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EC number: 694-898-7 | CAS number: 23121-00-8
- 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 21 - 22 Feb 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- No information provided on technical proficiency; no positive control data for 3 min exposure, 1 h exposure at room temperature (instead of 37°C)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- yes
- Remarks:
- No information provided on technical proficiency; no positive control data for 3 min exposure, 1 h exposure at room temperature (instead of 37°C)
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 Bis (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- 4-(2-phenylpropan-2-yl)phenyl 4-oxo-3-(λ⁵-diazynylidene)-3,4-dihydronaphthalene-1-sulfonate
- Cas Number:
- 23121-00-8
- Molecular formula:
- C25H20N2O4S
- IUPAC Name:
- 4-(2-phenylpropan-2-yl)phenyl 4-oxo-3-(λ⁵-diazynylidene)-3,4-dihydronaphthalene-1-sulfonate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep container closed and dry in a cool, well-ventilated place, protected from light
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The reconstructed human epidermis model in vitro method is an accepted in vitro method to replace animal testing. The human skin RHE™ model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- epidermis surface was wettened with 20 ± 2 µL of deionised water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Skin Ethic™ RHE-model RHE/S/17, manufactured by EPISKIN/Skin Ethic Laboratories, Lyon, France
- Tissue batch number: 17-RHE-021
- Date of initiation of testing: 21 Feb 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 min or 1 h)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume of washing steps: gently rinsed with approx. 20 mL DPBS solution
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h (± 15 min)
- Spectrophotometer: 96-well plate microplate reader (ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany)
- Wavelength: 570 nm
Isopropanol was used to extract the formazan salt from the tissues. The plates were put on a shaker (VWR Microplate Shaker, VWR GmbH, Darmstadt, Germany) with gentle agitation of about 120 rpm at room temperature for 2 h (± 5 min).
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD 570 = 1.3 (OD 570 historic negative control: 1.881 (3 min exposure) and 2.001 (1 h exposure)
- Barrier function: 4.6 h
- Morphology: 5.5 cell layers, well-differentiated epidermis consisting of basal, spinous, granular layers and a stratum corneum
- Reproducibility: yes
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the mean tissue viability after 3 min exposure is < 50%, or the mean tissue viability is ≥ 50% after 3 min exposure and < 15% after 1 h exposure.
(If the mean tissue viability after 3 min exposure is < 18% the substance is considered as corrosive Sub-categories 1A and if it is ≥ 18% the substance is considered as combination of optional Sub-categories 1B and 1C).
- The test substance is considered to be non-corrosive to skin if the viability is ≥ 50% after 3 min exposure and ≥ 15% after 1 h exposure. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 20 ± 3 mg
NEGATIVE CONTROL
- Amount(s) applied: 40 ± 3 µL
- Concentration: neat/ undiluted
POSITIVE CONTROL
- Amount(s) applied: 40 ± 3 µL
- Concentration: 8N - Duration of treatment / exposure:
- 3 min and 1 h
- Number of replicates:
- 2 per exposure time and per group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (of negative control)
- Run / experiment:
- mean value of test item, 3 min exposure
- Value:
- 98.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (of negative control)
- Run / experiment:
- mean value of test item, 1 h exposure
- Value:
- 116.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The mean OD value of the two negative control tissues was in the range of 0.8 - 3 at each exposure time (2.238 and 2.020 at at 3 min and 1 h exposure, respectively).
- Acceptance criteria met for positive control: Yes. The positive control treatment resulted in a viability of < 0,99% (0.6% at 1 h exposure).
- Acceptance criteria met for variability between replicate measurements: Yes. In the range 20 - 100 % viability and for ODs ≥ 0.3, difference of viability between the two tissue replicates did not exceed 30% in any case (negative control: 9% after 3 min exposure and 0.6% after 1 h exposure, treatment group: 10.5% and 2.1% after 3 min and 1 h exposure, respectively). Regarding the positive control the threshold of 30% was exceeded (40%), but as the OD 570 was < 0.3 it is not considered as a deviation.
Any other information on results incl. tables
Table 1: MTT assay after 3 min exposure
Negative control |
Positive control |
Test item |
||||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 |
2.142 |
2.334 |
- |
- |
2.091 |
2.301 |
OD570 (mean values of replicates) |
2.238 |
- |
2.196 |
|||
Viability (%) |
100 |
- |
98.1 |
Table 2: MTT assay after 1 h exposure
Negative control |
Positive control |
Test item |
||||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 |
2.027 |
2.013 |
0.010 |
0.014 |
2.331 |
2.368 |
OD570 (mean values of replicates) |
2.020 |
0.012 |
2.350 |
|||
Viability (%) |
100 |
0.60 |
116.3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat.1A) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant and shall therefore be subject to further evaluation.
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