Registration Dossier
Registration Dossier
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EC number: 213-926-7 | CAS number: 1067-25-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Pretest: 05 - 08 Aug 1996. Main test: 07 Oct - 06 Nov 1996
- 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:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- 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, that was performed prior to the adoption of OECD 429.
Test material
- Reference substance name:
- Trimethoxypropylsilane
- EC Number:
- 213-926-7
- EC Name:
- Trimethoxypropylsilane
- Cas Number:
- 1067-25-0
- Molecular formula:
- C6H16O3Si
- IUPAC Name:
- trimethoxy(propyl)silane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, GERMANY
- Age at study initiation: young adults
- Weight at study initiation: <500 g
- Housing: Makrolon Type IV, max 5/cage
- Diet: Ssniff G 4-diet for Guinea Pigs, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- 3 single treatments (6 h exposure), Days 0, 7 and 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- single treatment (6 h exposure), Day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pre-test: 6
Main test: 20 (test group); 10 (control) - Details on study design:
- RANGE FINDING TESTS:
Applications (6 h occluded contact) of 5, 25, 50 and 100% TS with examination at 24 and 48 h following patch removal. 100% was identified as a suitable induction concentration (causing mild irritation), while 25% was identified as the lowest non-irritant challenge concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 dermal occlusive
- Exposure period: 6 h
- Test groups: neat test substance (0.3 mL applied to a 2x2 cm patch)
- Control group: verhicle corn oil (0.3 mL applied to a 2x2 cm patch)
- Site: left flank
- Frequency of applications: application on Days 0, 7, 14
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: Day 28
- Exposure period: 6 h
- Test groups: test substance in corn oil and corn oil only
- Control group: test substance in corn oil and corn oil only
- Site: posterior right flank (test substance) and anteriour right flank (vehicle)
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h following patch removal - Challenge controls:
- The control group is actually a control.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol (MCBT)
Results and discussion
- Positive control results:
- Response rate of 30% (3/10 animals) indicates that the standard allergen is a sensitizer in the guinea pig under the conditions of this study. (See table 1.)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% MCBT
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL (AFTER 6h CHALLENGE) |
SKIN REACTIONS (NUMBER OF ANIMALS) |
NUMBER OF ANIMALS |
SENSITIZATION INCIDENCE INDEX** |
Test |
TS (25%) |
24h |
0 |
20 |
0/20=0% |
48h |
0 |
20 |
|||
Vehicle |
24h |
0 |
20 |
0/20=0% |
|
48h |
0 |
20 |
|||
Positive control (2-mercaptobenzothiazol) |
50% MCBT in vehicle |
24h |
3 |
10 |
3/10=30%* |
48h |
0 |
10 |
|||
Vehicle (Vaseline) |
24h |
0 |
5 |
0/5=0% |
|
48h |
0 |
5 |
|||
Negative (vehicle) control |
TS (25%) |
24h |
0 |
10 |
n/a |
48h |
0 |
10 |
|||
Vehicle |
24h |
0 |
10 |
n/a |
|
48h |
0 |
10 |
* The response of 30% in the positive controls confirms that the standard allergen tested is sensitizing in guinea pig under the conditions of this study.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In a guinea pig skin sensitisation study (Buehler test), conducted according to OECD 406 and to GLP (reliability score 1) trimethoxy(propyl)silane was not a skin sensitiser.
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