Registration Dossier
Registration Dossier
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EC number: 241-677-4 | CAS number: 17689-77-9
Skin sensitisation
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:
- supporting study
- Study period:
- during 1989-10-11 to 1990-07-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive control (reliability check) reported
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Viscous silicon preparation with ca. 5% mixture of triacetoxymethylsilane.
- IUPAC Name:
- Viscous silicon preparation with ca. 5% mixture of triacetoxymethylsilane.
- Details on test material:
- The study sponsor has indicated that the test material was a silicone material with ca. 5% triacetoxymethylsilane.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: young adult
- Weight at study initiation: 341-459 g
- Housing: 5 or 6 (same sex) per polystyrene cage with perforated flooring
- Diet: standard diet ad libitum
- Water : drinking water ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: within the period 1989-10-11 to 1990-07-09
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- material described as solid plaques
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- material described as solid plaques
- No. of animals per dose:
- 10 males, 10 females for test and control groups
- Details on study design:
- RANGE FINDING TESTS:
2 males, 2 females: 6h occluded exposure to neat solid material
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: n=20, test material (2cm x 2 cm) solid
- Control group: n=20, distilled water (0.5 ml)
- Site: left lateral abdominal
- Frequency of applications: 3 applications at weekly intervals
- Duration: 6h
- Concentrations: neat solid material
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after final induction application
- Exposure period: 6h
- Test groups: n=20, test material (2cm x 2 cm) solid
- Control group: n=20, test material (2cm x 2 cm) solid
- Site: right posterior abdominal
- Concentrations: neat solid material
- Evaluation (hr after challenge): 24 and 48h - Challenge controls:
- negative but not postitive controls included
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no reliability check included
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- neat solid material
- 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: neat solid material. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- neat solid material
- 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: neat solid material. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A well conducted, well reported guinea-pig skin sensitization test (Buehler Method) found no evidence of sensitization potential when the 'neat' solid material was applied during the induction and challenge phases. No data were provided on the reliability of this test using a known sensitiser, as required in the guideline.
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