Carbonic acid, ethyl methyl ester

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 performed under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-480-9

EC Name:

-

Cas Number:

623-53-0

Molecular formula:

C4 H8 O3

IUPAC Name:

ethyl methyl carbonate

Test material form:

other: liquid

Details on test material:

- Purity: >99.8%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, UK
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: males 160-180g, females 148-163g
- Fasting period before study: overnight before study
- Housing: Housed in solid-floor polypropylene cages with sawdust bedding in groups of 5.
- Diet: Rat and Mouse expanded Diet No.1 ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 42 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

All test animals were dosed once by gavage (metal cannula attached to a graduated syringe). The amount administered to each test animal was calculated according to its bodyweight at the time of dosing.

Doses:

Range-finding study: 5000 mg/kg
Definitive study: 5000 mg/kg

No. of animals per sex per dose:

Range-finding study: 1 male; 1 female
Definitive study: 5 male; 5 female

Control animals:

no

Details on study design:

Range-finding study: a range-finding study was conducted to determine a dosing regime for the definitive study. Animals were observed for signs of toxicity and mortality at 0.5, 1, 2 and 4 hours after dosing and then once daily for 5 days.

Definitive study: After dosing, animals are observed for signs of toxicity or mortality at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Body weights are recorded on day 0 (before dosing) and on days 7 and 14. At the end of the study, all test animals are killed and subjected to a gross pathological examination - this consists of an external examination and opening of the abdominal and thoracic cavities. Any macroscopic abnormalities were noted. No tissues were retained.

Results and discussion

Preliminary study:

No deaths were observed. Signs of toxicity observed include ataxia and/or hunched posture. Based on the result of this range-finding study a dose of 5000 mg/kg was selected for the definitive study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths observed.

Clinical signs:

other: Ataxia, hunched posture, lethargy, decreased respiratory rate and laboured respiration. All animals recovered 1 day after dosing.

Gross pathology:

No abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Under the conditions of this study, the acute oral toxicity of ethyl methyl carbonate to rats was evaluated and gave an LD50 of >5000 mg/kg.