Propane-1,3-diol

Skin irritation / corrosion

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

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

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

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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

Results 13

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.