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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; 50 mm3 (one sharp-edged spoon) of test material applied (OECD0.1 ml,< 100 mg); 2 animals were used (OECD: 3); the eyes were not washed out after 24 h (OECD: washing after 24 h); observation period was 3 days (OECD: 2); exam. using fluorescein (OECD no)
Principles of method if other than guideline:
BASF-Test:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl or one sharp-edged spoon in case of solids of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
EC Number:
205-685-1
EC Name:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
Cas Number:
147-14-8
Molecular formula:
C32H16CuN8
IUPAC Name:
[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Analytical purity: 100 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: ca. 3.0 kg
- Diet: Altromin-MS (Altrogge, Lage/L. Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of the same rabbit was treated with 50 mg talcum powder.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: one sharp-edged spoon of the test substance, undiluted; ca. 50 mg
Duration of treatment / exposure:
24 h; the substance was not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
One sharp-edged spoon of the undiluted, solid test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye, treated with physiological saline, served as a control. The substance was not washed out.
Ocular reactions were recorded after 10 min, 1, 3 and 24 hours, as well as 2 and 3 days after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation the BASF 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 2 animals
Time point:
other: 24-48-72 h
Score:
0.16
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: finding was also seen in control eye
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 2 animals
Time point:
other: 24-48-72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 2 animals
Time point:
other: 24-48-72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 2 animals
Time point:
other: 24-48-72 h
Score:
0
Irritant / corrosive response data:
Slight conjunctivae redness as well as substance residues were observed in both eyes of all animals after 1 min, 1 hour and 3 hours of test substance instillation. In animal 1, no more findings were seen after 24 hours in both eyes. In animal 2, very slight conjunctivae chemosis was seen only in the left control eye after 1 and 3 hours and slight conjunctivae redness was still seen in both eyes after 24 hours. No more findings were seen after 48 hours in both eyes.

Any other information on results incl. tables

Table 1: Eye irritation parameters of 2 rabbits after application of the test material; scores were determined according to the method of Draize

Reading time point

Animal 1, treated eye (right)

Cornea

Iris

Conjunctivae redness

Conjunctivae chemosis

Additional findings

10 min

0

0

1

0

substance residues

1 h

0

0

1

0

substance residues

3 h

0

0

1

0

substance residues

24 h

0

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

Reading time point

Animal 1, control eye (left)

Cornea

Iris

Conjunctivae redness

Conjunctivae chemosis

Additional findings

10 min

0

0

1

0

substance residues

1 h

0

0

1

0

substance residues

3 h

0

0

1

0

substance residues

24 h

0

0

0

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

Reading time point

Animal 2, treated eye (right)

Cornea

Iris

Conjunctivae redness

Conjunctivae chemosis

Additional findings

10 min

0

0

1

0

substance residues

1 h

0

0

1

0

substance residues

3 h

0

0

1

0

substance residues

24 h

0

0

1

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

Reading time point

Animal 2, control eye (left)

Cornea

Iris

Conjunctivae redness

Conjunctivae chemosis

Additional findings

10 min

0

0

1

0

substance residues

1 h

0

0

1

1

substance residues

3 h

0

0

1

1

substance residues

24 h

0

0

1

0

 

48 h

0

0

0

0

 

72 h

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met