Registration Dossier
Registration Dossier
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Reaction mass of tetrasodium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)] and tetraammonium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)]
EC number: 943-486-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Direct Blue 267
- IUPAC Name:
- Direct Blue 267
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 100 mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 1.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 1.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48 and 72h
- Score:
- 0
- Irritant / corrosive response data:
- changes fully reversible within 7 days
- Other effects:
- Blue discolouration of iris, eyelids (treated eye), fur
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested for eye irritation following EU MEthod B5. Under the experimental conditions the substance does not show any eye irritation potential.
- Executive summary:
The substance was tested for eye irritation following EU MEthod B5. Three NZW Rabbits were exposed to the test substance (one treated eye, the other control). Scores for conjunctivae, cornea, chemosis and iris were recorded. Under the experimental conditions the substance does not show any eye irritation potential.
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