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:

There are studies to determine the sensitizing potential of 1-ethyl-3-methylimidazolium chlorid available. In the combined local lymph node assay (LLNA) and irritancy assay (IRR) female BALB/c mice were applied dermally with concentrations of 6.25, 12.5, 25 and 50 % in olive oil (4:1; AOO). In the LLNA, EMI at concentrations of 6.25%-50% did not induce significant increase in lymph node cell proliferation when compared to the vehicle control. EMI was not an irritant at concentrations up to 50%, as demonstrated by a lack of effect on ear thickness at 24 hr following the last dermal exposure.

To confirm the negative LLNA response, the Mouse Ear Swelling Test (MEST) was performed following exposure to EMI. In the sensitization phase two concentrations of EMI (255 and 50%) were used, and a concentration of 50% was applied during the challenge phase. There was no significant difference in the percent ear swelling at 24 and 48 hr following challenge in mice treated with EMI when comparred to the vehicle irritancy control (VHIC).

In conclusion, under the experimental conditions utilized in this study of female BALB/c mice, EMI was negative in the LLNA, the irritancy assay, and the MEST (NTP, 2010).

Migrated from Short description of key information:
LLNA: not sensitising (NTP, 2010)
MEST: not sensitising (NTP, 2010)

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).