Registration Dossier

Administrative data

Description of key information

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:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH Laboratory Animal Breeder, Borchen, Germany
- Age at study initiation: approx. 4-6 weeeks
- Weight at study initiation: 317-344 g
- Diet and water: ad libitum
- Acclimation period: at least 7 days
Route:
epicutaneous, occlusive
Vehicle:
other: physiological saline (0.95 % NaCl)
Concentration / amount:
1st to 3rd induction: 12 % test substance formulation in saline (based on the test item as 100%); volume: 0.5 ml per animal
challenge: 6 % test substance formulation in saline (based on the test item as 100%); volume: 0.5 ml per animal
Route:
epicutaneous, occlusive
Vehicle:
other: physiological saline (0.95 % NaCl)
Concentration / amount:
1st to 3rd induction: 12 % test substance formulation in saline (based on the test item as 100%); volume: 0.5 ml per animal
challenge: 6 % test substance formulation in saline (based on the test item as 100%); volume: 0.5 ml per animal
No. of animals per dose:
experimental group: 20
control group: 10
Details on study design:
RANGE FINDING TESTS:
Range finding tests for induction were performed using 4 males. Due to the high pH value and the expected local irritancy the hightest concentration used in one animal was 25%.
For Induction:
- tested in one animal: 0.5 ml of 0%, 6%, 12% and 25% of the test item in saline were applied occlusively to the skin for 6 hours. Slight redness (grade 1) was seen 30 hours after treatment with 12%.
- tested in three further animals: 0.5 ml of 0%, 3%, 6% and 12% of the test item in saline were applied occlusively to the skin for 6 hours. Slight redness (grade 1) was seen 30 hours after treatment with 12% in one animal.
Based on the results of the range-finding study the concentration selected for inductions was 12%.
For Challenge:
Range finding tests for challenge were performed using 2 animals which were treated in the same manner als the control animals during induction.
- tested in two animals: 0.5 ml of 0%, 0.5%, 3%, and 6% of the test item in saline were applied occlusively to the skin for 6 hours. No signs of irritation occured.
Based on the results of the range-finding study the concentration selected for challenge was 6%.

MAIN STUDY
A. INDUCTION EXPOSURE
- the animals were treated with the test item three times at intervals of seven days. The suitable areas of the body were shaved one day (24 hours) before each treatment. The volume applied per animal was 0.5 m on a hypoallergic patch and held in place on the skin with an adhesive plaster. After six hours the patches were removed and any remaining test item was washed off the skin with physiological saline solution. Treatment areas were vusally assessed 30 hours after initiation of exposure.


B. CHALLENGE EXPOSURE
- the animals were treated with the test item four weeks after the first (two weeks after the last) dermal induction. Backs and right flanks were shaved one day before challenge. The test item (6% in saline) applied per animal was 0.5 m on a hypoallergic patch and held in place on the right flank with an adhesive plaster. Six hours after treatment the patches were removed and any remaining test item was washed off the skin with physiological saline solution. 24 hours later the treatment areas were shorn.
Skin reactions were assessed 30 and 54 hours after the beginning of the challenge.

OTHER:
In addition to the skin reactions the following data were recorded: Mortality/ Clinical signs once daily; Body weights prior to start, on day 30 and at termination of the study.
Challenge controls:
As a control a patch loaded only with the vehicle was applied and fixed also to the right flank, cranial to the test item patch.
Positive control substance(s):
yes
Remarks:
Reliability check of Buehler test with alpha-hexylcinnamic aldehyde in polyethylene glycol 400 revealed a sensitization rate of 65% (test substance concentration 40% for induction and 20% for challenge).
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
6%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 6%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 10.0.

The animals in the test item group and in the control group showed no clinical signs of toxicity.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

A skin sensitization test according to OECD guideline 406 (Buehler Patch Test) was conducted on female guinea pigs with 12% AAS-Loesung in saline (60 mg/animal) for dermal induction. For challenge test a concentration of 6% in saline was applied. 30 and 54 hours after start of challenge exposure the treated sites were assessed. The challenge with the test item let to slight skin effects (grade 1) in 1 of 20 animals after 30 hours and in 0 of 20 animals after 54 hours. Under the conditions of the Buehler Test AAS-Loesung exhibits no skin sensitization potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance did not show any skin sensitizing properties in Guinea pigs. There is no reason to believe that results obtained in Guinea pigs would not be applicable to humans.


Migrated from Short description of key information:
The substance showed no skin sensitizing properties in a Buehler Patch Test on Guinea pigs (OECD Guideline 406, GLP compliant).

Justification for selection of skin sensitisation endpoint:
only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is not any indication that AAS may cause respiratory sensitization. There is not any respective human evidence. An internally performed OECD Toolbox inquiry confirmed that based on the chemical structure of the compound there is no indication for a respiratory sensitization potential and no indication for a protein binding activity. In addition the compound was shown to be not sensitizing to Guinea pig skin in a Guideline- and GLP-compliant test system. Thus, there is no evidence for a skin sensitization potential and by that no evidence of a sensitization potential in general.

Justification for classification or non-classification

Based on the available data and in accordance with Regulation (EC) 1272/2008 the substance is not classified for skin or respiratory sensitization.