Propane-1,3-diol

Endpoint summary

Description of key information

The substance has low potential for skin and eye irritation based on two studies each in animals for these target tissues. Transient mild or slight reddening occurred on skin or eyes, but was insufficient for classification. Human skin patch tests supported a low potential for skin irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Exposure was 24 hours rather than 4 hours. Readings were not made at 48 hours or 7 days. Exposure was occlusive not semi-occlusive.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Adult
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

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

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Twenty four hours prior to applying the material, the hair was removed from the backs of the animals with an electric clipper.

Duration of treatment / exposure:

24 hours

Observation period:

Skin reactions were evaluated upon removal of the patch. A second reading was made 48 hours later (72 hours after application).

Number of animals:

12 rabbits - 6 treated on intact skin and 6 treated on abraded skin.

Details on study design:

TEST SITE
- Area of exposure: Patch measuring 1 inch x 1 inch

- Type of wrap if used: Patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits were wrapped in impervious material to maintain the test patches in position.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24 hours

Evaluation of test sites was conducted by the method of Draize.

SCORING SYSTEM: Draize and CIVO

Irritation parameter:

overall irritation score

Basis:

other: average

Time point:

other: 24 and 72 hours

Score:

>= 0.3 - <= 1.3

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Remarks on result:

other: 24 hours: erythema score was 2 for both intact and abraded skin 72 hours: erythema score was 1 for both intact and abraded skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Remarks on result:

other: 24 hours: erythema score was 2 for intact skin and 1 for abraded skin 72 hours: erythema score was 1 for both intact and abraded skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

4

Remarks on result:

other: 24 hours: erythema score was 1 for both intact and abraded skin 48 hours: erythema score was 0 for both intact and abraded skin

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 0 - <= 2

Max. score:

4

Remarks on result:

other: 24 hours: erythema score was 1 for intact skin and 2 for abraded skin 48 hours: erythema score was 0 for intact skin and 1 for abraded skin

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

4

Remarks on result:

other: 24 hours: erythema score was 1 for both intact and abraded skin 48 hours: erythema score was 0 for intact skin and 1 for abraded skin

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

4

Remarks on result:

other: 24 hours: erythema score was 1 for both intact and abraded skin 48 hours: erythema score was 0 for intact skin and 1 for abraded skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: readings taken at 24 and 72 hours only

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: readings taken at 24 and 72 hours only

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: readings taken at 24 and 72 hours only

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: readings taken at 24 and 72 hours only

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: readings taken at 24 and 72 hours only

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: readings taken at 24 and 72 hours only

Irritant / corrosive response data:

The test substance casued very sight or well-defined erythema of the treated skin of rabbits.

Animal Number	Intact Skin		Animal Number	Abraded skin
	24 Hours A B	72 Hours A B		24 Hours A B	72 Hours A B
8328	2-0	1-0	8322	2-0	1-0
8329	2-0	1-0	8323	1-0	1-0
8330	1-0	0-0	8324	1-0	0-0
8331	1-0	0-0	8325	2-0	1-0
8332	1-0	0-0	8326	1-0	1-0
8333	1-0	0-0	8327	1-0	1-0
Average	1.3	0.3		1.3	0.8

A=erythema; B=edema

Interpretation of results:

GHS criteria not met

Conclusions:

Propanediol-1,3 caused very slight or well-defined erythema of the treated skin and is, therefore, considered to be a slight primary skin irritant.

Executive summary:

The test substance was tested on intact and abraded skin of rabbits in a semi-occlusive test for 24 hours. Propanediol-1,3 caused very slight or well-defined erythema of the treated skin and is, therefore, considered to be a slight primary skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

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

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

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)

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)

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)

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

Irritation parameter:

conjunctivae score

Basis:

animal: all animals

Time point:

48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test substance did not produce significant skin or eye irritation/corrosion. The substance does not need to be classified for irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.