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EC number: 247-501-2 | CAS number: 26175-68-8
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-08-03 to 2011-09-01
- 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:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide
- EC Number:
- 247-501-2
- EC Name:
- 4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide
- Cas Number:
- 26175-68-8
- Molecular formula:
- C8H10Cl2N2O2S
- IUPAC Name:
- 4-amino-2,5-dichloro-N,N-dimethylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): 4-Amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide, trocken
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 Winke1mann, 33178 Barchen, Germany
- Age at study initiation: 8 -9 weeks
- Weight at study initiation: 18 - 22 g
- Housing: Full barrier in an air-conditioned room, in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Adequate acclimatisation period (at least five days)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 8.25%, 16.5%, 33%
- No. of animals per dose:
- 5
- Details on study design:
- A solubility test was performed to determine the highest applicable concentration.
A preliminary test was performed to determine the highest tolerated and non-irritant test concentration. - Positive control substance(s):
- other: p-Phenylenediamine
- Statistics:
- EC3=c+[(3-d)/(b-d)]x(a-c)
Results and discussion
- Positive control results:
- p-Phenylenediamine (1 %) S.I.: 13.4
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: negative control: 1.0 08.25 %: 1.6 16.50 %: 1.4 33.00 %: 1.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 1185 08.25 %: 1887 16.50 %: 1672 33.00 %: 1330
Any other information on results incl. tables
None of the three tested concentrations of the test item caused a stimulation index equal or greater than 3.
All animals survived throughout the test period without showing any clinical signs. All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the outcome of this study the test item 4-Arnino-2,5-dichloro-N,N-dimethylbenzenesulphonamide, trocken, as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.
- Executive summary:
SUMMARY
Based on the results of the preliminary test the test item was assessed for sensitizing properties at concentrations of 8.25%, 16.5% and 33% (each suspended in AOO 4:1, v/v) according to OECD 429.
At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed.
Species/strain: Mice, CBA/CaOlaHsd
Number of animals: 20/main test
Vehicle: AOO (4: I (v/v) acetone/olive oil)
Summary Results
None of the three tested concentrations of the test item caused a stimulation index equal or greater than 3
The stimulation index at a concentration of 08.25 % was 1.6
The stimulation index at a concentration of 16.50 % was 1.4
The stimulation index at a concentration of 33.00 % was 1.1
Conclusion
The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
Consequently, according to OECD 429 the test item 4-Arnino-2,5-dichloro-N,N-dimethylbenzenesulphonamide, trocken, as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.
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