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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1993-07-27 to 1993-07-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study. The study is performed similar to the method as described in OECD 405 and in accordance with GLP standards.

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

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=5

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.456-2.884 kg
- Housing: Rabbits were housed individually.
- Diet (e.g. ad libitum): Certified Purina Lab Rabbit Chox 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 (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: 2nd eye remained untreated and served as control.

Amount / concentration applied:

TEST MATERIAL
0.1 mL per treated eye

Duration of treatment / exposure:

Frequency of administration: once
The test article was placed in the conjunctival sac of the right eye of one animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for one second to prevent loss of material.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after treatment. The grades of ocular reaction were recorded at each examination period.

Number of animals or in vitro replicates:

6 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

6.3

Max. score:

8

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal No. 3345, animal No. 3346 and animal No. 3347

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal No. 3348

Time point:

other: 24, 48 and 72 hours

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal No. 3349

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal No. 3350

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Positive ocular responses were observed at the 1, 24 and 48-hour observation periods. All ocular scores returned to normal at 72 hours and the study was terminated.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was instilled in the right eye of six rabbits. Ocular readings were observed at 1, 24, 48 and 72 hours. Positive ocular responses were recorded at 1, 24 and 48 hours. The Maximum mean total score (MMTS) score was observed to be 6.3 but was fully reversible within 72h. According to the criteria of the DSD and CLP Regulation the substance should not be classified as irritating to the eyes.