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EC number: 202-902-1 | CAS number: 100-93-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- 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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- not specified
Test material
- Reference substance name:
- 4'-anilinotoluene-4-sulphonanilide
- EC Number:
- 202-902-1
- EC Name:
- 4'-anilinotoluene-4-sulphonanilide
- Cas Number:
- 100-93-6
- Molecular formula:
- C19H18N2O2S
- IUPAC Name:
- 4'-anilinotoluene-4-sulphonanilide
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Parameter:
- other: CRFT
- Value:
- 17.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Thisin vitrostudy was performed to investigate the potential ofN-(4-anilinophenyl)-4-methylbenzenesulfonamidetoactivate the Nrf2 transcription factor (sensitizing potential), by using the LuSens cell line.
A detailed listing of all measured and calculated values of the assay is given in Annex 2 (values of CRFT), Annex 3 (values of experiment I), and Annex 4 (values of experiment II). In addition, the final results of both experiments are summarized in table 8-a and 8-b and graphically illustrated in figure 8-a to 8-d.
The assay was performed in two independent experiments. 12concentrations of the test item were evaluated. The exposure time was 48 h. The following nominal concentrations of the test item were investigated in experiment I and II:
8.41 µM, 10.09 µM, 12.11 µM, 14.54 µM, 17.44 µM, 20.93 µM, 25.12 µM, 30.14 µM, 36.17 µM, 43.40 µM, 52.08 µM, 62.50 µM
None of the real treatment concentrations in both experiments deviated more than 10 % from the nominal concentration. At the end of treatmentprecipitates were visible in the CRFT at the concentrations15.63 µM to 2000 µM and in the experiments at the concentrations 17.44 µM to 62.50 µM.
EGDMA (120 µM) was used as positive control. The viability was above 70 % and a distinct increase in luciferase induction above 2.5 fold in comparison to the solvent control was detected. This luciferase induction is well within the historical data range of the positive control.
DL-lactic acid (5000 µM) was used as negative control. The viability was above 70 % and the induction of the luciferase was < 1.5 fold in comparison to the solvent control and well within the historical data range of the negative control (table 18-a).
The induction of the luciferase of the growth control (Medium no. 3) was < 1.5 fold.
Since all acceptability criteria of the assay were metthe study is valid.
In experiment I cytotoxic effects were observed at the concentration 17.44 µM as well as at the concentrations 25.12 µM to 62.5 µM. In experiment II cytotoxic effects were detected at the concentrations 14.54 µM to 62.5 µM.
Finally the following test item concentrations showed a viability ≥ 70 % and could therefore be evaluated for luciferase induction:
Experiment I: 8.41 µM, 10.09 µM, 12.11 µM, 14.54 µM, 20.93 µM
Experiment II: 8.41 µM, 10.09 µM, 12.11 µM
A substantial and reproducible dose dependent and statistically significantl (see Annex 8) increase in luciferase induction was measured in all non-cytotoxic test item concentrations. In those concentrations, the induction exceeded the threshold of 1.5 fold in comparison to the solvent control.
In conclusion, it can be stated that under the experimental conditions of this study, the test item,N-(4-anilinophenyl)-4-methylbenzenesulfonamide, was positive in the LuSens assay and is therefore considered to have the potential toactivate theNrf2transcription factor (sensitizing potential).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study, the test item, N-(4-anilinophenyl)-4-methylbenzenesulfonamide, was positive in the LuSens assay and is therefore considered to have the potential to activate the Nrf2 transcription factor (sensitizing potential).
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