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Diss Factsheets
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EC number: 604-942-9 | CAS number: 15414-04-7
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- yes
- Remarks:
- the deviation is related to the acceptability criteria and has an impact of the conclusion of the study (see below)
- Qualifier:
- according to guideline
- Guideline:
- other: method B.40bis of the Council regulation No. 440/2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Copper, diamminebis(nitrato-kO)
- EC Number:
- 604-942-9
- Cas Number:
- 15414-04-7
- Molecular formula:
- CuH6N4O6
- IUPAC Name:
- Copper, diamminebis(nitrato-kO)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- epiCS
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The reconstituted epidermis measured 0.6 cm².
The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The insert was placed in a 6 wells culture plate which had been previously filled with 1 mL of culture medium. The culture dishes were incubated at 37±2°C, 5% CO2 during 20 hours and 20 minutes before treatment. Just before the treatment, the culture medium was replaced by a new culture medium. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied as supplied, at the dose of 25 mg.
- Duration of treatment / exposure:
- during 3 minutes at room temperature and during 1 hour at 37°C ± 1°C
- Number of replicates:
- 2 living human skin models
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean percent viability of the epidermis skin treated during 3 minutes at room temperature
- Value:
- ca. 127.31
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean percent viability of the epidermis skin treated during 1 hour at 37°C
- Value:
- ca. 59.29
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The item is to be classified as non-corrosive: if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15 %
As the difference of viability between the two treated tissue replicates for the 1 hour treatment, was >30% (87.4%), the acceptability criteria define in OECD 431 are not respected. Moreover one epidermis treated with the test item presented with a viability at 15.60%, which is very closed to the cut off for the classification as corrosive. A second run is necessary to conclude on the corrosive effect of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 127.31 % and 59.29% (102.99% in one epidermis and 15.60% in the other one), versus 8.68% and 0.17%, respectively, with the positive control item (potassium hydroxide 8N).
As the difference of viability between the two treated tissue replicates for the 1 hour treatment, was >30% (87.4%), the acceptability criteria define in OECD 431 are not respected. Moreover one epidermis treated with the test item presented with a viability at 15.60%, which is very closed to the cut off for the classification as corrosive. A second run is necessary to conclude on the corrosive effect of the test item.
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