (male, 23.24%; 27.80%) was significantly decreased, and significant incidence of pericholangitis (male, 83.33%; female, 75%) was shown in males and females of high-dose groups. In repeated oral dose toxicity study, similar type effects were also observed after serum hematological and serum biochemical analysis, whereas additionally sever hepatic injury and focal ulceration in gastric mucosa also observed in high dose groups of both sexes after histopathological analysis. However these toxic effects of besifloxacin were transient and reversible and no-observed adverse effect level (NOAEL) were 300 mg/kg/day for acute and 100 mg/kg/day for repeated dose toxicity study, respectively.
authors.affiliation: Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India.
authors.forename: Bikash
authors.initials: B
authors.lastname: Roy
authors.forename: Utpal
authors.initials: U
authors.lastname: Nandi
authors.forename: Anjan
authors.initials: A
authors.lastname: Das
authors.forename: Tapan Kumar
authors.initials: TK
authors.lastname: Pal
mesh_terms: D000125:Achilles Tendon / Q000187:drug effects / Q000473:pathology; D000818:Animals; D000900:Anti-Bacterial Agents / Q000633:toxicity*; D001381:Azepines / Q000633:toxicity*; D001663:Bilirubin / Q000097:blood; D001792:Blood Platelets / Q000187:drug effects; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D004195:Disease Models, Animal; D005260:Female; D024841:Fluoroquinolones / Q000633:toxicity*; D006003:Glycogen / Q000378:metabolism; D007596:Joints / Q000187:drug effects / Q000473:pathology; D007958:Leukocyte Count; D008099:Liver / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D008297:Male; D010787:Photosensitivity Disorders / Q000139:chemically induced; D051381:Rats; D017208:Rats, Wistar; D013276:Stomach Ulcer / Q000139:chemically induced / Q000473:pathology; D013922:Thrombocytosis / Q000139:chemically induced; D023382:Toxicity Tests, Acute; D059551:Toxicity Tests, Subacute
chemical_list: D000900:Anti-Bacterial Agents; D001381:Azepines; D024841:Fluoroquinolones; D006003:Glycogen; C522124:besifloxacin; D001663:Bilirubin