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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:
other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines. Restrictions: Study terminated before reversibility was demonstrated. This does not affect interpretation of the test results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Copper hydroxide.
- Lot/batch No.: Not stated.
- Content of copper and content of copper hydroxide: Not stated.
- Storage condition of test material: The test substance was stored at ambient temperature in a dark place.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, 2740 Bremervorde, Neuendamm 88.
- Age at study initiation: Not stated.
- Weight at study initiation: 2.4 - 2.8 kg.
- Housing: Animals were kept separately in batteries.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: Not less than 7 days.

ENVIRONMENTAL CONDITIONS- Temperature (°C): 18°C +/- 2°C.
- Humidity (%): 50 - 85%.
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 grams.
Duration of treatment / exposure:
4 seconds (3 animals) or unwashed (3 animals).
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
Six.
Details on study design:
0.1 grams of the test substance was was administered into the conjunctival sac of the left eye of each of six rabbits. The treated eyes of three animals were washed with water 4 seconds after dosing. The eyes of the three other animals remained unwashed. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours. Irritation was scored according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animala
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
Copper hydroxide caused iris lesions, conjunctival redness and chemosis in unwashed eyes (scores in the range 1 - 3) in all animals 1, 24, 48 and 72 hours after instillation. Copper hydroxide also caused corneal opacity 24 - 48 hours after instillation in two animals (score 1 or 2). Iris lesion, conjunctival redness and chemosis (but not corneal opacity) also occurred in the washed eyes but effects were less severe. Refer to Table 1 for a summary of individual and mean eye irritation scores.
Other effects:
None.

Any other information on results incl. tables

Table 1. Copper hydroxide: Summary of individual and mean eye irritation scores according to Draize.

Assessment time

Scores according to Draize for animal number

Unwashed

Washed

1

2

3

4

5

6

Cornea opacity

1 hour

0

0

0

0

0

0

24 hours

0

0

0

0

0

0

48 hours

0

1

2

0

0

0

72 hours

0

1

2

0

0

0

Mean score per animal

0.0

0.7

1.3

0.0

0.0

0.0

Mean score for 3 animals

0.7

0.0

Iris lesion

1 hour

2

2

2

1

1

2

24 hours

2

2

2

1

1

1

48 hours

2

2

2

1

1

1

72 hours

1

1

1

0

0

0

Mean score per animal

1.7

1.7

1.7

0.7

0.7

0.7

Mean score for 3 animals

1.7

0.7

Conjunctival redness

1 hour

3

3

3

3

3

2

24 hours

3

3

3

3

2

2

48 hours

3

3

3

2

2

2

72 hours

3

3

3

2

2

2

Mean score per animal

3.0

3.0

3.0

2.3

2.0

2.0

Mean score for 3 animals

3.0

2.1

Conjunctival chemosis

1 hour

3

3

3

2

2

2

24 hours

3

3

3

2

2

2

48 hours

2

3

2

2

2

2

72 hours

2

2

1

2

2

2

Mean score per animal

2.3

2.7

2.0

2.0

2.0

2.0

Mean score for 3 animals

2.3

2.0

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean of the scores for Iris lesion in at least 2 out of 3 tested animals recorded at 24, 48 and 72 hours for unwashed eyes was > 1.5.
Classification according to Directive 67/548/EEC: Irritant (Xi). R41, Risk of serious damage to eyes.
Classification according to CLP/GHS: Eye Damage 1, H318: Causes serious eye damage.
Executive summary:

A GLP-compliant study was conducted in New Zealand White rabbits to determine the eye irritation potential of copper dihydroxide. The method followed the requirements of OECD Guideline 405, with the exception that the study was terminated before reversibility was demonstrated (this was not consideed to adversely affect the outcome). 0.1 grams of the test substance was was administered into the conjunctival sac of the left eye of each of six rabbits. The treated eyes of three animals were washed with water 4 seconds after dosing. The eyes of the three other animals remained unwashed. Animals were examined after 1, 24, 48 and 72 hours and irritation was scored according to Draize. The mean eye irritation scores recorded at 24, 48 and 72 hours for unwashed eyes in all three animals were 0.7 for corneal opacity (> 1.0 in one animal), 1.7 for iris lesion (> 1.5 in all three animals), 3.0 for conjunctival redness (> 2.0 in all three animals) and 2.3 for conjuntival chemosis (>= 2.0 in all three animals). In view of the iris lesion findings and lack of reversibility, copper dihydroxide is classified as Eye Damage Category 1, H318: Causes serious eye damage.