Trimethoxy(2,4,4-trimethylpentyl)silane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 October - 01 November 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxy(2,4,4-trimethylpentyl)silane

EC Number:

251-995-5

EC Name:

Trimethoxy(2,4,4-trimethylpentyl)silane

Cas Number:

34396-03-7

Molecular formula:

C11H26O3Si

IUPAC Name:

trimethoxy(2,4,4-trimethylpentyl)silane

Details on test material:

- Name of test material (as cited in study report): Wacker Silan I0-Trimethoxy, IO-Trimethoxy, Iso-octyltrimethoxysilan
- Molecular formula: C11H26O3Si
- Molecular weight: 234 g/mol
- Substance type: Alkoxysilane
- Physical state: colourless liquid
- Melting point: <-20 °C
- Boiling point: approx. 90 °C at 1013 hPa
- Density: 0.9kg/l at 25 °C
- Solubility in water: < 1 g/l
- Date of delivery: 24 September 1991
_storage conditions: at room temperature, protected from light in a chemicla hood
- Stability under storage conditions: Stable until 01 Feb 1992
- Lot/batch No.: 0356KE

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionell bred
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.3 kg
- Housing: in individual cages (battery housing)
- Diet: Altromin 2123 Haltungsdiät - Kaninchen (Altromin GmbH, Lage/Lippe, Germany), ad libitum; and 15 g hay daily
- Water: deionised and chlorised water, ad libitum, provided in automated drinking troughs

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 October 1991 to: 01 November 1991

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with physiol. NaCl solution at 37 °C
- Time after start of exposure: after 24 h and at every reading time point, when dicharge was observed or the eyes were determined for corneal damage using fluorescein

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia. After 48 hours the irritation had reversed.

Other effects:

None reported.

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:

The test item was tested for eye irritation according to OECD TG 405 and in compliance with GLP. One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia (grade 1). One animal fully recovered within 24 h, the other two animals fully recovered within 48 h. Based on these findings classification according to Regulation (EC) No. 1272/2008 is not warranted.