Registration Dossier
Registration Dossier
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EC number: 943-282-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Trimethyl(octadecyloxy)silane
- EC Number:
- 242-554-8
- EC Name:
- Trimethyl(octadecyloxy)silane
- Cas Number:
- 18748-98-6
- Molecular formula:
- C21H46OSi
- IUPAC Name:
- Silane, trimethyl(octadecyloxy)-
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH (Harlan)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gertenstrasse 27, D-33178 Borchen
- Weight at study initiation: 348-417 g
- Housing: individual in transparent macrolon cages (type V) on soft wood granulate in an air-conditioned room, 5 animals per cage
- Diet (e.g. ad libitum): ssniff Ms-H (V 2233), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 50±20%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- No. of animals per dose:
- determination of the primary non-irritant concentration - 3
control group - 10
treatment group - 20 - Details on study design:
- RANGE FINDING TESTS:
- The following test concentrations were administered:
Animal 1 - left flank 100% - right flank 20% in sesame oil
Animal 2 - left flank 100% - right flank 4% in sesame oil
Animal 3 - left flank 20% in sesame oil - right flank 4% in sesame oil
- The hair on the flanks was removed mechnically
- 0.5 ml of the test substance preparation was administered to a 2 x 2 cm cellulose patch, fixed to the flank and covered occlusively for 6 hours with a bandage and film.
- 24 hours after removal, the treated skin areas were examined for erythema and edema
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 6 hours
- Test groups: Patch fixed to front part of left flank of the 20 animals of the treatment group and covered with an occlusive polyethylene film and a bandage
- Control group: The 10 control animals were treated analogously with 0.5 ml sesame oil
- Site: left flank
- Frequency of applications: once a week
- Duration: 2 weeks (Day 1 to day 15)
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 6 hours
- Test groups: 0.5 ml of the test substance was administered to a 2 x 2 cm cellulose patch, which was placed on the right flank and covered with an occlusive bandage.
- Control group: as test groups
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches - Challenge controls:
- seseme oil
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Buehler test conducted according to OECD 406 and compliant with GLP, trimethyl(octadecyloxy)silane was not sensitising to the skin.
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