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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 2015 - February 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to current OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutoxy(dimethyl)silane
EC Number:
216-467-0
EC Name:
Dibutoxy(dimethyl)silane
Cas Number:
1591-02-2
Molecular formula:
C10H24O2Si
IUPAC Name:
dibutoxydimethylsilane

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: CrI: HA
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: 330 - 403 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding (lot no. 02102141114)
- Diet: Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs (lot no. 0830), rich in crude fibre
- Water: Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10%
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Concentration / amount:
Induction - 100%
Challenge - 25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Concentration / amount:
Induction - 100%
Challenge - 25%
No. of animals per dose:
preliminary test: 4
the test group: 20
negative-control group: 10
Details on study design:
RANGE FINDING TESTS:
Based on the results of this preliminary test the following concentrations were chosen for the main test:
100% for the dermal inductions (highest possible concentration that produced mild irritation)
25% for the challenge application (maximum non-irritant concentration)

MAIN STUDY
A. INDUCTION EXPOSURE
The left flank was cleared of hair (close-clipped) prior to the first application and again prior to further applications. A gauze patch was loaded with 0.5 mL of the test substance. The patch was applied to the test area of approximately 2.5 x 2.5 cm and was held in contact with the help of an occlusive dressing for 6 hours. This procedure was repeated once a week at the same test area at weekly intervals for 3 weeks. Control group received a similar treatment with no test item.

B. CHALLENGE EXPOSURE
Both flanks were cleared of hair (close-clipped) prior to the challenge application. 14 days after the last induction application the prepared test substance was applied to an area of approximately 2.5 x 2.5 cm on the right flank and was held in contact with the help of an occlusive dressing for 6 hours. A patch loaded with the vehicle was applied to an area of approximately 2.5 x 2.5 cm on the left flank (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours.

Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Induction 1
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Erythema Grade 1
Remarks on result:
other: Reading: other: Induction 1. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Erythema Grade 1 .
Reading:
other: Induction 2
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
15
Total no. in group:
20
Clinical observations:
Erythema Grade 1
Remarks on result:
other: Reading: other: Induction 2. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 15.0. Total no. in groups: 20.0. Clinical observations: Erythema Grade 1 .
Reading:
other: Induction 3
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
Erythema Grade 1
Remarks on result:
other: Reading: other: Induction 3. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: Erythema Grade 1 .
Reading:
other: Challenge
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No evidence of sensitisation in any animals at any time point.
Remarks on result:
other: Reading: other: Challenge. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No evidence of sensitisation in any animals at any time point..
Reading:
other: induction and challenge
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No reactions were recorded at any time point in any animals.
Remarks on result:
other: Reading: other: induction and challenge. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were recorded at any time point in any animals..
Reading:
other: challenge
Hours after challenge:
24
Group:
positive control
Dose level:
15%
Clinical observations:
60% of the animals were sensitised at 24 hours
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 15%. Clinical observations: 60% of the animals were sensitised at 24 hours.
Reading:
other: challenge
Hours after challenge:
48
Group:
positive control
Dose level:
15%
Clinical observations:
40% of the animals were sensitised at 48 hours
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 15%. Clinical observations: 40% of the animals were sensitised at 48 hours.

Any other information on results incl. tables

The body weight development of all animals was within the range of variation for the strain of animals used.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found not sensitising in a Buehler test, in a study conducted according to guideline and in compliance with GLP.