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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1998-03-03 to 1998-03-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 6.2, 12.5, 25, 50, 100 mg/L
- Sampling method: No data - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Dilution of stock solution in test medium
- Controls: Inoculum in nutrient medium and water for dilution - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Scenedcsmus subspicatus CHODAT
- Source (laboratory, culture collection): Institute of Plant Physiology, University of Goettingen
- Inoculum: Algal suspension taken from an exponentially growing pre-culture which serves to adjust an initial cell density of 10 000 cells per milliliter
- Method of cultivation: in a light chamber at 23 ± 2 degrees C and with a quantum flux which equals 120 µE/m²/s - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- None
- Test temperature:
- 23°C
- pH:
- 7.0-10.4
- Dissolved oxygen:
- N/A
- Salinity:
- N/A
- Nominal and measured concentrations:
- Nominal concentrations: 6.2, 12.5, 25, 50, and 100 mg/L
Measured concentrations: 8.2, 11.0, 19.2, 38.3, and 76.7 mg/L (at 0 h); 11.0, 13.7, 21.9, 41.1, and 76.7 mg/L (at 72 h) - Details on test conditions:
- TEST SYSTEM
- Initial cells density: 10 000 cells per milliliter
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water
- 100 ml of test medium
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: counting - Microcellcounter Sysmex F-300 Digitana (SOP 2030-0001902-96 D)
TEST CONCENTRATIONS
- Test concentrations: 6.2,12.5, 25, 50, 100 mg/L
- Results used to determine the conditions for the definitive study: biomass, growth rate, cell density, TOC determination
TEST SYSTEM
- Test vessel: Erlenmeyer flasks (300 ml) with stoppers
- Material, size, headspace, fill volume: 100 mL test medium
- Aeration: No
- Initial cell density: 10,000 per mL
- Control end cells density: 674,000
- No. of vessels per concentration (replicates): No data
- No. of vessels per control (replicates): No data
GROWTH MEDIUM
- Standard medium used: No data
- Detailed composition if non-standard medium was used: No data
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionised water
- Total organic carbon: No data
- Particulate matter: No data
- Metals: No data
- Pesticides: No data
- Chlorine: No data
- Alkalinity: See pH measurements
- Ca/Mg ratio: No data
- Conductivity: No data
- Culture medium different from test medium: No data
- Intervals of water quality measurement: No data
OTHER TEST CONDITIONS
- Sterile test conditions: No data
- Adjustment of pH: No data
- Photoperiod: Continuous
- Light intensity and quality: 120 µE/m²/s
- Salinity (for marine algae): N.a.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Electronic particle counter
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Factor 2
- Range finding study: No - Reference substance (positive control):
- not specified
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- ca. 20.3 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- ca. 13.2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 29.7 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 20.3 - < 39.2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 39.2 - < 75.6 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): No data
- Any stimulation of growth found in any treatment: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No data
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- EC50 and EC10 estimated using binary regression (probit).
NOEC and LOEC determined using Dunnett's test. - Validity criteria fulfilled:
- yes
- Conclusions:
- The NOEC and LOEC for Reactive Navy FC63805 on Scenedesmus subspicatus (CHODAT) is 12.2 mg/L and 20.3 mg/L, respectively. The EC10 and EC50 (biomass) over 72 hours are 13.2 and 29.7 mg/L, respectively. The EC10 and EC50 (growth rate) are 13.2 and 20.3-39.2 mg/L, respectively.
- Executive summary:
In a 72 hour growth inhibition study, cultures of Scenedesmus subspicatus (CHODAT) were exposed to Reactive Navy FC63805 at concentrations of 6.2, 12.5, 25, 50, and 100 mg/L in accordance with EU method C.3. The NOEC and LOEC values based on cell density were 12.2 and 20.3 mg/L, respectively. The EC10 and EC50 values based on biomass were 13.2 and 29.7 mg/L, respectively. The EC10 and EC50 values based on growth rate were 20.3–39.2 and 39.2–75.6 mg/L, respectively.
This toxicity study is classified as acceptable and satisfies the guideline requirements for an algal inhibition test. However, due to reporting deficiencies and inaccurate presentation of effect values derivation of distinct key values for chemical assessment (i.e. EC10, EC50, or NOEC for chemical action) is not possible.
Results Synopsis
Test organism: Scenedesmus subspicatus (CHODAT)
72 hr NOEC based on cell density: 12.2 mg/L
72 hr LOEC based on cell density: 20.3 mg/L
72 hr EC10 based on biomass: 13.2 mg/L
72 hr EC50 based on biomass: 29.7 mg/L
72 hr EC10 based on growth rate: 20.3–39.2 mg/L
72 hr EC50 based on growth rate: 39.2–75.6 mg/L
Reference
Description of key information
Two studies on algal growth inhibition by Reactive Navy FC63805 were conducted according to EU method C.3. The test design of one study was modified in order to allow discrimination of effects caused by chemical action (toxicity) vs physical effects (light attenuation). There are indications of slight chemical toxicity of Reactive Navy FC63805 to algae, but the presentation of the data does not allow derivation of an EC10, EC50, or NOEC for chemical effects. Therefore, all effects are related to chemical exposure and substance toxicity to represent the worst-case in the chemical safety report.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 27 mg/L
- EC10 or NOEC for freshwater algae:
- 8.1 mg/L
Additional information
In a 72 hour growth inhibition study cultures of Scenedesmus subspicatus (CHODAT) were exposed to Reactive Navy FC63805 at nominal concentrations of 0, 12.5, 2.5, 50, 100 mg/L in accordance with EU method C.3. The test design was modified to allow discrimination between chemical action (toxicity) and physical effects (light attenuation by the coloured test substance). The EC10 and EC50 values based on biomass in the algicidal test (direct exposure) were < 9.5 and 9.5–20.3 mg/L, respectively. The EC10 and EC50 values based on growth rate in the algicidal test (direct exposure) were 8.1 and 27 mg/L, respectively. The EC10 and EC50 values based on biomass in the algistatic test (light attenuation) were < 9.5 and 9.5–20.3 mg/L, respectively. The EC10 and EC50 values based on growth rate in the algistatic test (light attenuation) were 9.5–20.3 and 20.3–37.8 mg/L, respectively. Due to reporting deficiencies and inaccurate presentation of effect values, derivation of key values for chemical assessment (i.e. EC10, EC50, or NOEC for chemical action) are directly referred to chemical exposure and substance toxicity to represent the worst-case scenario. The supporting study without modification for light absorption effects confirms the results (72 -h ErC10 >20.3 and <39.2 mg/L; 72 -h ErC50 >39 and <76 mg/L)
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.