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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 5,5'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[3-methylsalicylic] acid, potassium salt, compound with 2,2',2''-nitrilotriethanol and potassium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxy-7-sulfonaphthalene-2-sulfonate - 2,2',2''-nitrilotriethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, potassium salt, compound with 2,2',2''-nitrilotriethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, potassium salt, compound with 2,2',2''-nitrilotriethanol
EC number: 943-311-5 | 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:
- 2018-02-22 and 2018-04-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 50, 20, 10, 5, 2, 1 and 0.5 μg/mL
- Samples of each test item concentration and the control were collected at exposure initiation and at exposure termination. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- The definitive test was performed with the test item concentration 120 mg/L plus the control.
- 480.3 mg of the test item were weighed into a glass crystallizer and quantitatively transferred into a glass aquarium using the test medium. After mixing, the resulting test item concentration 120 mg/L of a total volume 4 L in the aquarium was homogeneous, without visible non-dissolved particles and black-colored.
- The control was the test medium of a total volume 4 L in an aquarium. Seven fish were introduced into every aquarium. Every treatment was tested in one replicate (i.e. a total of 2 test vessels). - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Brachydanio rerio, syn. Danio rerio
- Source: Laboratory of Aquatic Toxicology at the Institute of Industrial Organic Chemistry Branch Pszczyna, initiated from the fish acquired from ‘The Culture of fish in Goczałkowice’
- Age at study initiation: approximately 3 months old
- Length at study initiation (average): 2.51 cm ± 0.13
- Weight at study initiation (average): 0.2 g ± 0.02
- Feeding during test: none
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: yes
- Type and amount of food: flake food and live feed (i.e. Daphnia magna and Artemia salina)
- Health during acclimation (any mortality observed): The mortality in the fish population during the quarantine period was 0.8% (one dead fish out of 125 in the batch). The fish were healthy, free from external parasites and visible deformations. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 233 mg/L CaCO3
- Test temperature:
- 21.7 – 23.5 ºC
- pH:
- 7.35 - 7.61
- Dissolved oxygen:
- 94 – 99%
- Salinity:
- not applicable
- Conductivity:
- 628 µS/cm
- Nominal and measured concentrations:
- nominal concentrations: 120 mg/L (101.8 mg/L nom conc of main ingredient)
measured concentrations: 97.2 mg/L (at exposure initiation) and 96.6 mg/L (at exposure termination) - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquaria
- Type: closed (Glass aquaria covered with glass lids in order to minimize evaporation and to prevent accidental loss of fish (due to jumping out) and accidental contamination.)
- Material, size, headspace, fill volume: 4 L
- Aeration: constant aeration
- No. of organisms per vessel: 7
TEST MEDIUM / WATER PARAMETERS
- Reconstituted water according to OECD guideline
EFFECT PARAMETERS MEASURED:
- pH values were measured at exposure initiation, at 24 h of exposure, at 48 h of exposure, at 72 h of exposure and at exposure termination.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 120.0 mg/L
- Results used to determine the conditions for the definitive study: The results of the observations for fish mortality and changes in behaviour, respiration and pigmentation were conducted repeatedly during the exposure after 3, 6, 24, 48, 72 and 96h. In the control and in the test item concentration 120 mg/L neither mortality of fish nor any symptoms of intoxication were observed. Therefore, a limit test was to be performed in the definitive test. - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 120 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 120 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 120 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- No mortality of fish and no other symptom was observed.
Reference
Description of key information
In a 96 hours acute toxicity study, approximately 3 months old zebrafish (Danio rerio) were exposed to the test item, Direct Black 18L NA active dye, in groups of seven animals per treatment in one replicate. The test was of static design. The test item concentration was prepared by mixing the proper amount of the test item with the test medium (i.e. reconstituted water). The resulting test item concentration 120 mg/L was visually homogeneous, colored and without visible non-dissolved particles. The control was test medium.
The content of the main ingredient in the test item concentrations was determined with a validated spectrophotometric method. Samples of the test item concentration 120 mg/L and the control collected at exposure initiation and at exposure termination were chemically analyzed. At exposure initiation the determined content of the main ingredient in the test item concentration was 97.2 mg/L, i.e. 115 mg test item/L and 95.5% of the nominal concentration. At exposure termination the determined content of the main ingredient in the test item concentration was 96.6 mg/L, i.e. 114 mg test item/L and 94.9% of the nominal concentration. Therefore, the test item concentration was stable under test conditions. At exposure termination in the control and in the test item concentration 120 mg/L no mortality of fish nor any symptoms of intoxication were observed.
Results:
The endpoint values:
LC50/96 h is higher than 120 mg/L
LOEC/96 h is higher than 120 mg/L
NOEC/96 h is higher than or equal to 120 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 120 mg/L
Additional information
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.