2-ethoxyethyl ethyl carbonic acid ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 June 2013 to 04 July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

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:

2-ethoxyethyl ethyl carbonic acid ester

EC Number:

809-934-0

Cas Number:

627034-93-9

Molecular formula:

C7H14O4

IUPAC Name:

2-ethoxyethyl ethyl carbonic acid ester

Test material form:

liquid

Details on test material:

- Appearance: transparent colourless liquid
- Storage conditions: Refrigerated (2-8 °C), under inert gas, protected from light

Test animals

Species:

rat

Strain:

other: RccHan:(WIST)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: ca. 10 weeks old at dosing
- Weight at study initiation: 180 - 187 g at dosing
- Fasting period before study: Food was witheld from the animals overnight before dosing and was made available again 3 hours after treatment
- Housing: Animals were housed in groups of three in Type II polypropylene/polycarbonate cages furnished with Lignocel Bedding for Laboratory Animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 - 23.6 °C
- Humidity (%): 41 - 68 %
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Two groups of three females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter as applicable. Body weight was measured on Days -1, 0 and 7 and before necropsy.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Clinical signs:

No clinical signs were noted during the 14-day observation period.

Body weight:

Body weight gains of treated animals during the study showed no indication of a test material-related effect.

Gross pathology:

No macroscopic observations were noted at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test material was found to be above 2000 mg/kg bw in female RccHan:(WIST) rats.

Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris, under GLP conditions, following the acute toxic class method.

During the study, two groups of three female RccHan:(WIST) rats were treated with the test material at a dose level of 2000 mg/kg bw (Group 1 and Group 2).

Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required.

A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test material was administered formulated in polyethylene glycol 400 at a concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw.

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter as applicable. Body weight was measured on Days -1, 0 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.

Treatment with the test material did not cause mortality at a dose level of 2000 mg/kg bw and no clinical signs were noted during the 14 -day observation period. Body weight gains of treated animals during the study showed no indication of a test material-related effect and no macroscopic observations were noted at necropsy.

Therefore, under the conditions of the study, the acute oral LD50 value of the test material was concluded to be in excess of 2000 mg/kg bw in female RccHan:(WIST) rats.