Decane-1,10-diol

Endpoint summary

Description of key information

The skin sensitisation potential of 1,10 -decanediol was evaluated in guinea pigs. According to the results of the Buehler test, 1,10 -decanediol is not considered to be a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

A skin sensitisation study in guinea pigs was available before the REACH regulation on 1,10-decanediol. No new study was performed because the guinea pigs study is reliable and conclusive.

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source:Harlan Winkelmann GmbH, Versuchstierzucht, Gartenstraße 27, 33176 Borchen
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known:
- Age at study initiation: no data
- Weight at study initiation:less than 500 g
- Housing: standard, maximum of 5 animals / type IV Makrolon cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route:

epicutaneous, occlusive

Vehicle:

other: vaseline

Concentration / amount:

50%

Day(s)/duration:

day 0, 7, 14

Adequacy of induction:

highest technically applicable concentration used

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: vaseline

Concentration / amount:

50%

Day(s)/duration:

day 28

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

test group = 20
control group = 10

Details on study design:

Volume/type of application: approx. 0.5 g of the test substance preparation or of the medium for occlusive dermal application (gauze pad was well supplied).
Skin preparation in the application area: 2-3 hours before each treatment (pretest and main test): Removal of hair with small animal clippers.
Medium: vaseline
Form of administration: paste

In order to be able to experimentally reproduce the two parts of the sensitisation, the skin sensitisation study is likewise divided into two parts: the three dermal inductions and the challenge exposure. In addition, a pretest for determining the dose is carried out to provide the animal model, guinea pigs, in the main test with the maximum sensitivity to sensitising compounds. The Buehler test is performed on guinea pigs, which, as a non-adjuvant process, is an alternative method to the Magnusson and Kligman test.

PRETEST
Dermal application : Dermal application:
The left and right flank of 3 animals was mechanically dehaired 2-3 hours prior to application. Gauze pads with an area of 2 x 2 cm were each supplied with approx. 0.5 g of the corresponding test substance concentration (2.5, 10, 25 and 50 % in vaseline) and applied to the animals on the sheared area of the flank. Each gauze pad was covered with an occlusive patch and secured with a bandage for 6 hours. Each animal received two gauze pads on one flank.
After removing the patch, the application areas were wiped with corn oil and cellulose. The dermal reactions were evaluated 30 and 54 hours after the start of the application.

Determination of the challenge concentration
In the fourth week of the experiment, a further determination of the maximum non-irritant concentration for the challenge exposure was made using 3 additional guinea pigs who had not yet been treated up to that point.
This additional concentration testing was carried out on the basis of a suspected different skin sensitivity during the weight development of the animals. It was therefore possible to ensure that the challenge concentration was determined for animals of approximately equal body weights as the 30 animals in the challenge period. The same concentrations as in the pre-test (2.5, 10, 25 and 50 % in vaseline) were applied. The experiment conditions remained unchanged.

MAIN TEST
Dermal induction Induction period I (day 0) : The gauze pads (2 x 2 cm) were supplied with the 50 % test substance preparation and the medium (approx. 0.5 g / patch) and applied to the skin of the left flank area sheared 2-3 hours previously. Each gauze pad was covered with an occlusive patch and secured with a bandage for 6 hours.
After removing the dressing, the application areas were wiped with corn oil and cellulose. The dermal reaction was evaluated 30 hours after the start of the application.
Induction period II (day 7): The course of induction period II corresponded to induction period I.
Induction period III (day 14): The course of the induction period III corresponded to induction periods I and II
Challenge exposure (day 28): For the challenge exposure, the right flank of the test and control animals was mechanically dehaired 2 to 3 hours before the application. The gauze pads (2 x 2 cm) were supplied with approx. 0.5 g of the 50 % test substance preparation and applied to the sheared skin of the right rear flank under an occlusive patch. An occlusive patch with just the medium was applied to the front flank area. The patches were fixed with a bandage for 6 hours. After removing the dressing, the application areas were wiped with corn oil and cellulose.

Interpretation criteria :
An animal of the test group is considered sensitive if the observed dermal reaction, which occurs due to the challenge exposure, is stronger and/or more persistent than the reactions in the control group.
If the dermal reaction of an animal of the test group, which occurs due to the challenge exposure, is not clearly distinguishable from the reaction of the control animals, the result for this animal is said to be unclear.
An animal of the test group is considered as not sensitive if the dermal reaction, which occurs due to the challenge exposure, is the same, milder and/or less persistent than the reactions of the control animals.

