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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
EC number: 222-426-8 | CAS number: 3468-11-9
- 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:
- 2017-08-07 to 2017-08-11
- 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:
- - Nominal concentrations: Control and 43.4, 52.1, 62.5, 75.0 and 90.0 mg/L test item nominal
- Sampling method: taken in 24 h intervals from fresh and aged test solutions. For each sampling also a retain sample was taken.
- Sample storage conditions before analysis: 10 mL samples were taken and stabilized with 50 µL acetic acid and analyzed immediately - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stock solution: weighed necessary amounts of test item into a volumetric flask and added test medium up to the bench mark then homogenized by 2 minutes of ultrasonication - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: own stock breeding of the lab, originally purchased from the Karlsruhe Institute of Technology
- Method of breeding: fed with commercial fish flake food (TetraMin) and protein-enriched pellet food (Caviar) at least once per day
- Maintenance of the brood fish: continuously reared in the lab
FEEDING DURING TEST
- Frequency: none - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 250 mg CaCO3/L
- Test temperature:
- 21.9 – 24.4 °C
- pH:
- 7.20 – 8.78
- Dissolved oxygen:
- 68 - 104 % of air saturation
- Conductivity:
- 792 µS/cm
- Nominal and measured concentrations:
- Nominal: 43.4, 52.1, 62.5, 75.0 and 90.0 mg/L
Measured: 23.3, 28.4, 32.4, 42.1, 42.6 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 2 L glass beaker
- Fill volume: filled with 2 L of test solution
- Aeration: none
- Renewal of test solution: every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: max. loading of 0.41 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water consisting of analytical grade salts dissolved in purified water with a ratio of Ca:Mg and Na:K of 4:1 and 10:1, respectively
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Biological Assessment: effects and mortality assessed at 0, 4, 24, 48, 72 and 96 hours after test start; all fish were euthanized, weighed and measured at the end of test.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 50, 70, 90 mg/L
- Results used to determine the conditions for the definitive study: Mortality [%]: 33% at 70 mg/L, 100% at 100 mg/L. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 25.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 23.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality: see section 'Any other information on results'
- Clinical signs: No sublethal effects were observed after 4 hours. After 24 hours many fish showed reduced activity and were swimming at the bottom of the test vessel in the two highest test concentrations. Additionally, after 24 hours, some fish showed increased respiration at 42.1 mg/L. After 48 hours, one fish was swimming at the bottom at 42.1 mg/L. After 72 hours, fish were swimming at the surface at 28.4 mg/L and 32.4 mg/L.
- Length and weight: The average weight of the test organisms was 0.0838 ± 0.0443 g; the average length was 19.1 ± 2.8 mm.
- Analytical Results: The measured content of test in fresh test solutions was between 73 % and 92 % of nominal and 26-38 % of nominal in aged test solutions - Reported statistics and error estimates:
- The NOEC (mortality) was established based on the highest test concentration at which no mortality above the allowed control mortality was observed. The LC50-values after 4, 24, 48 and 72 h were determined by Logit analysis using linear max. likelihood regression.
- Sublethal observations / clinical signs:
Biological results:
% mortality of fish in the main test:
Nominal test item conc. [mg/L]
Control
43.4
52.1
62.5
75.0
90.0
Measured test item conc
(mg/L)
Control
23.3
28.4
32.4
42.1
42.6
Time [h]
Mortality [%]
4 h
0
0
0
0
0
0
24 h
0
0
0
0
0
14
48 h
0
0
0
14
57
100
72 h
0
0
29
71
100
100
96 h
0
14
100
100
100
100
pre-test
Determined concentrations of test item during the test:
Test item
nominal
Sampling
Test item
Geometric mean
Test item concentration
measured
[mg/L]
[mg/L]
% of
nominal
[%]
[mg/L]
0
0 h fresh
n.d.
-
-
24 h aged
n.d.
-
24 h fresh
n.d.
-
48 h fresh
n.d.
-
72 h fresh
n.d.
