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EC number: 263-606-6 | CAS number: 62570-50-7
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Additional procedure for test items that induce both colour interference and reduction of MTT was not performed. Procedure is designed to avoid possible double correction, without correction the test item is clearly negative. Does not affect study outcome
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile
- EC Number:
- 263-606-6
- EC Name:
- 1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile
- Cas Number:
- 62570-50-7
- Molecular formula:
- C16H14N2O2
- IUPAC Name:
- 1-amino-4-(ethylamino)-9,10-dioxo-9,10-dihydroanthracene-2-carbonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch 135214 of Disperse Blue 359 was a dark blue powder with a purity of 99 %
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKIN Small Model (0.38 cm² reconstructed epidermis of normal human keratinocyes grown on a collegen matrix for 13 days.)
- Vehicle:
- other: Milli-Q water
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 11.0-13.8 mg of test item was added to the appropriate tissue samples
- Duration of treatment / exposure:
- Exposure period of 15 ± 0.5 minutes, following this the tissues were washed with phosphate buffered saline to remove residual test item
- Duration of post-treatment incubation (if applicable):
- Tissues were incubated for 48 hours at 37 °C
- Number of replicates:
- 15 test tissued used, consiting of 5 replicatex of 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 ± 0.5 minutes
- Value:
- ca. 98
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative man tissue validity obtained after 15 ± 0.5 minutes treatment with Disperse Blue 359 compared to the negative control tissues was 98 %. Since the mean relative tissue viability for Disperse Blue 359 was above 50 % after 15 ± 0.5 minutes treatment Disperse Blue 359 is considered to be a non-irritant.
The positive control had a mean cell viability of 6.2 % after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissue was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 10 %, indicating that the test system function properly.
Finally, it is concluded that this test is valid and that Disperse Blue 359 is a non-irritant in the in vitro skin irritation test under the experimental conditions described. - Executive summary:
Batch 135214 of Disperse Blue 359 was a dark blue powder with a purity of 99%. Skin tissue was moistened with 5µL of Milli-Q water and at least 10 mg of Disperse Blue 359 was applied directly on top of the tissue for 15 ± 0.5 minutes. After a 42-hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Disperse Blue 359 did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal procedure, three killed tissues treated with test item and three killed untreated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by Disperse Blue 359 was 4.4 % of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test item treated viable tissues.
Furthermore, Disperse Blue 359 showed colour interference in aqueous solutions. In addition to the normal procedure, three tissue were treated with test item. Instead of MTT solution this tissue was incubated with assay medium. The non-specific colour by Disperse Blue 359 was 4.9 % of the negative control tissues. The OD of the tissue incubated with assay medium was subtracted from the ODs of the test item treated tissues incubated with MTT medium.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue validity obtained after 15 ± 0.5 minutes treatment with Disperse Blue 359 compared to the negative control tissues was 98 %. Since the mean relative tissue viability for Disperse Blue 359 was above 50 % after 15 ± 0.5 minutes treatment Disperse Blue 359 is considered to be a non-irritant.
The positive control had a mean cell viability of 6.2 % after 15 ± 0.5 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissue was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 10 %, indicating that the test system function properly.
Finally, it is concluded that this test is valid and that Disperse Blue 359 is a non-irritant in the in vitro skin irritation test under the experimental conditions described.
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