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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:
1995/01/06 - 1995/03/09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dow Corning 1-6376 Alkoxysilane

- Substance type: Alkoxy-Si

- Physical state: Clear liquid

- Storage condition of test material: room temperature

Test animals

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

- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan

- Age at study initiation: ca. 3.5 months

- Weight at study initiation: 2147-2405g

- Housing: Individual hanging stainless steel wire mesh cages.

- Diet: 125g/day of Certified Rabbit Chow (#5322, Purina Mills, Inc. St. Louis, Missouri)

- Water: ad libitum

- Acclimation period: 11


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-68 (19.4-20 °C)

- Humidity (%): 54% (single reading taken)

- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 30/12/1994 To: 16/01/1995

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): 0.5ml

- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3F
Details on study design:
TEST SITE

- Area of exposure: dorsal skin


- Type of wrap if used: The test material was applied under a one inch square gauze patch secured with strips of tape. The test site was then wrapped with 8 ply gauze bandaging and overwrapped with tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The bandaging was removed and the test sites wiped with disposable towelling moistened with water to remove any residual material.

- 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:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
All scores at all time points (30 minute, 1, 24, 48 and 72 hours) were zero for erythema and eschar and edema.
Other effects:
No signs of ill health were observed during the study. A single semi-occlusive contact of 0.5ml of Dow Corning 1-6376 Alkoxysilane with the intact skin of 3 female albino rabbits for four hours produced no irritation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found to not be irritating to skin as determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.