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EC number: 288-950-4 | CAS number: 85940-63-2
- 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:
- 1981-10-12 to 1981-11-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The test item (25%, diluted in demineralized water) was applied in a dose of 5000 mg/kg by gavage to 10 female Wistar rats after 16 hours and before 2 hours fasting period. The animals were observed for 14 days after application. Symptoms, mortility rate and time of death was examined. Animals which died caused by poisoning were dissected and macroscopic examined. After observation period, survivor animals were killed by CO2, dissected and also macroscopally examined.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- EC Number:
- 288-950-4
- EC Name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- Cas Number:
- 85940-63-2
- Molecular formula:
- C22H17N4Na3O13S4
- IUPAC Name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hoe WISKf(SPF71
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Weight at study initiation: 213 to 230 g
- Fasting period before study: 16 hours
- Housing: in groups in plastic cages on softwood granules
- Diet (e.g. ad libitum): ad libitum, food AL TROMIN 1324 from Altromin GmbH, Lage/Lippe
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- demineralized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% (25 g/ ad 100 ml)
MAXIMUM DOSE VOLUME APPLIED: 4.6 ml (230 g rat) - Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 10 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: body weight (weekly), mortality, clinical signs, time of death - Statistics:
- Determination of LD50
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- One animal died 120 min after application
- Clinical signs:
- 60 to 120 min after application following symptoms occurred: passivity, trembling, twitching, isolated tonic-clonic cramps, belly-tightened, extended eye lids. On day 2 these clinical signs returned and after 3 days all animals were free of symptoms.
- Body weight:
- No changes in body weight were observed.
- Gross pathology:
- In 5 of 9 animals, which have been killed after termination of the study, a spotted kidney were observed. In all other animals there were no macroscopically conspicuous findings.
- Other findings:
- Faeces and urine were coloured yellow.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to this study, the LD50 in female rats is >5000 mg/gk bw and thus a classification for acute toxicity is not required for the test item.
- Executive summary:
In an acute oral toxicity study, 10 female Wistar rats were given a single oral dose of the test item in a concentration of 25%, diluted in demineralized water at a dose of 5000 mg/kg bw and observed for 14 days.
Oral LD50 = >5000 mg/kg bw
During observation period, one animal died 120 min after treatment. Passivity, trembling, twitching, isolated tonic-clonic cramps, belly-tightened and extended eye lids were observed during the first two days after application. A spotted kidney was observed at necropsy in 5 of the 9 surviving animals. No other macroscopically conspicuous findings were reported.
Based on these results, the test item is of low toxicity based on the LD50 in female Wistar rats and according to CLP criteria classification of acute toxicity is not required.
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