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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(Basic data given. Limited data on animal husbandry, test substance purity not specified.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Draize Testing method (Draize JH et al., J. Pharm. Exp. Ther. 82: 377-390, 1944) as prescribed by the FDA (in The Federal Register 38 No.187 §15000.42, USA).
GLP compliance:
no

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
- Housing: individually
- Diet: 2 oz/day (equivalent to 56.7 g/day) Purina Rabbit Chow
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served for control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 24, 48, 72 and 96 h and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
1.61
Max. score:
4
Reversibility:
not fully reversible within: 7 days in 6 animals
Remarks on result:
other: The chemosis effect was so severe that only 25% of the cornea was observable. The cornea scores are a minimum of the approximated score, however, maximum scores of up to 4 were included in the study report between bracket.
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 5 animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days in 3 animals. For 2 of these animals no score could be given on day 7.
Remarks on result:
other: The chemosis effect was so severe that only 25% of the iris was observable. For 1/6 animals no iris scores could be assigned at any reading time point; for 1/6 animals no score was assigned at the 7-day reading time point.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days in 6 animals
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
3.39
Max. score:
4
Reversibility:
not fully reversible within: 7 days in 2 animals
Remarks on result:
other: Fully reversible within: 7 days in 4 animals
Irritant / corrosive response data:
The chemosis was so severe that only 25% of the cornea and iris were observable. The cornea scores are the minimum score given, however, a maximum score of up to 4 was included in the study report between brackets, indicating that scoring was difficult (see Table 1 and Table 2 under 'Any other information on results incl. tables'). Some corneal effects (score 1 - 2) were observed in 6/6 animals at the 24-, 48-, 72- and 96-hour reading time points. 7 days after instillation, the effects remained the same in 4/6 animals, and had become more severe (score 3) in 2/6 animals. In general, a worsening of the severity was observed in 4/6 animals during the observation period, while it remained the same for 2/6 animals. The highest conjunctivae score of 3 was assigned 6/6 animals at the 24-, 48- and 72-hour reading time points. The severity was reduced in 4/6 animals (score 1 - 2) 7 days after instillation and remained unchanged (score 3) in 2/6 animals. The conjunctivae was irreversible in 6/6 animals. The chemosis was severe (score 3 - 4) in all animals at the 24-, 48- and 72-hour reading time points. 96 hours after instillation, the effect had reduced in severity in 4/6 animals (score 1 - 2) while the severity was unchanged in 2/6 animals (score 3 - 4). At the 7-day reading time point, the chemosis had reversed completely in 4/6 animals, while in 2/6 the effect was still present (score 2 and 4, respectively). In 5/6 animals the iris effects were marked (score 1) from the 24-hour reading time point until the 96-hour reading time point. For 1/6 animals it was not possible to assign an iris score at any reading time point. 7 days after application, the effects has cleared in 3/6 animals, the effects remained marked (score 1) in 1/6, and for 2/6 animals it was not possible to assign an iris score.

Any other information on results incl. tables

Table 1: Individual eye irritation scores

 

Rabbit #

 

Time

 

conjunctivae

 

iris**

 

cornea***

 

redness

swelling

1

 

 

 

 

24 h

3

4

?

2

48 h

3

4

?

2

72 h

3

4

?

2

96 h

7 d

3

3

4

4

?

?

2

3

Average*

3.0

4.0

-

2.0

2

 

 

 

 

24 h

2.5

3

1

1

48 h

3

3

1

1

72 h

3

3

1

2

96 h

7 d

2

1

1

0

1

0

2

2

Average*

3.0

3.0

1.0

1.33

3

 

 

 

 

24 h

3

4

1

1

48 h

3

3

1

1

72 h

3

3

1

2

96 h

7 d

3

2

3

0

1

0

2

2

Average*

3.0

3.33

1.0

1.33

4

 

 

 

 

24 h

3

4

1

2

48 h

3

4

1

2

72 h

3

3

1

2

96 h

7 d

3

1

2

0

1

0

2

2

Average*

3.0

3.67

1.0

2.0

5

 

 

 

 

24 h

3

4

1

1

48 h

3

3

1

2

72 h

3

3

1

2

96 h

7 d

3

1

1

0

1

1

2

2

Average*

3.0

3.33

1.0

1.67

6

 

 

 

 

24 h

3

3

1

1

48 h

3

3

1

1

72 h

3

3

1

2

96 h

7 d

3

3

2

2

1

?

2

3

Average*

3.0

3.0

1.0

1.33

*(24h+48h+72h)/3.

** Only 25% of the iris was observable due to severe chemosis; the eye of animal 1

could not be scored at all and the eye of animal 6 could not be socred on day 7.

*** Only 25% of the cornea was observable due to severe chemosis.

The cornea scores are the minimum score given, however, a maximum score

(up to 4) was included in the study report between brackets indicating that scoring was difficult.

Table 2: Individual minimum and maximum cornea scores

Observation time

Rabbit No.

 

1

2

3

4

5

6

Cornea score

Minimum

Maximum

Minimum

Maximum

Minimum

Maximum

Minimum

Maximum

Minimum

Maximum

Minimum

Maximum

24 h

2

4

1

4

1

3

2

2

1

4

1

4

48 h

2

4

1

3

1

2

2

2

2

3

1

4

72 h

2

4

2

3

2

2

2

3

2

4

2

4

7 days

3

4

2

2

2

2

2

2

2

1

3

4

 

Applicant's summary and conclusion

Interpretation of results:
other: Cat. 1, H318 according to Regulation (EC) No 1272/2008
Conclusions:
CLP: Cat. 1, H318