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 study was carried out based on the guidelines described in: OECD, Section 4, Health Effects, No.429 (2002), Paris Cedex; EC, Council Directive 67/548/EEC, Annex V, B.42 (2004); Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.2600 "Skin Sensitisation" (2003). Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, three groups of five experimental animals were epidermally exposed to a 25%, 50% and 100% concentration respectively on three consecutive days. Five vehicle control animals were similarly treated, but with vehicle alone (N,N-dimethylformamide (NOTOX Project 418534). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were done. The majority of the nodes of the experimental and control groups were considered normal in size. The nodes of two animals treated at 25 and 100% were decreased in size. No other macroscopic abnormalities of the nodes were noted. Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 411, 385 and 243 respectively. The mean DPM/animal value for the vehicle control group was 373 (NOTOX Project 418534). The SI values calculated for the substance concentrations 25, 50 and 100% were 1.1, 1.0 and 0.7 respectively. There was no indication that the test substance could elicit an SI > = 3. Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE should not be regarded as a skin sensitiser.

Based on these results and according to the:

- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified for sensitisation by skin contact.

- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact.


Migrated from Short description of key information:
The SI values calculated for the substance concentrations 25, 50 and 100% were 1.1, 1.0 and 0.7 respectively. There was no indication that the test substance could elicit an SI > = 3. Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE should not be regarded as a skin sensitiser.

Justification for classification or non-classification