Registration Dossier

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:
other: GLP and 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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: 1-Ethyl-3-methyl-1-imidazolium chloride (EMIM CI)
- Analytical purity: 97.4 g/100 g
- Lot/batch No.: EMIMCI31F221105

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH- 4414 Füllinsdorf, Switzerland
- Age at study initiation: young adult animals (female animals approx. 8-12 weeks)
- Weight at study initiation: Young adult animals of a comparable weight (± 20% of the mean weight)
- Housing: Single housing in stainless steel wire mesh cages, type DK-III.
- Diet (e.g. ad libitum): ad libitum, Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water (e.g. ad libitum): ad libitum, Tap water
- Acclimation period: at least 5 days before administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The aqueous formulation corresponds to the physiological medium.
The test-substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer.
Form of administration: solution
Concentrations used: 3 and 20 g/100 ml
Administration volume: 10 ml/kg
Doses:
300, 2000 mg/kg
No. of animals per sex per dose:
2000 mg/kg in 3 females, 300 mg/kg in 6 females
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 by 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:
> 300 - < 2 000 mg/kg bw
Mortality:
Two animals of the 2000 mg/kg administration group were found dead within 1 hour after administration.
No mortality occurred in the 300 mg/kg administration groups.
Clinical signs:
Animals that died of the 2000 mg/kg administration group: impaired and poor general state, dyspnoea, lateral position, staggering and tremor.
Findings were observed within 0 hour after administration.
No clinical signs and findings were observed in the 300 mg/kg administration groups and in the surviving animal of the 2000 mg/kg administration group.
Body weight:
The body weight of the surviving animal of the 2000 mg/kg administration group increased during the first post-exposure observation week, but did not adequately increase during the second week.
The mean body weights of the 300 mg/kg administration groups increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals that died and in the surviving animals examined at the end of the observation period.

Applicant's summary and conclusion