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: official guideline method, GLP with certificate, good documentation, identity of substance clear with details on its purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Safepharm Standard Method Number OECD 1

GLP compliance:

yes (incl. QA statement)

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:

C4H8O3

IUPAC Name:

ethyl methyl carbonate

Details on test material:

Test material as stated in study report ("Sponsor's identification"): ETHYL METHYL CARBONATE
Purity: > 99.8 %
Date received: 11 Feb 1993
Description: colourless liquid
Container: clear glass jar
Storage conditions: room temperature

Remark of the author of this IUCLID dossier concerning the substance identity:
Every page of the copy of the study report contains an annotation referring to the data sharing agreement in place between the licensee that uses this study report and the data owner. In this data sharing agreement the identity of the chemical substance is specified with "Ethyl Methyl Carbonate - EC No. 433-480-9, CAS Nr. 623-53-0".

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female Sprague-Dawley strain rats were supplied by Charles River (UK) Ltd., Manston, Kent, U.K.
Initial male animals weight: 160-180 g
Initial female animals weight: 148-163 g
Animal age: approximately five to eight weeks
Acclimatisation period: minimum 5 d
Animal identification: unique number for each animal, marking on tail and cage ID card with indelible ink

Husbandry: solid-floor polypropylene cages with sawdust bedding, groups up to five, separate cages for sexes, overnight fast immediately before dosing and two hours after dosing, other than that drinking water and food ad libitum (food: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.); temperature 20-22 °C, relative humidity 42-56 %, air exchange rate ca. 15 times/h, light-darkness periods of 12 h/12 h (electric lighting)

Administration / exposure

Route of administration:

oral: gavage

Doses:

5000 mg/kg

No. of animals per sex per dose:

range finding study: 1 animal per sex (dose 5000 mg/kg)
main study: 5 animals per sex (dose 5000 mg/kg)

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

no deaths (range-finding and main study)

Clinical signs:

other: ataxia and/or hunched posture (range-finding study) ataxia, hunched posture and lethargy with additional signs of decreased respiratory rate and laboured respiration; all animals recovered one day after dosing (main study)

Gross pathology:

No abnormalities were noted at necroscopy (main study)

Any other information on results incl. tables

Range-finding study: Based on the results of the range-finding study a dose level of 5000 mg/kg bw was selected for the main study.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test material, ETHYL METHYL CARBONATE, in the Sprague-Dawley strain rat was found to be greater than 5000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.