2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Eye irritation

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, 1500.42, S. 27019 vom 27.09.73

Principles of method if other than guideline:

The substance is applied in the eye of the rabbit undiluted. Observations are recorded 1 hour, 24 hours, 48 hours, 72 hours after application.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

EC Number:

221-264-5

EC Name:

2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Cas Number:

3049-71-6

Molecular formula:

C48H26N6O4

IUPAC Name:

2,9-bis[4-(phenyldiazenyl)phenyl]isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone

Details on test material:

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average weight 3.46 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

undiluted, 100 µl

Duration of treatment / exposure:

one single application without washing was performed

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Minimal erythema reactions were reported (maximum score = 1), reversible within 72 hours. One hour after instillation discharge was reported in all animals and in 2/6 rabbits edema formation was observed. These effects were reversible within the first 24 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was concluded not to be irritating to the eye.

Executive summary:

100 µl of the test substance was applied to the eyes of 6 rabbits in an eye irritation study comparable to OECD guideline 405. The animals were observed after 24, 48 and 72 hours after the treatment. The cornea, iris and chemosis scores were 0 at time points 24, 48 and 72 hours. The application caused a mean (24, 48 and 72 hours) conjunctivae redness score of 0.4 which was reversible within 72 hours. The test article was determined to be not irritating to the rabbit eye.