4-hydroxymethyl-1,3-dioxolan-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dose-range: June 18, 1993 through June 21, 1993; Limit test: June 21, 1993 through July 5, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented GLP study performed according to a method equivalent to OECD guideline n°401 (1987) but showing minor deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

minor deviations based on number of animals, lack of information on pregnancy status of the females and data lacking concerning the duration of the fasting period

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxymethyl-1,3-dioxolan-2-one

EC Number:

213-235-0

EC Name:

4-hydroxymethyl-1,3-dioxolan-2-one

Cas Number:

931-40-8

Molecular formula:

C4H6O4

IUPAC Name:

4-(hydroxymethyl)-1,3-dioxolan-2-one

Details on test material:

- Name of test material (as cited in study report): Glycerine carbonate
- Physical state: clear, colorless liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during storage or administration
- Specific gravity: 1.4 gm/mL

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 Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Dose-range: 219-311 g ; Limit Test: 210-341 g
- Fasting period before study: Yes
- Housing: Rats were housed individually in stainless steel 1/2" wire mesh cages.
- Diet (e.g. ad libitum): Harlan Teklad Lab Blox, ad libitum, checked daily and added or replaced as needed.
- Water (e.g. ad libitum): no data
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- 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:

DOSAGE PREPARATION: The test article was dosed as received using specific gravity calculation.

Doses:

Range finding study: 500, 2500 and 5000 mg/kg
Limit test: 5000 mg/kg

No. of animals per sex per dose:

Range finding study: 1male and 1 female per dose
Limit test: 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Dose-range-finding study: The rats were observed at approximately 1, 4, 24, 48 and 72 hours after dosing for pharmacological and toxicological effects.
Limit test: The rats were observed at approximately 1, 4 and 24 hours after dosing and once daily through Day 14 for pharmacological and toxicological effects. Viability was checked daily. Body weights were recorded at study initiation, Days 7 and 14.

- Necropsy of survivors performed: yes, all rats were sacrificed by CO2 inhalation and a gross necropsy performed at termination of the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died at the 500, 2500 or 5000 mg/kg (dose range finding study).
None of the animals died at the 5000 mg/kg dose level (limit test).

Clinical signs:

No clinical signs were observed in any animal during the study.

Body weight:

There was an apparent increase in body weight for all animals during the study in the limit test.

Gross pathology:

No visible lesion were observed in any of the animals at terminal necropsy in the limit test.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results from the Acute Exposure Oral Toxicity in rats, the estimated acute oral LD50 (combined sexes) for glycerine carbonate was determined to be greater than 5000 mg/kg.