Registration Dossier
Registration Dossier
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EC number: 221-328-2 | CAS number: 3068-76-6
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]aniline
- EC Number:
- 221-328-2
- EC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Cas Number:
- 3068-76-6
- Molecular formula:
- C12H21NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Test material form:
- other: pale yellow liquid
- Details on test material:
- Name of test material (as cited in study report): N-phenyl-3-aminopropyltrimethoxysilane
- Physical state: pale yellow liquid
- Expiration date of the lot/batch: 09 April 2017
- Storage condition of test material: room temperature
- Specific gravity/density: 1.03 g/cm³
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 100%
Challenge
- 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
Results and discussion
- 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.
In vivo (non-LLNA)
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
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