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EC number: 442-450-4 | 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Please refer to Test guideline in 'Materials and methods'
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- Measured concentrations were below loading rate, effect concentrations refer to loading rate. Test item dispersion was filtered before testing
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, Switzerland
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: stock solutions, control, solvent control and 1 mg/L
- Sampling method: Duplicate samples were taken from the approximate center of the aquaria without mixing of the test medium and from freshly prepared test soutions, control and solvent control at the start of the test (Day 0) and at the last test medium preparation on Day 3.
- Sample storage conditions before analysis: deep-frozen (at about -20 °C) immediately after sampling - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solutions were prepared at the start of the test and at each test medium renewal by diluting 300 mg of the test item in 3 mL N,N-dimethylformamide (DMF) and ultrasonicating for 15 minutes. 250 mL were dosed into 2500 mL test water to obtain a loading rate of 10 mg/L. The dispersion was then stirred at room temperature over 96 hours. After stirring, the dispersion was filtered through a membrane filter (0.45 µm) just before test start and medium renewal.
- Controls: control: dilution water only, solvent control: dilution water and DMF
- Chemical name of vehicle: DMF
- Concentration of vehicle in test medium: stock solution: 100%, final test solutions: 100 µL/L, control: 0%, solvent control: 100 µL/L - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: obtained from Zoohaus Schaub, Liestal, Switzerland
- Length at study initiation: mean: 3.3 cm (SD: 0.2 cm)
- Weight at study initiation: mean: 0.37 g (SD: 0.11 g)
ACCLIMATION
- Acclimation period: 1 week
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Tetra Min® Hauptfutter (TETRA-Werke, Germany)
- Feeding frequency during acclimation: not reported, fish were fed until one day before the start of the test
- Health during acclimation: no mortality observed - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 250 mg/L as CaCO3
- Test temperature:
- 21 - 22 °C
- pH:
- 7.8 - 7.9
- Dissolved oxygen:
- 8.3 - 9.5 mg/L
- Nominal and measured concentrations:
- Nominal loading rate: 0 (control), 0 (solvent control), 10 mg/L
Measured concentrations: please refer to 'Any other information on results incl. tables' - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Material, fill volume: glass, 5 L
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.51 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water, composition: CaCI2 x 2H2O (294 mg/L), MgSO4 x 7H2O (123 mg/L), NaHCO3 (65 mg/L), KCl (65 mg/L)
- Ca/Mg ratio: 4:1
- Intervals of water quality measurement: appearance of medium, pH, dissolved oxygen and temperature were measured daily in freshly prepared and old medium before water renewal
OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark with a 30-minute transition period
- Light intensity: 280 - 500 lux
EFFECT PARAMETERS MEASURED: mortality and visible abnormalities after 3, 24, 48, 72 and 96 hours - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- loading rate
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: No toxic effect up to its solubility limit in the test water
- Details on results:
- - Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: clear test medium during the whole test - Sublethal observations / clinical signs:
Table 1: Number of affected fish during the test
Concentration (mg/L)
Number of affected fish* / number of dead fish
3 h
24 h
48 h
72 h
96 h
Control
0/0
0/0
0/0
0/0
0/0
Solvent control
0/0
0/0
0/0
0/0
0/0
10
0/0
0/0
0/0
0/0
0/0
Table 2: Measured test item concentrations
Nominal concentration of the test item [µg/L]
Sampling day / Age of sample (h)
Measured concentration
[µg/L]
% of nominal concentration
Stock solution
10000
0 / 0
91660
92
3 / 0
83835
84
Treatment samples
Undiluted filtrate
10 mg/L loading rate
0 / 0
1.67
n.a.
0 / 0
2.26
n.a.
1 / 24
0.785
n.a.
1 / 24
n.d.
n.a.
3 / 0
n.d.
n.a.
3 / 0
n.d.
n.a.
4 / 24
n.d.
n.a.
4 / 24
n.d.
n.a.
Biological control samples
0 / 0
n.d.
n.a.
1 / 24
n.d.
n.a.
3 / 0
n.d.
n.a.
4 / 24
n.d.
n.a.
Solvent control
0 / 0
n.d.
n.a.
1 / 24
n.d.
n.a.
3 / 0
n.d.
n.a.
4 / 24
n.d.
n.a.
Spiked water samples
50.3
0 / 0
41.0
82
0 / 0
48.4
96
n.a. = not applicable
n.d. = no test item detected, respectively < LOD of 0.2 µg/L
LOQ = 0.6 µg/L
Table 3: Validity criteria of OECD 203
Criterion from the guideline
Outcome
Criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
0
yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
8.3 - 9.5 mg/L
yes
Analytical measurement of test concentrations is compulsory
Test item concentrations were measured
yes
- Validity criteria fulfilled:
- yes
Reference
Description of key information
No adverse effect up to its solubility limit in the test water
LC50 (96 h): >10 mg/L (Danio rerio, OECD 203, loading rate)
Key value for chemical safety assessment
Additional information
A GLP study according to OECD guideline 203 on the acute toxicity to the zebrafish Danio rerio was performed in 96-hour semi-static test with a daily test medium renewal.
Due to the very low water solubility of the test item, an undiluted filtrate (0.45 µm filter pore size) of a supersaturated dispersion with the maximum concentration of dissolved test item was used as the only test concentration. The limit test was performed with the test substance loading rate of 10 mg/L. Additionally, a control and a solvent control (100 µL/L N,N-dimethylformamide) were tested in parallel.
The analytically determined test item concentrations in the freshly prepared test medium were in the range of 2.3 µg/L to < LOD (limit of detection: 0.2 µg/L). At the end of the test medium renewal periods of one day, the test item concentrations were in the range of 0.79 µg/L to < LOD. In the control, the solvent control and at the loading rate of 10 mg/L no mortality or other visible abnormalities were determined up to the solubility limits of the test item.
The LC50 (96 h) was therefore determined to be at a loading rate of > 10 mg/L.
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