Ethoxytrimethylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 - 17 May 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted July 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Ethoxytrimethylsilane

EC Number:

217-370-6

EC Name:

Ethoxytrimethylsilane

Cas Number:

1825-62-3

Molecular formula:

C5H14OSi

IUPAC Name:

ethoxytrimethylsilane

Details on test material:

- Name of test material (as cited in study report): Silan M3-Ethoxy
- Physical state: colourless liquid
- Storage condition of test material: cool, dark, dry

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4.5 and 5.5 months
- Weight at study initiation: 2.1-2.3 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. During exposure the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 June 2002 To: 22 Aug 2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin site served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: Test site covered with a gauze patch, which was held in contact to the skin by means of a semi-occlusive dressing (non-irritating tape).

REMOVAL OF TEST SUBSTANCE
No residual test substance was removed.

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:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

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: not applicable

Irritant / corrosive response data:

Erythema grade 1 (3/3 animals) were observed 60 min and 24 h after patch removal. Erythema reactions were fully reversible within 48 h. No oedema reactions were observed in any animal. No other findings were observed.

Any other information on results incl. tables

Table 1: Individual results of the skin irritation test.

Rabbit No.	1		2		3
Observation time	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	1	0	1	0	1	0
24 h	1	0	1	0	1	0
48 h	0	0	0	0	0	0
72 h	0	0	0	0	0	0
Mean value	0.33	0	0.33	0	0.33	0
24 + 48 + 72 h

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

In a skin irritation study with ethoxy(trimethyl)silane (according to OECD 404, GLP compliant) the substance was found to be not irritating. Treatment of 3 male Himalayan rabbits under semi-occlusive conditions with 0.5 mL undiluted test substance only provoked slight erythema reactions being fully reversible within 48 h. Mean erythema and oedema scores over 24, 48, and 72 h were 0.33 and 0, respectively.