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EC number: 271-351-7 | CAS number: 68541-71-9
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- EC Number:
- 271-351-7
- EC Name:
- Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- Cas Number:
- 68541-71-9
- Molecular formula:
- C32H17CrN6O11S.2Na
- IUPAC Name:
- disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- Test material form:
- other: Presscake
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Identification: FAT 20011/E TE
Batch: 130923 (China)
Purity: 65 %
Physical state / Appearance: dark blue solid
Sponsor (bulk) description: black powder which makes a blue solution.
Expiry date: 30 Sept 2018
Storage Conditions: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan™:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Weight at study initiation: 154 - 170 g
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light/day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): Volume (ml/kg body weight) applied: 10 - Doses:
- 3077 mg/kg bw (2000 mg a.i./kg bw)
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: Clinical observations were made 30 minutes, I, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: yes, At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 3 077 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period. Blue/black colored staining of the feces was noted in the initial treated animal 1 to 5 days after dosing. Blue colored staining of the urine and/or feces was noted in the four additi
- Gross pathology:
- No abnormalities were noted at necropsy of the initial treated animal. Patchy pallor of the liver and dark kidneys were noted at necropsy of the four additional treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 3077 mg/kg bw (equivalent to 2000 mg active ingredient/kg bw).
- Executive summary:
The study was performed to assess the acute oral toxicity of FAT 20011/E in the Wistar strain rats, according to OECD Guideline 420 and Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008. Following a sighting test at a dose level of 3077 mg/kg bw (equivalent to 2000 mg active ingredient/kg bw) in one female rat, an additional four fasted female animals were given a single oral dose of test item, as a solution in distilled water, at a dose level of 3077 mg/kg bw ( equivalent to 2000 mg active ingredient/kg bw). Mortality, clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy after observation period of 14 days. No deaths were observed during the course of study. No signs of systemic toxicity were noted during the observation period. Blue/black colored staining of the feces was noted in the initially treated animal 1 to 5 days after dosing. Blue colored staining of the urine and/or feces was noted in the four additional treated animals 2 hours to 7 days after dosing. All animals showed expected gains in body weight. No abnormalities were noted at necropsy of the initially treated animal. Patchy pallor of the liver and dark kidneys were noted at necropsy of the four additional treated animals.Based on these findings, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rats was estimated to be greater than 3077 mg/kg bw (equivalent to 2000 mg/kg active ingredient/kg bw) (Globally Harmonized Classification System - Unclassified).
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