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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 279-967-8 | CAS number: 82461-14-1
- 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:
- 18 August to 22 September 2014
- 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)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- date of Inspection: 31 July 2013 / date of Signature: 20/01/10
- Analytical monitoring:
- yes
- Details on sampling:
- At the start of the test, ca 200 mg of test substance was dissolved in a final volume of 2000 mL of Elendt M4 medium to give the 100 mg/L test concentration. Aliquots (100, 180, 320 and 560 mL) of the 100 mg/L test concentration were each separately diluted in a final volume of 1000 mL of Elendt M4 medium to give the remainder of the test concentrations of 10, 18, 32 and 56 mg/L, respectively.
Concentrations of test substance in Elendt M4 medium were determined by gas chromatography with mass spectrometric detection (GC-MS) following salination and partitioning into hexane.
At the start of the test (0 hours), 10 mL samples of freshly prepared test media were taken from the control and each test media preparation flask for chemical analysis. At 48 hours, 10 mL samples were also taken for chemical analysis from the pooled expired test media at each test concentration including the control.
In each case duplicate samples were taken, one for chemical analysis and one as a ‘back-up’ should further analysis be required. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Juvenile Daphnia magna (Straus), less than 24 hours old, were taken from healthy parental laboratory cultures, held and maintained at the test facility. The culture was originally obtained from Smithers Viscient, Shawbury, UK.
The cultures were originally obtained from Smithers Viscient, Shawbury, UK. The Daphnia magna are cultured in 1 litre glass beakers containing 800 mL of Elendt M4 medium. Each vessel and its contents are referred to as a 'culture'. New cultures are initiated with juvenile Daphnia magna (less than 24 hours old), at a density of approximately 15 daphnids per litre. The cultures are fed daily with a concentrated suspension of Chlorella vulgaris prepared in accordance with standard operating procedures.
The water in each culture was renewed or partially renewed at least twice a week. Juveniles were removed when present in cultures using a sieve. Cultures were maintained up to a maximum of 4 to 5 weeks. Juveniles for use in acute toxicity tests were collected from the second brood onwards. Approximately 24 hours before a test was set up, juveniles present in the cultures were removed and discarded. Over the next 24 hours, juveniles for use in the test were removed from the culture using a wide bore pipette and transferred to fresh culture medium. The juveniles were then left for at least 1 hour before selecting actively swimming individuals for use. All juveniles used to initiate a test were less than 24 hours old.
All cultures, prior to and during toxicity tests, are maintained under fluorescent lighting on a 16-hour light: 8-hour dark photoperiod.
Regular tests are conducted using a reference toxicant to ensure that Daphnia magna cultures are of the highest quality and sensitivity. - Test type:
- static
- Water media type:
- other: Elendt M4 medium
- Total exposure duration:
- 48 h
- Test temperature:
- 19.3-19.6 °C
- pH:
- 7.84-8.10
- Dissolved oxygen:
- 8-9.54 mg/L
- Nominal and measured concentrations:
- Nominal concentration: 10, 18, 32, 56 and 100 mg/L
Measured concentration: 9.2, 17, 28, 48 and 66 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass jars
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 60 mL
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
OTHER TEST CONDITIONS
- Photoperiod: 16-hour light: 8-hour dark photoperiod
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mobility and dissolved oxygen concentration
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: 48-hour EC50 > 10 and <100 mg/L. - Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 24 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hour acute toxicity of test substance to the freshwater planktonic crustacean, Daphnia magna, was determined in accordance with the requirements of OECD Chemicals Testing Guideline No. 202 Daphnia sp. Acute Immobilisation Test (adopted April 13 2004).
The validity criteria for control immobility (≤10%) and dissolved oxygen (>3 mg/L) were both satisfied.
Based on geometric mean measured concentrations, the 48-hour EC50 value was determined to be 24 mg/L. The corresponding No Observed Effect Concentration (NOEC) was considered to be 17 mg/L. - Executive summary:
The 48-hour acute toxicity of test substance to the freshwater planktonic crustacean, Daphnia magna was conducted in accordance with the requirements of OECD Guideline 202 Daphnia sp. Acute Immobilisation Test.
Based on the results of a range-finding test, for which the key results only have been reported, the definitive test was conducted at nominal concentrations of 10, 18, 32, 56 and 100 mg/L. A control group was also included. The test was conducted using filled and sealed test vessels, to minimise potential losses due to volatility, under static test conditions.
At the start of the test, five juvenile Daphnia magna were added to each test vessel. The Daphnia magna in each test vessel were observed at 24 and 48 hours. The Daphnia magna were not fed during the test.
Analysis of the test media samples was conducted at 0 (fresh media) and 48 hours (old media). Analysis of the freshly prepared test media at 0 hours showed measured concentrations to range from 87% to 119% of nominal. Analysis of the old media at 48 hours showed measured concentrations to range from 71% to 76% of nominal with the exception of the 100 mg/L test concentration which showed a measured concentration of 49% of nominal. It was unclear as to why this result was considerably lower than the remaining concentrations. However, as 100% immobilisation was also observed at 56 mg/L it was considered that the results for the 100 mg/L would not affect the calculation of the 48-hour EC50 value and hence the integrity of the test.
