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EC number: 277-616-3 | CAS number: 73816-74-7
- 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
- Study period:
- 19.04-29.07.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- EC Number:
- 277-616-3
- EC Name:
- Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- Cas Number:
- 73816-74-7
- Molecular formula:
- C28H24ClN7O10S3.3Na
- IUPAC Name:
- trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Red 45:1
- Physical state: red solid powder
- Analytical purity: 85% (w/w)
- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 15% (w/w)
- Lot/batch No.: 7010
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.
Constituent 1
impurity 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human-derived epidermal keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: model EpiDermTM
- Tissue: The reconstructed human epidermal model EpiDerm™ (EPI-200 ver. 2.0, MatTek, Bratislava, Slovakia); Lot No. 23329)
- Date of initiation of testing: 19.04.2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 g
NEGATIVE CONTROL
PBS (phosphate buffered saline) prepared 25/02/2016, exp. 25/08/2016 and prepared 23/03/2016 exp. 23/09/2016
- Amount(s) applied: 25 µL
POSITIVE CONTROL
5 % SDS (sodium dodecyl sulphate), MatTek, Lot No. 012616TMB, exp. 26/01/2017 - Duration of treatment / exposure:
- 60 min.
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 54.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the above-described experimental design, average viability of tissues treated by the test item Reactive Red 45:1 was 54.3 % of negative control average value. The measured value was then corrected, due to red colour of the test substance.
Corrected viability of treated tissues was 53.4 %, i.e. viability was > 50 %. - Executive summary:
The test item, Reactive Red 45:1, was assayed for the in vitro skin irritation
in human epidermal model EpiDermTM.The test was performed according to the OECD Test Guideline No.439: In VitroSkin Irritation: Reconstructed Human Epidermis Test Method (2015) and Protocol for: In Vitro EpiDermTMSkin Irritation Test For use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT (see par. 1.4).After pre-incubation of tissues, 25 mg of the test item was placed directly a top to the previously moistened tissue and it was spread on the entire tissuesurface. Length of exposition was 60 minutes. Three tissues were used for the test item and every control.
After removal of the test substance, tissues were post-incubated for approximately
42 hours due to leave of damage reparation. Three hours incubation with MTT and two hours extraction period with shaking followed then. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.At direct reduction assay in a test tube MTT medium was coloured red, so direct MTT reduction was excluded.
In the first experiment too high differenceamong viability of tissues was observed in range close to cut off value. The experiment was then repeated. In the repeated experiment all test conditions were fulfilled and average viability of treated tissues was54.3% (53. 4 % after correction),i.e. viability was >50 %.
The effect of the test item was negative in EpiDermTMmodel (tissues were not damaged).
According to the classification criteria given in chapter 4.5., the test item, Reactive Red 45:1, is considered to have no category in regard to skin irritation.
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