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EC number: 422-120-6 | CAS number: 166432-53-7
- 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:
- 16-08-2000 to 29-11-2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: February 2000 ; signature: April 2000
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0 (control), 0.0708, 0.132, 0.210, 0.342, 0.796, 1.41, 2.47, 4.29 and 6.05 mg/L (nominal ; based on the results of the pre-study media preparation trials and range-finder).
Time Weighted Mean Measured equivalent concentrations: 0 (control), of 0.0713, 0.116, 0.179, 0.273, 0.700, 1.29, 2.26, 3.42 and 5.32 mg/L
- Sampling method: Where possible all samples were prepared for analysis on the day of sampling. Duplicate samples were taken and stored frozen (approximately -20°C) for further analysis if necessary.
- Sample storage conditions before analysis: See above. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct dissolution of test item in culture medium to prepare stock; serial dilution of stock to prepare test media. The test concentrations used in the definitive study were prepared by diluting (with reconstituted water) a saturated solution prepared from an initial test item dispersion at a concentration of 1000 mg/L. Prior to addition of the test item, the reconstituted water was stirred by magnetic stirrer using a stirring rate such that a vortex depth of approximately 5% of the overall height of the water column was achieved. An amount of test item (10.0 g) was added to the vortex of 10 litres of reconstituted water to give an initial test item dispersion at a concentration of 1000 mg/L. This was stirred for 23 hours. The stirring was stopped after 23 hours and the mixture allowed to stand for 1 hour, prior to removal of the aqueous phase by siphon to give a saturated solution with a measured test concentration of 6.05 mg/L. Aliquots (50, 90, 500 and 900 ml) of this saturated solution were each separately dispersed in reconstituted water and the volume adjusted to 5 litres to provide the measured concentration of 0.0708, 0.132, 0.796 and 1.41 mg/L, whilst further aliquots (64, 112, 640 and 1120 ml) were separately dispersed in a final volume of 2 litres of reconstituted water to provide the measured concentrations of0.210, 0.342, 2.47 and 4.29 mg/L. Varying volumes of test media were prepared due to the sampling requirements of the study. The concentration and stability of the test item in the test solutions (centrifuged and uncentrifuged) were verified by chemical analysis at 0 and 48 hours. During validation: Recoveries were in the region of 98 to 111% at 0.105 to 11.1 mg/L concentrations. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in reconstituted water for a period of time and then removing the aqueous phase by siphon to produce a saturated solution with a measured concentration of 6.05 mg/L. This saturated solution was then further diluted, as necessary, to produce the remaining measured test concentrations of 0.0708, 0.132, 0.210, 0.342, 0.796, 1.41, 2.47 and 4.29 mg/L.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable.
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No precipitate reported. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: not reported
- Source: in-house laboratory cultures
- Age at study initiation (mean and range, SD): < 24 hours
- Method of breeding: Parthenogenesis
- Feeding during test: No. The daphnids were not fed during the study. During culture: The culture daphnids are fed daily ad libitum with algae suspension
- Food type: Not applicable.
- Amount: Not applicable.
- Frequency: Not applicable.
ACCLIMATION
- Acclimation period: None reported. Can be presumed to be < 2 hours in dilution water.
- Acclimation conditions (same as test or not): Yes.
- Type and amount of food: Not applicable.
- Feeding frequency: Not applicable.
- Health during acclimation (any mortality observed): Not applicable. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- In accordance with OECD TG 202 guideline.
- Hardness:
- Dilution water quality parameters: 0 hours: 250 mg CaCO3/L
- Test temperature:
- Actual: 21ºC
- pH:
- Control: 0 hours: pH 7.9 and 48 hours: 7.9 ; test groups: 0 hours: pH 7.9 and 48 hours: 7.9
- Dissolved oxygen:
- Control: 0 hours: 8.5 mg O2/L and 48 hours: 8.1 - 8.2 mg O2/L ; test groups: 0 hours: 8.4 - 8.5 mg O2/L and 48 hours: 8.1-8.2 mg O2/L
- Salinity:
- Not applicable.
- Nominal and measured concentrations:
- Definitive test: 0 (control), 0.0708, 0.132, 0.210, 0.342, 0.796, 1.41, 2.47, 4.29 and 6.05 mg/L (nominal ; based on the results of the pre-study media preparation trials and range-finder).
