title: A 90-day subchronic toxicity study with sodium formononetin-3'-sulphonate (Sul-F) delivered to dogs via intravenous administration.
abstract: Sodium formononetin-3'-sulphonate (Sul-F) is a water-soluble derivate of formononetin, and an increasing number of studies have shown that Sul-F not only possesses favorable water solubility but also exhibits good lipid-lowering and bioactivities. In the current study, the toxicity of Sul-F was evaluated in dogs after 90-day intravenous infusion. Dogs were treated with Sul-F at dose of 0, 33.3, 100, and 300 mg/kg, and observed for 90-day followed by 28-day recovery period. Weekly measurement of body weight, temperature and food consumption were conducted. Ophthalmoscopy, ECG examination, urinalysis, serum biochemistry and hematology examination were performed at pre-test, on days 45 and 90, and following by 28-day recovery period. Histological examination was performed on day 90 and 28-day recovery period. No mortality, ophthalmic abnormalities or treatment-related findings in body weight, clinical chemistry, hematology, and histopathological examination were detected. However, a white crystal (non-metabolic Sul-F), transient vomiting and recoverable vascular stimulation were observed in 300 mg/kg/day Sul-F treated dogs. Under the conditions, the no-observed-adverse-effect-level (NOAEL) for Sul-F was 100 mg/kg in dogs.
authors.affiliation: School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, 264005, PR China.
authors.forename: Chunmei
authors.initials: C
authors.lastname: Li
authors.affiliation: School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, 264005, PR China.
authors.forename: Guisheng
authors.initials: G
authors.lastname: Li
authors.affiliation: School of Life Sciences, Yantai University, Yantai, 264005, PR China. Electronic address: gylbill@163.com.
authors.forename: Yonglin
authors.initials: Y
authors.lastname: Gao
authors.affiliation: School of Life Sciences, Yantai University, Yantai, 264005, PR China.
authors.forename: Chengfeng
authors.initials: C
authors.lastname: Sun
authors.affiliation: School of Life Sciences, Yantai University, Yantai, 264005, PR China.
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Wang
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000097:blood / Q000652:urine; D003460:Crystallization; D004285:Dogs; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D007262:Infusions, Intravenous; D007529:Isoflavones / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D018570:Risk Assessment; D013997:Time Factors; D059551:Toxicity Tests, Subacute / Q000379:methods*; D014839:Vomiting / Q000139:chemically induced; D015431:Weight Loss / Q000187:drug effects
chemical_list: D015415:Biomarkers; D000960:Hypolipidemic Agents; D007529:Isoflavones; C548268:formononetin-3-sulfonate
keywords: Dogs; Intravenous administration; Sodium formononetin-3′-sulphonate (Sul-F); Subchronic toxicity