Dimethoxymethylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Feb - 16 Feb 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik

Test material

Test material information

Constituent 1

Reference substance name:

Diethoxy(methyl)silane

EC Number:

217-982-3

EC Name:

Diethoxy(methyl)silane

Cas Number:

2031-62-1

Molecular formula:

C5H14O2Si

IUPAC Name:

Diethoxy(methyl)silane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Diethoxymethylsilane
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, protect from light and humidity
- Purity test date: 09 January 2007
- Expiration date of the lot/batch: 12 January 2008

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 3800 - 4500 g
- Housing: Animals were caged in plastic rabbit cages (4200 cm² floor)
- Diet: Altromin 2123 maintenance diet for rabbits, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: adequate period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

3 days
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on one site of the dorsal area
- Type of wrap if used: The treated skin was covered with a gauze patch, which was held in place with non-irritating tape. The patch was fixed with a semi-occlusive dressing.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Based on the results of the study the test item is non-irritant.

Other effects:

There were no remarkable body weight changes during the contact and observation period.

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 the reliable skin irritation study performed according to OECD TG 404 and in compliance with GLP, the mean values for erythema and edema in rabbits were 0.0 and 0.0, respectively. Therefore, the test substance does not need to be classified for skin irritation according to Regulation (EC) No 1272/2008.