LAUSR

&NA; 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 LD50 was 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. HighlightsIt was for the first time reported the toxicity of viacoxib as a new development compound coxibs of NSAIDs drug.The acute and subacute oral toxicity were evaluated, respectively.Significant pathological alterations were noted in kidneys and liver.LD50 of vitacoxib was greater than 5000 mg/kg in SD rats and ICR mice mg/kg BW.The NOAEL for sub‐chronic toxicity of vitacoxib was considered to be 20 mg/kg bw/day for rats.