-
96 h aged
n.d.
-
43.4
0 h fresh
31.6
73
53.7
23.3
24 h aged
16.7
38
24 h fresh
36.9
85
48 h fresh
36.1
83
72 h fresh
34.5
79
96 h aged
14.9
34
52.1
0 h fresh
47.8
92
54.6
28.4
24 h aged
18.8
36
24 h fresh
41.3
79
48 h fresh
45.6
88
72 h fresh
42.5
82
96 h aged
17.8
34
62.5
0 h fresh
56.9
91
51.8
32.4
24 h aged
21.1
34
24 h fresh
48.9
78
48 h fresh
55.6
89
72 h fresh
48.9
78
96 h aged
18.5
30
75.0
0 h fresh
67.3
90
56.1
42.1
24 h aged
27.9
37
24 h fresh
59.7
80
48 h fresh
64.0
85
90.0
0 h
82.1
91
47.3
42.6
24 h aged
23.4
26
24 h fresh
73.3
81
- Validity criteria fulfilled:
- yes
- Conclusions:
- The LC50 (96 h) of the test item was determined to be 25.7 mg/L (geometric mean of measured concentrations). The corresponding NOEC (mortality) (96 h) was 23.3 mg/L (geometric mean of measured concentrations). No sublethal effects were observed in the control and at 23.3 mg/L, 28.4 mg/L and 32.4 mg/L (geometric mean of measured concentrations) after 96 h.
- Executive summary:
The effects of the test item on the mortality of the Zebrafish Danio rerio were determined under worst-case exposure conditions according to OECD 203. The test item was evaluated in a semi-static dose response test with daily water renewal, with five test item (43.4, 52.1, 62.5, 75.0 and 90.0 mg/L) nominal concentrations and one control with untreated test medium. The test concentrations and control contained seven fish. The test duration was 96 hours. Assessments on sublethal effects and mortality were conducted after 0, 4, 24, 48, 72 and 96 hours.
The measured content of test item in fresh test solutions was between 73 % and 92 % of nominal concentration. In the aged solutions, 26-38 % of the nominal concentration was measured. The toxicological endpoints were evaluated using geometric mean of the measured test item concentrations.
The LC50 (96 h) of the test item was determined to be 25.7 mg/L (geometric mean of measured concentrations). The corresponding NOEC (mortality) (96 h) was 23.3 mg/L (geometric mean of measured concentrations). No sublethal effects were observed in the control and at 23.3 mg/L, 28.4 mg/L and 32.4 mg/L (geometric mean of measured concentrations) after 96 h.
Reference
Description of key information
For this endpoint, one short-term toxicity to fish study is available which has been performed according to OECD 203. The toxicity towards Danio rerio was assessed in a semi-static dose response test with daily water renewal and 5 test item concentrations plus control. Fish were exposed for 96h.
The LC50 (96 h) of the test item was determined to be 25.7 mg/L (geometric mean, measured concentration). The corresponding NOEC (mortality) (96 h) was 23.3 mg/L (geometric mean, measured concentration).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 25.7 mg/L
Additional information
For this endpoint only one test is available. The effects of the test item on the mortality of the Zebrafish Danio rerio were determined under worst-case exposure conditions according to OECD 203.
The test item was evaluated in a semi-static dose response test with daily water renewal, with five test item (43.4, 52.1, 62.5, 75.0 and 90.0 mg/L) nominal concentrations and one control with untreated test medium. The test concentrations and control contained seven fish. The test duration was 96 hours. Assessments on sublethal effects and mortality were conducted after 0, 4, 24, 48, 72 and 96 hours.
The LC50 (96 h) of the test item was determined to be 25.7 mg/L (geometric mean, measured concentration). The corresponding NOEC (mortality) (96 h) was 23.3 mg/L (geometric mean, measured concentration). No sublethal effects were observed in the control and at 23.3 mg/L, 28.4 mg/L and 32.4 mg/L (geometric mean, measured concentration) after 96h.
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.