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 substance was investigated in the modified local lymph node assay (LLNA-IMDS) on female mice according to OECD TG 429 (Vohr, 2011). Concentrations of 0 (vehicle control), 2, 10 and 50 % formulated in methyl ethyl ketone were tested. Compared to vehicle treated animals there was an increase in cell counts in the mid and the high dose group (indices of 1.51 and 1.58, resp.). These increases are of no statistical significance. However, the "positive level" of index 1.4 for the cell counts has been exceeded in both dose groups. The EC 1.4 value calculated for this test item is 3.71 %. In accordance with the classification proposed in the Technical Report No. 78 of the ECETOC (2003) this value corresponds to a moderate skin sensitizer.

In summary, these results show that the substance has a moderate sensitising potential in mice after dermal application of a 10 % concentration.

Migrated from Short description of key information:  

Skin sensitisation (mouse LLNA) : moderatly sensitising  

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

Based on the study results (moderate skin sensitising potential detected in a LLNA; EC 1.4 value = 3.71 %) a classification with Skin Sensitisation Cat. 1B (H317: May cause an allergic skin reaction) according to Regulation (EC) No. 1272/2008 (CLP) is required.