After 48 hours, the concentration at which no significant (≤10%) dose related immobility occurred was 17 mg/L. The NOEC was considered to be 17 mg/L. After 48 hours 100% immobility was recorded at 48 mg/L. In terms of geometric mean measured concentrations the 48-hour EC50 value was determined to be 24 mg/L. The validity criteria for control immobility (≤10%) and dissolved oxygen (>3 mg/L) were both satisfied.
Reference
Range-finding Test
The results of the range-finding test are summarised below:
Table 6.1.3/1: Immobility of Daphnia magna
Nominal concentration (mg/L) |
Cumulative immobilised Daphnia magna* |
||||
24 hours |
48 hours |
% Immobility |
|||
R1 |
R2 |
R1 |
R2 |
||
Control |
0 |
0 |
0 |
0 |
0 |
0.10 |
0 |
0 |
0 |
0 |
0 |
1.0 |
0 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
0 |
100 |
5 |
5 |
5 |
5 |
5 |
* Initial population of Daphnia magna: five per replicate
R Replicate
Table 6.1.3/2: Concentration of test substance
Nominal concentration (mg/L) |
Measured Concentration (mg/L) |
|
0 Hours (New) |
48 Hours (Old) |
|
Control |
- |
- |
0.10 |
0.104 (104) |
0.0869 (87) |
1.0 |
0.904 (90) |
0.822 (82) |
10 |
38.8 (388) |
10.8 (108) |
100 |
79.3 (79) |
114 (114) |
Values in brackets = % nominal concentration
Analysis of the test concentrations at 0 and 48 hours showed measured concentrations to range from 79% to 114% of nominal with the exception of the 10 mg/L test concentration at 0 hours which showed a measured concentration of 38.8 mg/L (388% of nominal). This was considered to be due to an analytical error given the result from the corresponding 48-hour sample which showed a measured concentration of 108% of nominal. It was therefore considered that the test substance was stable in the test system of a 48-hour period.
The results of the range-finding test suggested that the 48-hour EC50 value would be between 10 and 100 mg/L, based on nominal test substance concentrations.
Definitive Test
Chemical Analysis
The results of the chemical analysis are presented in the table below.
Table 6.1.3/3: Measured concentrations of test substance in test media during the definitive test with Daphnia magna
Measured Concentration (mg/L) |
Geometric mean measured concentration (mg/L) |
||||
Nominal concentration (mg/L) |
0 Hours (New media) |
% of nominal concentration |
48 Hours (Old media) |
% of nominal concentration |
|
Control |
- |
- |
- |
- |
- |
10 |
11.9 |
119 |
7.12 |
71 |
9.2 |
18 |
21.5 |
119 |
13.2 |
73 |
17 |
32 |
31.0 |
97 |
24.4 |
76 |
28 |
56 |
58.7 |
105 |
39.7 |
71 |
48 |
100 |
87.4 |
87 |
49.1 |
49 |
66 |
“-“Test substance not detected above the limit of quantification (0.002 mg/L)
Analysis of the freshly prepared test media at 0 hours showed measured concentrations to range from 87% to 119% of nominal. Analysis of the old media at 48 hours showed measured concentrations to range from 71% to 76% of nominal with the exception of the 100 mg/L test concentration which showed a measured concentration of 49% of nominal. It was unclear as to why this result was considerably lower than the remaining concentrations. However, as 100% immobilisation was also observed at 56 mg/L it was considered that the results for the 100 mg/L would not affect the calculation of the 48-hour EC50 value and hence the integrity of the test.
Given that a slight decline in measured concentration was observed over the 48-hour test period, it was considered justifiable to base the results on geometric mean measured test concentrations. These were calculated to be 9.2, 17, 28, 48 and 66 mg/L.
Water Quality
Water quality determinations for pH, temperature and dissolved oxygen (% ASV and mg/L) during the definitive test are presented in table below
Table 6.1.3/4: percentage immobility
Parameter |
Geometric mean Measured concentration (mg/L) |
0 hour (new) |
48 hours (old) |
*Temperature Range (°C) |
20.1 – 20.9 |
||
Temperature (°C) |
Control |
19.3 |
19.6 |
9.2 |
19.3 |
19.6 |
|
17 |
19.4 |
19.6 |
|
28 |
19.5 |
19.5 |
|
48 |
19.5 |
19.5 |
|
66 |
19.5 |
19.5 |
|
pH |
Control |
8.09 |
7.90 |
9.2 |
8.09 |
7.85 |
|
17 |
8.09 |
7.84 |
|
28 |
8.09 |
7.86 |
|
48 |
8.09 |
7.85 |
|
66 |
8.10 |
7.87 |
|
Dissolved oxygen (% ASV and mg/L) |
Control |
101 (9.39) |
90 (8.29) |
9.2 |
101 (9.43) |
87 (8.03) |
|
17 |
101 (9.47) |
87 (8.12) |
|
28 |
101 (9.43) |
87 (8.04) |
|
48 |
102 (9.52) |
87 (8.04) |
|
66 |
102 (9.54) |
86 (8.00) |
* Continuous temperature measurement of the test area by use of a digital maximum / minimum thermometer
ASV: Air saturation value (mg/L value presented in brackets)
Test Media Descriptions
The test preparations were observed to be colourless solutions throughout the duration of the test.
