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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 - 24 Sep 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- GLP compliance:
- yes
- Remarks:
- Ministerium für Arbeit, Integration und Soziales des Landes Nordrhein-Westfalen, Germany
Test material
- Details on test material:
- - Name of test material: reaction mass of potassium sodium (2R,3R)-2-hydroxy-3-(phosphonatooxy)butanedioate and potassium sodium (2S,3S)-2-hydroxy-3-(phosphonatooxy)butanedioate
- Physical state: white to slightly yellow powder of crystalline appearance
- Lot/batch No.: 010-2065
- Expiration date of the lot/batch: 16 Sep 2019
- Chemical stability: insensitive to exposure to light, considered to be stable in alkaline and neutral solutions (6 < pH <1 2)
- Storage condition of test material: storage at < 40 °C in a tightly closed container under dry conditions (substance very hygroscopic)
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: 2 x 20 mL samples were taken from all test solutions and control and at the beginning of the exposure period prior to addition of the algae. After 72 h representative replicates were sampled for chemical analysis. 2 x 20 mL were taken from every test concentration level. One 20 mL sample was frozen as retain sample.
- Sample storage conditions before analysis: samples were acidified for storage. Potassium concentrations were determined within one week after sampling. For more details see section `Details on analytical methods´
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: all stock solutions and the medium were prepared with purified water processed using an ELGA „PURELAB Ultra“. Since the test item was water soluble, the highest test concentration was prepared by adding the required amount of the test item (100.0 mg) to 1 L sterile growth medium under sterile conditions to obtain a nominal concentration of 100 mg/L. The solution was stirred vigorously using a magnetic stirring bar for about 1 h at room temperature (ca. 20 °C). An aliquot of the clear test solution was then be diluted with sterile growth medium to obtain the other 4 test concentrations.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Source (laboratory, culture collection): SAG, Culture Collection of Algae at Pflanzenphysiologisches Institut of the University at Göttingen, Albrecht von Haller Institut, Göttingen, Germany
- Age of inoculum (at test initiation): 3 d
- Stock culture: the stock cultures are maintained fulfilling the criteria of the OECD guideline. The culture medium was recommended by Bringmann und Kühn (Bringmann, G. and Kühn, R. (1980). Comparison of the toxicity thresholds of water pollutants to bacteria, algae, and protozoa in the cell multiplication inhibition test. Water Research 14(3), 231-241.).
- Pre-culture: a pre-culture was established in standard OECD growth medium to obtain exponentially-growing algae for the test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 21.0 °C - 21.5 °C
- pH:
- 7.83 - 8.47
- Nominal and measured concentrations:
- Nominal test item concentrations: control, 6.25, 12.5, 25.0, 50.0 and 100 mg/L test item (corresponding to following nominal potassium concentrations: 1.94, 3.88, 7.75, 15.5 and 31.0 mg K/L)
Measured test item concentrations at test initiation: 1.9, 3.63, 7.27, 15.3, 30.7 mg/L (after background correction) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL conical glass flasks covered with air-permeable silicone-sponge caps
- Initial cells density: 10^4/mL
- Control end cells density: 119.63 x 10^4/mL (Std. dev.: 25.8 x 10^4/mL)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 8
GROWTH MEDIUM
- Standard medium used: yes, according to guideline
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Chlorine: NH4Cl 15 mg/L
- Ca/mg ratio: CaCl2 x 2 H2O = 18 mg/L, MgSO4 x 7 H2O = 15 mg/L, MgCl2 x 6 H2O = 12 mg/L
- Intervals of water quality measurement: during the exposure period, the incubation temperature was measured daily with a calibrated thermometer in an additionally prepared control vessel kept under the same conditions. The pH values were measured in the additionally prepared replicate at the beginning of the test and directly in the test vessels at the end of the test.
- Other: the light intensity was measured daily using a cosine (2 π) receptor (LI-250A, LI-COR) in μE m^-2 s^-1 at level of the test media surface
OTHER TEST CONDITIONS
- Photoperiod: continuously illuminated
- Light intensity and quality: 4440 and 8880 lux, day light: OSRAM “day light”
- Other: algae were continuously shaken
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : the cell concentrations were determined in the inoculum culture prior to the addition to the test vessels at test start and after 24, 48 and 72 h in the test cultures
- Determination of cell concentrations: the cell density was measured using an electronic particle counter (CASY® TT, Innovatis, Germany). A calibration curve for relating cell count to fluorescence was prepared. If the cell counts could not be determined using electronic counting or fluorescence measurements, the cells were counted microscopically.
