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EC number: 203-657-3 | CAS number: 109-23-9
- 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
- Study period:
- 22 Aug 2018 to 22 Sep 2018
- 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:
- as Method C.3 of Commission Regulation (EC) No 761/2009.(2006)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from the control and the 100% v/v saturated solution test group from the bulk test preparation at 0 hours and from the pooled replicates at 72 hours for quantitative analysis. All samples were stored frozen prior to analysis. A duplicate set of samples was taken at each occasion and stored frozen for further analysis if necessary.
- Preparation of the test samples: The test samples were thawed in a water bath. The test samples (200 mL) plus 60 g of sodium chloride were extracted three times with 50 mL of chloroform. The combined organic extracts were dried using anhydrous sodium sulfate and evaporated to dryness using rotary evaporation. The residues were dissolved in 5 mL of tetrahydrofuran and then an aliquot was taken for instrumental analysis. - Vehicle:
- no
- Details on test solutions:
- - Method: Preliminary solubility work conducted indicated that the test item was practically insoluble in water using traditional methods of preparation e.g. ultrasonication and high shear mixing. Based on this information the test item was categorized as being a ‘difficult substance’ as defined by the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD 2000). Therefore a media preparation trial was conducted in order to determine the solubility of the test item under test conditions. A nominal amount of test item (275 mg) was dispersed in 11 liters of culture medium with the aid of propeller stirring at approximately 1500 rpm for 48 hours. After 48 hours the stirring was stopped and any undissolved test item was removed by filtration through a 0.2 μm Sartorius Sartopore filter (first approximate 2 liters discarded in order to pre-condition the filter) to give a 100% v/v saturated solution. An aliquot (1 liter) of this saturated solution was inoculated with algal suspension (20.8 mL) to give the required test concentration of 100% v/v saturated solution. The prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: CCAP 278/4
- Source: Liquid cultures were obtained from the Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Scottish Marine Institute, Oban, Argyll, Scotland.
- Method of cultivation: Master cultures were maintained in the laboratory by the periodic replenishment of culture medium. The master cultures were kept under constant agitation by orbital shaker (approximately 150 rpm) and constant illumination at 24 ±1 °C. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 23 - 25 °C
- pH:
- - At t=0h: 7.6 - 7.8
- At t=72h: 8.4 - 8.5 - Nominal and measured concentrations:
- - Nominal concentrations: 0 (control) and 100 % (v/v) saturated solution.
- Mean measured concentratoins:- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass conical flasks, constantly shaken at approximately 150 rpm for 72 hours
- Type: closed with polyurethane foam bungs to reduce evaporation.
- Fill volume: 100 mL
- Aeration: No
- Incubator: INFORS Multitron(R) Version 2 incubator
- Initial cells density: 5.00E+03 cells/mL
- Control end cells density: 8.98E+03 cells/mL
- No. of vessels per concentration: 6
- No. of vessels per control: 6
GROWTH MEDIUM
- Standard medium used: yes (AAP growth medium)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The culture medium was prepared using reverse osmosis purified deionized water (*Elga Optima 15+ or Elga Purelab Option R-15 BP)
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: pH adjusted to 7.5 with 0.1N NaOH or HCl.
- Photoperiod: Continuous illumination
- Light intensity and quality: Approximately 7000 lux provided by warm white lighting (380 to 730 nm)
WATER QUALITY PARAMETERS
- pH: The pH of the control and 100% v/v saturated solution test group was determined at initiation of the test and after 72 hours exposure. The pH was measured using a Hach HQ30d Flexi handheld meter.
- Temperature: The temperature within the incubator was recorded daily.
- Test solution appearance: The appearance of the test media was recorded daily.
EFFECT PARAMETERS MEASURED: cell density, appearance
Samples were taken at 23, 47 and 72 hours and the cell densities determined using a Coulter® Multisizer Particle Counter. Three determinations were made for each sample. The nominal inoculated cell concentration was taken as the starting cell density. To determine the potential effect of the test item on the appearance of algal cells, a sample was removed from each test and control culture (replicates pooled) at the end of the test. The shape and size of the algal cells was inspected microscopically and any abnormalities recorded.
RANGE FINDING TEST
The test concentration to be used in the definitive test was determined by a preliminary range-finding test. The range-finding test was conducted by exposing Pseudokirchneriella subcapitata cells to a series of nominal test concentrations of 1.0, 10 and 100% v/v saturated solution for a period of 72 hours. The results showed no effect on growth at the test concentrations of 1.0, 10 and 100% v/v saturated solution.
Based on this information a single test concentration of six replicates, of 100% v/v saturated solution was selected for the definitive test. This experimental design conforms to a "limit test" to confirm that at the highest attainable test concentration no effect on growth was observed.- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate; the positive control was conducted between 06 November 2017 and 09 November 2017.
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 other: % (v/v) saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: No effects observed. The ErC10 was determined as greater than the maximum water solubility of test item (<0.00026 mg/L).
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % (v/v) saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: No effects observed. The ErC50 was determined as greater than the maximum water solubility of test item (<0.00026 mg/L).
- Details on results:
- - Test solution appearance: At the start of the test all control and test cultures were observed to be clear colorless solutions. After the 72-Hour test period all control and test cultures were observed to be green dispersions.
- Growth rate and yield: Growth rate and yield of Pseudokirchneriella subcapitata (CCAP 278/4) were not affected by the presence of the test item over the 72-Hour exposure period.
