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:

An LLNA test was performed according to OECD 429 guideline and GLP principles.The majority of nodes were considered normal in size, except for one or both nodes of one animal at 10%, two animals at 25% and two animals at 50% which were considered enlarged in size. Median DPM/animal values were reported due to possible outlier responses for individual animals within groups. Median DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 797, 1674 and 1299 respectively. The median DPM/animal value for the vehicle control group was 300. The SI values calculated for the substance concentrations 10, 25 and 50% were 2.7, 5.5 and 4.3 respectively. An EC3 value of 11.6% was calculated.

Based on these results, the test substance should be classified as a skin sensitizer (category 1B) according to Regulation EC 1272/2008.


Migrated from Short description of key information:
The in vivo LLNA study was performed according to OECD Guideline 429 and GLP principles.

Justification for selection of skin sensitisation endpoint:
One key study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the above results, the test substance should be classified as a skin sensitizer (category 1B) and labelled with H317 (may cause an allergic skin reaction) according to Regulation EC 1272/2008.