Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21/09/1995-05/03/1996
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 guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
10217-34-2
Cas Number:
10217-34-2
IUPAC Name:
10217-34-2
Constituent 2
Reference substance name:
-
EC Number:
425-050-4
EC Name:
-
IUPAC Name:
425-050-4
Constituent 3
Reference substance name:
[2-(3,4-epoxycyclohexyl)ethyl]triethoxysilane
IUPAC Name:
[2-(3,4-epoxycyclohexyl)ethyl]triethoxysilane
Details on test material:
- Name of test material (as cited in study report): Y-4036

- Physical state: clear, colourless liquid

- Storage condition of test material: original container at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc., Denver, PA
- Age at study initiation: young adult
- Weight at study initiation: 2339-2705g
- Housing: individual suspended mesh cages
- Diet: Purina Certified Rabbit Chow, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-20.1
- Humidity (%): 35.6-56.1
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10/10/1995 To: 14/10/1995

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): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
2M, 4F
Details on study design:
TEST SITE
- Area of exposure: Dorsal skin
- Type of wrap if used: Each dose was applied to an area of skin approximately 1" x 1" under a secured 2-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped with disposable paper towels moistened with deionized water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize (1965)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 30-60 minutes, 24,48, 72h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
Very slight erythema was observed on a single male rabbit at 72 hours post dose which subsided by day 4. There was no oedema or other dermal findings.
Other effects:
There were no deaths during the study. One female had a body weight loss of 129 grams (5%) from day 0 to day 3. A body weight loss of this magnitude is common in animals which have been bandaged and collared for 4 hours, and was not attributed to the test material. There were no other remarkable body weight changes during the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found not irritating to skin as determined in a guideline study, compliant with GLP.