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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 482-280-8 | 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:
- 10 April 2018 - 08 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0, 24 and 48 hours.
- Vehicle:
- yes
- Details on test solutions:
- Reconstituted water (Elendt M7 medium) was used as the test water. A positive control used potassium dichromate as the reference item but was conducted at a separate time between 23 January 2018 and 25 January 2018.
A preliminary range finding test was conducted to determine the test concentrations to be used in the definitive test.
In the definitive test, a nominal amount fo test item (200 mg) was dissolved in water and the volume adjusted to 2 L to give the 100 mg/L test concentration from which a series of dilutions was made to give further test concentrations. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Age of stock: Less than 24 hours old
- Fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin flake food suspension. During exposure, the daphnids received no food.
- Adult daphnids were maintained in 150 mL glass beakers containing 100 mL Elendt M7 medium in a temperature controlled room.
-Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that young daphids produced overnight were less than 24 hours old. - Test type:
- semi-static
- Water media type:
- freshwater
- Total exposure duration:
- 48 h
- Hardness:
- Not measured
- Test temperature:
- 18 to 22 °C
- pH:
- 7.9 to 8.1
- Dissolved oxygen:
- 8.9 to 9.7 mg O2/L
- Salinity:
- Not measured
- Conductivity:
- Not measured
- Nominal and measured concentrations:
- The test preparations were measured at 0 and 24 hours and range from 5.8 to 31 mg/L.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 mL glass beakers containing approximately 100 mL of test preparation.
- No. of organisms per vessel: Five daphnids in each test and control vessel.
- No. of vessels per concentration (replicates): Four replicate tests and control vessels were prepared.
- No food was received during exposure.
TEST MEDIUM
- Reconstituted water (Elendt M7 medium). The pH of the prepared media was 7.9 and stored at 21 °C.
OTHER TEST CONDITIONS
- 16 hours light and 8 hours of darkness
RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: The results of the initial range finding test showed an unusual immobilisation pattern therefore a second range finding test was conducted using the same nominal test concntrations as the initial range finding test. The second and third range finding tests were described as an initial experiment and are reported below. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 58 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 22 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 36 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Range finding test
No immobilization was observed at the test concentrations of 0.10, 1.0 and 10 mg/L, however, 50% immobilization was observed at 100 mg/L. Based on this information 10, 18, 32, 56 and 100 mg/L were selected for the definitive test.
Chemical analysis of the test preparations at 0 hours showed measured test concentrations to range from 9.1 to 76 mg/L. There was a significant decline in the measured concentrations at 48 hours indicating that the test item was not stable under test conditions.
Definitive test
Analysis of the freshly prepared test preparations at 0 and 24 hours showed test concentrations to range from 7.8 to 67 mg/L. Analysis of old or expired test preparations at 24 and 48 hour showed measured test concentrations had declined, to range from 5.8 to 31 mg/L. Even analysis of additional samples containing no daphnids showed a decline in the measured concentrations indicating that the losses observed were primarily attributable to adsorption to the glassware. The results are therefore calculated based on the 0 hour measured test concentrations.
Analysis of the immobilization data by probit analysis using Linear Maximum-Likelihood regression at 24 and 48 hours based on the 0 hour measured test concentration gave the following results;
48 h EC50 = 58 mg/L
48 h NOEC = 22 mg/L
48 h LOEC = 36 mg/L
The test was considered valid given that no more than 10% of the control daphnids showed immobilization or other signs of disease or stress and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels. - Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of freshwater invertebrates, Daphnia magna to the test item has been investigated and gave an EC50 of 58 mg/L after 48 hours.
- Executive summary:
A study was performed to assess the acute toxicity of the test item to Daphnia magna using OECD Method 202. Following preliminary range finding tests and an initial experiment, 20 daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at nominal concentrations of 10, 18, 32, 56 and 100 mg/L for 48 hours. The number of immobilized daphnia were recorded after 24 and 48 hours.
Analysis of the freshly prepared test preparations at 0 and 24 hours showed test concentrations ranged from 7.8 to 67 mg/L. Analysis of old or expired test preparations at 24 and 48 hour showed measured test concentrations had declined, to range from 5.8 to 31 mg/L. Even analysis of additional samples containing no daphnids showed a decline in the measured concentrations indicating that the losses observed were primarily attributable to adsorption to the glassware. The results are therefore calculated based on the 0 hour measured test concentrations.
Analysis of the immobilization data by probit analysis using Linear Maximum-Likelihood regression at 24 and 48 hours based on the 0 hour measured test concentration gave the following results;
48 h EC50 = 58 mg/L
48 h NOEC = 22 mg/L
48 h LOEC = 36 mg/L
Reference
Table 1: Cumulative Immobilization Data and Observations in the Third Range-finding Test
Nominal Concentration (mg/L) |
24 Hours |
48 Hours |
||||||
Cumulative Immobilized Daphnia |
Observations |
Cumulative Immobilized Daphnia |
Observations |
|||||
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Rep1 |
Rep2 |
Rep1 |
Rep2 |
|
Control |
0 |
0 |
5 N |
5 N |
0 |
0 |
5 N |
5 N |
0.1 |
0 |
0 |
5 N |
5 N |
0 |
0 |
5 N |
5 N |
1.0 |
0 |
0 |
5 N |
5 N |
0 |
0 |
5 N |
5 N |
10 |
0 |
0 |
5 N |
5 N |
0 |
0 |
5 N |
5 N |
100 |
0 |
0 |
5 N |
5 N |
2 |
3 |
3 N |
2 N |
Table 2: Cumulative Immobilization Data and Observations in Definitive Test
0-Hour Measured Concentration (mg/L) |
24 Hours |
|||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
|||||||||
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Total |
% |
Rep1 |
Rep2 |
Rep3 |
Rep4 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
7.8 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
36 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
62 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
0-Hour Measured Concentration (mg/L) |
48 Hours |
|||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
|||||||||
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Total |
% |
Rep1 |
Rep2 |
Rep3 |
Rep4 |
|
Control |
1 |
0 |
0 |
1 |
2 |
10 |
1 R 3 N |
5 N |
5 N |
1 R 3 N |
7.8 |
0 |
0 |
1 |
1 |
2 |
10 |
1 C 4 N |
5 N |
4 N |
4 N |
13 |
2 |
0 |
0 |
0 |
2 |
10 |
3 N |
5 N |
5 N |
5 N |
22 |
1 |
1 |
0 |
0 |
2 |
10 |
2 R 2 N |
3 R 1 N |
2 R 3 N |
1 R 4 N |
36 |
2 |
2 |
1 |
3 |
8 |
40 |
1 R 2 N |
2 P 1 N |
4 R |
1 R 1 N |
62 |
3 |
2 |
2 |
4 |
11 |
55 |
1 R 1 C |
3 R |
3 R |
1 R |
Rep = Replicate C = Covered in debris R = Reduced mobility N = Normal P = Pale
Description of key information
A study was performed to assess the acute toxicity of the test item to Daphnia magna using OECD Method 202. Analysis of the immobilization data by probit analysis using Linear Maximum-Likelihood regression at 24 and 48 hours based on the 0 hour measured test concentration gave the following results;
48 h EC50 = 58 mg/L
48 h NOEC = 22 mg/L
48 h LOEC = 36 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 58 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.