1-Ethyl-3-methylimidazolium benzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - August 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

OECD423, version 2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Ethyl-3-methylimidazolium benzoate

EC Number:

695-723-7

Cas Number:

150999-33-0

Molecular formula:

C13H16N2O2

IUPAC Name:

1-Ethyl-3-methylimidazolium benzoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0015064167
- Expiration date of the lot/batch: March 01, 2018
- Purity test date: Aug 02, 2017 (date of report 17L00118)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 184.7 g (mean experiment 1, n = 3); 184.3 (mean experiment 2, n = 3)
- Fasting period before study: at least 16 hours before administration
- Housing: Single housingin Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: To: April/May 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: no
DOSE VOLUME APPLIED: 1.75 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality, gross-pathology, no histological examination

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no

Clinical signs:

other: impaired general state and piloerection were observed until study day 1 after administration

Gross pathology:

no macroscopic pathological findings in any animal sacrificed at the end of the observation period

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

virtually non-toxic

Executive summary:

In an acute oral toxicity study in 2017 (GLP, OECD423 ATC method), a dose of 2000 mg/kg of the undiluted test substance was administered by gavage to two test groups of three fasted Wistar rats each (6 females). No mortality occured, but impaired general state and piloerection until day 1 after administration were observed in all animals. The body weights increased within the normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period. Therefore, the acute oral LD50 (rat) was calculated to be > 2000 mg/kg bw.