2,11-Dioxa-3,10-disiladodecane, 3,3,10,10-tetramethoxy-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-04-14 to 2009-04-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

87135-01-1

Molecular formula:

C12H30O6Si2

Constituent 2

Reference substance name:

3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane

EC Number:

617-969-6

Cas Number:

87135-01-1

Molecular formula:

(CH3O)3Si(CH2)6Si(OCH3)3 C12 H30 O6 Si2

IUPAC Name:

3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no details
- Age at study initiation: at least 6 months
- Weight at study initiation: 3070-3080 g
- Housing: 1/cage with suspended metal slats
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2-21.7
- Humidity (%): 43-50
- Air changes (per hr): 13.1
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: 2009-04-14 To: 2009-04-17

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml
Approximately 0.1 ml of test article was placed in the lower conjunctival sac of the right eye of each of three animals. The eyelids were held gently together for about one second. The other eye, which remained untreated, served as the control.

Duration of treatment / exposure:

single administration, observations from 1 h

Observation period (in vivo):

1 h, 24 h, 48 h, 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed

SCORING SYSTEM: As specified in OECD 405

TOOL USED TO ASSESS SCORE: The eyes were examined with a penlight. All treated eyes were further examined subsequent to the day of dosing by application of fluorescein dye. One drop of fluorescein dye was dropped directly onto the cornea, and excess reagent removed by flushing with physiological saline.

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:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

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

Irritant / corrosive response data:

Redness and chemosis were noted in one animal, and redness only was noted in another animal at 1 h. There were no observations indicating irritation or corrosion at 24 h, 48 h or 72 h.

The test article is not considered to be irritant or corrosive to the eyes of rabbits.

Other effects:

No remarkable body weight changes were recorded during the experimental phase of the study.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal: mean 24, 48 and 72h scores

Animal	Cornea	Cornea area affected	Iris	Conjunctival redness	Conjunctival chemosis
	Max. score: 4		Max. score: 2	Max. score: 3	Max. score: 4
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0

Right eye treated, left eye used as control.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study, conducted according to OECD 405 and GLP, found no indication of irritation to rabbit eyes 24, 48 and 72 hours following treatment. The test material would be considered not irritating or corrosive based on EU criteria.