Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The test substance was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman and according to OECD 406 guideline and GLP (BASF, 2001). The test substance concentrations for the main test were selected based on the results of the pretests. The intradermal induction was performed with 5% test substance preparations, the epicutaneous induction with the undiluted test substance . For the challenge a 75% test substance preparation in doubly distilled water was chosen . The study was initiated with 2 control groups and 1 test group. The intradermal induction was performed on day 0, the epicutaneous induction on day 7. The challenge was carried out 14 days after the epicutaneous induction . The intradermal induction caused moderate and confluent erythema and swelling, or in almost all injection sites necrotic skin changes and swelling in the test group animals. After the epicutaneous induction, necrotic skin changes, partially open (caused by the intradermal induction) could be observed in addition to swelling in all test group animals . After the challenge, moderate and confluent erythema to intense erythema, swelling, scaling or severe scaling, eczematoid skin change and incrustation could be observed in all test group animals. No skin reactions were observed in the control animals.

Based on the results of this study and applying the evaluation criteria it was concluded that the test substance has a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.

Migrated from Short description of key information:
GPMT (BASF, 2001): sensitizing

Justification for classification or non-classification

Korantin MAT was demonstrated to be a skin sensitizer. The substance will therefore be classified as sensitizing according to EU (R43) and GHS/CLP (Category 1b) criteria.