- Appearance: There were no abnormalities detected in any of the control or test cultures at 72 hours.- Results with reference substance (positive control):
- The 72-h ErC50 was determined to be 1.6 mg/L; 95% confidence limits 1.4 to 1.8 mg/L. The 72-h EyC50 was determined to be 0.77 mg/L; 95% confidence limits 0.68 to 0.87 mg/L. The NOECs and LOECs for growth rate and yield were 0.25 mg/L and 0.50 mg/L, respectively. The results from the positive control with potassium dichromate were within the normal ranges for this reference item.
- Reported statistics and error estimates:
- A Student’s t-test incorporating Bartlett's test for homogeneity of variance (Sokal and Rohlf, 1981) was carried out on the growth rate and yield data after 72 hours for the control and the 100% v/v saturated solution test concentration to determine any statistically significant differences between the test and control groups. All statistical analyses were performed using the SAS computer software package (SAS, 1999 - 2001).
Table: Cell Densities and pH Values in the Definitive Test
Nominal
Concentration (% v/v Saturated Solution)
pH
Cell Densities* (cells per mL)
pH
0 Hours
23 Hour
47 Hour
72 Hour
72
Hours
Control
R1
7.6
1.77E+04
1.22E+05
9.19E+05
8.5
R2
1.76E+04
1.07E+05
9.14E+05
R3
2.05E+04
1.04E+05
9.01E+05
R4
1.78E+04
1.06E+05
8.79E+05
R5
1.59E+04
1.06E+05
9.36E+05
R6
1.53E+04
9.17E+04
8.38E+05
Mean
1.75E+04
1.06E+05
8.98E+05
100
R1
7.8
1.90E+04
1.34E+05
1.08E+06
8.4
R2
1.69E+04
9.87E+04
8.15E+05
R3
1.68E+04
1.21E+05
8.88E+05
R4
1.49E+04
8.86E+04
8.29E+05
R5
1.58E+04
1.07E+05
9.42E+05
R6
1.46E+04
8.59E+04
7.14E+05
Mean
1.63E+04
1.06E+05
8.78E+05
*Cell densities represent the mean number of cells per mL calculated from the mean of the cell counts from 3 counts for each of the replicate flasks
R = Replicate
Table: Daily Specific Growth Rates for the Control Cultures in the Definitive Test
Treatment
Daily Specific Growth Rate (cells/mL/hour)
Day 0 to 1
Day 1 to 2
Day 2 to 3
Control
R1
0.055
0.080
0.081
R2
0.055
0.075
0.086
R3
0.061
0.068
0.086
R4
0.055
0.074
0.085
R5
0.050
0.079
0.087
R6
0.048
0.075
0.088
Mean
0.054
0.075
0.086
R = Replicate
Table: Inhibition of Growth Rate and Yield in the Definitive Test
Nominal Concentration (% v/v Saturated Solution)
Growth Rate (cells/mL/hour)
Yield (cells/mL)
0 to 72 Hour
% Inhibition
0 to 72 Hour
% Inhibition*
Control
R1
0.072
-
9.14E+05
-
R2
0.072
9.09E+05
R3
0.072
8.96E+05
R4
0.072
8.74E+05
R5
0.073
9.31E+05
R6
0.071
8.33E+05
Mean
0.072
8.93E+05
SD
0.001
3.49E+04
100
R1
0.075
[4]
1.08E+06
R2
0.071
1
8.10E+05
R3
0.072
0
8.83E+05
R4
0.071
1
8.24E+05
R5
0.073
[1]
9.37E+05
R6
0.069
4
7.09E+05
Mean
0.072
0
8.73E+05
2
SD
0.002
1.25E+05
* In accordance with the OECD test guideline only the mean value for yield for each test concentration is calculated
R = Replicate
- = Not applicable
SD= Standard Deviation
[ ] = Increase in growth compared to controls
- Validity criteria fulfilled:
- yes
- Remarks:
- See 'Any other information on results incl. tables'.
- Conclusions:
- Based on these findings, the 72-h EC50 values for growth rate and yield/biomass are determined to be >100% v/v of a saturated aqueous solution. The 72-h ErC10 was also determined to be >100% v/v of a saturated aqueous solution for both endpoints.
- Executive summary:
The toxicity towards freshwater algae was determined in a study according to OECD TG 201 and in compliance with GLP criteria (Envigo, 2018). In this study, exponentially growing freshwater alga (Pseudokirchneriella subcapitata) were exposed in a limit test (based on a preliminary range-finding study) to saturated aqueous solutions of the test substance of 0, (control) and 100% (v/v) for 72 hours under static conditions. The test was performed in six replicates per test concentration. The initial concentrations and the maintenance of the exposure concentrations during the test were analytically determined. Cell density was measured after 24, 48 and 72 hours exposure and the growth rate, yield and biomass per time point were determined. Throughout the test, no effects on the growth rate and yield were observed. Based on these findings, the 72-h EC50 values for growth rate and yield/biomass are determined to be >100% v/v of a saturated aqueous solution. The 72-h ErC10 was also determined to be >100% v/v of a saturated aqueous solution for both endpoints.
Reference
Description of key information
72-h ErC50: >100% (v/v) of a saturated aqueous solution (Pseudokirchneriella subcapitata)
72-h ErC10: >100% (v/v) of a saturated aqueous solution (Pseudokirchneriella subcapitata)
Key value for chemical safety assessment
Additional information
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