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An acute oral toxicity study with 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE

was carried out based on the guidelines described in: "Acute Toxicity-Oral, Acute Toxic Class Method", OECD No.423 (2001); "Acute Oral Toxicity"; EC Council Directive 67/548/EEC, Annex V, B.1 tris (2004); Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.1100 (2002), "Acute Oral Toxicity - Acute Toxic Class Method" and JMAFF Japanese test guidelines (2000). 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. On day 1, hunched posture was noted in all females and piloerection was noted in one female. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50value of 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified and has no obligatory labeling requirement for oral toxicity according to the OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).

Assessment of acute dermal toxicity with 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in the rat. The study was carried out based on the guidelines described in: OECD No402 (1987) "Acute Toxicity-Dermal" EC, Council Directive 67/548/EEC, Annex V, B.3 (1992) "Acute Dermal Toxicity" EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity" JMAFF Guidelines (2000). including the most recent revisions. 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE was administered to five Wi star rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Flat and/or hunched posture, chromodacryorrhoea, lethargy and/or ptosis were shown by most animals on days 1 and/or 2. Scales were seen in the treated skin~area of one male and two females between days 3 and 9. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. No test substance related abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified and has no obligatory labelling requirement for dermal toxicity according to the OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and EC criteria for classification and labelling requirements for dangerous substance and preparations (Council Directive 67/548/EEC).

Justification for classification or non-classification

No classification required.