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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: Well documented study, sufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500, 42
Principles of method if other than guideline:
This test was used for eye irritation test before OECD guideline 405 was established. It is generally similar to the Draize test, with the following deviations: 100 mg of the test substance was applied to the right eye (OECD recommends a volume of 0.1 ml), 6 animals were used (OECD: 3); observation period was 7 days (OECD: 21).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Polychloro copper phthalocyanine
EC Number:
215-524-7
EC Name:
Polychloro copper phthalocyanine
Cas Number:
1328-53-6
Molecular formula:
C32HxClyCuN8
IUPAC Name:
polychloro copper phthalocyanine
Test material form:
solid
Specific details on test material used for the study:
- Analytical purity: ca. 98 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: at the start of the test, the animals weighed ca. 2.5 kg
- Housing: Rabbits were kept in individual cages (540 x 360 x 315 mm) or in restraining devices
- Diet: 200 g of food per animal per day (Granules Lapin "entretien", Sanders)
- Water: softened and filtrated water ad libitum, automatically given

ENVIRONMENTAL CONDITIONS
- Temperature (°C): minimum 20 °C
- Air changes: ventilation (renewal of air 12 times per hour)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was treated with 50 mg talcum powder and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
- Concentration: undiluted
Duration of treatment / exposure:
24 h; the substance was not washed out.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
100 mg of the undiluted test substance was applied to the right conjuntival sac of 6 New Zealand White rabbits. The left eye was treated with 50 mg talcum powder and served as control. The substance was not washed out.
Ocular reactions were recorded at 1 h, 24 h, 48 h, 72 h, 96 h and 7 days after instillation using a scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours after application.
Observations of the condition of the cornea were made with the naked eye and also with the aid of an ophtalmoscope of Heine.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24-48-72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24-48-72 h
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24-48-72 h
Score:
0.06
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
The following effects were observed, but were completely reversible within 72 hours:
- Test animals showed slight conjunctiva chemosis and redness, which were completely reversible in 5/6 animals within 48 hours;
- Iris congestion was also observed in 3/6 animals and was also completely reversible within 48 hours in 2 of the animals concerned;
- The cornea was slightly affected in 1/6 animals at 24 h only.

Any other information on results incl. tables

Table 1: Eye irritation parameters according to the method of Draize

Reading time point

Animal 1, treated eye (right)

Conjunctiva Chemosis

Conjunctiva Redness

Iris score

Cornea score

Additional findings

1 h

1

1

1

0

 

24 h

1

0

0

0

 

48 h

1

0

0

0

 

72 h

0

0

0

0

 

96 h

0

0

0

0

 

7 d

0

0

0

0

 

Reading time point

Animal 2, treated eye (right)

Conjunctiva Chemosis

Conjunctiva Redness

Iris score

Cornea score

Additional findings

1 h

1

0

1

0

 

24 h

0

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

96 h

0

0

0

0

 

7 d

0

0

0

0

 

Reading time point

Animal 3, treated eye (right)

Conjunctiva Chemosis

Conjunctiva Redness

Iris score

Cornea score

Additional findings

1 h

1

1

0

0

 

24 h

2

1

1

1

discharge

48 h

0

1

1

0

 

72 h

0

0

0

0

 

96 h

0

0

0

0

 

7 d

0

0

0

0

 

Reading time point

Animal 4, treated eye (right)

Conjunctiva Chemosis

Conjunctiva Redness

Iris score

Cornea score

Additional findings

1 h

1

1

0

0

 

24 h

0

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

96 h

0

0

0

0

 

7 d

0

0

0

0

 

Reading time point

Animal 5, treated eye (right)

Conjunctiva Chemosis

Conjunctiva Redness

Iris score

Cornea score

Additional findings

1 h

1

0

1

0

 

24 h

1

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

96 h

0

0

0

0

 

7 d

0

0

0

0

 

Reading time point

Animal 6, treated eye (right)

Conjunctiva Chemosis

Conjunctiva Redness

Iris score

Cornea score

Additional findings

1 h

1

0

0

0

 

24 h

1

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

96 h

0

0

0

0

 

7 d

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met