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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1H-imidazolium, 1-ethyl-3-methyl-, acetate
Cas Number:
143314-17-4
Molecular formula:
C6 H11 N2 .C2 H3 02
IUPAC Name:
1H-imidazolium, 1-ethyl-3-methyl-, acetate
Test material form:
liquid
Details on test material:
Name of the test substance used in the study report: 1-Ethyl-3-methylimidazolium acetate
Purity: 96.2 g/100 g
Density [g/mL]: 1.109
PSN 06/0363-1

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Young adult animals of a comparable weight were used.
Acclimatization for at least 5 days before administration.
Individual animal identification by cage cards and tail marking.
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for temperature and of 30 – 70% for relative humidity. The day/night rhythm was 12 h light and 12 h darkness.
Single housing in stainless steel wire mesh cages, type DK-III.
Feeding: Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
Drinking water: Tap water ad libitum
Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Administration volume: 1.8 ml/kg
Doses:
2000 mg/kg (2 sequential groups)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Observation period: At least 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2-inhalation. Necropsy of all animals that died before as early as possible after death.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Mortality:
One animal of the first and one animal of the second 2000 mg/kg administration group were found dead within 1 hour after application.
Clinical signs:
other: Impaired and poor general state, dyspnoea, apathy, abdominal position, staggering, tremor, twitching, saltatory spasm, piloerection and salivation. Findings were observed from hour 0 through to study day 2 after administration.
Gross pathology:
During necropsy one animal that died showed a red discoloration of a part of the glandular stomach and a slightly red discoloration of the contents of the small intestine. The other showed a pale red erosion/ulcer of the glandular stomach with a diameter of 3 mm.
No macroscopic pathologic abnormalities were noted in the surviving animals of the administration groups examined at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria