1-ethyl-3-methyl-3H-imidazolium dicyanidoamide(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:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-ethyl-1-methyl-1H-Imidazolium salt with N-cyanocyanamide (1:1)

EC Number:

609-330-5

Cas Number:

370865-89-7

Molecular formula:

C6 H11 N2 .C2 N3

IUPAC Name:

3-ethyl-1-methyl-1H-Imidazolium salt with N-cyanocyanamide (1:1)

Specific details on test material used for the study:

- Name of the test substance (as cited in study report): EMIM Dicyanamid
- Purity: 97.4 g/100 g
- Density [g/mL]: 1.099 (determined by Bioassay)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

- Age/weight: Young adult animals of a comparable weight were used.
- Acclimatization period: 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.
- Conditions: 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.
- Housing: single housing in Makrolon cages, type III.
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany. Feed was withdrawn from the animals at least 16 hours before administration.
- Water: Tap water ad libitum

Administration / exposure

Route of administration:

oral: capsule

Vehicle:

other: unchanged and water

Details on oral exposure:

For the high dose, the liquid test item was administered unchanged. For the lower dose, an administration volume of 2 mL/kg bw of suitable test item preparations was used to facilitate application. The test item preparation was produced for the 500 mg/kg application group shortly before application by stirring with a magnetic stirrer. Concentration used: 25 g/100 mL (500 mg/kg dose level). Form of administration: solution.

Doses:

500 and 2000 mg/kg

No. of animals per sex per dose:

- 500 mg/kg: 3
- 2000 mg/kg: 6

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 animal that died before as early as possible after death.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

- 2000 mg/kg (first test group): 1/3 animals
- 2000 mg/kg (second test group): no deaths

Clinical signs:

other: - 2000 mg/kg (first test group): Impaired and poor general state, dyspnoea, piloerection, tremor, staggering, abdominal position, tonic convulsions, exsiccosis, reduced feces, none feces - 2000 mg/kg (second test group): impaired and poor general state, d

Gross pathology:

Animal that died: liquid clear content in the stomach, red discoloration of the glandular stomach, dark red discoloration of the liver. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria