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4-amino-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-3-(2-sulfonato-4-(2-sulfonatooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate potassium/sodium;reaction mass of: 4-amino-3-(4-ethenesulfonyl-2-sulfonatophenylazo)-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)naphthalene-2,7-disulfonate potassium/sodium
EC number: 451-440-9 | CAS number: 586372-44-3
- 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:
- June 05 to Jully 30, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Experimental test performed under GLP conditions and according to OECD Guideline and EC method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Identification FAT 40'815/A
Description Dark shining solid
Batch number WP 8/03
Purity Approx. 75 %
Expiry date 01-MAY-2010
Stability of test item dilution Stable in water for at least 7 days at room temperature.
Storage conditions In the original container, at room temperature
(range of 20 ± 3 °C), away from direct sunlight.
Safety precautions Routine hygienic procedures were used to ensure the health
and safety of the personnel.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Test system : Rat, HanBrl: Wist (SPF)
- Rationale : Recognized by the international guidelines as a recommended test system.
- Source : RCC Ltd, Laboratory Animal Services
CH-4414 Füllinsdorf / Switzerland
- Number of animals per group : 3 females
- Total number of animals : 6 females
- Age when treated : 12 weeks
- Identification : Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
- Randomization : Selected by hand at time of delivery. No computer generated randomization program.
- Acclimatization : Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
- Husbandry conditions : Conditions Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 %
during cleaning process possible), 12 hours fluorescent light/ 12 hours dark, music during the light period.
- Diet : Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 04/03 (Provimi Kliba AG, CH-4303
Kaiseraugst/Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water : Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Faste period before treatment : approximately 17 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: purified water
- Details on oral exposure:
- The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL and administered at a volume dosage of 10mL/kg.
- Doses:
- a single dose of 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 females
- Details on study design:
- The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for approximately 17 hours (access to water was permitted). Food was provided again 3 hours after dosing.
The application volume was 10 mL/kg body weight.
Rationale: Oral administration was considered to be an appropriate application method as it
is a possible route of human exposure during manufacture, handling and use of the test
item.
Observations :
Mortality / Viability Daily during acclimatization and twice daily during days 1 -15.
Body weights On test days 1 (prior to administration), 8 and 15.
Clinical signs Daily during acclimatization and at approximately 1,2,3 and 5 hours after administration on test day 1. Once daily during days 2-15. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
- Clinical signs:
- other: No clinical signs were observed during the course of the study.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of FAT40'815/A after single oral administration to female rats, observed over a period of 14 days is:
LD50 (female rat): greater than 2000 mg/kg body weight - Executive summary:
All animals survived, no clinical signs were observed during the course of the study. Only one animal showed a loss of body weight (0.5%), another animal did not gain body weight from test day 8 to the end of the observation period and for the remaining animals their body weight was within the range commonly recorded for this strain and age.
No significant adversed effect of FAT40812/A via single oral dose of 2000 mg/kg bw in female rat can be concluded.
LD50 (female rat) >2000 mg/kg body weight
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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