Time Weighted Mean Measured equivalent concentrations: 0 (control), of 0.0713, 0.116, 0.179, 0.273, 0.700, 1.29, 2.26, 3.42 and 5.32 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass jars
- Type (delete if not applicable): open, but covered to reduce test item losses
- Material, size, headspace, fill volume: glass; 250 mL fill volume, headspace ca. 0 mL (minimal)
- Aeration: No aeration of the test solutions.
- No. of organisms per vessel: Control and test item: 20 per concentration, 10 per vessel (divided into 2 replicates)
- No. of vessels per concentration (replicates): 2 (two replicates, 10 daphnia per vessel).
- No. of vessels per control (replicates): 2 (two replicates, 10 daphnia per vessel).
- No. of vessels per vehicle control (replicates): Not applicable.
- Biomass loading rate: equivalent to 25 mL test media per animal
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water - analytical grade salts dissolved in purified water equivalent or similar to ISO Test water, according to OECD 202, Annex 3: composition. pH 7.8 (adjusted if necessary).
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported
- Pesticides: Not reported
- Chlorine: Not reported
- Alkalinity: Not reported
- Ca/mg ratio: Not reported
- Conductivity: <5 µS/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: 0 hours and 48 hours, (dissolved oxygen, pH and temperature)
OTHER TEST CONDITIONS
- Adjustment of pH: No.
- Photoperiod: 16 h light / 8 hours dark, 20 minute dawn and dusk transition periods.
- Light intensity: Not reported
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility (or adverse effects including mortality), 24 hours and at 48 hours. An organism was considered to be immobile, if it was not able to swim in the water phase within 15 seconds after gentle agitation of the test vessel.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Between 1.86 and 1.4.
- Justification for using less concentrations than requested by guideline: Not applicable.
- Range finding study: Yes.
- Test concentrations: 0 (control), 0.12, 1.2 and 12 mg/L ; nominal test item concentration.
- Results used to determine the conditions for the definitive study: Yes. - Reference substance (positive control):
- no
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.4 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (95% CL. 0.33-0.50 mg/L) ; time weighted mean measured concentrations
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.51 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (95% CL. 0.42-0.64 mg/L) ; time weighted mean measured concentrations
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.179 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: time weighted mean measured concentrations
- Details on results:
- - Behavioural abnormalities: None reported.
- Observations on body length and weight: Not applicable.
- Other biological observations:
- Mortality of control: No mortalities in control.
- Other adverse effects control: None reported.
- Abnormal responses: None reported.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None. It was speculated the decline in measured test concentrations was therefore considered to be due to possible accumulation of the test item in the test organisms or to any organic waste matter present in the test system.
- Effect concentrations exceeding solubility of substance in test medium: No. - Reported statistics and error estimates:
- The EC50 values and associated confidence limits at 24 and 48 hours were calculated by the maximum-likelihood probit method (DJ Finney, 1971) using a ToxCalc computer software package (v5.0.23C).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item 48h-EC50 was 0.40 mg/L (C.I: 0.33 – 0.50 mg/L) based on time weighted mean measured concentrations.
- Executive summary:
The acute toxicity to Daphnia magna was carried out according to OECD TG 202 Daphnia sp., Acute Immobilisation Test and EU Method C.2 guidelines under GLP. Following preliminary range finding test, twenty daphnids in two replicates of 10 were exposed for 48 hours under static test conditions to an aqueous solution of the test item at the following nominal concentrations:0 (control), 0.0708, 0.132, 0.210, 0.342, 0.796, 1.41, 2.47, 4.29 and 6.05 mg/L. The equivalent Time Weighted Mean Measured concentrations were: 0 (control), of 0.0713, 0.116, 0.179, 0.273, 0.700, 1.29, 2.26, 3.42 and 5.32 mg/L based on the results of chemical analysis at 0 hours, 24 hours and 48 hours.The test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in reconstituted water for a period of time and then removing the aqueous phase by siphon to produce a saturated solution with a measured concentration of 6.05 mg/L. This saturated solution was then further diluted, as necessary, to produce the remaining measured test concentrations. Samples of centrifuged and uncentrifuged test media were analysed to determine the amount of dissolved test item present within the test system.The number of immobilised Daphnia were recorded after 24 and 48 hours. Physicochemical measurements on water quality were made throughout the test including: temperature, pH and oxygen concentration. The temperature was maintained at 21°C and the pH was 7.9 and the dissolved oxygen concentrations were > 8.0 mgO2/L. The validity criteria of the test guideline were fulfilled. A marked decline was shown in the measured concentrations of the old or expired test media with values ranging from 0.0553 mg/L to 4.83 mg/L for uncentrifuged samples and 0.0718 mg/L to 4.66 mg/L for the centrifuged samples. On this basis the test item was not maintained at ±20% of the nominal/initial concentrations therefore the effect levels were estimated based on time weighted mean measured concentrations. Under the conditions of this study, the 48h-EC50 was 0.40 (C.I: 0.33 – 0.50) mg/L based on time weighted mean measured concentrations.
