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Diss Factsheets

Administrative data

Description of key information

Buehler-test (OECD 406): not sensitizing

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
Study period:
2014-11-19 to 2014-12-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The Buehler type of sensitization test was selected since the test substance is a functional silane and the Local Lymph Node Assay as the preferred alternative has shown to provide false positive results for silicone substances.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: Charles River France, L’Arbresle Cedex, France
- Weight at study initiation: 252 - 302 g
- Age at study initiation: approx. 4 weeks
- Housing: Group housing of maximally 5 animals per Noryl cage
- Bedding: sawdust from JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany
- Diet: maintenance diet for guinea pigs (MS-H, SSNIFF® Spezialdiäten GmbH, Soest, Germany). Hay (TecniLab-BMI BV, Someren, The Netherlands), provided at least twice a week
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
No. of animals per dose:
10 (controls), 20 (in test groups)
Details on study design:
RANGE FINDING TESTS
- For the dermal inductions the initially test item concentrations were 1, 2, 5, 10, 20, 50 and 100%. The undiluted test item was selected for main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in corn oil
- Control group: water
- Site: left scapular region
- Frequency of applications: every 7 days
- Duration: days 0-21
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test substance in corn oil
- Control group: water
- Site: right flank
- Concentrations: 100%
- Evaluation: 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control
Positive control substance(s):
yes
Remarks:
a-hexylcinnamicaldehyde
Positive control results:
The six-month reliability check with a-hexylcinnamicaldehyde indicates that the Buehler Test is an appropriate model for testing for contact hypersensitivity. The skin reactions observed in four experimental animals in response to the 50% test substance concentration in the challenge phase were considered indicative of sensitization, based on the absence of any response in the control animals. These results lead to a sensitization rate of 40 percent.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.

TOXICITY/MORTALITY

No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

BODY WEIGHT

Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing properties of N-phenyl-3-aminopropyltrimethoxysilane (CAS 3068-76-6) were tested in a study according to OECD TG 406 under GLP conditions using the test for delayed contact hypersensitivity in guinea pigs (Buehler-test, WIL, 2015).

For the dermal inductions the initially test item concentration was 100% (v/v). A 100% (v/v) preparation of the test item was selected for the challenge application. Topical application of the appropriate test substance concentrations (20 test animals) or vehicle (10 control animals) was performed once a week at the right flanks of each animal for three consecutive weeks. Seven days following the last topical application of the test substance or vehicle (corn oil) all animals were challenged with the test substance at a concentration of 100% (v/v). Skin reactions of all animals were evaluated 24 and 48 hours after challenge administration. No animal showed any skin reactions. Positive controls were included in the study and gave the expected result.No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.Thus, N-phenyl-3-aminopropyltrimethoxysilane (CAS 3068-76-6) was not skin sensitizing under the conditions of this Buehler test.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The study is not required according to Annex VII-X of Regulation (EC) No 1907/2006.


Justification for classification or non-classification

Based on the reliable data on the registered substance it is concluded that the data does not meet the criteria for classification according to Regulation (EC) 1272/2008 and according to Directive 67/548/EEC, and therefore conclusive but not sufficient for classification.