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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
An in vivo study was conducted because at the time the study was commissioned the available OECD test guidelines for in vitro skin irritation were not validated for silicon-containing substances.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate
EC Number:
642-902-2
Cas Number:
163802-53-7
Molecular formula:
C12H22O5Si
IUPAC Name:
3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate
Constituent 2
Reference substance name:
3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
IUPAC Name:
3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
Constituent 3
Reference substance name:
2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-
IUPAC Name:
2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 10-11 weeks
- Weight at study initiation: > 2 kg
- Housing: ABS plastic rabbit cages.
- Diet: autoclaved hay and Altromin 2123 maintenance rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
A dose of 0.5 mL of the test item was applied to each test site.
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
All animals were observed for 72 hours after patch removal.
Number of animals:
3 (male)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: non-irritating tape, semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Score 0 in all animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Score 0 in all animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Score 0 in all animals
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Score 0 in all animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Score 0 in all animals
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Score 0 in all animals
Irritant / corrosive response data:
No irritation/ corrosion was observed during the study period.
Other effects:
No changes were observed during the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation/ corrosion toxicity study for 2,4-hexadienoic acid, 3-(trimethoxysilyl)propyl ester concludes that the test material is not irritating or corrosive to the skin.
Executive summary:

The study was performed in order to assess the potential of the test item to induce acute dermal irritation/corrosion when applied directly to the skin of rabbits. Animals were exposed to 0.5 mL of the test item by application onto clipped skin for four hours using a semi-occlusive dressing. The test sites were assessed one, 24, 48, and 72 hours following patch removal. Three male New Zealand White rabbits (Crl: KBL (NZW)) were selected for testing. An initial test was conducted with one of the animals to determine if the test item produced significant irritation. The test item was applied to the two remaining animals selected for testing when the initial test showed that the test item was neither corrosive nor a severe irritant. During the initial test, no irritant or corrosive effects were observed on the intact skin of animal no. 1 immediately after the patch removal. However, very slight erythema was observed 24 and 48 hours after patch removal for this animal. No irritation was observed at any of the scoring intervals for the remaining two animals selected for testing following patch removal. The irritant effects observed were resolved at the end of the 72 hour observation period. No mortalities, significant body weight changes or significant clinical signs of toxicity were observed during the 72 hour observation period. The study was terminated at the end of the 72 hour observation period. As the Total Mean Value for erythema was 0.22 (Maximum Value = 4) and 0.0 for oedema (Maximum Value = 4), under the conditions of this study, the single dermal application of the test item is not expected to produce significant dermal irritation or corrosion.