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:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line OECD 423
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the EU Parliament and of the Council on the Registration, Evaluation, Authorization and Restrietion of Chemieals (REACH), Part B
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: 1 H-lmidazolium, 3-ethyl-1-methyl-, trifluoromethanesulfonate
- Test item No.: 09/0070-1
- Physical state: Liquid / yellowish, clear
- Analytical purity: 99.9g /100 g (1H-NMR analysis)
- Lot/batch No.: VM2010/34
- Stability under test conditions: The stability of the test item under storage conditions over the test period will be guaranteed by the sponsor,
and the sponsor holds this responsibility
- Storage condition of test material: Room temperature, protect against humidity

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Young adult animals of a comparable weight were used.
Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
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 22°C ± 3°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 Makrolon cages (type III).
Feeding: VRF 1 (P); SOS Special Diets Services, 67122 Altrip, Germany
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: 1.44 ml/kg
Doses:
2000 mg/kg (2 administrations)
No. of animals per sex per dose:
3 per administration
Control animals:
no
Details on study design:
Observation period: 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and on the last day of observation.
Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
A check for any dead or moribund animals was made at least once each workday.
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured.
Clinical signs:
Impaired general state, dyspnoea, staggering and piloerection and was observed from hour 0 until hour 3 after administration. Tw animals did not
show any clinical signs at all.
Body weight:
The mean body weight of the animals increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the median Iethai dose of 1H-Imidazolium, 3-ethyl-1-methyl-, trifluoromethanesulfonate after oral administration was found to be greater than 2000 mg/kg bw in rats.
Executive summary:

ln an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the undiluted test item 1 H-lmidazolium, 3-ethyl-1-methyl-, trifluoromethanesulfonate was administered to two test groups of three fasted Wistar rats by gavage.

No mortality occurred in the six females administered 2000 mg/kg bw. The combined acute oral LD50 was calculated tobe

LDso. oral, rat > 2000 mg/kg bw.

Clinical observation revealed impaired general state, dyspnoea, staggering and piloerection and was observed from hour 0 until hour 3 after administration. The mean body weight of the animals increased throughout the study period within the normal range.

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.