Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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).

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.