Registration Dossier
Registration Dossier
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EC number: 220-449-8 | CAS number: 2768-02-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- not conducted in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Handbook Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics
- GLP compliance:
- no
Test material
- Reference substance name:
- Trimethoxyvinylsilane
- EC Number:
- 220-449-8
- EC Name:
- Trimethoxyvinylsilane
- Cas Number:
- 2768-02-7
- Molecular formula:
- C5H12O3Si
- IUPAC Name:
- ethenyltrimethoxysilane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No data available.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml of the test substance was applied to both the intact and abraded skin.
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: the back of the animal
- % coverage: unspecified.
- Type of wrap if used: The test areas were occluded by means of one inch gauze pads secured with adhesive tape and further occluded with a 'stockinette' sleeve covering the entire trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data, but after 24 hours the patches were removed and the resultant reactions evaluated.
SCORING SYSTEM: Draize scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no signs of erythema or edema at any time point. The Primary Irritation Index was 0.0. The test material was a non-irritant under these conditions.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
All values were zero at all recorded time points.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vivo skin irritation study, conducted according to FDA Handbook Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, but prior to GLP, the test material, trimethoxy(vinyl)silane, was concluded to be not irritating to skin.
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