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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:
3 March 1999 - 20 May 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-methoxyethoxy)vinylsilane
EC Number:
213-934-0
EC Name:
Tris(2-methoxyethoxy)vinylsilane
Cas Number:
1067-53-4
Molecular formula:
C11H24O6Si
IUPAC Name:
ethenyl-tris(2-methoxyethoxy)silane

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc., Denver PA
- Age at study initiation: young adult
- Weight at study initiation: 3507 - 3642 g
- Housing:Individual, suspended in wire mesh cages.
- Diet: PMI Nutrition International, Inc. Certified Lab Diet 5322, circa 150 g/day
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 19.4 °C
- Humidity (%): 45.6-46.8 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
semiocclusive
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): 0.5 mL

- Concentration: undiluted


Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: Cotton gauze patches, secured with a gauze binder and surgical tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Excess test material was removed from treated skin areas following exposure.
- Time after start of exposure:4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 4 days
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See results section.
Other effects:
See results section.

Any other information on results incl. tables

No deaths or body weight changes were observed. Very slight erythema was noted for one animal at the 48- and 72-hour
observations. There was no edema or other dermal irritation noted. A primary irritation index score of 0.2 was
calculated from the results, consistent with a slight skin irritation potential in the rabbit.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation toxicity study, conducted according to OECD test guideline 404 and in compliance with GLP, the test substance was found to be slightly irritating, as determined in a reliable study. The observed effects do not meet the criteria for classification as a skin irritant in the EU.