title: Safety assessment of vitacoxib: Acute and 90-day sub-chronic oral toxicity studies.
abstract: Vitacoxib, is a newly developed coxibs NSAID (selective inhibitors of cyclooxygenase-2). To date, no experimental data have been published concerning its safety for use as an additive in the human diet. In the present study, we assessed the acute and sub-chronic toxicity of vitacoxib administered by gavage. The acute toxicity tests in Sprague Dawley (SD) rats and ICR mice demonstrated that vitacoxib at a dose of 5000 mg/kg BW failed to alter any of the parameters studied. In the 90-day sub-chronic toxicity test, vitacoxib was administered to SD rats at the doses of 0 (control), 5, 10, 20, 30, and 60 mg/kg BW. The results demonstrated that there were no significant differences for most indexes of sub-chronic toxicity throughout the experiment at the dose of 5-20 mg/kg BW, indicating no apparent dose-dependent. However, there were significant histopathology changes in the liver and kidney, and alterations in some biochemical parameters in the 60 mg/kg BW group. Based on these findings, the gavage LD50was determined to be > 5000 mg/kg in SD rats and ICR mice, and the 90-day gavage no-observed-adverse-effect level (NOAEL) of vitacoxib was considered to be 20 mg/kg BW under the present study conditions.
authors.affiliation: Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, People's Republic of China; Laboratory of Quality & Safety Risk Assessment for Animal Products on Chemical Hazards (Beijing), Ministry of Agriculture, Beijing 100193, People's Republic of China.
authors.forename: Jianzhong
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, People's Republic of China; Laboratory of Quality & Safety Risk Assessment for Animal Products on Chemical Hazards (Beijing), Ministry of Agriculture, Beijing 100193, People's Republic of China.
authors.forename: Feifei
authors.initials: F
authors.lastname: Sun
authors.affiliation: Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, People's Republic of China; Laboratory of Quality & Safety Risk Assessment for Animal Products on Chemical Hazards (Beijing), Ministry of Agriculture, Beijing 100193, People's Republic of China.
authors.forename: Shusheng
authors.initials: S
authors.lastname: Tang
authors.affiliation: Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, People's Republic of China; Laboratory of Quality & Safety Risk Assessment for Animal Products on Chemical Hazards (Beijing), Ministry of Agriculture, Beijing 100193, People's Republic of China.
authors.forename: Suxia
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Beijing Orbiepharm Co., Ltd, Beijing 100185, People's Republic of China.
authors.forename: Pengyue
authors.initials: P
authors.lastname: Lv
authors.affiliation: Beijing Orbiepharm Co., Ltd, Beijing 100185, People's Republic of China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, People's Republic of China; Laboratory of Quality & Safety Risk Assessment for Animal Products on Chemical Hazards (Beijing), Ministry of Agriculture, Beijing 100193, People's Republic of China; Key Laboratory of Detection for Veterinary Drug Residue and Illegal Additive, Ministry of Agriculture, Beijing 100193, People's Republic of China. Electronic address: cxy@cau.edu.cn.
authors.forename: Xingyuan
authors.initials: X
authors.lastname: Cao
mesh_terms: D000818:Animals; D001835:Body Weight; D007093:Imidazoles / Q000008:administration & dosage / Q000633:toxicity*; D007668:Kidney / Q000187:drug effects; D008099:Liver / Q000187:drug effects; D051379:Mice; D008813:Mice, Inbred ICR; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017207:Rats, Sprague-Dawley; D013450:Sulfones / Q000008:administration & dosage / Q000633:toxicity*; D023382:Toxicity Tests, Acute; D036401:Toxicity Tests, Chronic; D059550:Toxicity Tests, Subchronic
chemical_list: D007093:Imidazoles; D013450:Sulfones; C000622772:vitacoxib
keywords: Acute toxicity; Coxibs; NSAIDs; Subchronic toxicity; Vitacoxib