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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 942-424-7 | 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2011
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Federal Office for the Environment (FOEN)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: the test item was determined in one of the duplicate test medium samples from the control and the test concentrations of 46 and 100 mg/L, since the remaining concentrations were below the NOEC determined in this test.
-Sampling method: duplicate samples were taken from the test media of all test concentrations and the control at the start of the test (without algae) and at the end of the test (containing algae). Test media of the replicates were pooled before sampling at the end of the test
- Sample storage conditions before analysis: after sampling, samples were stabilized with acetonitrile (1 mL acetonitrile per 10 mL sample volume) and deep-frozen (at about -20 °C) (method based on pre-experiments) - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: a 100 mg/L solution was prepared by dissolving the test item in 1 L test water using intense stirring for 10 min at room temperature. This test concentration was further diluted with test water to prepare the remaining test concentrations. - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Strain: No. 61.81 SAG
- Age of inoculum (at test initiation): 4 d (exponential growth phase by inoculation time)
- Method of cultivation: same as test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- -
- Test temperature:
- 23 °C
- pH:
- Test item vessels: 7.1 - 8.6
Control: 7.3 - 8.4 - Dissolved oxygen:
- -
- Salinity:
- -
- Conductivity:
- -
- Nominal and measured concentrations:
- Nominal: 4.6, 10, 22, 46 and 100 mg/L
Mean measured: n.d., n.d., n.d, 27 and 85 mg/L (geom. mean) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 75 mL Erlenmeyer flasks (covered with a glass dish)
- Fill volume: 30 mL
- Initial cells density: 5000 cells/mL (determined using an electronic particle counter)
- Control end cells density: 235.5 x 10^4 relative fluorescence units
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Intervals of water quality measurement: pH was recorded in all treatments at the start and end of the test. The temperature in the incubator was monitored continuously. The appearance of the test media was visually controlled daily.
OTHER TEST CONDITIONS
- Photoperiod: continuously illuminated
- Light intensity and quality: LED light, 77 μE s^-1 m^-2
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: 100 μL algal suspension was withdrawn daily from each test flask and biomass was determined by duplicate fluorescence
- Other: at the end of the test, a sample was taken from the control and from the concentration of 46 mg/L and inspected for shape and size of the algal cells. This test concentration was chosen since the algal cell density was too low for an examination at the concentration of 100 mg/L.
TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: 2.1, 1.8 and 5.9 % inhibition of the growth rate at concentrations of 1, 10 and 100 respectively after 72 h - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 77 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 68 – 81 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 42 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 19 – 54 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 27 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 85 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 46 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95% CI: 44 - 47 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 29 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95% CI: 28 - 30 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 27 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 85 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Exponential growth in the control (for algal test): yes (biomass increased by a factor of 222)
- Observation of abnormalities (for algal test): no difference between the algae growing at the nominal test concentration of 46 mg/L and the algal cells in the control at the end of the test (microscopic examination)
- Uncommon observations concerning the appearance of the media: no - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- ErC50 (72 h): 0.74 mg/L - Reported statistics and error estimates:
- The 72-hour EC10 and EC50 values for the inhibition of average growth rate and yield and their 95% confidence intervals were calculated by Probit Analysis using linear maximum likelihood regression.
For the determination of the LOEC and NOEC, the average growth rate and yield at the test concentrations were compared to the control values by Dunnett t-test, Williams t-test or Welch t-test, where appropriate.
Statistical analysis was performed using ToxRat Professional®.
The values for the validity criteria of the test were also calculated by the statistic program ToxRat Professional® - Validity criteria fulfilled:
- yes
- Conclusions:
- Growth inhibition of the freshwater green algal species Pseudokirchneriella subcapitata was observed in a 72 h test (OECD 201). The ErC50 (72 h) was 77 mg/L and ErC10 (72 h) = 42 mg/L.
Reference
87 and 91% of the nominal values were recovered for the test item concentrations of 46 and 100 mg/L at the start of the test, respectively. At the end of the test, 39 and 79% of the nominal values were recovered, respectively.
Table 1: Analytical results.
Nominal test concentration [mg/L] | Mean measured concentration of the test item (geometric mean) |
|
[mg/L] | % of nominal | |
4.6 | -- | -- |
10 | -- | -- |
22 | -- | -- |
46 | 27 | 58 |
100 | 85 | 85 |
Table 2: Effect concentrations (0 -72 h) in mg/L.
Growth Rate | Yield | |
EC10 95% CI |
42 19 -54 |
29 28 -30 |
EC50 95% CI |
77 68 -81 |
46 44 -47 |
NOEC | 27 | 27 |
LOEC | 85 | 85 |
Table 3: % Inhibition of growth rate and yield.
Nominal concentration [mg/L] | 24 h | 48 h | 72 h |
% inhibition of growth rate | |||
Control | 0 | 0 | 0 |
4.6 | -6.4 | -0.7 | -0.2 |
10 | -4 | -0.8 | 0 |
22 | -2.2 | 0.3 | 2.5 |
46 | -3.3 | 0.8 | 1.2 |
100 | 9.4 | 27.8 | 58.4 |
% inhibition of yield | |||
Control | 0 | 0 | 0 |
4.6 | -14.6 | -2.9 | -0.9 |
10 | -9 | -3.1 | 0 |
22 | -4.6 | 1.1 | 12.8 |
46 | -7.3 | 2.9 | 6.2 |
100 | 19.7 | 66.7 | 96.1 |
Description of key information
ErC50 (72 h) = 77 mg/L and ErC10 (72 h) = 42 mg/L, based on growth rate of Pseudokirchneriella subcapitata (OECD 201, GLP).
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 77 mg/L
- EC10 or NOEC for freshwater algae:
- 42 mg/L
Additional information
One experimental study is available investigating the toxicity of the substance to aquatic freshwater algae. The study was conducted according to OECD 201 and GLP using Pseudokirchneriella subcapitata as the test species. The test organism was exposed at nominal test item concentrations of 4.6, 10, 22, 46 and 100 mg/L for 72 h. Only the test concentrations 46 and 100 mg/L were analyzed at the beginning and at the end of the test by HPLC/UV, since the remaining concentrations were below the NOEC determined in this test. The analysis indicated that the test item concentrations were within 87 - 91% of nominal at the beginning of the test and dropped to 39 – 79% after 72 h. The biological results were related to the mean measured test item concentrations (geometric mean of concentrations measured at the start and end of the test). Based on growth rate inhibition the test resulted in an ErC50 (72 h) of 77 mg/L and an ErC10 (72 h) of 42 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.