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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-478-8 | CAS number: 20039-37-6
- 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:
- from 2010-10-05 to 2010-11-18
- 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)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Following nominal concentrations were measured: 0.00, 0.13, 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 mg/L
- Sampling method: Actual concentrations of the test substance in the test media were determined in the surplus of the test media at the beginning of the test and in the pooled test media of the replicates at the end of the test.
- Sample storage conditions before analysis: deep frozen - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A first stock solution (ST1) with a nominal test substance concentration of 800 mg/L was prepared at the start of the test by dissolving 82.2 mg test substance in 100 mL reconstituted water according to ISO 6341 by manual homogenisation. To obtain the final stock solution which was used for the test (ST2, nominal 8 mg/L), 3 mL of ST1 were filled up to 300 mL reconstituted water. The test media were prepared by diluting the ST2 with reconstituted water.
- Controls: Blank control performed with reconstituted water only (ISO6341) without test substance
- Evidence of undissolved material: no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Source: Neonates of Daphnia magna (Crustacea, Cladocera), were obtained by hatching ephippia, supplied as "Daphtoxkit F TM magna" (Daphnia magna; Fa. Micro BioTests Inc; Kleimoer 15, B-9030 Mariakerke (Gent); BELGIUM).
- Age at study initiation : less than 24 hours old.
- Method of breeding: Neonates were obtained by hatching ephippia. The ephippia were hatched in the laboratory in a petri dish containing reconstituted water in a temperature controlled room at approx. 20 - 22 °C under continuous illumination of approximately 6 000 Lux. According to MicroBioTests Inc. the largest hatching occurs between 72 and 80 hours and the Daphnia must be collected at the latest 90 hours after initiation of hatching. The neonates were collected for this test at approximately 82 hours after initiation of hatching.
- Feeding during test: none.
ACCLIMATION
- Acclimation period: 82 hours
- Acclimation conditions; Same as the test
- Feeding during acclimation perios: Approximately 1 hour before the start of the test the neonates were fed with a suspension of Spirulina powder (MicroBioTests Inc.), as also in traditional Daphnia cultures the neonates have the opportunity to take up some feed particles. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
- Hardness:
- 250 mg CaCO3/L
- Test temperature:
- 18 - 19 °C
- pH:
- The pH of the relevant test media ranged from 7.6 to 7.9.
- Dissolved oxygen:
- At least 8.8 mg/L
- Salinity:
- Not applicable.
- Nominal and measured concentrations:
- Nominal concentrations: 0.00, 0.13, 0.25, 0.50, 1.00, 2.00, 4.00, 8.00 mg/L
Measured concentrations at start of test:Measured concentrations at end of test: Geometric mean concentrations (0-48 h): - Details on test conditions:
- TEST SYSTEM
- Test vessel: Disposable multiwell test plates with 30 test wells with a transparent lid, provided with the Daphtoxkit F. Each plate has four 15 mL wells for each of the control and the concentrations tested. Additionally, for each concentration the plates are provided with "rinsing wells" to prevent dilution of the test substance during the transfer of the daphnia from the hatching petri dish to the test wells.
- Material, size, headspace, fill volume: 15 mL polycarbonate wells (according to Microbiotest), filled with 10 mL medium.
- Aeration: No extra aeration, but slight circulation of air is still possible when the test plate is closed.
- 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: The stock solutions for preparation of the reconstituted water according to ISO 6341 were obtained by MicroBioTests Inc. The water was aerated and the pH, the dissolved oxygen concentration and the water hardness were checked before using.
- Culture medium different from test medium: no.
- Intervals of water quality measurement: Temperature was measured daily. Oxygen and pH at the start and the end of the test. Total hardness before the start.
OTHER TEST CONDITIONS
- Adjustment of pH: no.
- Photoperiod: 4 a.m. to 8 p.m.
- Light intensity: not applicable.
EFFECT PARAMETERS MEASURED
24 and 48 hours after the start of the exposure to the test substance the neonates were observed for their swimming behaviour. Animals not able to swim within approximately 15 s after gentle agitation of the test container were evaluated as immobilised. Animals trapped at the surface were counted, to evaluate a possible influence of the test substance to the water surface tension. Only the mobile daphnia trapped on the water surface were regarded as trapped but not the immobilised ones.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: Test concentrations: A static non GLP range finding study was conducted using 20 Daphnia per concentration and nominal concentrations of 100, 10, 1, and 0.1 mg/L.
- Results used to determine the conditions for the definitive study: This test revealed 100, 100, 40 and 0 % immobilisation respectively after 48 hours. Therefore nominal concentrations between 0.13 and 8.0 mg/L were chosen for the main experiment.- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.91 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CL: lower: 0.72 mg/L, upper: 1.2 mg/L, Slope: 2.4
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: lower 95 % CL:1.2 mg/L, upper CL: 2.0 mg/L, Slope: 2.4
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- ca. 7.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- ca. 3.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC0
- Effect conc.:
- ca. 0.49 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- ca. 0.24 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.24 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: One daphnia was trapped at the water surface in test medium (0.49 mg/L) after 24 and 48 hours of exposure. No other signs of disease or stress were observed.
- Observations on body length and weight: not observed.
- Other biological observations: none.
- Mortality of control: none.