Reference
Table 1.0: Cumulative immobilisation data in the definitive test
Nominal Concentration (mg/L) * |
Time Weighted Mean Measured Concentration (mg/L) |
Cumulative population immobilised (n=20) |
|||||||
|
|
24 hours |
48 hours |
||||||
|
|
R1 |
R2 |
Total |
% |
R1 |
R2 |
Total |
% |
0 (control) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0708 |
0.0713 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.132 |
0.116 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.210 |
0.179 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.342 |
0.273 |
3 |
2 |
5 |
25 |
4 |
3 |
7 |
35 |
0.796 |
0.700 |
5 |
6 |
11 |
55 |
8 |
8 |
16 |
80 |
1.41 |
1.29 |
10 |
10 |
20 |
100 |
10 |
10 |
20 |
100 |
2.47 |
2.26 |
10 |
10 |
20 |
100 |
10 |
10 |
20 |
100 |
4.29 |
3.42 |
10 |
10 |
20 |
100 |
10 |
10 |
20 |
100 |
6.05 |
5.32 |
10 |
10 |
20 |
100 |
10 |
10 |
20 |
100 |
|
|
|
|
|
|
|
|
|
|
*Measured concentrations of the freshly prepared centrifuged test media at 0 hours
Description of key information
EC50 (invertebrates) = 0.40 (C.I: 0.33 – 0.50) mg/L based time weighted mean measured concentrations, 48hour-freshwater, OECD TG 202, 2000
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.4 mg/L
Additional information
Key study : OECD TG 202, 2000 : The acute toxicity to Daphnia magna was carried out according to OECD TG 202 Daphnia sp., Acute Immobilisation Test and EU Method C.2 guidelines under GLP. Following preliminary range finding test, twenty daphnids in two replicates of 10 were exposed for 48 hours under static test conditions to an aqueous solution of the test item at the following nominal concentrations:0 (control), 0.0708, 0.132, 0.210, 0.342, 0.796, 1.41, 2.47, 4.29 and 6.05 mg/L. The equivalent Time Weighted Mean Measured concentrations were: 0 (control), of 0.0713, 0.116, 0.179, 0.273, 0.700, 1.29, 2.26, 3.42 and 5.32 mg/L based on the results of chemical analysis at 0 hours, 24 hours and 48 hours.The test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in reconstituted water for a period of time and then removing the aqueous phase by siphon to produce a saturated solution with a measured concentration of 6.05 mg/L. This saturated solution was then further diluted, as necessary, to produce the remaining measured test concentrations. Samples of centrifuged and uncentrifuged test media were analysed to determine the amount of dissolved test item present within the test system.The number of immobilised Daphnia were recorded after 24 and 48 hours. Physicochemical measurements on water quality were made throughout the test including: temperature, pH and oxygen concentration. The temperature was maintained at 21°C and the pH was 7.9 and the dissolved oxygen concentrations were > 8.0 mgO2/L. The validity criteria of the test guideline were fulfilled. A marked decline was shown in the measured concentrations of the old or expired test media with values ranging from 0.0553 mg/L to 4.83 mg/L for uncentrifuged samples and 0.0718 mg/L to 4.66 mg/L for the centrifuged samples. On this basis the test item was not maintained at ±20% of the nominal/initial concentrations therefore the effect levels were estimated based on time weighted mean measured concentrations. Under the conditions of this study, the 48h-EC50 was 0.40 (C.I: 0.33 – 0.50) mg/L based on time weighted mean measured concentrations.
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