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EC number: 246-467-6 | CAS number: 24801-88-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 8 Jan 1997 to 10 Feb 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (though not explicitly stated)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An 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:
- 3-aminopropyltriethoxysilane
- EC Number:
- 213-048-4
- EC Name:
- 3-aminopropyltriethoxysilane
- Cas Number:
- 919-30-2
- Molecular formula:
- C9H23NO3Si
- IUPAC Name:
- 3-triethoxysilylpropan-1-amine
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: Elm Hill Breeding Labs (no further information)
- Age at study initiation: 4 wk
- Weight at study initiation: 293-400 g
- Housing: 1/wire mesh cage
- Diet: standard dient ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 (the guideline recommends 20 +/- 3)
- Humidity (%): 40-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1997-01-08 To: 1997-02-10
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- induction: 20%
challenge: 5%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- induction: 20%
challenge: 5%
- No. of animals per dose:
- test group: 10/sex
negative control: 5/sex
positive control: 3/sex - Details on study design:
- RANGE FINDING TESTS:
1st: 40, 60, 80 and 100% (vehicle peanut oil), 4/concentration
2nd: 5, 10, 20 and 30% (vehicle peanut oil), 4/concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 10 males, 10 females
- Control groups: vehicle: 5 males, 5 females; positive: 3 males, 3 females
- Frequency of applications: 7-days between applications
- Concentrations: test groups 20% TS in peanut oil; positive control 0.3% DNCB in 80% ethanol
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenge exposure 14 days following last induction
- Exposure period: 6 h
- Test groups: as above
- Control groups: as above
- Site: test group TS 5% left flank; vehicle control group TS 5% left flank, vehicle right flank; positive control group DNCB 0.02% left flank, 0.2% right flank
- Concentrations: test group 5% TS in peanut oil; vehicle control 5% TS in peanut oil; positive control 0.02 and 0.2% DNCB in acetone
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- vehicle control group: 5/sex
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- See table 1. The sensitization incidence index of 100% from tests with the know n sensitizer DNCB at 0.2% confirms the validity of the test method.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- slight or moderate erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2 % DNCB
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2 % DNCB
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.02 % DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.02 % DNCB
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Peanut oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Peanut oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL |
DERMAL SCORES* |
SENSITIZATION INCIDENCE INDEX** |
SEVERITY INDEX*** |
||||
0 |
± |
1 |
2 |
3 |
|||||
Test |
TS 5% |
24h |
14/20 |
3/20 |
3/20 |
0/20 |
0/20 |
3/20 |
0.2 |
48h |
4/20 |
9/20 |
3/20 |
4/20 |
0/20 |
7/20 |
0.8 |
||
Positive control |
DNCB 0.2% |
24h |
0/6 |
0/6 |
1/6 |
3/6 |
2/6 |
6/6 |
2.2 |
48h |
0/6 |
0/6 |
1/6 |
3/6 |
2/6 |
6/6 |
2.2 |
||
DNCB 0.02% |
24h |
2/6 |
4/6 |
0/6 |
0/0 |
0/0 |
0/6 |
0.3 |
|
48h |
0/6 |
5/6 |
1/6 |
0/0 |
0/0 |
1/6 |
0.6 |
||
Vehicle control |
TS 5% |
24h |
9/10 |
1/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0.1 |
48h |
7/10 |
2/10 |
1/10 |
0/10 |
0/10 |
1/10 |
0.2 |
||
Peanut oil |
24h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
|
48h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
||
*Skin reactions were graded:
0 no reaction or very slight dispersed redness. No swelling.
± slight patchy erythema (equates to a score of 0.5)
1 slight confluent or moderately patchy erythema
2 moderate erythema
3 severe erythema with or without oedema
** 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. Grades of 1 or greater are considered indicative of sensitization in the positive control group
*** Severity index: the sum of test grades divided by the number of animals tested (given for 24h and 48h observations separately)
(From SIAR, 2003)
There were no signs of systemic toxicity during the study. All animals gained weight during the study and there was no significant test -article related differences in vehicle and test group mean body weight.
No positive responses were observed in the peanut oil control animals at either the vehicle or test article sites at the 24-hour grading. In the peanut oil control animals at the 48-hour grading one animal exhibited a positive response at the test article site, a grade of one (1). Of the twenty animals induced with the test article at 20% and challenged at 5%, three animals were observed with a positive response of one (1) at the 24-hour grading, and three exhibited a positive response of one (1) and four exhibited a positive response of two (2) at the 48 hour grading. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at challenge, indicating a reliable and valid test.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- A well conducted, well-documented guinea-pig skin sensitization test (Buehler method) reported that a 20% concentration of the test material in peanut oil induced a sensitization response (in 35%) when challenged with a 5% solution. Appropriate concurrent negative and positive compliance controls were included.
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