- Other adverse effects control: none.
- Abnormal responses: none.
- Any observations that might cause a difference between measured and nominal values: none. The test and control media were clear during the whole exposure time. The test media containing the two highest test substance concentrations were coloured light yellow throughout the exposure period. The remaining test and control media were colourless throughout the test period.- Results with reference substance (positive control):
- To check the reliability of the test conditions for acute toxicity studies to Daphnia magna at Seibersdorf Labor GmbH a static reference test with potassium dichromate is conducted twice a year. The last reference test was conducted in July 2010 and gave a 24 h EC50 of 1.0 mg potassium dichromate per litre (95% confidence interval of 0.82 to 1.3 mg/L) which is within the acceptability range of 0.6 - 2.1 mg/L given by the OECD guideline 202.
- Reported statistics and error estimates:
- The EC50-values and their confidence limits were calculated with the moving average method of W. Thompson, modified by C.S. Weil, Drug and Chemical Toxicology, 6 (6), 595-603 (1983).
Table 1: Actual test substance concentrations:
Group
Nominal test
substance
concentrationActual test substance concentration (mg/L)
atGeometric mean of the actual test substance concentration (mean actual)
0-48hDifference (0-48 h) between the actual concentrations
(mg/L)
0 h
48 h
(mg/L)
(%)
K (control)
0.00
<QL
<QL
<QL
C1
0.13
0.09
0.12
0.10
33 33
C2
0.25
0.25
0.23
0.24
-8.00
C3
0.50
0.52
0.46
0.49
-12.50
C4
1.00
0.98
0.76
0.86
-22.45
C5
2.00
1.89
1.83
1.86
-3.44
C6
4.00
3.80
2.53
3.10
-33.42
C7
8.00
8.05
7.22
7.62
-10.31
QL: Quantitation limit of the analytical method used (0.017 mg/L)
Table 2: Immobilisation
Group
Mean actual test substance concentration
(mg/L)Immobilisation
at 24 hImmobilisation
at 48 hK (Control)
<QL
0 / 20
0 / 20
C1
0.10
1 / 20
1 / 20
C2
0.24
0 / 20
0 / 20
C3
0.49
1 / 20
3 / 20
C4
0.86
4 / 20
8 / 20
C5
1.86
11 / 20
18 / 20
C6
3.10
18 / 20
20 / 20
C7
7.62
20 / 20
20 / 20
QL: Quantitation limit of the analytical method used (0.017 mg/L)
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 (48h) of the test item to Daphnia magna was determined to be 0.91 mg/L in a static test according to OECD 202 (1992) under GLP conditions.
- Executive summary:
The objective of this study was to determine the acute toxicity of the test material to Daphnia magna according to OECD 202 (1984) under GLP conditions. For this purpose, young Daphnia magna were exposed under static conditions in bottle system without pH adjustment of the test media. The Daphnia were exposed to a range of concentrations, nominally 0 (control), 0.13, 0.25, 0.50, 1, 2, 4 and 8 mg/L of the test substance dissolved in reconstituted water. Samples of the test media for determination of the actual test substance concentrations were taken immediately before introduction of the Daphnia and after 48 hours. The measured concentrations were determined to be 0.10, 0.24, 0.49, 0.86, 1.86, 3.10 and 7.62 mg/L. The samples were analyzed using HPLC with UV-detection and external calibration for quantification. Measured concentrations ranged from 72 – 104 % of nominal values. For the confirmation of the sensitivity of the test animals of the used batch the results of a reference test with potassium dichromate were provided. After 24 hours the EC50 of potassium dichromate was determined to be 1.26 mg/L. The validity criteria of the test were fulfilled. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. During the test a temperature range of 20 – 22 °C was maintained in the test vessels. Under the given conditions of the study the 48 h EC50 value for Daphnia was determined to be 0.91 mg/L.
Reference
Description of key information
The EC50 (48h) of the test item to Daphnia magna was determined to be 0.91 mg/L in a static test (reference 6.1.3-1) according to OECD 202 (1992) under GLP conditions.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.91 mg/L
Additional information
The objective of this study was to determine the acute toxicity of the test material to Daphnia magna according to OECD 202 (1984) under GLP conditions. For this purpose, young Daphnia magna were exposed under static conditions in bottle system without pH adjustment of the test media. The Daphnia were exposed to a range of concentrations, nominally 0 (control), 0.13, 0.25, 0.50, 1, 2, 4 and 8 mg/L of the test substance dissolved in reconstituted water. Samples of the test media for determination of the actual test substance concentrations were taken immediately before introduction of the Daphnia and after 48 hours. The measured concentrations were determined to be 0.10, 0.24, 0.49, 0.86, 1.86, 3.10 and 7.62 mg/L. The samples were analyzed using HPLC with UV-detection and external calibration for quantification. Measured concentrations ranged from 72 – 104 % of nominal values. For the confirmation of the sensitivity of the test animals of the used batch the results of a reference test with potassium dichromate were provided. After 24 hours the EC50 of potassium dichromate was determined to be 1.26 mg/L. The validity criteria of the test were fulfilled. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. During the test a temperature range of 20 – 22 °C was maintained in the test vessels. Under the given conditions of the study the 48 h EC50 value for Daphnia was determined to be 0.91 mg/L.
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.