Dibutylbis(dodecylthio)stannane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27/10/10 to 10/11/10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Conducted to recognised guideline and GLP, however, the study is a preliminary study and only one animal was used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Preliminary study where only one animal was used

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dibutylbis(dodecylthio)stannane

EC Number:

214-688-7

EC Name:

Dibutylbis(dodecylthio)stannane

Cas Number:

1185-81-5

Molecular formula:

C32H68S2Sn

IUPAC Name:

dibutylbis(dodecylsulfanyl)stannane

Details on test material:

Identity: Dabco T120 Catalyst, Batch# 817231
Date Received: 08/13/10
Storage: Room temperature and humidity
Description: Clear liquid
Sample Preparation: The test article was used as received.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc., Thompsons Station, TN
- Age at study initiation: The animal was born on 06/28/10 and exposure to the test material was on the 27/10/10 and so the animal was approximately 18 weeks old.
- Weight at study initiation: The pretest body weight was 2.9 kg.
- Housing: The animal was housed 1/cage in a suspended cage. Paper bedding was placed beneath the cage and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh PM1 Rabbit Chow (Diet #5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye served as a control

Amount / concentration applied:

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

Duration of treatment / exposure:

After instillation, the lids were held together for approximately one second to ensure adequate distribution of the test article.

Observation period (in vivo):

1, 24, 48 and 72 hours and again on day 7 & 14 postdose.

Number of animals or in vitro replicates:

1

Details on study design:

SCORING SYSTEM:
Ocular reactions were graded according to the numerical Draize technique.

(1) CORNEA:

(A) Opacity: Degree of density (area most dense taken for reading):

No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

(B) Area of cornea Involved:

One quarter (or less) but not zero 1
Greater than one-quarter, but less than one-half 2
Greater than one-half, but less than three-quarters 3
Greater than three quarters up to whole area 4

SCORE EQUALS A x B x 5 Maximum Total 80


(2) IRIS:

(A) Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof),
iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

SCORE EQUALS A x 5 Maximum Total 10


CONJUNCTIVAE:

(A) REDNESS (refers to palpebral and bulbar conjunctivae excluding cornea & iris):

Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

(B) CHEMOSIS

No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

(C) DISCHARGE

No Discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs and considerable area around the eye 3

SCORE EQUALS (A+B+C)x2 Maximum Total 20

The maximum total score Is the sum of all scores obtained for the cornea, iris and conjunctivae. Max. Total = 110.


TOOL USED TO ASSESS SCORE: Using a Mini-Maglite® flashlight equipped with a high intensity bulb, the treated eye of the rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours and again on day 7 & 14 postdose. The control eye was observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source.

ULTRAVIOLET FLUORESCEIN SCAN SCORING CODE:
0 = Negative
1 = Positive with an area 114 or less
2 = Positive with an area >114 but <112
3 = Positive with an area >112, but <314
4 = Positive with an area >314, up to entire area

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effects seen

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effects seen

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

other: 24, 48 & 72 hours

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 & 72 hours

Score:

>= 0 - <= 1

Max. score:

1

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(discharge)

Basis:

animal #1

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effects seen

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible

Results 9

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0 - 1

Max. score:

2

Reversibility:

fully reversible

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation cleared in the one eye by day 14.
The control eye appeared normal at all observation periods.

Other effects:

There were no abnormal physical signs noted during the observation period. The body weight change in the one animal was normal.

Any other information on results incl. tables

See table 1 (Illustration (picture/graph)) for scores

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not an ocular irritant.

Executive summary:

A study was conducted to determine the irritant or corrosive effects, if any, of a test article when instilled into the rabbit eye.

This study was designed to comply with the standards set forth in OECD Guidelines For Testing Chemicals, Number 405, adopted April 24, 2002.

Initially, one healthy New Zealand White rabbit (male), free from evidence of ocular irritation and corneal abnormalities, was dosed with the test material. The test material (0.1 ml) was placed into the conjunctival sac of one eye. The contralateral eye served as a control. The eye was examined pretest and scored by the Draize technique at 1, 24, 48 and 72 hours and again on day 7 & 14 postdose. The control eye was observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. At the request of the Sponsor, no additional animals were dosed and the study was terminated on day 14. Observations for toxicity and pharmacological effects were recorded at each ocular observation period and mortality observations were performed daily. Body weights were recorded pretest and at termination.

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation cleared in the one eye by day 14.

The control eye appeared normal at all observation periods.

There were no abnormal physical signs noted during the observation period. The body weight change in the one animal was normal.

The test material is not an ocular irritant.