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Diss Factsheets
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EC number: 228-326-0 | CAS number: 6227-14-1
- 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:
- other: read across from similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- EC Number:
- 228-327-6
- EC Name:
- Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- Cas Number:
- 6227-20-9
- Molecular formula:
- C34H27N5O11S3.3Na
- IUPAC Name:
- trisodium;3-[[4-[(2E)-2-(6-anilino-1-oxo-3-sulfonatonaphthalen-2-ylidene)hydrazinyl]-5-methoxy-2-methylphenyl]diazenyl]naphthalene-1,5-disulfonate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN Reconstructed Human Epidermis Model Kit
- Cell type:
- other: reconstructed (RhE)
- Details on animal used as source of test system:
- The procedure followed is based on the recommended EpiSkin SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- A 3 mg/mL MTT stock solution was prepared in DPBS. The stock solution was diluted to 0.3 mg/mL with assay medium when required
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tested substance - mean of replicates
- Value:
- 117.53
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Negative control group - mean of replicates
- Value:
- 100
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive control group - mean of replicates
- Value:
- 13.5
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into blue formazan salt that is quantified after extraction from tissues (Mosman T., 1983). The reduction of cell viability in treated tissues is compared to negative controls and expressed as a percentage. The percentage reduction in viability is used to predict the irritation potential.
Each test substance (test material, negative and positive controls) is topically applied concurrently on three tissues replicates for 42 minutes at room temperature (RT, comprised between 18°C to 24°C). Exposure to the test substance was followed by rinsing with phosphate buffer saline (PBS) and mechanically dried. Epidermis were then transferred to fresh medium and incubated at 37°C for 42 additional hours. Cell viability is assessed by incubating the tissues for 3 hours with 0.3 mL MTT solution (1 mg/mL). The formazan crystals are extracted using 1.5 mL isopropanol for 2 hours at RT and quantified by spectrophotometry at 570 nm wavelength. Sodium Dodecyl Sulphate (SDS 5%), and PBS treated epidermis are used as positive and negative controls, respectively. For each treated tissue, the cell viability is expressed as the percentage of the mean negative control tissues. Values under 50% is qualified the test substance as irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritant for skin
- Executive summary:
The substance was tested in the EPISKIN™ Reconstructed Human Epidermis Model using triplicate tissues during 15 minutes. Additional controls were included to account for direct MTT interference and color interference. The relative mean viability of the test substance treated tissues was 59.8 %. The test results does not show any effect on skin. The tested substance could be considered as not irritant for the skin and does not required any classification.
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