Reaction mass of 1,1,1,5,5,5-hexamethyl-3-phenyl-3-((trimethylsilyl)oxy)trisiloxane and 1,1,1,7,7,7-hexamethyl-3,5-diphenyl-3,5-bis[(trimethylsilyl)oxy]tetrasiloxane and 1,1,1,9,9,9-hexamethyl-3,5,7-triphenyl-3,5,7-tris((trimethylsilyl)oxy)pentasiloxane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 August 1995 to 30 September 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

temperature slightly higher than recommended (23-24 °C, temperature of 17-23 °C recommended)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbit Ranch
- Age at study initiation: ~ 4.5 months
- Weight at study initiation: 3.21 to 3.46 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): approximately 150 g daily
- Water (e.g. ad libitum): reverse osmosis-purified water ad libitum
- Acclimation period: ~ 9 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 24
- Humidity (%): 41 to 55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 June 1995 To: 1 September 1995

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eyes of each rabbit served as untreated control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

up to 72 hours after administration (observed at 1, 24, 48 and 72 hours)

Number of animals or in vitro replicates:

Three females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, rinsed with lukewarm water
- Time after start of exposure: 24 h

SCORING SYSTEM: according to the criteria of the Organisation for Economic Co-operation and Development, and Draize (see "Any other information on materials and methods incl. tables"

TOOL USED TO ASSESS SCORE: slit pen light. Fluorescein and ultraviolet light used to aid in the examination for corneal lesions after the 1-hour scoring (i.e. for the 24, 48 and 72-hour readings) and/or as long as corneal opacity persisted in individual rabbits.

Results and discussion

In vivo

Results

Results 1

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 2

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 3

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 4

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 5

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 6

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 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Remarks on result:

no indication of irritation

Results 10

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 11

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 12

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:

There was no irritation to the cornea or iris seen over the course of the experiment. At the 1-hour reading, conjunctival redness was observed in all animals (grade 2 in two, grade 1 in one), as was grade 1 chemosis. At the 24-hour reading, two animals exhibited grade 1 redness. There were no other irritant effects observed over the course of the study.

Other effects:

There were no deaths throughout the study.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae erythema	Conjunctivae chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/2/2	1/1/1
24 h	0/0/0	0/0/0	1/1/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	0/0/0	0/0/0
Reversibility*	n/a	n/a	c	c
Average time (unit) for reversion	n/a	n/a	~ 48 h	24 h

 *Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the tes material was concluded to be not irritating to the eyes of three female rabbits when applied for 24 hours.

Executive summary:

In a GLP-compliant study performed in accordance with OECD Test Guideline 405, the test material was tested for its potential to irritate the eyes of rabbits.

 

0.1 ml of the test material was applied to the right eyes of three female rabbits for 24 hours, with the left eyes of each animal serving as an untreated control. Animals were observed at 1, 24, 48 and 72 hours after test substance administration using a slit pen light. Fluorescein and UV light were used to aid in the examination of corneal lesions after the 1-hour scoring and/or as long as corneal opacity persisted in individual rabbits.

 

Following treatment, no adverse effects were seen on the cornea or iris. Conjunctival redness and slight swelling was seen in all animals at the 1-hour reading, with redness persisting in two animals at the 24-hour reading. There were no other significant effects seen over the course of the study, and no mortality was observed.

 

An overall irritation score of 5.3 was calculated according to the Draize system of scoring (maximum possible Draize score = 110). Under the conditions of this study, the test material was not considered to be an eye irritant in rabbits.