Registration Dossier

Administrative data

Description of key information

Murine Local Lymph Node Assay: sensitising (EC3 = 1%)

Key value for chemical safety assessment

Skin sensitisation

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

In the key study that was performed according to OECD guideline 429 in compliance with GLP the substance showed a skin sensitising effect (BASF SE, 2009). The threshold concentration for sensitisation induction was < 3%. The estimated concentration that leads to the SI of 1.5 for cell count (EC 1.5) and the estimated concentration that leads to the SI of 3.0 for 3H-thymidine incorporation (EC 3) was calculated by semi-logarithmical regression from the results of all concentrations to be about 1%, respectively.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no data available concerning respiratory sensitisation.

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- Skin sensitisation Cat. 1A

- Respiratory sensitisation: data lacking