Decyltrimethoxysilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 October 2004 to 25 October 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation period ended after seven days

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

422-350-7

EC Name:

-

Cas Number:

5575-48-4

Molecular formula:

C13H30O3Si

IUPAC Name:

decyltrimethoxysilane

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Suitable licensed provider (not specified)
- Age at study initiation: 3 months
- Weight at study initiation: 2 kg
- Housing: Stainless steel cages
- Diet: Certified Rabbit Diet #5322 at 100 gm/day/animal
- Water: water (source not specified) ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65 to 75°F (equivalent to 18.33 to 23.89°C)
- Humidity (%): Monitored (variations not specified)
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): room temperature distilled water
- Time after start of exposure: 24h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

3

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

1.5

Max. score:

3

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

1.33

Max. score:

2

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Decyltrimethoxysilane meets the criteria for classification as Eye Irrit. 2; H319 in accordance with Regulation (EC) N°1272/2008.

Executive summary:

The in vivo eye irritation of Decyltrimethoxysilane was evaluated during a GLP-compliant study using a method similar to the OECD Testing Guideline 405.

Six New Zealand white rabbits received a single intraocular application of 0.1 mL of the undiluted test article in one eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment, and at four and seven days if irritation persisted.

No effects on cornea and iris were observed in any animal. Conjunctivae were observed in all animals on Day 1 with a maximum score of 3. On Day 3, conjunctivae were still observed 5/6 animals with a maximum score of 2.

Based on these results, it is concluded that Decyltrimethoxysilane meets the criteria for classification as Eye Irrit. 2; H319 in accordance with Regulation (EC) N°1272/2008.