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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(observation period was up to 7 d instead of 21 d; eyes were not examined at 1 h after test substance application; clinical observations for systemic effects was not done)
Qualifier:
according to guideline
Guideline:
other: 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).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)
EC Number:
941-792-6
Cas Number:
not given
Molecular formula:
C46H32Cl2CoN8O14S2.3Na
IUPAC Name:
Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): FAT 20049/A
- Substance type: Dye
- Analytical purity: Approx. 89%
- Lot/batch No.: EN 14086
Specific details on test material used for the study:
Test Item: FAT 20049/A
Purity: approx. 89 %

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: The rabbits were caged singly in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food (ad libitum)
- Water: ad libitum
- Only rabbits showing normal ophthalmic findings were included in the test.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye served as control
Amount / concentration applied:
- Amount applied: 100 mg
- Concentration: Undiluted
Duration of treatment / exposure:
The treated eyes of three (out of six) rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
Observation period (in vivo):
7 d

Number of animals or in vitro replicates:
6 (i.e., 3 males and 3 females)
Details on study design:
- The test substance in an amount of 100 mg was inserted into the conjunctival sac of the left eye of the rabbits and the eyelids were held open for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approx. 30 seconds after treatment the treated eye was flushed with 10 mL of lukewarm water.

- The eye irritation was evaluated with a slit-lamp on 1, 2, 3, 4 and 7 d (i.e., 24, 48, 72, 96 and 168 h).

SCORING SYSTEM:
- The ocular reactions were scored by the method described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Fully reversible within 4 d when rinsed after 30 seconds
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Fully reversible within 7 d when rinsed after 30 seconds
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Fully reversible within 7 d when rinsed after 30 seconds
Irritant / corrosive response data:
- The irritation index was found to be 15.3 for the cornea, 0 for the iris and 9 for the conjunctivae.
- The observed cornea and conjunctivae reactions in the unwashed eyes were not reversible within the observation period of 7 d.
Other effects:
none

Any other information on results incl. tables

Results of the eye irritation:

Eyes washed after application of test substance:

Days

after

application

Rabbit 1 (F)

Rabbit 2 (F)

Rabbit 3 (F)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

0

0

8

15

0

10

10

0

12

2

0

0

6

5

0

6

10

0

8

3

0

0

6

0

0

0

5

0

6

4

0

0

0

0

0

0

0

0

6

7

0

0

0

0

0

0

0

0

0

 

Unwashed eyes after application of test substance:

 

Days

after

application

Rabbit 4 (M)

Rabbit 5 (M)

Rabbit 6 (M)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

30

0

16

20

0

16

20

0

16

2

30

0

14

30

0

14

20

0

14

3

40

0

14

30

0

12

30

0

14

4

40

0

12

30

0

12

30

0

12

7

40

0

12

5

0

12

20

0

12

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test substance was considered to be irritating to the eyes of rabbits.

Executive summary:

An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance (at ca. 89 % purity) in rabbits according to the procedure 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) which is similar to the OECD Guideline 405 but with few deviations.

 

100 mg of the test substance was placed into the conjunctival sac of the left eye of six rabbits (i.e. 3 male and 3 females). The right eye remained untreated and was used as control. In three rabbits, washing was done with 10 mL of lukewarm water after 30 seconds of test substance instillation. Assessment of ocular damage/irritation was made with a slit-lamp at 24, 48, 72, 96 and 168 h following treatment. The irritation index was calculated to be 15.3, 0 and 9 for the cornea, iris and conjunctivae, respectively. The mean scores for corneal opacity, iris, conjunctival redness and chemosis were considered to be 1.9, 0, 1.7 and 2.1. The score obtained for corneal opacity thus fulfils the criteria for classification as eye irritant category 2 as specified by the Regulation (EC) No. 1272/2008. Thus, the test substance was considered irritating to the eyes of rabbits.