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EC number: 257-821-4 | CAS number: 52298-44-9
- 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 vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- the relative humidity was between 30-75%. This did not affect the validity of the study
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide
- EC Number:
- 257-821-4
- EC Name:
- 4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide
- Cas Number:
- 52298-44-9
- Molecular formula:
- C14H16N2O4S
- IUPAC Name:
- 4-amino-2,5-dimethoxy-N-phenylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): Chinonbasesulfanilide TTR
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 7 - 12 weeks (beginning of acclimatisation)
- Weight at study initiation: average : 19.9 g
- Housing: single in Makrolon Type I, with wire mesh top
- Diet : pelleted standard diet, ad libitum
- Water : tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 30 - 75
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 6.25, 12.5, 25.0 % (in DMF)
- No. of animals per dose:
- 4 per dose group
- Details on study design:
- Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 6.25, 12.5, and 25 % (w/v) in DMF. The application volume, 25 µl, was spread over the entire dorsal surface (diameter: ca. 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
3H-methyl thymidine (3HTdR) was purchased from GE Healthcare (specific activity, 2 Ci/mmol; concentration, 1 mCi/ml). Five days after the first topical application, all mice were administered with 250 µl of 81.18 µCi/ml 3HTdR (corresponds to 20.3 µCi 3HTdR per mouse) by intravenous injection via a tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Na-thiopental.
The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to plastic scintillation vials with 10 ml of scintillation liquid and thoroughly mixed.
The level of 3HTdR incorporation was then measured on ß -scintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The ß-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive control substance: -Hexylcinnamaldehyde
Vehicle: acetone:olive oil (4+1)
Test Conc. / DPM / number of lymph nodes / DPM per ln / S.I.
0 % / 3088 / 8 / 386 / --
5% / 7489 / 8 / 936 / 2.43
10% / 12552 / 8 / 1569 / 4.07
25% / 11327 / 6 / 1883 / 4.88
EC3 = 6.7 %
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see compilation above
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Conc. (%) / DPM (background) / lymph nodes / DPM per lymph node / S.I control / 8293 / 8 / 1037 / -- 6.25 / 5982 / 8 / 748 / 0.72 12.5 / 5038 / 8 / 630 / 0.61 25.0 / 6657 / 8 / 824 / 0.80
Any other information on results incl. tables
No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weights of the animals, recorded prior to the 1st application and prior to necropsy was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Chinonbasesulfanilide TTR was found to be not a skin sensitiser.
- Executive summary:
In the study the test item Chinonbasesulfanilide TTR suspended in DMF was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 6.25, 12.5, and 25 %.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 0.72, 0.61, and 0.80 were determined with the test item at concentrations of 6.25, 12.5, and 25 % in DMF, respectively.
The test item Chinonbasesulfanilide TTR was not a skin sensitiser in this assay. The EC3 value could not be calculated, since all S.I. were below 3.
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