Ethoxytrimethylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 - 19 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Feb 1987

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 / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 11 months
- Weight at study initiation: 2.3-2.6 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. For 8 h following the test substance application the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
- 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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single application without rinsing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

The test substance was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours after the administration. 24 h after administration the eyes were treated additionally with fluorescein and examined.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 4

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 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No effects on cornea and iris were observed in any animal. After 1 h redness (grade 1) was observed in all 3/3 animals and was fully reversible within 48 h. After 1 h chemosis grade 1 (1/3) and grade 2 (2/3) was observed and was fully reversible within 48 h. No other findings were reported.

Other effects:

No systemic intolerance reactions were observed.

Any other information on results incl. tables

Table 1: Individual results of the eye irritation study in rabbits.

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	1	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
2	1	1	2	0	0
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.33	0	0
3	1	1	2	0	0
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.33	0	0

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 an eye irritation study with ethoxy(trimethyl)silane (according to OECD 405, GLP compliant) the substance was found to be not irritating. Treatment of 3 male Himalayan rabbits with 0.1 mL undiluted test substance only provoked slight redness and chemosis being fully reversible within 48 h. No effects on iris and cornea were observed. Mean conjunctivae and chemosis scores over 24, 48, and 72 h were 0, 0.33, 0.33 and 0, 0.33, 0.33, respectively, for the individual animals.