Registration Dossier

Administrative data

Description of key information

non-skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance was evaluated for its skin sensitisation potential in the LLNA study according to the OECD guideline 429 and EPA OPPTS 870.2600 in compliance with GLP.

The test substance concentrations used in the main LLNA study (25, 50 and 100 % (v/v)) were chosen such that the maximum concentration tested was the highest achievable solution of the test substance in the vehicle, while avoiding both overt systemic toxicity and excessive local dermal-irritation. Five animals per group were treated by topical application of the test substance concentrations, vehicle or positive control in the same manner as in the screen. A naive group of five animals was sham-treated. DMF was chosen as the vehicle. 

Under the test conditions, topical application of the test substances a 25 and 50 %(v/v)in the DMF vehicle, and at 100 % (v/v), resulted in SI values less than 3 (SI < 3.0). Therefore, the test substance is not a skin sensitizer in the LLNA.

Justification for classification or non-classification

The substance was assessed for its allergic potential in the in-vivo LLNA study. According to the CLP Regulation a substance is classified in sub-category 1 A if the EC3 is≤ 2 % and in sub-category 1B if the EC3 is > 2. In the present study, the EC3 value could not be determined as the Stimulation Index (S.I) in all the tested concentrations was below 3. Having a S.I. below 3 means that no significant effect and neither a sensitising potential can be identified.

Taking in consideration the above, the substance should not be classified as a skin sensitiser according to the CLP Regulation (EC) No. 1272/2008.