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Diss Factsheets

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:
1995-09-26 to 1995-10-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloropropyl)triethoxysilane
EC Number:
225-805-6
EC Name:
(3-chloropropyl)triethoxysilane
Cas Number:
5089-70-3
Molecular formula:
C9H21ClO3Si
IUPAC Name:
(3-chloropropyl)triethoxysilane
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: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: Young adult, age not specified
- Weight at study initiation: 2313 to 2463 g
- Housing: Individual suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow, ad libitum
- Water municipal water, ad libitum
- Acclimation period: minimum 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 67.5 - 68.6°F (19.4 - 20°C)
- Humidity: 38.4-45.8 %
- Air changes (per hr): not specified
- Photoperiod: 12 hours dark/ 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
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 h
Observation period:
until no abnormal observations at 11 days
Number of animals:
6 (2 males and 4 females)
Details on study design:
TEST SITE
- Area of exposure: 1x1 dorsal skin removed from hair
- % coverage: one inch square
- Type of wrap if used: 2-ply gauze path overwrapped with a gauze binder and se cured with Dermiform tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: at the end of 4 hours

OBSERVATION TIME POINTS
The animals were observed for mortality twice daily (morning and afternoon) for the duration of the study. The applications sites were observed for erythema, oedema, and other dermal findings approximately 30-60 minutes and 24,48 and 72 hours after patch removal and through day 11 if irritation persisted.
Body weights were obtained and recorded on study day 0 (initiation) and at each animal's termination from the study.
Upon termination from the study, the rabbits were euthanized by intravenous injection of sodium pentobarbital solution and discarded.

SCORING SYSTEM:
- Method of calculation: method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0.4
Max. score:
8
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
19703
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
probability of weak irritation
Remarks:
very slight erythema
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
19707
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
probability of weak irritation
Remarks:
very slight erythema
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
19722
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
Remarks:
19726
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
probability of weak irritation
Remarks:
very slight erythema
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
19731
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
19732
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
Remarks:
19703
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
Remarks:
19707
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
Remarks:
19722
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
Remarks:
19726
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
19731
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
19732
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test material induced very slight erythema (grade 1) in three of six animals at 24, 48 or 72 hours, and desquamation in all animals from 72 hours. There was no oedema or other dermal findings. All irritation was reversible; erythema and desquamation were no longer evident at day 6 and day 11, respectively. The Primary Irritation Index (mean at 1, 24, 48 and 72 h) was calculated to be 0.4. The test material was described as slightly irritating.
Other effects:
There were no deaths or remarkable body weight changes during the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study, conducted according to EPA OPP81-5 Test Guideline (similar to OECD Test Guideline 404) and in compliance with GLP, (3-chloropropyl)triethoxysilane did not cause significant irritation and was not corrosive to the rabbit skin.