1H-Imidazolium, 1,3-diethyl-, acetate (1:1)

Acute Toxicity: oral

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:

2012

Report date:

2012

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

Test material information

Constituent 1

Reference substance name:

1,3-diethyl-1H-imidazol-3-ium acetate

EC Number:

692-759-5

Cas Number:

1040916-84-4

Molecular formula:

C7 H13 N2 . C2 H3 O2

IUPAC Name:

1,3-diethyl-1H-imidazol-3-ium acetate

Details on test material:

Name of the test substance used in the study report: EEIM Acetate
Purity: Main component: 97.4 ± 0.1 g/ 100 g

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 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: VRF1(P); SDS 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Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.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: 1.87 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. 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:

> 2 000 mg/kg bw

Mortality:

2000 mg/kg (first test group): none
2000 mg/kg (second test group): 1/3

Clinical signs:

other: 2000 mg/kg (first test group): Impaired general state in two out of three animals, syspnoea in two out of three animals, piloerection in two out of three animals 2000 mg/kg (second test group): none

Gross pathology:

2000 mg/kg (second test group) - animal that died: liquid clear content in the stomach and enhanced bleeding in the glandular stomach
There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Conclusions:

The acute oral LD50 was calculated to be > 2000 mg/kg bw, because mortality occured in 1 / 6 animals.