Trichlorooctylstannane

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:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Method: other: Procedure adopted was described in US Association of Food and Drug Officials (AFDO)'s "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics."

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trichlorooctylstannane

EC Number:

221-435-4

EC Name:

Trichlorooctylstannane

Cas Number:

3091-25-6

Molecular formula:

C8H17Cl3Sn

IUPAC Name:

trichlorooctylstannane

Details on test material:

Monooctyltin Trichloride [CAS No. 3091-25-6]

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The substance was tested in 6 rabbits (3 males and 3 females). Animals were kept separately in V2A wire cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye in each rabbit used as control

Amount / concentration applied:

Undiluted test material used for testing.
Amount applied: 0.1 mL

Duration of treatment / exposure:

The test material was put in the left eye with a syringe for 30 seconds. The treated eyes of 3 rabbits were rinsed with 10 mL lukewarm water. The other 3 rabbits did not undergo rinsing.

Observation period (in vivo):

Reactions were observed with a slit lamp after 24 hours and after 2, 3, 4 and 7 days.

Number of animals or in vitro replicates:

6 rabbits (3 males, 3 females)

Details on study design:

Amounts of 0.1 ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe. After application, the eyelids were held open for a few seconds. The right eye served as control. The treated eyes of 3 rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. Reactions were appraised with a slit lamp after 24 hours and then after 2, 3, 4 and 7 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 1, 2, 3, 4 and 7 days

Score:

80

Max. score:

80

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1-7 days

Score:

10

Max. score:

10

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1-7 days

Score:

16.8

Max. score:

20

Irritant / corrosive response data:

PEII (cornea) = 80
PEII (iris) = 10
PEII (conjunctivae) = 16.8

Other effects:

no information

Any other information on results incl. tables

Table 1: Eyes rinsed

Days after Application	Rabbit 1 F			Rabbit 2 F			Rabbit 3 F
	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae
1	80	10	16	80	10	18	80	10	16
2	80	10	16	80	10	18	80	10	18
3	80	10	16	80	10	18	80	10	18
4	80	10	16	80	10	18	80	10	18
5	80	10	16	80	10	18	80	10	18
6	80	10	16	80	10	18	80	10	18
7	80	10	16	80	10	18	80	10	18

 

Table 2: Eyes not rinsed

Days after Application	Rabbit 3 M			Rabbit 5 M			Rabbit 6 M
	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae
1	80	10	14	80	10	16	80	10	18
2	80	10	14	80	10	16	80	10	18
3	80	10	16	80	10	16	80	10	18
4	80	10	16	80	10	16	80	10	18
5	80	10	16	80	10	16	80	10	18
6	80	10	16	80	10	16	80	10	18
7	80	10	16	80	10	16	80	10	18

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

TK-11386 (n-octyltin trichloride) had a primary irritation index of 80 for the cornea, 10 for the iris, and 16.8 for the conjunctivae. Therefore, it was considered a severe irritant to the rabbit eye.

Executive summary:

The eye irritation potential of octyltin trichloride was investigated in 6 New Zealand white rabbits. Amounts of 0.1 ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe. After application, the eyelids were held open for a few seconds. The right eye served as control. The treated eyes of 3 rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. Reactions were appraised with a slit lamp after 24 hours and then after 2, 3, 4 and 7 days. The cornea was scored on the basis of degree of opacity, and area involved. The iris was scored for the presence of folds, congestion, swelling, circumcorneal injection, reaction to light, hemorrhage and gross destruction. The conjunctivae were scored for redness, chemosis, and discharge. The maximum scores for the cornea, iris, and conjunctivae were 80, 10, and 20, respectively. TK-11386 (n-octyltin trichloride) had a primary irritation index of 80 for the cornea, 10 for the iris, and 16.8 for the conjunctivae. Therefore, it was considered a severe irritant to the rabbit eye.

These values corresponds to the highest values according to the scoring system. The mean scores at 24, 48 and 72 hours are 4 and 2 and 3 for the cornea and iris respectively according to the scoring system, these value are greater than the values stated in the DSD (67/548/EEC) and CLP (1272/2008) regulations, and therefore the test substance will be classified accordingly.