Triethoxyoctylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05.05.1992 to 21.05.1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxyoctylsilane

EC Number:

220-941-2

EC Name:

Triethoxyoctylsilane

Cas Number:

2943-75-1

Molecular formula:

C14H32O3Si

IUPAC Name:

triethoxy(octyl)silane

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: white russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: 8-10 months
- Weight at study initiation: Males: 2.58 kg; Females: 2.39 and 2.58 kg
- Housing: Individually in stainless steel cages
- Diet: Approx. 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20.0
- Humidity (%): 50-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11.05.1992 To: 21.05.1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

No rinsing

Observation period (in vivo):

Three days (including 1, 24, 48, 72 hours)

Number of animals or in vitro replicates:

Three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

2

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

other: The eye irritation did not meet EU classification criteria.

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Table 1. There were no changes to the cornea or iris. The conjunctiva of all three animals reacted with diffuse redness (grade 2). The finding had completely disappeared 48 hours after application. Slight swelling (grade 1) occurred in all three animals only one hour after application. In addition, discharge moistened lids and hair just adjacent to lids in one animal was observed one hour after application.

Other effects:

There were no systemic toxic effects in any of the animals.

Any other information on results incl. tables

Table 1 Summary of irritation scores

Reaction	Day/hours after exposure	Scores for each animal
		Animal 1	Animal 2	Animal 3
Corneal opacity	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
Area of cornea involved	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
Iris	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
Conjunctival redness	1 h	2	2	2
	24 h	1	1	1
	48 h	0	0	0
	72 h	0	0	0
Conjunctival Chemosis	1 h	1	1	1
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
Discharge	1 h	0	0	2
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) triethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.