Propane-1,3-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

PDO from chemical process.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Remarks:

Housing and Feeding Conditions

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,3-diol

EC Number:

207-997-3

EC Name:

Propane-1,3-diol

Cas Number:

504-63-2

Molecular formula:

C3H8O2

IUPAC Name:

propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): Propanediol-1,3
- Purity: Not reported

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Caged individually and received no hay or other extraneous material that might enter the eyes.
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported. The eyes of animals were examined before testing and only those animals without observable eye defects were used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

The upper and lower eye lid were carefully closed and held together for 1 second. The other eye, remaining untreated, served as the control.

Observation period (in vivo):

The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.

Number of animals or in vitro replicates:

6 New Zealand White albino rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not done.
- Time after start of exposure: The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.

SCORING SYSTEM: FDA-scoring scale

TOOL USED TO ASSESS SCORE: Binocular magnifying glass

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)

Results 2

Irritation parameter:

iris score

Basis:

animal: all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)

Results 3

Irritation parameter:

chemosis score

Basis:

animal: all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: all animals

Time point:

24 h

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: score of 1 was observed in 4 animals and score of 0 was observed in 2 animals

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: all animals

Time point:

48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: all animals

Time point:

72 h

Remarks on result:

other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)

Irritant / corrosive response data:

The ocular effects of propanediol-1,3 consisted of slight redness of the conjunctivae in four out of six rabbits.

Any other information on results incl. tables

Animal Number	Cornea	Iris	Conjunctivae
			Redness	Chemosis
After 24 Hours
1	0	0	1	0
2	0	0	0	0
3	0	0	1	0
4	0	0	1	0
5	0	0	1	0
6	0	0	0	0
After 48 Hours
1	0	0	0	0
2	0	0	0	0
3	0	0	0	0
4	0	0	0	0
5	0	0	0	0
6	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The ocular effects of propanediol-1,3 consisted of slight redness of the conjunctivae in four out of six rabbits. After 48 hours these effects had cleared up.

Executive summary:

The test substance (0.1 mL) was allowed to fall on the everted lower lid on one eye of each rabbit. The upper and lower eye lid were carefully closed and held together for 1 second. The other eye, remaining untreated, served as the control. The test substance was not washed from the eyes. The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.

The ocular effects of propanediol-1,3 consisted of slight redness of the conjunctivae in four out of six rabbits. After 48 hours these effects had cleared up.