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Toxicological information

Skin irritation / corrosion

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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:
1976
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

Constituent 1
Chemical structure
Reference substance name:
Trimethoxyvinylsilane
EC Number:
220-449-8
EC Name:
Trimethoxyvinylsilane
Cas Number:
2768-02-7
Molecular formula:
C5H12O3Si
IUPAC Name:
trimethoxy(vinyl)silane

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.