Carbonic acid, ethyl methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 16- March 2, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed in compliance with the Good Laboratory Practice (GLP) regulations (revised in 1997, ENV/MC/CHEM(98)17). The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 423 "Acute Oral Toxicity – Acute Toxic Class Method".

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

None

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:

-

EC Number:

433-480-9

EC Name:

-

Cas Number:

623-53-0

Molecular formula:

C4H8O3

IUPAC Name:

ethyl methyl carbonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Test system
Species: Rat, Wistar HsdCpb: WU, males (m) and females (f)
Breeder: commercial provider
Age: approx. 6 to 8 weeks

- Identification and adaptation
Healthy young animals were allocated to the study group at least 7 days before dosing to allow for acclimatization.
The rats were identified by an ear tattoo.

- Housing and diet
The rats were housed in an air-conditioned room of about 10 m^2. Lighting was controlled by a timer to provide a 12 hour light - 12 hour dark regime.

The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used
as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate.
The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per
week.

Temperature and humidity were measured using a thermohygrograph. The room temperature during the experimental period was 20 to 22 °C
and the relative atmospheric humidity 42 to 59 %.

Diet was withheld from 17 hours before until up to 4 hours after treatment. At all other times food and tap water from Makrolon drinking
bottles were available to the rats ad libitum.

According to the specifications given by the manufacturer, the diet, Altromin Standard, had been checked by independent laboratories.
Analysis included qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
The drinking water was periodically analyzed according to German regulations for human drinking water.

The softwood granulate was analytically checked by independent laboratories.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: see section Details on Test Materials

Details on oral exposure:

orally by means of stomach tube

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

3 (m) / 3 (f)

Control animals:

no

Details on study design:

according to guideline

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000

Mortality:

No mortality observed. All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg of the test item.

Gross pathology:

At necropsy, no organ alterations were seen.

Other findings:

None

Any other information on results incl. tables

see executive summary

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the result of this study, it is concluded, that the test material can be allocated to ATC class 0 , i.e. the LD50 value is expected to exceed 2000 mg/kg bw following oral treatment in rats.

Executive summary:

Purpose

The purpose of this assay was to provide information on possible health hazards for the test material and serves as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man.

Study design

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. The experiment was performed with the undiluted test material. This study was performed according to the ,,Acute toxic class method" (ATC).

Results

No signs of toxicity were detected in the 3 male and 3 female rats after treatment and no rat died.

The gross pathological examination revealed no organ alterations.

Conclusions

According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg.