Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Negative results were obtained in an invitro assay for gene mutation in Salmonella typhimurium TA98, TA100, TA1535, TA1538 with concentrations of methylprednisolone sulfonate in the range 250 to 2000 ug/plate. An invitro assay for gene mutation at the hprt locus in Chinese hamster ovary cells and concentrations in the range 2000 to 10,000 ug/ml of methylprednisolone sulfonate. Both these studies were carried out in the absence and presence of metabolic activation.

There was no increase in unscheduled DNA synthesis in primary rat hepatocytes with concentrations in the range 5 to 1000 ug/ml methylprednisolone suleptanate.

Methylprednisolone was not mutagenic in a DNA cell binding assay.


Short description of key information:
Read-across data on methylprednisolone.
Source: European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, Veterinary Medicines Evaluation Unit, Committee for Veterinary Medicinal Products; Methylprednisolone, Summary Report (2001).
Available from, as of November 20, 2007: http://www.emea.europa.eu/pdfs/vet/mrls/079801en.pdf **PEER REVIEWED**

Endpoint Conclusion:

Justification for classification or non-classification

On the basis of the negative results in the mutagenicity tests performed on the substance methylprednisolone, no classification is needed for methylprednisolone succinate.