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EC number: 219-154-7 | CAS number: 2374-14-3
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21st November 2012 to 1st February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the 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:
- 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
- EC Number:
- 219-154-7
- EC Name:
- 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
- Cas Number:
- 2374-14-3
- Molecular formula:
- C12H21F9O3Si3
- IUPAC Name:
- 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 364-440g
- Housing: In groups in Terluran cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±10
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27-11-2012 To: 01-02-2013
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5g of 100% test substance
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5g of 100% test substance
- No. of animals per dose:
- Test group: 20
Negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: Two animals were treated topically with concentrations of 50% and 100% of the test substance (suspended in vaseline) for six hours. A dry patch served as a negative control. Based on the results of this preliminary test a concentration of 100% was chosen for the induction and challenge phases of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
The left flank was cleared of hair, by close clipping, prior to the first application and again prior to further applications.
The test substance was loaded with 0.5g of the test substance. The patch was applied to the test area of approximately 2.5 x 2.5cm and was held in place by an occlusive dressing for six hours. The procedure was repeated once per week at the same test area at weekly intervals for a total of three weeks. In the negative control group, a dry gauze patch was applied to the test area under the same conditions as the test group.
B. CHALLENGE EXPOSURE
Both flanks were cleared of hair, by close clipping, prior to the challenge application.
13 days after the last induction application the test substance was applied to an area of approximately 2.5 x 2.5cm on the right flank and was held in contact with an occlusive dressing for six hours. A dry gauze patch was applied to an area of approximately 2.5 x 2.5cm on the left flank (intraspecies control) and was held in contact with an occlusive dressing for six hours.
Approximately 21 hours after removing the patch, the challenge area was cleaned and cleared of hair by the use of a depilatory cream. Approximately 24 and 48 hours after removing the patch the skin reaction was observed and recorded. Additionally, all animals were observed for signs of toxicity at least once daily during the test period. - Challenge controls:
- Dry patch
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive-control substance (25% in vaseline) was 20% confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Dry patch
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Dry patch
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% in vaseline
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: The sensitisation rate after application of the positive-control substance (25% in vaseline) was 20% confirming the reliability of the test system.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% in vaseline
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: The sensitisation rate after application of the positive-control substance (25% in vaseline) was 20% confirming the reliability of the test system.
Any other information on results incl. tables
The body weight gains of all animals were normal, when compared with the historical data.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin sensitisation study (Buehler study) conducted to OECD 406 and to GLP (reliability score 1) 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane did not cause a positive reaction in any of the guinea pigs tested, and therefore under the conditions of this study is not a skin sensitizer.
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