Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-982-1 | CAS number: 72905-97-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- EC Number:
- 276-982-1
- EC Name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- Cas Number:
- 72905-97-6
- Molecular formula:
- C44H24Cu2N8O17S4.xNa xNH4, x=0~4 , typical x=2
- IUPAC Name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- Details on test material:
- Purity: 95.2%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Duration of treatment / exposure:
- The right and left flank of animals was shaved at area about 6 x 6 cm.
The test sample 0.5 g, moistened with water, was applied on intact skin to 3 experimental animals. The test sample was covered by gauze, foil and cellulose wool. Cotton was held in place with technical tape so that the test sample was in contact with skin. Scarification was performed with using scarify needle (without bleeding). The test sample was applied on scarified skin by the same way as on intact skin. At the end of 4 hours exposition, dressing with the test sample was removed. - Observation period:
- Rabbits were examined for signs of erythema and oedema at 1, 24, 48 and 72 hr after patch removal.
- Number of animals:
- 3 females and males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0.75
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0.75
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 14
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48 and 72 hr
- Score:
- 0.75
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal: 15
- Time point:
- other: overall at 1, 24, 48, 72 hr
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other: Scarified skin, mean of all observation
Any other information on results incl. tables
Clinical examination of intact skin
Very slight erythema without oedema was observed in one animal 1 hour after patch removal. Very slight erythma was observed in the 2ndanimal and in the 3rdanimal no changes were observed.
No changes were observed in all animals in next time intervals.
Examination of scarified skin
Slight erythema and slight oedema were observed in one animal 1 hour after patch removal. Slight erythema and very oedema were observed in next one animal and in the 3rdanimal no changes were observed.
Very slight erythema and very slight oedema were observed in one animal 24 hrs after patch removal. Very slight erythema without oedema in next one animal and no changes in the 3rdanimal were recorded in 24 hrs.
No changes were observed in all animals in next time intervals.
RESULT
The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
- Executive summary:
Direct black 112 was tested for the dermal irritation. 3 male and female New Zealand Albino breed rabbits were used for the study. The test substance was exposed to skin for 4 hours. The examination for sign of erythema and oedema is at 1, 24, 48 and 72 hour after patch removal.
For the intact skin, very slight erythema was observed in 2 rabbits 1 hr after patch removal. No changes were observed in all animals in next time intervals.
For the sacrified skin, Slight erythema and slight oedema were observed in 2 animals 1 hour after patch removal. Very slight erythema and oedema were observed in one animal 24hrs. Very slight erythema without oedema in next one. No changes were observed in all animals in next time intervals.
The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.