Triethoxy(phenyl)silane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24-03-1980 to 27-03-1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The restrictions was feeding conditions and analytical purity of the test substance was not provided in the study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

feeding condition and analytical purity was not stated in the study report.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substances Act as stated in the Code of Federal Regulations, 16 CFR 1500.42.

Deviations:

yes

Remarks:

feeding condition and analytical purity was not stated in the study report.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxyphenylsilane

EC Number:

221-066-9

EC Name:

Trimethoxyphenylsilane

Cas Number:

2996-92-1

Molecular formula:

C9H14O3Si

IUPAC Name:

Trimethoxy(phenyl)silane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Phenyltrimethoxy silane
- Substance type: Alkoxysilane
- Physical state: Clear liquid
- Storage condition of test material: At room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Not stated.
- Weight at study initiation: Not stated.
- Housing: Individually in elevated metal cages.
- Diet : Commerical rabbit ration (Purina Lab Rabbit Chow©).
- Water : Water (via automated watering system) were available ad libitum.
- Acclimation period: Approximately for one-week period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated.
- Humidity (%): Not stated.
- Air changes (per hr):Not stated.
- Photoperiod (hrs dark / hrs light):Not stated.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Abraded and shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

24 h

Observation period:

Reading time points: 24 and 48 h. No further observation required.

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: Trunk. The skin at one site was abraded with minor incision and the skin of the other site remained intact.
- % coverage: Not stated
- Type of wrap if used: One-half-inch square gauze patch (two layers thick) which was secured with a non-absorbent binder composed of polyethylene tubing and Coban elastic bandage (Minnesota Minning and Manufacturing Company, St. Paul, Minnoesota).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure sites were wiped with gauze.
.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable.

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable.

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema, oedema, ot other dermal effects were noted at any exposure site. The primary irritation score was zero.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In a reliable skin irritation study conducted according to OECD TG 404 but not in compliance with GLP, showed the test material was not a skin irritant.