Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The test substance was investigated in the modified local lymph node assay (LLNA-IMDS) on female mice according to OECD TG 429. Concentrations of 0 (vehicle control), 2, 10 and 30 % formulated in dimethylformamide were tested. The results show that the test item has neither a non-specific (irritant) nor a specific immunostimulating (sensitizing) potential.These findings were verified by the results obtained with the positive control.

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:

Based on the available study result (non-sensitising) a classification according to EU-Directive 67/548/EEC, Annex VI and according to regulation (EC) No 1272/2008, Annex I, is not warranted.

Respiratory sensitisation:

No da available.