Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

The QSAR study carried out with Toxtree v.2.5.0 (2011), based on a decision support system (DSS) developed by the German Federal Institute for Risk Assessment (BfR) uses physico-chemical exclusion rules, excludes the potential activity irritating or corrosive to skin of betamethasone. The prediction is based on the exclusion rule that Melting Point[°C] is > 200.

Eye irritation:

The QSAR study carried out with Toxtree v.2.5.0 (2011), based on a decision support system (DSS) developed by the German Federal Institute for Risk Assessment (BfR) uses physico-chemical exclusion rules, excludes the potential activity irritating or corrosive to eye of prednisolone. The prediction is based on the exclusion rule, of the skin irritation/corrosion endpoint, that Melting Point[°C] is > 200. Because of prednisolone is neither irritating nor corrosive to skin, the DDS did not evaluate prednisolone for eye irritation potency.

Betamethasone is a compound of the most powerful and used to treat eye and skin inflammation.

Justification for classification or non-classification

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