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Toxicological information

Eye irritation

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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:
according to
Guideline:
other: Hadardous Substances Regulations under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
yes
Remarks:
slight modifications
GLP compliance:
no
Remarks:
Study Pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises maintained under a semi-barrier system.
- Age at study initiation: 2 - 4 months
- Weight at study initiation: Average male = 2.95 kg. Average female = 3.80 kg.
- Housing: Caged singly in an experimental room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): available at all times
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 ºC
- Humidity (%): 50 - 70 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 15 hours light daily from 08:00 - 23:00

Test system

Vehicle:
not specified
Controls:
other: Right eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 80 mg test compound


VEHICLE: NDA
Duration of treatment / exposure:
Test compound injected into left conjunctiva and then the eye was held shut for 1 second. Test compound was left on the eye for 30 seconds before swashing.
Observation period (in vivo):
Rabbits were examined after 1, 6, 24, 48 and 72 hours.
Number of animals or in vitro replicates:
3 male, 3 female.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was flushed with 30 ml of warm water.
- Time after start of exposure: 30 seconds


SCORING SYSTEM:

0: Non irritant
1 - 10: Minimally irritating
11 - 25: Slightly irritating
26 - 55: Moderately irritating
57 - 84: Markedly irritating
> 84: Extremely Irritating


TOOL USED TO ASSESS SCORE: NDA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 day
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 2 days
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 3 days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 day, 2 days and 3 days
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 day
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 2 days
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 3 days
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 day
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 2 days
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 3 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
Compound was visible in the eyes up to 24 hours after application, although washing tended to remove some of it.

The eye irritation was generally of a mild nature. A small area of superficial ulceration was seen in one of the rabbits at 24 hours, but this had resolved by 48 hours.
Other effects:
NDA

Any other information on results incl. tables

Table 1: Raw Eye Irritation data for rabbits 11 - 16

1 hour

6 hours

1 day

2 days

3 days

Rabbit Number

11

13

15

12

14

16

11

13

15

12

14

16

11

13

15

12

14

16

11

13

15

12

14

16

11

13

15

12

14

16

I. Cornea

    A Opacity

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

    B Area Involved

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

a = A x B x 5 (max. 80)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

0

0

0

0

II. Iris

b = Score x 5 (max. 10)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

III. Conjunctivae

     A Redness

1

1

1

1

1

1

2

2

1

1

2

2

2

2

1

2

1

2

1

0

0

1

1

1

0

0

0

0

0

0

     B Chemosis

1

1

0

1

1

1

1

3

1

1

1

3

1

1

1

1

1

2

0

0

0

0

0

0

0

0

0

0

0

0

     C Discharge

1

1

0

0

0

0

2

3

2

2

2

3

1

1

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

c = (A + B + C) x 2 (max. 20)

6

6

2

4

4

4

10

16

8

8

10

16

8

8

4

6

4

10

2

0

0

2

2

2

0

0

0

0

0

0

Total = a + b+ c (max. 110)

6

6

2

4

4

4

10

16

8

8

10

16

8

8

4

6

4

15

2

0

0

2

2

2

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Compound TK 11339 is slightly irritating to the eyes of New Zealand White rats when tested according to the method used.
Executive summary:

In a primary eye irritation study, 34/73/5.L, 80 mg of Compound TK 11339 (dioctyltin dichloride) was instilled into the conjunctival sac of the left eye of male and female New Zealand White rabbits and left for 30 seconds before washing. Animals then were observed for 72 hours. Total eye irritation out of 110 was determined.

 

Compound TK 11339 is slightly irritating to the eyes of New Zealand White rabbits when tested according to the method used.

According to the EU classification system the test material will not be considered irritating to the eye.