Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate;tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
EC number: 431-830-5 | 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-03-02 to 1998-05-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 mg/L and blank control
- Sampling method: water samples taken from the middle of the test chamber by pipetting approx 20 ml in to a screw neck glass bottle
- Sample storage conditions before analysis: No data - Vehicle:
- no
- Details on test solutions:
- Identity and concentration of auxiliary solvent for dispersal: None
Preparation details: Once the water had been added to the test substance, the mixture was homogenised using an Ultra Turrax and poured into the test chamber under stirring with a glass rod. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebra fish (Danio rerio Hamilton-Buchanan)
- Batch number: 16a/97/L2a
- Strain: not applicable
- Source: Hoechst Marion Roussel Deutschland GmbH Global preclinincal Development - Drug Safety
- Age at study initiation: > 71 days old at start of study (details not included in study report)
- Length at study initiation = mean 2.7 cm, variation 2.7-2.9, SD = 0.09 cm
ACCLIMATION
- Acclimation period: Stock held since 11 December 1997 and acclimated to for 15 days.
- Acclimation conditions
- Temp. = 22 ± 1 °C
- Type and amount of food: tetra Min, tetra Werke, twice daily
- Health during acclimation (any mortality observed): Not stated
- Population density: ≤1g fish/L water - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 2.1 mmol/L (Ca2+ and Mg2+)
- Test temperature:
- 21.3-21.7 °C (during test)
- pH:
- 7.5-8.0 (during test)
- Dissolved oxygen:
- 7.4-10.1 mg/L during study
- Salinity:
- N/A
- Nominal and measured concentrations:
- Nominal: 100 mg/L and 0 mg/L (control)
Measured concentrations: 96.8-97.1 mg/L and <0.5 mg/L (control) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria holding 4 L of test media
- Aeration: not aerrated during the course of the study
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water prepared according to the recommendations of ISO 7346
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Photoperiod: 12 light/12 h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Mortality. In addition subjective assessments were made on the type and incidence of sub-lethal effects compared with control fish, which included recording of visible changes in appearance and behaviour. Assessments were made at 3, 6, 24, 48, 72 and 96 hours.
TEST CONCENTRATIONS
- Range finding study: Not carried out
- Test concentrations: 100 mg/L - Reference substance (positive control):
- no
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- No mortality was observed at any point in time in either in the exposed or the control fish.
- Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- None
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 hour LC50, LC0 and NOEC of the test substance was determined to be > 100 mg/L (analytically verified).
- Executive summary:
A study was performed to assess the acute toxicity of test substance to Danio rerio (zebra fish) under static conditions. The study was conducted in accordance with EU Method C.1 and in compliance with GLP. Groups of seven fish of the recommended size were exposed to a limit test substance concentration of nominally 100 mg/L. The test substance was directly weighed to the test medium and no auxiliaries were used. The test substance was measured in the water at 96.97 mg/L. A control was also included (concentration <0.5 mg/L, limit of detection).
Observations were made on the number of dead fish and the incidence of sublethal effects after 3, 6, 24, 48, 72 and 96 hours of exposure. No mortality and no sublethal effects were observed in any of the test fish at any point in time. Therefore, under the employed test conditions the LC50 value at any time from 0-96 h was > 100 mg/L. An LC50 cannot be established, however it will be >100 mg/L.
This toxicity study is classified as acceptable and satisfies the guideline requirement.
Reference
Description of key information
The 96 hour LC50 value of the test substance was determined to be >100 mg/L (measured test substance). No mortality and no sublethal effects were observed in any of the test fish at any points in time. Therefore, no LC50 can be established.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
A study was performed to assess the acute toxicity of the test substance to Danio rerio (zebra fish) under static conditions. The study was conducted in accordance with EU method C.1 and in compliance with GLP. Groups of seven fish of the recommended size were exposed to a limit test substance concentration of nominally 100 mg/L. The test substance was directly weighed into the test medium and no auxiliaries were used. The test substance concentration in water was analytically measured at 96.97 mg/L. A control was included (concentration <0.5 mg/L).
Observations were made on the number of dead fish and the incidence of sublethal effects after 3, 6, 24, 48, 72 and 96 h of exposure. No mortality and no sublethal effects were observed in any of the test fish at any point in time. Therefore, under the employed test conditions the LC50 value at any time from 0-96 h was > 100 mg/L.
This toxicity study is classified as acceptable and satisfies the guideline requirement.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.