Registration Dossier
Registration Dossier
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EC number: 200-021-7 | CAS number: 50-24-8
Carcinogenicity
Administrative data
Description of key information
Prednisolone has no carcinogenic properties.
Key value for chemical safety assessment
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).
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).
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