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Diss Factsheets
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EC number: 276-057-2 | CAS number: 71832-85-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- information on start of stdy not yet available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across substance, well documented stdy, according GLP and guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]
- EC Number:
- 235-557-0
- EC Name:
- Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]
- Cas Number:
- 12286-65-6
- Molecular formula:
- C16H14N4O7S.1/2Ca
- IUPAC Name:
- calcium bis(3-nitro-4-{[2-oxo-1-(phenylcarbamoyl)propyl]diazenyl}benzenesulfonate)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ S.LO., Kolec u Kladna, Czech Republic, RCH CZ 21760118
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 16.6 - 19.22 g
- Housing: 6/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: DAB 433 - mixture of40% dimethylacetamide, 30% acetone and 30% ethanol
- Concentration:
- 0.2, 2, 20 % w/v
- No. of animals per dose:
- 5/dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 20% technically highest concentration
- Irritation: no effects or clinical symptoms
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: SI >=3
TREATMENT PREPARATION AND ADMINISTRATION: 25 ul of the appropriate dilution to the dorsum of each ear once a day morning for 3 consecutive days. The application was performed very slowly by micropipette. Losses caused by draining from the ear must be minimized.
Day 1:
Open application of 25f.lL (in the morning, by pipette) of appropriate suspensions of the test substance, the vehicle alone or the positive control to the dorsum of each ear.
Days 2 and 3:
The application procedure repeated as carried out on day 1.
Days 4 and 5:
No treatment.
Day 6:
Injection 250 ul of phosphate-buffered saline (PBS) containing 7.425 x10^5 Bq of 3H-methyl thymidine into all test and control mice via the tail vein. Five hours later, the animals were killed. - Positive control substance(s):
- other: Dinitrochlorobenzene (DNCB)
- Statistics:
- For statistical calculations the software Statgraphic ® Centurion (version XV, USA) was used. Statistical evaluation of measured parameters was performed at first by applying the non-parametric Kruskal-Wallis test for the comparison of the measured effect in all treatment groups with the vehicle control group, as global test, and then the non-parametric two-group Mann-Whitney rank test (probability level 0.05) for all two-group comparisons.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: negative control: 1, positive control: 9.56, 20% 1.58, 2% 1.05, 0.2% 1.18
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: mean 84.46, positive control: mean 807.23, 20% 133.59, 2% 88.33, 0.2% 99.78
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the given test conditions, the test substance does not elicit sensitising rl)~ponse in LLNA assay.
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