2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane

Skin irritation / corrosion

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

Test material information

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.