Challenge controls:

yes

Positive control substance(s):

no

Key result

Reading:

1st reading

Hours after challenge:

30

Group:

test chemical

Dose level:

50%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

54

Group:

test chemical

Dose level:

50%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

PRETEST results :

In order to determine a maximum, non-irritant and a slightly-to-moderate irritant concentration, 2.5, 10, 25 and 50 % concentrations in vaseline were tested for primary irritation on the skin of three guinea pigs. The exposure time was 6 hours.

None of the four administered test substance concentrations caused irritation of the three animals' skin in the pretest 30 or 54 hours post-application.

Based on these results, the 50 % test substance formulation was determined for the induction periods in the main test.

As a result, for the challenge exposure in the main test, the maximum test substance concentration that can be properly applied of 50 % in vaseline was administered.

MAIN STUDY

Clinical signs : The test and control animals exhibited normal body weight development for the duration of the experiment. Interim body weight fluctuations of the guinea pigs are physiological and therefore not due to the test substance. Systemic effects were not observed in the animals treated during the observation period.

Local effects: Thirty hours after the treatment as part of induction periods I, II and III, neither the animals of the test group nor those of the control group showed any skin irritation.

After the challenge exposure, skin irritation in the form of erythema and oedema was not found 30 or 54 hours after the start of the application on the right rear flank of the test animals or of the animals of the control group. The patch with the medium did not trigger any skin reactions in the test or control animals either.

Interpretation of results:

GHS criteria not met

Conclusions:

Thus, 1,10 -decandiol did not show any sensitising effect on the guinea pigs' skin under the experiment conditions described.

Executive summary:

The test substance, 1,10 -decandiol, was tested for skin sensitisation in guinea pigs using the Buehler method. In order to determine the potentially sensitising effect of the test substance, 20 test animals and 10 control animals were used for the study. Any reactions, particularly erythema and oedema formation, were evaluated 30 and 54 hours after the challenge exposure.

The highest concentration of the test substance that can be properly applied (50 % in vaseline), which was administered in the pretest, resulted in no primary skin irritation of the guinea pigs and was therefore set for the treatment during induction periods I, II and III.

For the challenge exposure, 50 % of the test substance preparation (highest formulation that can be applied properly) was tested out as a non-irritating concentration in the fourth week of the experiment (3 animals of the same age as the animals in the main test) as already in the pretest.

During the experiment, no substance-related systemic effects nor substance-related impairment of body weight development were observed in the animals of the test or control groups.The dermal treatments during induction periods I, II and III did not result in the skin irritation of any of the test animals 30 hours post application (p.a.). The controls treated with the medium showed no skin irritation at these observation times either.The challenge exposure with the 50 % test substance preparation resulted in no skin reactions on the rear right flank of any animal of the test or control groups in the form of erythema or oedema neither 30 nor 54 hours p.a. Likewise, the patch with the medium resulted in no skin reactions of any animal of the test or control groups.

Thus, 1,10 -decandiol did not show any sensitising effect on the guinea pigs' skin under the experiment conditions described.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The test substance, 1,10 -decandiol, was tested for skin sensitisation in guinea pigs using the Buehler method. In order to determine the potentially sensitising effect of the test substance, 20 test animals and 10 control animals were used for the study. Any reactions, particularly erythema and oedema formation, were evaluated 30 and 54 hours after the challenge exposure.

The highest concentration of the test substance that can be properly applied (50 % in vaseline), which was administered in the pretest, resulted in no primary skin irritation of the guinea pigs and was therefore set for the treatment during induction periods I, II and III.

For the challenge exposure, 50 % of the test substance preparation (highest formulation that can be applied properly) was tested out as a non-irritating concentration in the fourth week of the experiment (3 animals of the same age as the animals in the main test) as already in the pretest.

During the experiment, no substance-related systemic effects nor substance-related impairment of body weight development were observed in the animals of the test or control groups.The dermal treatments during induction periods I, II and III did not result in the skin irritation of any of the test animals 30 hours post application (p.a.). The controls treated with the medium showed no skin irritation at these observation times either.The challenge exposure with the 50 % test substance preparation resulted in no skin reactions on the rear right flank of any animal of the test or control groups in the form of erythema or oedema neither 30 nor 54 hours p.a. Likewise, the patch with the medium resulted in no skin reactions of any animal of the test or control groups.

Thus, 1,10 -decandiol did not show any sensitising effect on the guinea pigs' skin under the experiment conditions described.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, 1,10 -decanediol is not be classified for skin sensitisation according to the Regulation EC. 1272/2008.