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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

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).
GLP compliance:
no
Remarks:
pre GLP

Test material

Constituent 1
Reference substance name:
similar substance 01
IUPAC Name:
similar substance 01

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: russian breed.
- Weight at study initiation: 2.1 to 2.9 kg.
- Acclimation period: at least 8 days.
- Housing: animals were kept separately in metal cages (overall dimensions 47x32x34 cm).
- Diet: standard diet of Nafag, ad libitum.
- Water: drinking water, ad libitum.
- Health check: only rabbits showing normal ophtalamic findings were included in the test.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g


Duration of treatment / exposure:
1 minute in three animals (eyes of the remaining 3 animals were not rinsed).
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
APPLICATION
The test substance was introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control.

REMOVAL OF TEST SUBSTANCE
The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.

TOOL USED TO ASSESS SCORE: hand-slit lamp.

SCORING SYSTEM
The reactions were appraised after 1 and 6 hours; 1, 2, 3, 6 and 8 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

CORNEA
A Opacity and degree of density (most dense area scored) .
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4

B Area of cornea involved
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
A x B x 5; Maximum possible score = 80

IRITIS
A Values
Normal: 0
Folds above normal, congestion, swelling, circumcornea 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, haemorrhage, gross destruction (any or all of these): 2
A x 5; Maximum possible score = 10

CONJUNCTIVAE
A Redness (refers to lids and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 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 membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4

C Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner cantus 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
(A + B + C) x 2; Maximum possible score = 20

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
> 2
Reversibility:
not fully reversible within: 8 days in 2 animals
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Reversibility:
not fully reversible within: 8 days in two animals
Remarks on result:
other: rinsed eye
Irritant / corrosive response data:
Test item was found to cause moderate irritation: mean reaction score after 48 hours in unrinsed eyes: 43.7 and in rinsed eyes: 38.3.
The irritation consisted of conjunctival reaction, of reflective hyperemia of the iris and of corneal reaction.
There was a tendency to regress. Rinsing the eyes led to practically the same results.

Any other information on results incl. tables

Mean values from gradings at 24, 48 and 72 hours

Reaction Animal N. Eye After Mean
24 hrs 48 hrs 72 hrs
Cornea 154 not rinsed 1 1 1 1.00
117 not rinsed 1 1 1 1.00
25 not rinsed 1 2 2 1.67
104 rinsed 1 1 1 1.00
102 rinsed 1 1 1 1.00
133 rinsed 1 1 1 1.00
Iris 154 not rinsed 1 1 1 1.00
117 not rinsed 1 1 1 1.00
25 not rinsed 1 1 1 1.00
104 rinsed 1 1 1 1.00
102 rinsed 1 1 1 1.00
133 rinsed 1 1 1 1.00
Conjunctival redness 154 not rinsed 3 3 3 3.00
117 not rinsed 3 3 3 3.00
25 not rinsed 3 3 3 3.00
104 rinsed 3 3 3 3.00
102 rinsed 2 3 2

2.33

133

rinsed

3

3

1

2.33

Conjunctival chemosis

154

not rinsed

2

1

1

1.33

117

not rinsed

2

1

1

1.33

25

not rinsed

2

1

1

1.33

104

rinsed

2

2

1

1.67

102

rinsed

2

1

1

1.33

133

rinsed

2

1

1

1.33

Rabbit eye irritation scores-feference procedure

1 hrs

6 hrs

1 days

2 days

Rabbit No.

154

117

25

140

102

133

154

117

25

140

102

133

154

117

25

140

102

133

154

117

25

140

102

133

Eye, left/right

n

n

n

r

r

r

n

n

n

r

r

r

n

n

n

r

r

r

n

n

n

r

r

r

I . Cornea

A Opacity

0

0

0

 0 0 0 0 0 0 0 0 0

1

1

1

1

1

1

1

1

2

1

1

1

B Area involved

0

0

0

0

0

0

0

0

0

0

0

0

4

4

4

4

4

4

4

4

4

4

4

4

a = AxBx5 (Max. 80)

0

0

0

0

0

0

0

0

0

0

0

0

20

20

20

20

20

20

20

20

20

20

20

20

II . Iritis

1

0

1

0

0

0

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

b = Score x 5 (Max. 10)

5

0

5

0

0

0

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

III . Conjunctivae 

A Redness

2

3

3

2

1

2

3

3

3

2

1

2

3

3

3

3

2

3

3

3

3

3

3

3

B Chemosis

2

3

2

2

1

2

2

2

2

2

2

2

2

2

2

2

2

2

1

1

1

2

1

1

C Discharge

2

3

3

2

1

2

3

2

2

3

3

3

3p

2

2p

3p

2p

2

2

2

2p

3

3

1

c = (A+B+C)x2 (Max. 20)

12

18

16

12

6

12

16

14

14

14

12

14

16

14

14

16

12

14

12

12

12

16

14

10

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

17

 18 21 12 6 12 21 19 19 19 17 19 41 39 39 41 37 39 37 37 57 41 39 35

Group mean

18.7

10.0

19.7

18.3

39.7

39.0

43.7

39.3

3 days 4 days 8 days
Rabbit No. 154 117 25 140 102 133

154

117

25

140

102

133

154

117

25

140

102

133

Eye, left/right

n

n

n

r

r

r

n

n

n

r

r

r

n

n

n

r

r

r

I . Cornea

A Opacity

1

1

2

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

B Area involved

4

4

4

4

4

4

4

4

4

4

4

4

4

4

4

4

4

4

a = AxBx5 (Max. 80)

20

20

40

20

20

20

20

20

40

20

20

20

20

20

20

20

20

20

II . Iritis

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

b = Score x 5 (Max. 10)

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

III . Conjuctivae

A Redness

3

3

3

3

2

1

1

2

1

1

1

1

1

1

1

1

1

0

B Chemosis

1

1

1

1

1

1

1

1

1

1

0

0

1

1

1

1

1

0

C Discharge

1

1

1p

1p

1

1

1

1

1

0

1

1

1

1

1

0

1

1

c = (A+B+C)x2 (Max. 20)

10

10

10

10

8

6

6

8

6

4

4

4

6

6

6

4

6

2

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

35

35

55

35

33

31

35

33

51

29

29

29

31

31

31

29

31

27

Group mean

41.7

33.0

39.3

29.0

31.0

29.0

n = not rinsed

r = rinsed after 1 minute

p = purulent

Applicant's summary and conclusion

Interpretation of results:
other: Irritant according to the CLP Regulation
Conclusions:
Irritant
Executive summary:

Method

The substance has been tested for eye irritation according to the method inserted into the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Under the conditions of this experiment 6 rabbits were tested with 0.1 g of test item inserted into the conjunctival sac of the left eye and the lids were held open for a few seconds. The right eye was not treated and served as a control. In 3 of the 6 rabbits approximately 1 minute after treatment both eyes were rinsed with physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1, 2, 3, 6 and 8 days.

Results

Under the conditions of this experiment preparation the test item was found to cause moderate irritation when applied to the rabbit eye mucosa.

Rinsing the eyes led to practically the same results. There was a tendency to regress.