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EC number: 876-151-9 | CAS number: 2292123-68-1
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- June 18, 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea
- EC Number:
- 876-151-9
- Cas Number:
- 2292123-68-1
- Molecular formula:
- C27H24N2O7S2
- IUPAC Name:
- N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended in the test guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: LabCyte EPI-MODEL24 - SIT
- Tissue batch number(s): LCE24-200727-A
- Expiry date: 31 July 2020
- Date of initiation of testing: 29 July 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsed 15 times or more with PBS
- Observable damage in the tissue due to washing: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.5mg/mL per well
- Incubation time: 180 +/- 5 minutes
- Spectrophotometer: FLUOstar Omega, BMG LABTECH
- Wavelength: 570 and 650nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD 1.1
- Barrier function: IC50 = 0.27%
- Morphology: Observation of multilayered epidermis with a stratum corneum
NUMBER OF REPLICATE TISSUES: 3 - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- Negative control: Distilled water - 25µl
Positive control: 5% w/v SDS solution - 25µl
Test item: neat (triplicate) - 25 mg - Duration of treatment / exposure:
- 15 minutes +/- 3 minutes
- Duration of post-treatment incubation (if applicable):
- 42 +/- 1 hr
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 92.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 90.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 103.4
- Vehicle controls validity:
- not applicable
- 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 - mean measurement OD was 0.737
- Acceptance criteria met for positive control: yes - mean cell viability was 2.8
- Acceptance criteria met for variability between replicate measurements: yes - SDs of cell viability were, 2.7%, 1.0% and 7.1%
Any other information on results incl. tables
Table 2: Result of skin irritation test
Group | Tissue no. | Measurement value | Cell viabilitya)(%) | SDc) (%) | Category | ||
Mean | Meand) | ||||||
Negative control (Distilled water) | 1 | 0.759 | 0.737 | 103.0 | 100.0 | 2.7 | - |
2 | 0.721 | 97.8 | |||||
3 | 0.731 | 99.2 | |||||
Positive control (5% w/w SDS solution) | 1 | 0.014 | 0.021 | 1.9 | 2.8 | 1.0 | - |
2 | 0.02 | 2.7 | |||||
3 | 0.029 | 3.9 | |||||
Test Itemd) | 1 | 0.679 | 0.702 | 92.1 | 95.3 | 7.1 | Non-irritant |
2 | 0.665 | 90.2 | |||||
3 | 0.762 | 103.4 |
a) Cell viability in the negative control was regarded as 100%
b) The mean cell viability was calculated from mean OD value of each group
c) The SD was calculated from the cell viability (n=3) of each tissue insert
d) The mean OD value was not corrected because the staining ratio was <5%
Table 3: Results of tissue-binding test
Group | Tissue no. | Measurement value | Staining ratiob) (%) | |
Mean | ||||
Negative contol itema) | 1 | 0.000 | 0.0 | - |
2 | 0.000 | |||
Test itema) | 1 | 0.000 | 0.0 | 0.0 |
2 | 0.000 |
a) Medium without MTT was used instead of MTT medium
b) staining ratio ([mean OD value of the test item (without MTT)] - [mean OD value of negative control (without MTT)] / [mean OD value of negative control (with MTT)]) x 100
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean cell viability of the test item was 95.3% and therefore the substance is not classified as a skin irritant.
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