Registration Dossier
Registration Dossier
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EC number: 237-731-1 | CAS number: 13951-70-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential of 16alpha-hydroxyprednisolone to be a dermal sensitiser was assessed using a Local Lymph Node Assay study performed with prednisolone and supported by QSAR prediction of skin sensitisation of 16alpha-hydroxyprednisolone using the OECD toolbox software.
The biological assay (OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) shows that the test item Prednisolone, is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser (BSL Bioservice 104857).
The QSAR study carried out with QSAR OECD Toolbox v.2.0 (2010), based on the general model for Skin sensitisation (Danish EPA DB), predicted that prednisolone is not a skin sensitiser (Prednisolone REACH dossier). A newer version of the model (OECD Toolbox v.3.1, 2013) was used with 16alpha-hydroxyprednisolone and predicted that the notified substance is not a skin sensitiser either. Like prednisolone, 16alpha-hydroxyprednisolone is not predicted to be skin sensitiser.
Migrated from Short description of key information:
Based on a Local Lymph Node Assay study performed with prednisolone and a QSAR study carried out with 16alpha-hydroxyprednisolone, the test substance is demed not to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance to Directive 67/548/EEC, classification is not necessary for sensitisation based on the available data.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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