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EC number: 428-190-4 | CAS number: 68490-66-4 CUREZOL 2MA-OK
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 - 19 Mar 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt, Messungen und Naturschutz, Karlsruhe, Germany (10 Dec 2015)
Test material
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and highest test item concentration at test start, after 24 h (fresh and aged solutions) and after 48 h (aged solutions).
- Sampling method: Two samples were taken and a retain sample was also taken for each sampling.
- Sample storage conditions before analysis: Deep frozen (≤ 18 °C)
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 100 mg/L test item was prepared by adding the necessary amount of test item to the test medium and treating the solution with 10 min ultrasonication. Lower test solutions were prepared by dilution of the stock solution or appropriate solution with test medium. The preparation procedure was repeated after 24 h.
- Differential loading: No
- Controls: Same test medium and exposure conditions but without test item.
- Evidence of undissolved material: The stock solution was clear and transparent.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Waterflea
- Strain/clone: Clone V
- Source: Originally purchased from the Federal Environment Agency (Berlin, Germany) and bred in the in-house laboratory.
- Breeding conditions: D. magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pH-value of the aerated water was within a range of 6.0 - 9.0. The dissolved oxygen was above 60% saturation and the total hardness 140 - 250 mg/L (CaCO3), corresponding to 7.8 - 14 °dH. The animals were fed with single cell green alga (D. subspicatus) at least 3 times a week. The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 h illumination and 8 h darkness. The medium was changed 3 times per week. A pipette was used to separate the young daphnids from the adults.
- Age of daphnids at test start: freshly hatched, < 24 h old
- Feeding during test: No feeding during test
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 140 - 250 mg/L = 7.8 - 14 °dH (Elendt M4 medium)
- Test temperature:
- 18.8 - 18.9 °C (mean)
- pH:
- 7.73 - 7.90 (mean)
- Dissolved oxygen:
- 9.1 - 9.2 mg/L (mean)
- Nominal and measured concentrations:
- Control, and 100 mg/L (nominal)
< LOQ, and 102 mg/L (mean measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL glass vessels filled with ~ 50 mL test solution and covered with a glass plate to reduce evaporation.
- Renewal rate of test solution: 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 1 daphnid per ~10 mL test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium
- Culture medium different from test medium: Culture medium same as test medium
- Intervals of water quality measurement: The test temperature and the pH values as well as the oxygen concentration of the test solutions were measured at all concentration levels at 0 h (fresh medium), 24 h (fresh and aged medium) and at 48 h (aged medium) in one separate replicate per test item concentration without test organisms.
OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark
EFFECT PARAMETERS MEASURED:
- Immobilization: after 0, 24, and 48 h
RANGE-FINDING STUDY
- Test concentrations: Control, 0.01, 0.1, 1.0, 10.0, and 100 mg/L
- Results used to determine the conditions for the definitive study: Results are not reported. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: No
- Mortality of control: 0%
- Any observations that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid?
Yes, the test was performed in accordance with OECD guideline and the results fell within the historical data generated with the reference item potassium dichromate at the testing facility.
- Relevant effect levels: EC50 (24 h) was between 1.00 and 2.00 mg/L
- Other: 100% immobilization after 48 h (2.0 mg/L), 65% immobilization after 48 h (1.0 mg/L) - Reported statistics and error estimates:
- The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (≤ 10%). Due to a lack of immobilisation, the EC50 could not be statistically determined.
Any other information on results incl. tables
VALIDITY CRITERIA
The study met the validity criteria laid down by the guideline (Table 1).
Table 1: Validity criteria for OECD 202.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
The control immobilization was 0%. |
Yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
The dissolved oxygen concentration in this test was ≥ 9.0 mg/L at the end of the test. |
Yes |
ANALYTICAL RESULTS
The measured test item concentration was between 92 and 101% of nominal in fresh samples with a mean initial concentration of 97% of nominal. In aged samples, the measured test item content ranged from 101 – 103% of nominal with a mean measured concentration of 102% of nominal (Table 2). Therefore, the toxicological assessment was based on the nominal concentrations.
Table 2. Measured test item concentrations.
nominal concentration |
sampling |
test item |
|
[mg/L] |
[h] |
[mg/L] |
% of nominal |
Control |
0 (fresh medium) |
n.d. |
- |
24 (aged medium) |
n.d. |
- |
|
24 (fresh medium) |
n.d. |
- |
|
48 (aged medium) |
n.d. |
- |
|
100 |
0 (fresh medium) |
101 |
101 |
24 (aged medium) |
101 |
101 |
|
24 (fresh medium) |
92.4 |
92 |
|
48 (aged medium) |
103 |
103 |
- = not calculated; n.d. = not detectable; LOQ = 1.00 mg/L
BIOLOGICAL RESULTS
After 48 h no immobilization was observed up to and including 10.0 mg/L. No immobilization higher than the allowed control immobilization was observed at 100 mg/L (Table 3).
Table 3. Immobilization after 48 h
|
nominal test item concentration [mg/L] |
|||||
|
control |
0.01 |
0.10 |
1.00 |
10.0 |
100 |
rep 1 |
0 |
0 |
0 |
0 |
0 |
1 |
rep 2 |
0 |
0 |
0 |
0 |
0 |
0 |
rep 3 |
0 |
0 |
0 |
0 |
0 |
1 |
rep 4 |
0 |
0 |
0 |
0 |
0 |
0 |
Σ |
0 |
0 |
0 |
0 |
0 |
2 |
% |
0 |
0 |
0 |
0 |
0 |
10 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
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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