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EC number: 947-125-5 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 4th June 1997 to 20th June 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of diazotized 4'-Amino-4-Nitrodiphenylamine-2-Sulfonic Acid coupled with Resorcinol, sodium salts
- EC Number:
- 947-125-5
- Molecular formula:
- Not applicable for UVCB substance
- IUPAC Name:
- Reaction products of diazotized 4'-Amino-4-Nitrodiphenylamine-2-Sulfonic Acid coupled with Resorcinol, sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER
- Age at study initiation: 4 weeks
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 108 - 130 g
- Fasting period before study: Food was removed approximately t8 hours prior to treatment.
- Housing: 5 housed in Malcrolon cages (55 x 32.7 x 19 cm) with sawdust bedding
- Diet: free access to a standard rat diet UAR A04C
- Water: ad libitum, in bottles.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 56 - 86 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Volume: 10 ml/kg - Doses:
- 2000 mg/kg b.w
- No. of animals per sex per dose:
- Main test: 5 per sex per dose
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed:
The necropsy included a revision ofthe intact animal and all its superficial tissues, followed by an observation of the cranial, thoracic and abdominal cavities both in situ and after evisceration.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the 14 day observation period.
- Clinical signs:
- The only observations made on the day of treatment were diarrhoea and the excretion of black-coloured faeces by all the animals on the following two days post-treatment
During the remaining days ofthe Study, no alterations were observed in any of the animals treated at 2000 mg/kg. - Body weight:
- All the animals of the dose group of 2000 mg/kg presented a normal evolution of growth.
- Gross pathology:
- In the necropsies carried out, the animals ofthe 2000 mg/kg dose did not show any visible macroscopic lesions.
Any other information on results incl. tables
PRELIMINARY STUDY
No mortality was recorded in the animal of the preliminary study, one female treated at 2000 mg/kg.
This female, treated at 2000 mg/kg, presented black-coloured faeces in the course of the following two days post-treatment.
No clinical signs were observed for the remaining days ofthe treatment. The female showed a normal evolution of growth.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) no 1272/2008
- Conclusions:
- The LD50 of test item in rats was found to be greater than 2000 mg/kg bw.
- Executive summary:
The acute toxicity of the substance was assessed following oral administration, in Sprague Dawley rats, by the fixed dose method according to the OECD Guideline No.420 (1992) and the Method B.1 bis of the Directive of the Commission of European Communities 92/69/EEC. The substance was administered at the dose of 2000 mg/kg.
None of the animals treated at the dose of 2000 mg/kg died in the course of the Study. The only observations made on the day of treatment and the following day were diarrhoea and the excretion of black-coloured faeces by all the animals. The evolution in bodyweight of all the animals was normal. In the necropsies. there were no macroscopic alterations detected.
The LD50 (oral, rat) was found to be greater than 2000 mg/kg bw.
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