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EC number: 443-090-0 | 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 October 24, 2001 to November 08, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- 443-090-0
- EC Name:
- -
- Cas Number:
- 477795-15-6
- Molecular formula:
- C26H24FN8Na3O14S4
- IUPAC Name:
- Trisodium 2-{2-[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazen-1-yl}-4-{[4-fluoro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktivgelb F-97494
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: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: Males: mean=199 g (=100%) (S.D.=±11.5 g); female animals: mean=180 g (= 100%) (S.D.=±7.5 g)
- 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
-Randomization procedure: Computer generated algorithm (archived with raw data) randomization schemes 2001.0529, 2001.0530
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: October 24, 2001 to November 08, 2001
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% solution in deionized water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION :Test substance was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test (according to toxicity data of related compounds)
-Duration of treatment: single dose - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Test Procedure:
The prepared test substance was administered by gavage to fasted animals at the stated dosage. 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 killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No symptoms were observed in male animals. Few clinical signs stilted gait and yellowish discoloured urine were observed after the administration of the test substance in female animals. However, from 2 d until the end of the study no symptoms were obser
- Gross pathology:
- The animals killed at the end of observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the oral LD50 of the test substance was found to be >2,000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP.
Group of three female and three male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% solution of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw.
No mortality occurred, no clinical signs were observed in male and no significant macroscopic abnormalities were seen at necropsy. Stilted gait and yellowish discolored urine were observed after the administration of test substance in female animals. However, there were no symptoms in female rats from Day 2 until the end of the study.
Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
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