Toxicity to Daphnia magna
The numbers of immobilised Daphnia magna at 24 and 48 hours, following exposure are presented table below. The percentage immobility data is summarised below.
Table 6.1.3/5: Immobilisation of Daphnia magna after 24 hours exposure during the Definitive test
Geometric mean measured concentration (mg/L) |
Number of Daphnia magna exposed |
Mobile Daphnia magna |
Immobile Daphnia magna |
||
Submerged |
Surface |
Submerged |
Surface |
||
Control |
20 |
20 |
- |
- |
- |
9.2 |
20 |
20 |
- |
- |
- |
17 |
20 |
20 |
- |
- |
- |
28 |
20 |
20* |
- |
- |
- |
48 |
20 |
1 |
- |
19 |
- |
66 |
20 |
- |
- |
20 |
- |
- Value not applicable
* Daphnids observed at the bottom of the vessel
Table 6.1.3/6: Immobilisation of Daphnia magna after 48 hours exposure during the Definitive test
Geometric mean measured concentration (mg/L) |
Number of Daphnia magna exposed |
Mobile Daphnia magna |
Immobile Daphnia magna |
||
Submerged |
Surface |
Submerged |
Surface |
||
Control |
20 |
20 |
- |
- |
- |
9.2 |
20 |
20 |
- |
- |
- |
17 |
20 |
20 |
- |
- |
- |
28 |
20 |
5 |
- |
15 |
- |
48 |
20 |
- |
- |
20 |
- |
66 |
20 |
- |
- |
20 |
- |
- Value not applicable
Table 6.1.3/7: percentage immobility
Geometric mean measured concentration (mg/L) |
Number of Daphnia magna exposed |
% Immobility at 24 hours |
% Immobility at 48 hours |
Control |
20 |
0 |
0 |
9.2 |
20 |
0 |
0 |
17 |
20 |
0 |
0 |
28 |
20 |
0 |
75 |
48 |
20 |
95 |
100 |
66 |
20 |
100 |
100 |
Toxicity values and the corresponding NOEC and LOEC values are presented in the following table. Values are presented in terms of geometric mean measured concentrations.
Table 6.1.3/8: geometric mean measured concentrations
|
Geometric mean measured concentration (mg/L) |
|
24-hour |
48-hour |
|
EC50 |
37 (36 – 39) |
24 (22 – 27) |
LOEC |
28 |
28 |
NOEC |
17 |
17 |
Values in brackets are 95% confidence limits
After 48 hours, the concentration at which no significant (≤10%) dose related immobility occurred was 17 mg/L. The NOEC was therefore 17 mg/L. After 48 hours 100% immobility was recorded at a concentration of 48 mg/L.
The 48-hour EC50 value was determined to be 24 mg/L.
Validity Criteria
The validity criteria for control immobility (≤10%) and dissolved oxygen (>3mg/L) were both satisfied. The test is therefore considered valid.Validity Criteria The validity criteria for control immobility (≤10%) and dissolved oxygen (>3mg/L) were both satisfied. The test is therefore considered valid.
Description of key information
OECD Guideline 202, GLP, key study, validity 1:
48h-EC50 (Daphnia magna) = 24 mg/L based on measured geometric mean concentration
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 24 mg/L
Additional information
To assess the short-term toxicity of the registered substance to aquatic invertebrates, one key experimental study is available.
The 48-hour acute toxicity of test substance to the freshwater planktonic crustacean, Daphnia magna was conducted according to OECD Guideline 202 with GLP statement.
Based on the results of a range-finding test, for which the key results only have been reported, the definitive test was conducted at nominal concentrations of 10, 18, 32, 56 and 100 mg/L. A control group was also included. The test was conducted using filled and sealed test vessels, to minimise potential losses due to volatility, under static test conditions.
At the start of the test, five juvenile Daphnia magna were added to each test vessel. The Daphnia magna in each test vessel were observed at 24 and 48 hours. The Daphnia magna were not fed during the test.
After 48 hours, the concentration at which no significant (≤10%) dose related immobility occurred was 17 mg/L. The NOEC was considered to be 17 mg/L. After 48 hours 100% immobility was recorded at 48 mg/L. In terms of geometric mean measured concentrations the 48-hour EC50 value was determined to be 24 mg/L. The validity criteria for control immobility (≤10%) and dissolved oxygen (>3 mg/L) were both satisfied.
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.