Chlorotrioctylstannane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

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:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO).

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted in 1973, prior to inception of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Chlorotrioctylstannane

EC Number:

219-969-8

EC Name:

Chlorotrioctylstannane

Cas Number:

2587-76-0

Molecular formula:

C24H51ClSn

IUPAC Name:

chlorotrioctylstannane

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: Kept separately
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as a control.

Amount / concentration applied:

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

Duration of treatment / exposure:

The test material was introduced into the conjunctival sac of the left eye with a syringe. After application, the eyelids were held open for a few seconds.

Observation period (in vivo):

24 hours and 2, 3, 4 and 7 days post instillation.

Number of animals or in vitro replicates:

Six rabbits (3 male/3 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water.
- Time after start of exposure: About 30 seconds after treatment.

TOOL USED TO ASSESS SCORE: hand-slit lamp

SCORING SYSTEM:

CORNEA
Opacity: degree of density (area most dense is taken for reading)
0: No ulceration or opacity
1: Scattered or diffuse areas of opacity, details of iris clearly visible
2: Easily discernible translucent areas, details of iris slightly obscured
3: Opalescent areas, no details of iris visible, size of pupil barely discernible
4: Opaque cornea, iris not discernible through the opacity

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

CONJUNCTIVAE
- Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae excluding cornea and iris)
0: Blood vessels normal
1 Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red

- Chemosis: lids and/or nictating membranes.
0: No swelling
1: Any swelling above normal (includes nictating membranes)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids about half closed to completely closed

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: Mean of 24, 48 and 72 hour observations

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Eyes rinsed

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: Mean of 24, 48 and 72 hour observations

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Eyes not rinsed

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: Mean of 24, 48 and 72 hour observations

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Eyes rinsed

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: Mean of 24, 48 and 72 hour observations

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Eyes not rinsed

Results 5

Irritation parameter:

other: combined redness, chemosis and discharge scores

Basis:

mean

Remarks:

of 3 animals

Time point:

other: Mean of 24, 48 and 72 hour observations

Score:

1.33

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Eyes rinsed. The redness, chemosis and discharge scores were reported as one combined figure; it was not possible to assign a value to each of the individual parameters.

Results 6

Irritation parameter:

other: combined redness, chemosis and discharge scores

Basis:

mean

Remarks:

of 3 animals

Time point:

other: Mean of 24, 48 and 72 hour observations

Score:

1.33

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Eyes not rinsed. The redness, chemosis and discharge scores were reported as one combined figure; it was not possible to assign a value to each of the individual parameters.

Irritant / corrosive response data:

No corneal or iridial effects were observed in any rabbit at any time point.
Day 1 after application of the test material, five out of the six rabbits (3 with rinsed eyes and 2 with not rinsed eyes) demonstrated signs of eye irritation (redness, chemosis and discharge); one score was reported for each animal for the three parameters. The maximum combined score was 5.
On Day 2, the signs of irritation in four animals were completely resolved. The remaining animal still exhibiting signs of irritation (eyes not rinsed) received a combined score of 3 for redness, chemosis and discharge. These signs were completely resolved by 72 hours post installation of the test material.

Any other information on results incl. tables

Table 1: Summary of Individual Scores

	Eyes rinsed									Eyes not rinsed
Days after Application	Rabbit 1 (F)			Rabbit 2 (F)			Rabbit 3 (F)			Rabbit 4 (M)			Rabbit 5 (M)			Rabbit 6 (M)
	Cornea	Iris	Conjunct.	Cornea	Iris	Conjunct.	Cornea	Iris	Conjunct.	Cornea	Iris	Conjunct.	Cornea	Iris	Conjunct.	Cornea	Iris	Conjunct.
1	0	0	3	0	0	5	0	0	4	0	0	5	0	0	4	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Conjunct. = The combined score for redness, chemosis and discharge.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the test material was determined not to be an eye irritant to rabbits.

Executive summary:

The potential of the test material to cause eye irritation or corrosion was investigated following the technique described in the “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics” (1959) of the US Association of Food and Drug Officials (AFDO).

The test material (0.1 mL) was administered into the left eye of 6 New Zealand White rabbits (3 male/3 female). The right eye remained untreated and served as a control. The eyes of the female rabbits were rinsed approximately 30 seconds after administration with lukewarm water.

The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.

No corneal or iridial effects were observed in any rabbit at any time point. Day 1 after application of the test material, five out of the six rabbits (3 with rinsed eyes and 2 with not rinsed eyes) demonstrated signs of eye irritation (redness, chemosis and discharge). On day 2, the signs of irritation in four animals were completely resolved. One remaining animal still exhibited signs of irritation (eyes not rinsed); these signs were completely resolved by 72 hours post installation of the test material.

Under the conditions of this study, the test material was determined not to be an eye irritant to rabbits.