Dibutyl carbonate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

March, 1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Sept., 1996

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

August 1998

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:

Dibutyl carbonate

EC Number:

208-816-0

EC Name:

Dibutyl carbonate

Cas Number:

542-52-9

Molecular formula:

C9H18O3

IUPAC Name:

dibutyl carbonate

Constituent 2

Reference substance name:

Butyl carbamate

EC Number:

209-751-0

EC Name:

Butyl carbamate

Cas Number:

592-35-8

Molecular formula:

C5H11NO2

IUPAC Name:

butyl carbamate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B323
- Purity test date: July 4, 2001

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: confirmed for at least 4h

OTHER SPECIFICS: Colorless liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: males: 8-12 weeks, females: 14-18 weeks
- Weight at study initiation: males: 224, 231, 232g, females: 197, 200, 204g
- Fasting period before study: feed was withdrawn for at least 16h before administration. Water was available ad lib.
- Housing: single in stainless steel wire mesh cages, type DK-III
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40g/100g
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: 5ml/kg

Doses:

2000mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday thereafter. Body weights were determined weekly. A check for mortality was performed twice each workday and once on weekends and public holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other:

Remarks:

no mortality occured

Mortality:

none

Clinical signs:

other: none in males Females showed impaired general state, dyspnoea and staggering starting 4h after administration and ending 1-2 hours later.

Gross pathology:

No macroscopic pathologic abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met