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EC number: 617-969-6 | CAS number: 87135-01-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-05-20 to 2009-07-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- full details of positive control not supplied
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Scientifically accepted guideline study
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 87135-01-1
- Molecular formula:
- C12H30O6Si2
- Reference substance name:
- 3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane
- EC Number:
- 617-969-6
- Cas Number:
- 87135-01-1
- Molecular formula:
- (CH3O)3Si(CH2)6Si(OCH3)3 C12 H30 O6 Si2
- IUPAC Name:
- 3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no details
- Age at study initiation: 4-6 wk
- Weight at study initiation: 245-368 g
- Housing: 1/ Makrolon type-4 cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 7 days after heath examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 2009-06-03 To: 2009-07-07
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Test substance:
induction: 50%
challenge: 1%, 10%
Positive control:
induction: 25%
challenge: 1%, 5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Test substance:
induction: 50%
challenge: 1%, 10%
Positive control:
induction: 25%
challenge: 1%, 5%
- No. of animals per dose:
- 20 test
10 control - Details on study design:
- RANGE FINDING TESTS:
3 irritation screening tests:
1. 100%
2. 75%, 50%, 25% and 15%
3. 10%, 5%, 3% and 1%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (test days 1, 8, 15)
- Exposure period: 6h
- Test groups: 20 animals
- Control group: 10 animals
- Site: Each animal received one patch on left shoulder per week which was remained in place for approximately 6 hours each. The patches were applied over a period of 3 weeks. The repeated application was performed at the same site. The interval between exposures was a week. The test item was applied at 50% in PEG 300 and the control animals were treated in the same way as the test animals with the vehicle (PEG 300) only and also covered occlusively.
- Frequency of applications: single application
- Concentration: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: test day 29
- Exposure period: 6h
- Test groups: 20 animals
- Control group: 10 animals
- Site: The test item was applied at 10% (highest tested non-irritating concentration) and 1% in PEG 300 in a similar manner used for the epidermal induction. The vehicle PEG 300 was applied too.
10% applied on the left middle flank (control and test group)
1% applied to the right shoulder (control and test group)
vehicle only applied on the right middle flank (control and test group)
- Concentrations: 1% and 10%
- Evaluation: 24 and 48 hr after challenge - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- None of the control animals were observed with skin reactions after the challenge treatment with the highest non-irritating concentration of alpha-hexylcinnamaldehyde at 5% and 1% in PEG 300.
Fifty percent of the positive control animals were observed with discrete/patchy erythema at the 24-hour observation after the first challenge treatment with the highest non-irritating concentration of alpha-hexylcinnamaldehyde at 5% in PEG 300. All of the skin reactions had faded at the 48-hour observation. No skin reactions were observed at the 24 or 48-hour observations after the challenge treatment with alpha-hexylcinnamaldehyde at 1% in PEG 300.
Discrete/patchy erythema was observed in 75% or 50% of the positive control animals at the 24 and 48-hour observations following a second challenge with alpha-hexylcinnamaldehyde at 5% in PEG 300.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% and 10%
- 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:
- 1% and 10%
- 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:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- see 'Results and Discussion' above
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see 'Results and Discussion' above
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- see 'Results and Discussion' above
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- see 'Results and Discussion' above
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: 1st and 2nd readings
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see 'Results and Discussion' above
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
MATERIAL |
INTERVAL |
TEST GROUP Number with dermal score* =0 |
CONTROL GROUP Number with dermal score =0 |
TS 1% |
24h |
0/20 |
0/10 |
|
48h |
0/20 |
0/10 |
TS 10% |
24h |
0/20 |
0/10 |
|
48h |
0/20 |
0/10 |
Vehicle (PEG 300) |
24h |
0/20 |
0/10 |
|
48h |
0/20 |
0/10 |
*Skin reactions were graded:
0 no reaction or very slight dispersed redness. No swelling.
1 slight patchy or confluent erythema
2 moderate and confluent erythema and/or slight swelling
3 severe erythema and/or moderate to severe swelling
Sensitization incidence index (number of animals with dermal scores greater than those of the negative control group at 24h or 48h, divided by the number of animals tested) = 0.
Severity index (sum of test grades divided by the number of animals tested) = 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 and generally well reported guinea-pig skin sensitization test (Buehler Method) reported that a concentration of 50% of the test material in PEG 300 failed to induce a sensitization response in guinea pigs when subsequently challenged with 1% and 10% solutions. There were no responses to either challenge concentration at 24h or 48h.
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