Methylprednisolone (Veterinary MedicinalProducts)

摘要

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment ofmethylprednisolone (CAS No. 83-43-2), a steroidal anti-inflammatory agent, usingthe evaluation reports from EMA (EMEA) and other related documents. Although nogenotoxicty study was available, all the genotoxicitystudies were negative. In addition, prednisolone, astructural analogue of methylprednisolone, is judged to have no genotoxicityrelevant to human health. Thus, methylprednisolone is considered to have nogenotoxicity relevant to human health. Therefore, FSCJ concluded it possible tospecify an acceptable daily intake (ADI) of methylprednisolone. Major adverseeffects of methylprednisolone observed are reduced counts of leukocyte, thymicatrophy, decreased weights of spleen, and glycogen accumulation in hepatocyte.FSCJ specified an ADI of 0.0003 mg/kg bw/day for methylprednisolone applying asafety factor of 1,000 to the LOAEL of 0.3 mg/kg bw/day in the 63-day subacutetoxicity study in rats.