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EC number: 269-505-3 | CAS number: 68259-02-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 September, 1992 to 08 October, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
- EC Number:
- 269-505-3
- EC Name:
- Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
- Cas Number:
- 68259-02-9
- Molecular formula:
- C25H19ClN10O16S5.5Na
- IUPAC Name:
- pentasodium 4-amino-6-({5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfonatophenyl}diazenyl)-3-[(2,5-disulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: and BRL, Biological Research Laboratories, Ltd. Wolferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 190-205 g; females: 172-182 g
- Housing: Groups of five in Makrolon type-3 cages (size: 22 x 37.5 x 15 cm) with standard (softwood bedding ("Lignocel" , Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batch 88/92 rat maintenance diet ("Kliba". Klingentalmuehle AG. CH-4303 Kaiseraugst) (ad libitum except for overnight fasting period)
- Water: Community tap water ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination. Only animals without any visual signs of illness were used for the study.
- Identification: by unique cage number and corresponding color-coded spots on the tail
- Randomization: Randomly selected at time of delivery in groups of five.
- Fasting period before study: 16 to 17 h
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 air changes/h
- Photoperiod: 12 h/12 h (music during the light period)
IN-LIFE DATES: From: September 17, 1992; To: October 8, 1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: bidistilled water
- Details on oral exposure:
- TEST SUBSTANCE PREPARATION
The test substance was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bidistilled water) was added. A w/v dilution was prepared using a homogenizer. Homogeneity of the test substance in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to each dosing.
Application Volume/kg bw: 10 mL at 2000 mg/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 d
- Necropsy of survivors performed: yes; all animals were necropsied. All animals were euthanized by intraperitoneal injection of sodium pentobarbitone.
- Other examinations performed: clinical signs, body weight
- Mortality/Viability: Four times during test Day 1 (according to the laboratories SOP's the last check was conducted 5 h after application), and daily during Days 2-15.
- Body Weights: Test Days 1 (pre-administration), 8 and 15.
- Clinical Signs: Each animal was examined for changes in appearance and behaviour four times during Day 1, and daily during Days 2-15. All abnormalities were recorded. The animals were checked for the clinical signs. - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
Results and discussion
- Preliminary study:
- No data
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: other details not available
- Mortality:
- No premature death occurred.
- Clinical signs:
- other: Sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after administration of test substance.
- Gross pathology:
- No macroscopic findings were observed.
- Other findings:
- No data
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test substance was found to be >2000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance (of 100 % purity) in HanIbm: WIST (SPF) rats according to OECD Guideline 401and EU Method B.1 in compliance with GLP.
Groups of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals after a 15 d observation period.
No mortality occurred and no significant macroscopic abnormalities were seen at necropsy. Further, there were no effect on body weight gain. However, sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after dosing.
Under the study conditions, the oral LD50 of the test substance was found to be >2000 mg/kg bw in rats.
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