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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7
Specific details on test material used for the study:
Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: >85%
- Lot/batch No.: M200058
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Weight at study initiation: 2.6 - 2.9 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff (R) K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h after administration of the test material
Number of animals or in vitro replicates:
3 females
Details on study design:
About 24 h before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
100 mg of the test material was administered once to the conjunctival sac of the left eyeof three animals. In each case the untreated eye served as control.
24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 h after administration of the test material. At 24 and 72 h, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically acc. to Draize. All other changes or toxic effects were recorded when apparent.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

One hour after administration the conjunctiva of one animal was very slightly swollen. Furthermore, all animals showed definitely injected blood vessels at one hour up to 48 h after administration. In addition to these observations, serious eye discharge discoloured by compound was noted. 72 h after administration all signs of irritation had disappeared.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Slight signs of irritation (a mean score of 0.56 for 3 animals at 24 -48 -72 h for conjunctivae redness) were seen in the eyes of the rabbits which were fully reversible within 72 h under the experimental conditions chosen here. Therefore, the test material has not to be classified according to GHS- or EU criteria.