Registration Dossier
Registration Dossier
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EC number: 422-350-7 | CAS number: 5575-48-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 14 October 2004 to 19 November 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Reduced number of animals compared to number recommended in the Guideline.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Existing study performed in 2004 is used for the purpose of the REACH Registration of the substance.
Test material
- Reference substance name:
- -
- EC Number:
- 422-350-7
- EC Name:
- -
- Cas Number:
- 5575-48-4
- Molecular formula:
- C13H30O3Si
- IUPAC Name:
- decyltrimethoxysilane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals (Chelmsford, Massachusetts)
- Weight at study initiation: 326 to 446 g
- Housing: stainless steel cages
- Diet: Certified Guinea Pig Diet #5026 ad libitum
- Water: water (source not specified) ad libitum
- Acclimation period: eight days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65 to 75°F (equivalent to 18.33 to 23.89°C)
- Humidity (%): Monitored (variations not specified)
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.4 mL test substance at 50% in corn oil
- Day(s)/duration:
- Applications of six hours were made once per week for three consecutive weeks.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.4 mL test substance at 25% in corn oil
- Day(s)/duration:
- 6h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Six animals per sex
- Details on study design:
- RANGE FINDING TESTS: Mildly irritating and highest non-irritating concentrations were determined before the induction phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6h
- Test groups: One treated group
- Control group: Five animals per sex
- Site: n°1
- Frequency of applications: 3
- Duration: 3 weeks
- Concentrations: 50% in corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 6h
- Test groups: One treated group
- Control group: Five animals per sex
- Site: n°3
- Concentrations: 25% in corn oil
- Evaluation: 7, 24, and 48 hr after challenge
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 7
- Group:
- test chemical
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Reading:
- 1st reading
- Hours after challenge:
- 4
- Group:
- negative control
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitisation of Decyltrimethoxysilane was evaluated using the Buelher’s Test. None of the treated animals showed any sign of irritancy at 7, 24 and 48 hours following the challenge. The substance does not meet the criteria for classification as a skin sensitiser in accordance with Regulation (EC) No.1272/2008.
- Executive summary:
The in vivo skin sensitisation of Decyltrimethoxysilane was evaluated during a GLP-compliant study performed according to the method described by Buehler. This method is described in the OECD Testing Guideline 406.
Six male and six female Hartley albino guinea pigs received three topical, occluded applications of the test substance at 50% in corn oil during the induction period of three weeks. An additional group of five male and five female Hartley albino guinea pigs served as a control group.
Two weeks following the last induction application, the animals in the test group received a topical application of the test article, at the determined highest non-irritating concentration of 25% in corn oil, to a dorsal, virgin site. At the same time, the control group animals received an identical dosage of the test article. All challenges dosages were made without patches.
Observations of irritation and other effects were recorded 7 and 24 hours after each induction application and 7, 24 and 48 hours following the challenge applications.
None of the treated animals showed any sign of irritancy at 7, 24 and 48 hours following the challenge.
The substance does not meet the criteria for classification as a skin sensitiser in accordance with Regulation (EC) No.1272/2008.
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