Registration Dossier
Registration Dossier
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EC number: 240-816-6 | CAS number: 16753-62-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. Read-across is considered to be scientifically valid and reliability 2.
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
- IUPAC Name:
- trimethoxy(vinyl)silane
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:
- other: none
- 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
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- 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:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A primary irritation index value of zero was determined in a reliable skin irritation study conducted according to generally accepted scientific principles.
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