Decane-1,10-diol

Endpoint summary

Description of key information

The irritating potential of 1,10 -decanediol has been evaluated in rabbits. The substance is considered to be not skin or eye irritating.

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

Study period:

February 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

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

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.

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

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.

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.

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

Study period:

February 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madderin, Fuellinsdorf, Swizerland
- Age at study initiation: 12-16 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

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

1h

Observation period (in vivo):

1,24,48,72 hours, 7, 14, 21 days after treatment.

Number of animals or in vitro replicates:

6 rabbits (3M, 3F)

Details on study design:

Before testing, both eyes of each animal were examined and any animals with eye defect were rejected.
A single dose of the test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbit and the lid was gently closed for a few seconds.
The right eye remained untreated and served as a control. In 3 out of the 6 rabbits approxiamtely 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.

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

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

not rinsed

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

not rinsed

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

other: not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Test item showed no irritation when applied on the rabbit eye mucosa.
No coloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to compound effects.

Rinsing of the eyes following substance instillation showed a very good effect.

Other effects:

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

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 the rabbit eye mucosa.

Executive summary:

The purpose of this primary eye irritation study was to assess possible irritation potential when single doses of decanediol are placed in the conjunctival sac of 6 rabbit eyes (3 not rinsed/3 rinsed). Very slight effects on conjunctivae were observed in rabbits 'not rinsed' ; the effects are fully reversible into 7 days.

Under the conditions of this experiment, the test material was found to cause no irritation when applied to the rabbit eye mucosa.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation study in rabbits (RCC 1982) :

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.

Eye irritation in rabbits (RCC 1982):

The purpose of this primary eye irritation study was to assess possible irritation potential when single doses of decanediol are placed in the conjunctival sac of 6 rabbit eyes (3 not rinsed/3 rinsed). Very slight effects on conjunctivae were observed in rabbits 'not rinsed' ; the effects are fully reversible into 7 days.

Under the conditions of this experiment, the test material was found to cause no irritation when applied to the rabbit eye mucosa.

Justification for classification or non-classification

Based on the available experimental data, 1,10 -decanediol should be not classified as skin or eye irritating according to the Regulation EC n°1272/2008.