1H-Imidazolium, 3-ethyl-1-methyl-, ethyl sulfate (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:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Details on test material:

- Physical appearance: Light yellow viscous liquid
- Batch 99/484
- Purity 99.0% (HPLC)
- Storage: RT in the dark
- Stability under storage conditions: Not indicated
- Specific Gravity: 1.23
- Expiry date: 10 june 2005 (allocated by NOTOX, 1 year after receipt of the test substance)

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(W1) BR (outbred, SPF-quality)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 8 weeks old) were selected
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean
- Fasting period before study: withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance
- Housing: 3/cage
- Diet: ad libitum; standard pelleted laboratory animal diet (from Altromin (code VRF 1),
- Water: ad libitum; tap water
- Acclimation period: 5


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2-22.5
- Humidity (%): 38-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: undiluted

Details on oral exposure:

VOLUME APPLIED: 1.626 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data

FREQUENCY OF APPLICATION: single dosage, on day 1

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females/dose

Control animals:

no

Details on study design:

The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The oral LD50 value of the test substance was ranked within the following ranges: 0-5, 5-50, 50-300 or 300-2000 mg/kg b .w. or as exceeding 2000 mg/kg bw. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on day 1 and then once daily till sacrifice
- Frequency of weighing: 1 (pre-administration), 8 and 15 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality occured

Mortality:

No mortality occurred .

Clinical signs:

other: On day 1, hunched posture was noted in all females and piloerection was noted in one female

Gross pathology:

No abnormalities were found at macroscopic post mo rtem examination of the animals.