Risk Assessment Report: Veterinary Medicinal Products
Methylprednisolone
Summary
2016 Volume 4 Issue 2 Pages 54-55
Details
2016 Volume 4 Issue 2 Pages 54-55
The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of methylprednisolone (CAS No. 83-43-2), a steroidal anti-inflammatory agent, using the evaluation reports from EMA (EMEA) and other related documents. Although no genotoxicty study in vivo was available, all the genotoxicity studies in vitro were negative. In addition, prednisolone, a structural analogue of methylprednisolone, is judged to have no genotoxicity relevant to human health. Thus, methylprednisolone is considered to have no genotoxicity relevant to human health. Therefore, FSCJ concluded it possible to specify an acceptable daily intake (ADI) of methylprednisolone. Major adverse effects of methylprednisolone observed are reduced counts of leukocyte, thymic atrophy, decreased weights of spleen, and glycogen accumulation in hepatocyte. FSCJ specified an ADI of 0.0003 mg/kg bw/day for methylprednisolone applying a safety factor of 1,000 to the LOAEL of 0.3 mg/kg bw/day in the 63-day subacute toxicity study in rats.
