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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hours
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.