Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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