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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

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:
[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
EC Number:
220-780-8
EC Name:
[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
Cas Number:
2897-60-1
Molecular formula:
C11H24O4Si
IUPAC Name:
diethoxy(methyl){3-[(oxiran-2-yl)methoxy]propyl}silane
Constituent 2
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
IUPAC Name:
[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: young adult
- Weight at study initiation: 3475-3602g
- Housing: Individually suspended wire mesh cages
- Diet: ca. 150 g of a commercial feed was offered per day
- Water: ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66.1-66.9
- Humidity (%): 57.7-64.1
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure:backs and flanks
- Type of wrap if used: gauze, gauze binder, secured with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site of administration was wiped with a disposable paper towel moistened with deionized water
- Time after start of exposure: 4h

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:
0.33
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:
0.33
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
Irritant / corrosive response data:
The test article induced very slight erythema on all animals, which subsided within 48 hours. No edema or other dermal findings were noted during the test period.
Other effects:
There were no deaths during the study, nor remarkable body weight changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating to rabbit skin in a study conducted according to an appropriate guideline and in compliance with GLP. The test article induced very slight erythema on all animals, which subsided wihin 48 hours. No edema or other dermal findings were noted during the test period.