Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Less observation time points, only 2 animals, 8 days observation

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper

EC Number:

261-638-5

EC Name:

[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper

Cas Number:

59160-79-1

Molecular formula:

C59 H31 Cu N11 O6

IUPAC Name:

[[2,2',2''-[(29H,31H-phthalocyanine-C,C,C-triyl-kN29,kN30,kN31,kN32)tris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)]-copper

Test material form:

solid

Details on test material:

Name of the test substance used in the study report: Oligo-phthalimidomethyl-Kupfer-phthalocyanin

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the animal

Amount / concentration applied:

About 50 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

The test substance was not washed out.
On day eight, the eyes were invesigated using fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: day 1 - day 8

Score:

0

Max. score:

4

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: day - day 8

Score:

0

Max. score:

4

Irritant / corrosive response data:

After 1h, grade 2 (of max 4) of irration and dark bluish substance residues were observed for the treated eyes. Grade 2 irritation was also observed at the 24h reading in one animal. It was no longer observed at 24 or 48h reading and no further effects were observed until the last investigation on day 8.

Other effects:

Body weight development:
Animal 1: Start 3.26 kg - end 3.19 kg
Animal 2: Start 3.14 - end 3.04

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met