Registration Dossier

Administrative data

Description of key information

Prednisolone has no carcinogenic properties.

Key value for chemical safety assessment

Additional information

This study compares long term toxic effects of prednisolone (3 mg/kg) in comparison to vehicle treated controls after regular administration over a period of 18 months to 30 female Sprague Dawley rats per dose. Frequency of administration to subgroups (30 rats each) varied between 9, 4.5, 2 times or once a month. When comparing organ specific, age-adjusted expected versus observed incidences after natural death of animals no increased tumor risk was found in organ systems of all prednisolone treatment modalities (EMEA, 1999).

Justification for classification or non-classification

Based on the available data, prednisolone has to be classified for developmental toxicity / teratogenicity in accordance to Directive 67/548/EEC (T; R61 Repr. Cat. 2).