Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
06 Feb to 16 Mar 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TD 406 and in compliance with GLP and was considered to be reliability 1. Read-across is considered to be scientifically valid and reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Duesseldorf, Germany
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DYNASYLAN D 6010, Dimethoxydiphenylsilan
- ID No.: 0637/81 547
- Internal No.: 0149
- Physical state: colourless liquid
- Density: approximately 1.07 g/cm³
- Miscibility in water: not miscible due to hydrolysis
- Homogeneity: optically homogenous
- Stability under test conditions: < 1 year
- Storage condition of test material: in closed vial in a chemical hood

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley, Pirbright White Hsd/Win:DH [SPF]
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen, Gartenstraße 27
- Age at study initiation: young, healthy adults
- Weight at study initiation: < 500 g
- Housing: conventional, a maximum of 5 animals per Makrolon cage Type IV bedded with softwood fibre Type HW 300/500 W, JELU-Werk, Ludwigsmuehle, 73494 Rosenberg (certificate of contaminant analysis regularly provided by the producer)
- Diet: Ssniff G 4 - complete diet for guinea pigs (Ssniff, Spezialfuttermittel GmbH, 59494 Soest, analyses regularly conducted by producer), ad libitum
- Water: tap water (Gelsenwasser, Wasserwerk, 45721 Haltern, samples of tap water quarterly analysed), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70 (with temporary variations due to cleaning work in the animal rooms)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
during main study; for the pretest maize oil was used
Concentration / amount:
Pretest: each animal of the test group received applications of 5, 25, 50, and 100 % (w/w) test material concentration
Main study: 100 % (undiluted)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
during main study; for the pretest maize oil was used
Concentration / amount:
Pretest: each animal of the test group received applications of 5, 25, 50, and 100 % (w/w) test material concentration
Main study: 100 % (undiluted)
No. of animals per dose:
Pretest: 3 animals in test group, 3 animals in control group
Main study: 20 animals in test group, 10 animals in control group.
Details on study design:
RANGE FINDING TESTS:
- Induction: 2 x 2 cm gauze patches with the test material (0.3 cm³/patch) were placed on the shaved skin and occlusively fixed with adhesive strips and wraps. Each animal received 2 patches on each flank with 5, 25, 50, and 100% (w/w) test material concentration. After removal the test sites were cleaned with maize oil and chemical pulp. The skin reactions were recorded 30 and 54 hours after start of application.
- Challenge: Animals, which were not included into the induction procedure, received patches analogous to the induction procedure. The reason for this additional test was a presumed difference in sensitivity to the test material concentrations due to the body weight development. Animals tested in this part of the pretest had similar body weight to those of the main study during challenge application.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: days 1-14
- Test groups:
Induction phase I (day 0): 2 x 2 cm gauze patches with the test material (0.3 cm³/patch) were placed on the shaved skin and occlusively fixed with adhesive strips and wraps. After removal the test sites were cleaned with maize oil and chemical pulp. The skin reactions were recorded 30 hours after start of application.
Induction phase II (day 7) and Induction phase III (day 14): analogous to Induction Phase I
- Control group:
Induction phase I (day 0): 2 x 2 cm gauze patches with the vehicle (0.3 cm³/patch) were placed on the shaved skin and occlusively fixed with adhesive strips and wraps. After removal the test sites were cleaned with maize oil and chemical pulp. The skin reactions were recorded 30 hours after start of application.
Induction phase II (day 7) and Induction phase III (day 14): analogous to Induction Phase I
- Site: posterior part of the left flanks
- Frequency of applications: days 0, 7, and 14
- Duration: 6 hours
- Concentrations: 100% (undiluted)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: Two 2 x 2 cm gauze patches with the vehicle or the test material (0.3 cm³/patch) were placed on the clipped skin and occlusively fixed with adhesive strips and wraps. After removal the test sites were cleaned with maize oil and chemical pulp. The skin reactions were recorded 30 and 54 hours after start of application.
- Control group: Two 2 x 2 cm gauze patches with the vehicle or the test material (0.3 cm³/patch) were placed on the clipped skin and occlusively fixed with adhesive strips and wraps. After removal the test sites were cleaned with maize oil and chemical pulp.
- Site: test material: posterior part of the right flanks; vehicle: anterior part of the right flanks
- Concentrations: 100% (undiluted)
- Evaluation (hr after challenge): The skin reactions were recorded 30 and 54 hours after start of application.
Challenge controls:
For the challenge exposure the test group animals received also a patch with vehicle.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
100% (undiluted)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 100% (undiluted). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
100% (undiluted)
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: 100% (undiluted). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
100% (undiluted)
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: 100% (undiluted). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
100% (undiluted)
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: 100% (undiluted). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was tested for skin sensitising properties according to OECD TG 406 (1992), and in compliance with GLP. None of the animals showed any skin reactions at the test sites 30 and 54 hours after challenge exposure. Hence, classification for skin sensitisation according to Regulation (EC) No 1272/2008 is not warranted.