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EC number: 434-050-3 | 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-04 to 2003-06-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- Part I, 1984-04-04
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2003-04-29
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
at ambient temp., dark, dry and in original container - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 27%, 37%, 53%, 72% and 100% saturated solutions starting from a 1000 mg/L stock solution
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna STRAUSS (Berlin)
- Age at study initiation: ≤ 24 h
- Method of breeding: In M4-medium at 20 ± 2°C in a 2 L beaker under a 16 h light/8 h dark cycle and medium renewal twice per week.
- Source: Umweltbundesamt Berlin
- Age of parental stock: Sep. 2001 (pretest), 2003-04-02 (main test)
- Feeding during test: No
- Food type: Finely ground fish feed Tetra Animin®, plus boiled and in M4-medium suspended single celled fresh water green algae (Desmodesmus subspicatus, Pseudokirchneriella subcapitata).
ACCLIMATION
- Acclimation period: 30 min in the water used in the preparation of the dilutions of the test substance. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- 21 ± 1°C
- pH:
- 7.8 - 7.9 (t= 0 h) and 8.2 - 8.3 (t= 48 h)
- Dissolved oxygen:
- 8.2 - 8.4 mg/L (t= 0 h) and 7.8 - 8.1 mg/L (t= 48 h)
- Salinity:
- CaCl2*2H2O: 179.0 mg/L
MgSO4*7H2O: 69.5 mg/L
NaCl: 16.1 mg/L
KCl: 0.65 mg/L - Nominal and measured concentrations:
- Pre-test: 0, 10, 100 and 1000 mg/L (nominal concentration)
Main-test: 0, 27, 37, 52, 72 and 100% (nominal saturation in respect to a 1000 mg/L stock solution) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 50 mL glass beaker
- Volume of solution: 20 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Neustader tap water with the addition of 179. 0 mg/L CaCl2*2H2O, 69.5 mg/L MgSO4*7H2O, 16.1 mg/L NaCl and 0.65 mg/L KCl to satisfy the criteria for minerals of the ISO 6341 and OECD No. 202 guidelines.
- Culture medium different from test medium: The culture medium was M4-medium, while the tests were conducted in supplemented Neustader tap water.
OTHER TEST CONDITIONS
- Light intensity: The tests were conducted without light.
EFFECT PARAMETERS MEASURED: Number of immobilized Daphnia after 24 and 48 h.
RANGE-FINDING STUDY
- Test concentrations: 0, 10, 100 and 1000 mg/L (nominal concentration) - Reference substance (positive control):
- yes
- Remarks:
- The positive control was performed with potassium dichromate (K2Cr2O7) at 7 different concentrations (3.0, 2.5, 1.5, 1.25, 1.0 and 0.625 mg/L) for 24 h at 21 ± 1°C. The Number of replicates und used Daphnia were the same as in the main test.
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: EC(50) > solubility of test material in test medium
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: NOEC >= solubility of test material in test medium
- Details on results:
- - Immobilisation of control:
0
- Effect concentrations exceeding solubility of substance in test water: Yes - Results with reference substance (positive control):
- - Results with reference substance valid:
Yes
-24 h EC50: 0.625 mg/L
-NOEC 48 h: 0.652 mg/L
- Reported statistics and error estimates:
- only for the test with reference material needed:
Program: Origin TM - Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of the test substance on Daphnia magna (age: <= 24 h) was assessed in a 48 h acute toxicity test conducted in freshwater in accordance with EN ISO 6341, following OECD 202 (1984). 5 concentrations (between 100% saturated solution and 27%) were tested resulting in an EC50 (48h) of > solubility of the test item in test medium (dissolved test item).
- Executive summary:
In this study, the water accommodated fraction of the test substance, was evaluated under laboratory conditions according to the OECD 202, for its potential acute toxicity on the aquatic invertebrate Daphnia magna. Following a pretest with nominal concentrations of 0, 10, 100 and 1000 mg/L, the main test was conducted with a saturated test solution (100%) and diluted samples of 72, 52, 37, 27 % test substance. The stock solution used was set up with an in-weight of 1000 mg/L. After 2 h of shaking the stock solution was filtered (0.45 µm) and used for testing.
Both tests were carried out under the same conditions: For 48 h at 21°C in a test volume of 20 mL without light and 4 replicas with each 5 Daphnia per concentration. Because a direct analytical verification method of the test substance was not available an unspecific DOC-analysis was performed as an alternative method (LOQ: 1 mg/L). In addition, a positive control test with the reference substance potassium dichromat was performed. Based on the number of immobilized Daphnia, the effect concentrations (48 h EC50) and the no-observed-effect concentration (NOEC) were determined. The conducted reference test with potassium dichromate as positive control resulted in a 24 h EC50 of 1.1 mg/L, which is in the range (0.6-2.4 mg/L) of the test requirements. In case of the main test, no immobilized Daphnia were observed in the negative control nor at nominal test substance concentrations of 27% and 100% after 48 h. At concentrations of 37% and 52% each a single individuum showed immobilization effects whereas and at 72% two individuals in different replicates were immobilized. The estimated immobilization values (5-10%) at these concentrations are in the uncritical range of the test criteria and is considered to be not significant. Because no effects were observed at the nominal test substance concentration of 1000 mg/L, the key effect concentration after 48 h (48 h EC50) was estimated to be above the tested maximum concentration. The corresponding NOEC is stated to be 100% (solubility of the test item in test medium.
