Diethyl carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Details about origin of study report/performing laboratory. No info about origin of method, the analyses of symptoms, the batch and purity of "Diätyhlcarbonat". However, details about test animals and test conditions were stated and as no symptoms and stable body weights were found for a relatively high number of animals (10) the report is regarded as reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Principles of method if other than guideline:

single dose of 5 ml/kg bw administered by a stomach probe to 10 male rats; observation of clinicals symptoms over a period of 14 days

GLP compliance:

no

Test type:

other: single dose limit test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diäthylcarbonat

IUPAC Name:

Diäthylcarbonat

Details on test material:

- Name of test material (as cited in study report): Diäthylcarbonat
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

other: SPF rats, breeding strain Wistar TNO W 74

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: ca. 9 - 14 weeks
- Weight at study initiation: 169 g
- Fasting period before study: no data
- Housing: kept in conventional Makrolon cages type III and on dust-free wood granulate
- Grouping: animals kept in groups of 5
- Diet ad libitum: Altromin R 1324 (manufacturer: Altromin GmbH, Lage)
- Water ad libitum: tap drinking water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature, 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 (artificial lighting from 7 am to 7 pm)

IN-LIFE DATES: From: To: no data

Identification of animals: with picric acid marking on fur and codes on cages

Administration / exposure

Route of administration:

other: oral, with a rigid metal stomach probe

Vehicle:

unchanged (no vehicle)

Doses:

5 ml/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing at the time of administration and at the end of the 14-day observation period (alive animals);
examinations several times/d on 1st day (day of administration), normally 2 times/d and on weekends and holidays 1 time/d.

- Necropsy of survivors performed: yes/no: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
weighing of body weights performed, limited data about other performed examinations:
"recording type, beginning, duration and intensity of clinical symptoms"

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: valid for all test animals (10)

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 876 mg/kg bw

Based on:

test mat.

Remarks on result:

other: This value was calculated by the author of this IUCLID dossier by multiplying the density of the test substance (0.9752 g/mL) with the measured LD50 volume (5 mL).

Mortality:

no mortality

Clinical signs:

other: none

Any other information on results incl. tables

Information extracted from the study report:

Based on the test results the LD50 is > 5 ml/kg bw for male rats. No symptoms developed and the body weights were stable. Therefore, Diäthylcarbonat (engl.: diethyl carbonate) has proven to be relatively non-toxic in this acute toxicity test.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: other: as concluded in study report

Conclusions:

According to the determined LD50 of > 5.0 mL/kg (4876 mg/kg) of the test substance diethyl carbonate by oral administration to male Wistar rats, the test substance is practically nontoxic.