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Diss Factsheets
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EC number: 252-305-5 | CAS number: 34977-63-4
- 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
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Direct Black 51- Molecular formula (if other than submission substance): C27H17N5Na2O7S- Molecular weight (if other than submission substance): 601.5- Substance type: organic- Physical state: solid- Analytical purity: cca 80 % w/w- Impurities (identity and concentrations): cca 20 % NaCl (CAS: 7647-14-5)- Lot/batch No.: 9013- Storage condition of test material: stored in dry room in dark in closed container at the room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- TISSUESThe reconstructed human epidermal model EpiDerm™ (EPI-200 ver. 2.0, MatTek, Ashland, USA); Lot No. 21675, kit A) has been obtained from MatTek Bratislava
- Vehicle:
- physiological saline
- Details on test system:
- PROCEDUREOn the day of receipt, EpiDerm tissues were conditioned by incubation to release transport stress related compounds and debris. After pre-incubations (1 and 18±3hours), tissues were topically exposed to the test chemicals for 1 hour. Three tissues were used per the test substance (C1), for the positive (PC) and negative (NC) controls. Tissues were then thoroughly rinsed, blotted to remove the test substance, and transferred to fresh medium. After 24±2 hours incubation period, the medium was replaced by fresh one. Tissues were incubated for another 18±2 hours. Afterwards, the MTT assay was performed by transferring the tissues to 24-well plates containing MTT medium (1 mg/mL). After 3 hour MTT incubation, the blue formazan salt formed by cellular mitochondria was extracted with 2.0 mL/tissue of isopropyl alcohol and the optical density of the extracted formazan was determined using a spectrophotometer at 570 nm. Detailed procedure is described in SOP M/48/3 (VUOS-CETA, 2011).OD570 MEASURINGOD570 (optical density at 570 nm) was measured on a spectrophotometer Libra S22. Isopropyl alcohol serves as a blank.NEGATIVE CONTROLThe absolute optical density of the negative control (NC) tissues (treated with sterile phosphate buffered saline) in the MTT test is an indicator of tissue viability obtained in the testing laboratory after shipping and storing procedures and under specific conditions of use. The assay meets the acceptance criterion if the mean OD570 of the NC tissues is ≥ 0.8 and ≤ 2.8.POSITIVE CONTROLA 5% solution sodium dodecyl sulphate in water is used as positive control (PC) and tested concurrently with the test chemicals. Concurrent means here the PC has to be tested in each assay, but not more than one PC is required per testing day. Viability of positive control should be within 95±1 % confidence interval of the historical data. The assay meets the acceptance criterion if the mean viability of PC tissues expressed as % of the negative control tissues is ≤ 20 %.
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL- Amount(s) applied: 25 mg
- Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Test system
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 94.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- see Table No. 1
Any other information on results incl. tables
Table No. 1: Viability values
| Treatment | OD(570) | Mean | SD | Relative viability (% NC) | ||
1 | 2 | 3 | |||||
NC | PBS | 2.076 | 2.058 | 1.934 | 2.023 | 0.063 | 100.0 |
viability (% NC) | 102.6 | 101.7 | 95.6 | 100.0 | 3.12 | ||
C1 | 270/15 | 1.767 | 2.065 | 1.897 | 1.910 | 0.122 | 94.4 |
viability (% NC) | 87.4 | 102.1 | 93.8 | 94.4 | 6.031 | ||
PC | 5% SDS | 0.058 | 0.049 | 0.062 | 0.056 | 0.005 | 2.8 |
viability (% NC) | 2.9 | 2.4 | 3.1 | 2.8 | 0.269 |
NC - negative control
PC - positive control
C1 - test substance
SD - Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Average viability of tissues treated by the test substance was 94.4 % of negative control average value. i.e. viability was > 50 %. The effect of the test substance was negative in EpiDermTM model. According to the classification criteria given in chapter 4.5. of this method, the test substance, Direct Black 51, is considered to have no category in regard to skin irritation.
- Executive summary:
Test substance, Direct Black 51, was assayed for the in vitro skin irritation in human epidermal model EpiDerm™. The test was performed according to the EU Method B.46. In vitro skin irritation: Reconstructed human epidermis model test and Protocol for: In Vitro EpiDerm™ Skin Irritation Test For use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT.
Average viability of tissues treated by the test substance was 94.4 %, i.e.viability was > 50 %.
The effect of the test substance was negative in EpiDerm™ model (the tissue was not damaged).
According to the classification criteria, the test substance is considered to have no category in regard to skin irritation.
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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