Decane-1,10-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decane-1,10-diol

EC Number:

203-975-2

EC Name:

Decane-1,10-diol

Cas Number:

112-47-0

Molecular formula:

C10H22O2

IUPAC Name:

decane-1,10-diol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madderin, Fuellinsdorf, Swizerland
- Age at study initiation: 12-19 weeks old
- Weight at study initiation: 2.3 - 3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): "air conditioned" without details
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: PEG 400 + saline (70:30)

Amount / concentration applied:

Concentration : 50%

Duration of treatment / exposure:

24 hours

Observation period:

1, 24, 48, 72h, 7, 14, and 21 days following removal of bandage and gauze patches

Number of animals:

3 males and 3 females

Details on study design:

Before treatment, the entire back and the flank of the rabbits were closely clipped with electric clippers and immediately before treatment the shaven skin on one side was slighlty scarified by making minor incisions through the stratum corneaum, but not into the dermis or deep enogh to cause bleeding.
Application was made to one intact and one abraded skin site on the clipped dorsum of each rabbit. The test material in a amount of 0.5 g was applied under a patch of surgical gauze and covered with aluminium foil appox. 2.5 x 2.5 cm. When the patches were in place the trunk of the animal was wrapped with an occlusive bandage of elestic adhesive dressing. When the patches were in place the trunk of the animal was wrapped with an occlusive bandage of elastic adhesive dressing. The bandages and gauze patches remained in place for 24 hours. The animals are not restrained during this period.

Scoring according the Draize scale.
All rabbits were killed at the end of the observation period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(intact and abraded skin)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

(intact and abraded skin)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Test item showed no irritation, when applied to intact and abraded rabbit skin.
No destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect was occurred on the skin.
In the area of application no coloration of the skin was observed.

Other effects:

No acute toxicological signs were observed in the animals during the test period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment, the test material was found to cause no irritation when applied to intact and abraded rabbit skin.

Executive summary:

The purpose of this primary skin irritation study was to assess possible irritation potential when single doses of decanediol are exposed on the skin of rabbits.

Six rabbits were exposed to test substance during 24 hours on intact and abraded skin with occlusive patch.

Test item showed no irritation, when applied to intact and abraded rabbit skin. No destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect was occurred on the skin. In the area of application no coloration of the skin was observed.

Under the conditions of this experiment, the test material was found to cause no irritation when applied to intact and abraded rabbit skin.