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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1993-06-17 to 1993-07-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented GLP study performed according to a method equivalent to the OECD guideline n° 402, 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

some information is missing about the dose application

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 colourless liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during storage or administration

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.581-3.069 kg
- Fasting period before study: no
- Housing: Rabbits were housed individually in cages.
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow H.F., checked daily and added or replaced as needed.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure and % coverage: no data
Within 24 hours before testing, fur was clipped from the dorsal area of the trunk of the test animals. The test article was applied directly onto the exposed intact skin of the animals taking care to spread the substance evenly over the entire area. A square gauze patch was placed on the animals to cover the dosed area. The animals were wrapped with rubber dam and an elastic bandage to retard evaporation. The test article was held in contact with the skin for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and gauze
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

One dose at 3000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes, all rabbits were sacrificed by a lethal injection on Day 14 and a gross necropsy was performed.
- Other examinations performed: Body weight were recorded at initiation and on Days 7 and 14. Observations were recorded daily through Day 14.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Clinical signs:

No clinical signs were observed in any animal at any observation period.

Body weight:

There was an apparent increase in mean bodyweight during the study.

Gross pathology:

No visible lesion were observed in any animal at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the observations made in the acute exposure dermal toxicity study in rabbits, the estimated acute dermal LD50 (combined sexes for glycerine carbonate was determined to be greater than 3000 mg/kg.