Registration Dossier

Administrative data

Description of key information

No skin irritation was caused by 4 hours exposure to 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE , irritating effects on eyes were slight and completely reversible within 72 hours.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Primary skin irritation/corrosion study with 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines described in: OECD No.404, "Acute Dermal Irritation/Corrosion" (2002); EC Commission Directive 2004/73/EC, BA, "Acute Toxicity - Skin irritation" (2004); US EPA, OPPTS 870.2500, Acute Dermal Irritation (1998) and JMAFF, Japanese Test Guidelines (2000). Three rabbits were exposed to 0.5 ml of 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE. 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 skin irritation.

- 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 skin irritation.

Acute eye irritation/corrosion study with 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in the rabbit.

The study was carried out based on the guidelines described in: - OECD No 405 (2002) "Acute Eye Irritation / Corrosion" - EC Commission Directive, Annex 5, B.5, (2004) "Acute Toxicity: Eye Irritation / Corrosion" - EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation" - JMAFF guidelines (2000). Single samples of 0.1 ml of 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 48 hours in two animals and within 72 in the other animal.

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 eye irritation.

- 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 eye irritation. -

Justification for classification or non-classification

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 skin irritation.

- 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 skin irritation.

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 ETHYL..SULFATE does not have to be classified for eye irritation.

- 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 eye irritation. -