Risk Assessment Report: Veterinary Medicinal Products
Orbifloxacin
Summary
2014 Volume 2 Issue 2 Pages 34-35
Details
2014 Volume 2 Issue 2 Pages 34-35
The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of orbifloxacin (CAS No.113617–63-3), a family of synthetic antimicrobial agents of fluoroquinolones, based on a written application for the marketing approval of new veterinary medicinal products and its attached documents. All the in vivo data were negative in studies on genotoxicity of orbifloxacin, although some in vitro data were positive. Therefore, FSCJ concludes that orbifloxacin has no genotoxicity relevant to human health. Orbifloxacin showed photogenotoxicity in vitro and in vivo through the indirect action to DNA, suggesting that orbifloxacin has no photogenotoxicity relevant to human health. No carcinogenicity was observed in a 2 year carcinogenicity study in rats. From the results of toxicity studies, FSCJ judged it appropriate to use a lowest-observed-adverse-effect level (LOAEL) of 12.5 mg/kg bw/day observed in a 30-day subacute toxicity study in dogs, and to specify the toxicological ADI as 0.013 mg/kg bw/day, applying a safety factor of 1000 to this LOAEL. Microbiological ADI was estimated to be 0.012 mg/kg bw/day based on the VICH (the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) guideline 36. FSCJ specified the ADI of orbifloxacin as 0.012 mg/kg bw/day which is smaller than the toxicological ADI.
