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EC number: 464-700-1 | CAS number: 607724-42-5
- 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 Mar. 22, 2005 to Apr. 06, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 464-700-1
- EC Name:
- -
- Cas Number:
- 607724-42-5
- Molecular formula:
- Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na
- IUPAC Name:
- pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red F01-0481
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27. D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 178.5± 8.8 g (mean)
- Fasting period before study: yes
- Housing: In transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: ssniff® R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d
- Animal identification: fur marking with KMnO4 and cage numbering
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (short lasting deviations were permissible, e.g., during cleaning processes)
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From Mar. 22, 2005 to Apr. 06, 2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% suspension in deionized water
- Amount of vehicle (if gavage): 10 mL/kg bw
DOSAGE PREPARATION: Test substance was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer
CLASS METHOD: Acute toxic class method
- Rationale for the selection of the starting dose: The acute oral toxicity of test substance was tested only at a dose level of 2,000 mg/kg bw (limit test) according to toxicity data of related compounds. The animals received the test substance as a 20% suspension in deionized water, the administration volume was 10 mL/kg bw. As no compound-related mortality was produced in this limit test, no further dose was tested. - Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Twice every day (in the morning and in the afternoon), on weekends and public holidays only once
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, body weight, clinical observations and macroscopic examinations
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: Dark red discolored feces was the only clinical sign observed in the animals at the time point of 4-8 h after the administration of the test substance: From Day 2 until the end of the study no symptoms were observed.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 value for the test substance was found to be >2000 mg/kg bw.
- Executive summary:
A study was conducted to assess the acute toxicity of the test substance on rats according to EU Method B.1 and OECD Guideline 423, in compliance with GLP.
The substance was tested only at a dose of 2,000 mg/kg bw (limit test). The substance was administered by gavage to fasted animals as a 20% suspension in deionized water. The administration volume was 10 mL/kg bw. The observation period following treatment lasted for 14 d. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time, the animals were weighed weekly. At the end of the observation period, the animals were sacrificed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
No mortality or adverse effect on development of body weight was observed. No clinical signs, except discoloured feces at the time point of 4-8 h after administration, were observed. The macroscopic examination after sacrifice did not reveal any adverse effects.
Hence, under the test conditions, the oral LD50 was > 2,000 mg/kg bw (Kauffmann, 2005a).
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