Trimethoxyoctadecylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Nov - 24 Nov 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

No data for analytical purity is reported.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxyoctadecylsilane

EC Number:

221-339-2

EC Name:

Trimethoxyoctadecylsilane

Cas Number:

3069-42-9

Molecular formula:

C21H46O3Si

IUPAC Name:

trimethoxyoctadecylsilane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Si 118 (Degussa-Silan Si 118)
- Physical state: colourless liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 6 months
- Weight at study initiation: 2400 – 2700 g
- Housing: animals were caged individually in stainless-steel cages
- Diet: maintenance diet for rabbits (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contralateral 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):

7 days
Reading time points: 1, 24, 48 and 72 h and daily up to 7 days

Number of animals or in vitro replicates:

2 males and 1 female

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Cliptrix fluorescent marker

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed were fully reversed at the end of the observation period.

Any other information on results incl. tables

Table 1: Summary of eye irritation parameters

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	3	0	0	0
	24	2	0	0	0
	48	2	0	0	0
	72	0	0	0	0
	average	1.33	0	0	0
2	1	3	0	0	0
	24	2	0	0	0
	48	2	0	0	0
	72	1	0	0	0
	average	1.67	0	0	0
3	1	3	0	0	0
	24	1	0	0	0
	48	1	0	0	0
	72	1	0	0	0
	average	1	0	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 performed according to OECD 405 the substance was found to be not irritating to eyes. Treatment of 3 White Russian rabbits with 0.1 ml test substance resulted in no effects on cornea and iris in any animal at any time point. No chemosis was observed in any animal. One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed were fully reversed at the end of the observation period. Based on the results of the study the test item is considered as non-irritant.