Registration Dossier

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 reported study, based on an elaborated sensitisation assay, shows that Betamethasone, with a SI of 0.98, is not a sentisizing compound.

Moreover, the read-across biological assay (OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) from Prednisolone (CAS 50 -24 -8) and the criteria given in Annex I of Regulation (EC) 1272/2008), shows that the test item Betamethasone, as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.

The QSAR study carried out with QSAR Toolbox v.2.2 (2011), based on the general model for Skin sensitisation (Danish EPA DB), showed that Betamethasone is NOT skin sensitising. Due to the reliability of the source of this software, OECD, it was considered reliable as supporting tool for this assessment.

Migrated from Short description of key information:
Betamethasone is not a skin sensitising.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and Regulation 1272/2008/EC, classification is not necessary for sensitisation based on the available data.