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: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Direct Blue 267
- IUPAC Name:
- Direct Blue 267
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: distilled water
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0.3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritant / corrosive response data:
- Changes fully reversible within 2 days
- Other effects:
- Blue staining of application site
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 skin irritation following EU Method B4. Under the experimental conditions the substance does not show any skin irritation potential
- Executive summary:
The substance was tested for skin irritation following EU Method B4. Three NZW Rabbits were exposed with a semi-occlusive patch to the tested substance for 4h. Erythema and edema score were registered. Under the experimental conditions the substance does not show any skin irritation potential
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