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EC number: 305-897-5 | CAS number: 95193-83-2
- 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:
- From March 2nd to March 31st, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted June 18th, 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DB-ALM Protocol n°135: SkinEthicTM Skin Irritation Test
- Version / remarks:
- Adopted April 5th, 2018
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- EC Number:
- 305-897-5
- EC Name:
- 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- Cas Number:
- 95193-83-2
- Molecular formula:
- C18H11NO5S to C18H8NO11S3.3Na
- IUPAC Name:
- trisodium hydrogen bis(2-(1,3-dioxo-5-sulfonato-2,3-dihydro-1H-inden-2-yl)quinoline-8-sulfonate)
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- SkinEthic RHE/Human Epidermis (RHE/S/17)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: Normal human keratinocytes were grown on inert polycarbonate filters in chemically defined medium for 17 days. The product was prepared and packaged using aseptic techniques. Store in incubator at 37 °C, 5% CO2 with saturated humidity.
- Quality control for skin discs: Exposure time inducing 50% viability using Triton X-100 1% = 5.3h (required: 4.0h ≤ ET50 ≤ 10.0h).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure: Room temperature.
- Temperature of post-treatment incubation: 37 °C.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Multiple washing with PBS
CELL VIABILITY ASSAY: MTT assay. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test material: 16 ± 2 mg
Negative control (PBS without Ca and Mg): 16 ± 2 µl
Positive control (SDS 5%): 16 ± 2 µl - Duration of treatment / exposure:
- 42 minutes (room temperature)
- Duration of post-treatment incubation (if applicable):
- 42 hours (37°C, 5% CO2)
- Number of replicates:
- 3
Test system
- Details on study design:
- The test item was preliminary tested to evaluate its interference with MTT endopoint. 16 mg ± 2 mg of the test item were put in contact with 0.3 ml of MTT and incubated for 180 ± 15 minutes at 37 °C and 5% CO2. A negative control (16 µl of sterile deionized water) was run concurrently. MTT solution color did not change its color into blue/purple, indicating that the test item was not reducing the MTT.
Furthermore the test item was preliminary tested to evaluate its colorant properties. 10 mg ± 1 mg of the test item were put in contact with 0.09 ml of water and incubated for 30 minutes at room temperature after shaking. A negative control (10 µl of sterile deionized water) was run concurrently. The absorbance was measured with a plate reader equipped with the MTT measurement wavelength filter. After subtraction of the OD of negative control, the OD of the test item solution was < 0.1 (0.0357), indicating that the test item does not interact with the MTT measurement.
In the definitive test, after over-night incubation in the growth medium, the epidermis units were treated with the test item. 16 mg ± 2 mg of test item, and 16 µl ± 2 µl of positive (SDS 5%) and negative (PBS without Ca and Mg) controls were applied on epidermis units in three replicates. The exposition was carried out for 42 minutes at room temperature. At the end of the exposure period the samples were removed with multiple washing with PBS and the tissues were further incubated in 2 ml of medium at 37°C, 5% CO2 for 42 h. At the end of the exposure, the viability assay was performed to evaluate the cell survival in the epidermis units. Epidermis units were treated with 0.3 ml 1 mg/ml MTT solution (3-[4,5dimethylthiazol-2-yl]-2,5-diphenyl tetrazolium bromide) for 3 h at 37°C. The solution was then removed and replaced with isopropanol, with further 2 h incubation at room temperature under solution speed shaking. 2 aliquots of isopropanol were sampled for every epidermis units and transferred to a 96 well plate for the reading (6 readings for each units of test item, positive and negative controls). The absorbance was read with a microplate reader equipped with the 570 nm. The absorbance values were corrected by subtracting the reading of the blanks (diluent only).
After the blanks subtraction the results are expressed in terms of cell viability expressed as percentage:
Cell viability = [OD(570 nm) test item per tissue /mean OD(570 nm) negative control] x 100.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 106.74
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes. OD = 2.10; standard deviation = 2.73%
- Acceptance criteria met for positive control: yes. Mean viability = 0.87; standard deviation = 0.87%
- Test item: yes. Standard deviation = 5.10 %
- Blank (isopropanol): yes. OD < 0.1.
Any other information on results incl. tables
The test item results is not irritant to the skin, because its mean cell viability is higher than 50%.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritant according to the CLP Regulation (EC) No. 1272/2008.
- Conclusions:
- Under the conditions of the test, the test item resulted to be not irritant to the skin.
- Executive summary:
The skin irritation potential of the test item on Reconstructed Human Epidermis (RHE SkinEthic) was investigated according to the OECD Guideline 439 in triplicates. The test item, under the conditions of the test, showed a mean cell survival of 106.74% (±5.10) and therefore it resulted to be non skin irritant as its cell viability is higher than 50%. All the acceptance criteria were passed.
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