Prednisolone (Veterinary Medicinal Products)

摘要

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment ofprednisolone (CAS No. 50-24-8), a steroidal anti-inflammatory agent, using theevaluation reports of EMA (EMEA) and documents for the re-evaluation* ofveterinary medicinal products. All the genotoxicity studies were negative, although some of genotoxicity studies showed positive results. Prednisolone was thus judged tohave no genotoxicity relevant to human health. FSCJ concluded it possible tospecify an acceptable daily intake (ADI) of prednisolone. Major adverse effectsof prednisolone observed are reduced counts of leukocyte and decreased weighs ofthe thymus, spleen and adrenal gland. Slight decreases were also observed onbone marrow cells. There is no substantial evidence to suggest thecarcinogenicity of prednisolone. Prednisolone treatment resulted in an increasedrate of embryonal resorption and a decrease of fetal body weights in adevelopmental toxicity study in rats. No teratogenicity was observed. FSCJspecified an ADI of 0.00025 mg/kg bw/day (0.25 µg/kg bw/day) for prednisoloneapplying a safety factor of 1,000 to the LOAEL of 0.25 mg/kg bw/day obtainedfrom the LOAEL of prednisone in 18-month carcinogenicity study in mice.