Registration Dossier

Administrative data

Description of key information

Prednisolone appeared to be neither irritating nor corrosive to the skin; the test substance is not irritating to the eyes.

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:

An in vitro biological assay (OECD 439) based on the three-dimensional Reconstituted Human Epithelium (RHE) SKINETHIC test was carried out. On the basis of the results, interpreted according to OECD 439 and SKINETHIC SOP (January 2009), the test product "PREDNISOLONE" must be

considered NOT IRRITANT for the skin. (Eurofins Biolab 2010/1006 AMi)

An in vitro biological assay (OECD 435) based on the membrane barrier test method for skin corrosion CORROSITEX was carried out.

On the basis of the results, interpreted according to OECD 435, the test substance "PREDNISOLONE" is classified as NOT CORROSIVE for the skin. (Eurofins Biolab 2010/1000 AMi)

The QSAR study carried out with QSAR Toolbox v.2.0 (2010), based on the BfR skin irritation/corrosion model, showed that prednisolone is neihter irritating nor corrosive to the skin. Due to the reliability of the source of this software, OECD, it was considered reliable for the first evaluation of this assessment.

In another QSAR study carried out with Toxtree v.2.1.0 (2010), 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 prednisolone. The prediction is based on the exclusion rule that Melting Point[°C] is > 200.

Eye irritation:

In the in vitro biological assay (Draft Updated ICCVAM Recommended HET-CAM Protocol) (BSL Bioservice 104856) the irritancy potential of prednisolone was investigated in the chorioallantoic membrane. The calculated mean irritation score was 0. Thus prednisolone was classified as non-irritant. Positive and negative controls to demonstrate the validity and sensitivity of the test were used.

According to the evaluation criteria prednisolone was classified as non-irritant to mucous membranes. Thus, no irritation can be expected if prednisolone comes in contact with the eyes.

The QSAR study carried out with Toxtree v.2.1.0 (2010), 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.

Justification for classification or non-classification

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