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)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The substance was tested for its sensitizing effect an the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman according to the OECD Guideline 406. The intradermal induction with 0.5 % test substance preparations caused slight to well-defined signs of 5km irritation or necrotic skin changes in test group animais. After the percutaneous induction with a 50 % test substance preparation incrustation, partially open (caused by the intradermal induction; could be observed in addition to well-defined erythema and slight edemna or necrotic skin changes (caused by the * intradermal induction) and slight edema in test group animais. Two challenges were performed 14 and 21 days after the percutaneous induction.

After the first challenge with a 25 % test substance preparation very slight to well-defined 5km reactions could be observed in test group animais. The second challenge with a 25 % test substance preparation did not cause any skin reaction.

Based on the results of this study it was concluded that the test item does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.

Justification for classification or non-classification

The substance was assessed for its allergic potential in the in vivo guinea pig in the Maximization Test study. According to the CLP Regulation a substance is classified in sub-category 1 A if ≥ 30 % responding at ≤ 0.1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose. It is classified in sub-category 1B if ≥ 30 % to <60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose

In the present study an intradermal induction of 0.5 % was used. The percentage of the animals giving a positive response was 26 % and 16 % after 24 and 48 hours during the 1st challange, while it was 0 % after 24 and 48 hours in the second challenge.

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