Safety assessment of vitacoxib: Acute and 90-day sub-chronic oral toxicity studies

- It 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.

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.