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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- 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
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- RECONSTRUCTED HUMAN CORNEAL (EIT) TISSUE
- Model used: LabCyte CORNEAL-MODEL24 EIT (model recommended in test method)
- Tissue batch number(s): LCC24-200817-A
- Expiry date: 21 August 2020
- Date of initiation of testing: 19 August 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent no treatment
- Amount / concentration applied:
- Negative control: No treatment
Positive control: Lauric acid - 10 mg
Test item: neat (triplicate) - 10 mg - Duration of treatment / exposure:
- 24 hours
- Duration of post- treatment incubation (in vitro):
- 240 minutes +/- 15 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissue insert is completely submerged three times
(in a beaker with approx. 100mL PBS) for rinsing. Rinsed ten times or more with PBS
- Observable damage in the tissue due to washing: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- WST-8 solution*: 200µL per well
- Incubation time: 240 +/- 15 minutes
- Spectrophotometer: FLUOstar Omega, BMG LABTECH
- Wavelength: 450 and 650nm
*WST-8 solution: Cell counting Kit-8 (WST-8: Lot number NG023, DOJINDO Laboratories) diluted with Earle's balanced salt solution (EBSS: Lot number RNBG9914, SIGMA-ALDRICH). WST-8 : EBSS 1 : 10.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD 1.3
- Barrier function: IC50 = 0.28%
- Morphology: Observation of Corneal model(including at least 3 layers of epithelial cells and a non-keratinized surface)
NUMBER OF REPLICATE TISSUES: 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- mean percent tissue viability
- Value:
- 91.1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 1
- Value:
- 95.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 2
- Value:
- 95.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 3
- Value:
- 81.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 2: Result of eye irritation test
Group | Tissue no. | Measurement value | Cell viabilityb), c) (%) | SDe) (%) | Category | |||
Corrected valuea) | Mean | Meand) | ||||||
Negative control (non-treatment) | 1 | 1.179 | - | 1.300 | 90.7 | 100.0 | 15.4 | - |
2 | 1.531 | - | 117.8 | |||||
3 | 1.189 | - | 91.5 | |||||
Positive control (Lauric acid) | 1 | -0.004 | - | -0.004 | 0.0 | 0.0 | 0.0 | - |
2 | -0.005 | - | 0.0 | |||||
3 | -0.004 | - | 0.0 | |||||
Test Item | 1 | 1.247 | 1.247 | 1.184 | 95.9 | 91.1 | 0.0 | Non-irritant |
2 | 1.241 | 1.241 | 95.5 | |||||
3 | 1.063 | 1.063 | 81.8 |
a) OD value was corrected by the result of the binding test
Corrected measurement value = [OD value of the test item (with WST-8)] - {[mean OD value of othe test item (without WST-8)] / [mean OD value of negative control (without WST-8)]}
b) Cell viability in the negative control was regarded as 100%
c) If cell viability was <0, the value was considered to 0%
d) the mean cell viability was calculated from mean OD value of each group
e) The SD was calculated from the cell viability (n=3) of each tissue insert
Table 3: Results of tissue-binding test
Group | Tissue no. | Measurement value | |
Mean | |||
Negative contol (no treatment)a) | 1 | -0.045 | -0.045 |
2 | -0.045 | ||
Test itema) | 1 | -0.045 | -0.045 |
2 | -0.045 |
a) EBSS was used instead of WST-8 solution
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The mean cell viability of the test item was 91.1% and therefore the substance is not classified as an eye irritant.
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