1-Ethyl-3-methylimidazolium benzoate

Endpoint summary

Description of key information

LD50 (oral, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.