Thus, under the condition of the test the EC(50) is > solubility of the test item in test medium.
Reference
Table 1: pH and O2-concentration
Saturation [%] |
pH [t = 0 h] |
pH [t = 48 h] |
O2-concentration [mg/L, t = 0 h] |
O2-concentration [mg/L, t = 48 h] |
0 |
7.9 |
8.2 |
8.3 |
7.8 |
100 |
7.8 |
8.2 |
8.4 |
7.9 |
72 |
7.8 |
8.3 |
8.2 |
8.0 |
52 |
7.8 |
8.3 |
8.2 |
8.0 |
37 |
7.8 |
8.3 |
8.2 |
8.0 |
27 |
7.8 |
8.3 |
8.3 |
8.1 |
Table 2: Results of the reference test
Conc. [mg/L] |
Immobilization [absolute num.] |
Immobilization [%] |
pH [t = 0 h] |
pH [t = 48 h] |
O2-conc. [mg/L, t = 0 h] |
O2-conc. [mg/L, t = 48 h] |
|||
0 |
0 |
0 |
0 |
0 |
0 |
7.8 |
8.0 |
8.6 |
8.6 |
3.0 |
5 |
5 |
5 |
5 |
100 |
7.7 |
7.8 |
8.8 |
8.6 |
2.5 |
5 |
5 |
5 |
5 |
100 |
7.7 |
7.8 |
8.8 |
8.6 |
2.0 |
5 |
5 |
5 |
5 |
100 |
7.7 |
7.8 |
8.9 |
8.5 |
1.5 |
5 |
5 |
5 |
4 |
95 |
7.8 |
7.8 |
8.8 |
8.7 |
1.25 |
2 |
4 |
0 |
4 |
50 |
7.8 |
7.8 |
8.8 |
8.6 |
1.0 |
0 |
0 |
3 |
5 |
40 |
7.8 |
7.7 |
8.7 |
8.8 |
0.625 |
0 |
0 |
0 |
1 |
5 |
7.8 |
7.7 |
8.5 |
8.8 |
Table 3: Endpoints determined form the reference test
Endpoint |
Value [mg/L] |
Error |
NOEC 48 h |
0.625 |
n.a. |
24 h EC50i |
1.1 |
n.a. |
24 h EC100i |
2.0 |
n.a. |
Table 4: Results of the pre-test
Conc. [mg/L] |
Immobilization [absolute num.] |
Immobilization [%] |
pH [t = 0 h] |
pH [t = 48 h] |
O2-conc. [mg/L, t = 0 h] |
O2-conc. [mg/L, t = 48 h] |
|||
0 |
0 |
0 |
0 |
0 |
0 |
7.9 |
8.1 |
8.3 |
8.2 |
1000 |
2 |
1 |
2 |
1 |
30 |
7.9 |
8.0 |
8.4 |
8.2 |
100 |
0 |
0 |
0 |
0 |
0 |
7.9 |
8.0 |
8.1 |
8.3 |
10 |
0 |
0 |
0 |
0 |
0 |
7.9 |
8.1 |
8.0 |
8.2 |
Table 5: Results of the main test
Conc. [mg/L] |
Immobilization [absolute num., t = 24 h] |
Immobilization [%, t = 24 h] |
Immobilization [absolute num., t = 48 h] |
Immobilization [%, t = 48 h] |
||||||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
1 |
0 |
0 |
5 |
1 |
1 |
0 |
0 |
10 |
52 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
1 |
0 |
5 |
37 |
1 |
0 |
0 |
0 |
5 |
1 |
0 |
0 |
0 |
5 |
27 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 6: Endpoints determined from the main test
Endpoint |
Value |
95 % confidence interval |
NOEC 48 h |
100 % saturation |
n.a. |
48 h EC50i |
>100 % saturation |
n.a. |
48 h EC100i |
>>100 % saturation |
n.a. |
Table 7: Results of the DOC-analysis
Saturation [%] |
DOC -conc. [mg/L] |
DOC [%] |
|
0 h |
48 h |
48 h |
|
0 |
5.11 |
4.56 |
89 |
100 |
3.58 |
3.86 |
108 |
72 |
2.77 |
3.15 |
114 |
52 |
2.35 |
3.36 |
143 |
37 |
2.05 |
2.72 |
133 |
27 |
2.50 |
3.41 |
136 |
Description of key information
The effect of the test substance on Daphnia magna (age: <= 24 h) was assessed in a 48 h acute toxicity test conducted in freshwater in accordance with EN ISO 6341, following OECD 202 (1984). 5 concentrations (between 100% saturated solution and 27%) were tested resulting in an EC50 (48h) of > solubility of the test item in test medium (dissolved test item).
Key value for chemical safety assessment
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.
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