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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1993-06-17 to 1993-06-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study. The study is performed similar to the method as described in OECD 404 and in accordance with GLP standards. However, 6 animals were used instead of 1+2 and treatment on one abraded site on the lower dorsal trunk was included.

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

6 animals were used instead of 1+2; treatment on one abraded site on the lower dorsal trunk was included

GLP compliance:

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 visible change in the physical state of the test article during storage or administration.
- pH=4

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.366-2.765 kg
- 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; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Minimum of 5 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site

Duration of treatment / exposure:

The test article was administered once per site and remained in contact with the skin for 3 minutes, 60 minutes, 4 and 24 hours, resepctively.

Observation period:

After removal of the patch, animals were examined for signs of erythema, edema, corrositivy and necrosis and the responses scored immediately and then at 24, 48 and 72 hours after patch removal.

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
Approximately 24 hours before the test, fur was removed from the test area by clipping from the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used.
The test article was administered to one intact site on the upper left dorsal trunk of the animal. The exposure duration for this site was 3 minutes.
Following the 3 minute exposure time, the site was unwrapped and scored. The test article was then administered to two intact sites, one on the upper right dorsal trunk of the animal and one on the mid-dorsal trunk of the animal. The exposure durations for these sites were 60 minutes and 4 hours, respectively.
The test article was also applied to two additional sites (one intact and one abraded) on the lower dorsal trunk of the animal. The exposure duration for these sites was 24 hours. The skin was abraded using a burred needle; the abrasion penetrated the stratum cornuem, but not the derma.

The test substance was applied to a small area (approximately 6 cm²) of skin and covered with a gauze patch. The patch was held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period. The entire trunk of each animal was covered with an impervious material and held in place with non-irritating tape. Access by the animal to the patch and resultant ingestion/inhalation was prevented.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure periods, residual test substance was removed using water and gauze without altering the existing response or the integrity of the epidermis.

SCORING SYSTEM: The irritation was scored according to the technique of Draize. The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 rabbits

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 rabbits

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No signs of erythema, edema or necrosis were observed at any observation period at the 3 and 60 minute, 4 and 24 hour (intact and abraded) exposure sites.
Primary Irritation Index (4 hour exposure) = 0.00
Primary Irritation Index (24 hour exposure) = 0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article was considered to be non-irritant to the skin, and non-corrosive according to the DOT Packing Group Classification.