TEST CONCENTRATIONS
- Range finding study: yes, 72 h, non-GLP, 3 nominal test concentrations of 1.0, 10 and 100 mg test item/L had been tested with stirring the highest test solution for about 1 h with subsequent dilution. Based on visual observations, the test item was soluble at these concentrations.
- Results of range finding test: test item concentrations of 1, 10, 100 mg/L resulted to 2.6, 3.3, 20.1 % growth rate and 14.5, 18.8, 67.6% yield, respectively - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 87.3
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95% CL: 37 - 128
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Exponential growth in the control (for algal test): yes (increase by a factor of 119.6 within the 72 h test period)
- Results with reference substance (positive control):
- - ErC50: 2.83 mg/L
- Reported statistics and error estimates:
- The EC50 and EC10 for yield were calculated using non-linear regression. For the determination of EyC50 and EyC10 values for yield a 3-parametric cumulative distribution function (CDF) based on normal distribution of the data was used (Normal-CDF), according to Bruce and Versteeg (Bruce, R.D. and Versteeg, D.J. (1992). A statistical procedure for modeling continuous toxicity data. Environ. Toxicol. Chem. 11, 1485-1494.).
Effective concentrations for growth rate were calculated using linear regression (Probit analysis), since there was a significant lack of fit using nonlinear models (e.g. 3-param. normal cumulative distribution function (CDF)).
Any other information on results incl. tables
The concentrations of the test item in the test media were stable during the test based on the potassium concentrations (94 – 99% of nominal at test start and 96 – 100% of nominal at test end). Therefore, the test evaluation was based on the nominal concentrations of the test item.
Table 1: Measured concentrations of potassium in the test item.
Nominal concentration | Measured concentration | Measured concentration (minus background) | |||||
mg TI/L | mg K/L | 0 h mg K/L | 72 h aged mg K/L | 0 h mg K/L | 0 h % nominal | 48 h aged mg K/L | 48 h aged % nominal |
Control | 0.459 | 0.535 | 0.481 | - | - | - | - |
6.25 | 1.94 | 2.44 | 2.35 | 1.9 | 98 | 1.87 | 96 |
12.5 | 3.88 | 4.16 | 4.2 | 3.63 | 94 | 3.71 | 96 |
25 | 7.75 | 7.81 | 8.09 | 7.27 | 94 | 7.61 | 98 |
50 | 15.5 | 15.8 | 16 | 15.3 | 99 | 15.5 | 100 |
100 | 31 | 31.2 | 30.9 | 30.7 | 99 | 30.4 | 98 |
TI = Test Item K = Potassium |
Table 2: Effect concentrations of the test item for the exposure of Pseudokirchneriella subcapitata for 72 h
Parameter* | EC50 | EC20 | EC10 | LOEC | NOEC | |
Nominal concentrations [mg test item/L] | ||||||
Growth rate (r) | Value | > 100 | > 100 | n.d. | 100 | 50.0** |
95 %-cl lower | ||||||
95 %-cl upper | ||||||
Yield (y) | Value | 87.3* | 28.8* | 13.8* | 50 | 25 |
95 %-cl lower | 37 | 2.06 | 0.27 | |||
95 %-cl upper | 128 | 57.1 | 34.9 | |||
n.d. not determined due to the low inhibition of 15.5% at the highest test concentration * EC-values were calculated using non-linear cumulative distribution function according to Bruce and Versteeg (1992)). ** Due to the low inhibition of 9.7% at 50 mg/L, the NOEC was set to 50 mg/L, since effects below 10% compared to control are generally not considered to be ecotoxicologically relevant. The statistically significant effect is a result of the low variability of the replicates. |
Table 3: Cell number (x 10^4) per mL dependent on test item and time
Treatment nominal [mg test item/L] | Control | 6.25 | 12.5 | 25 | 50 | 100 |
0 h | ||||||
1 | 1 | 1 | 1 | 1 | 1 | |
24 h | ||||||
Replicates: | 8 | 4 | 4 | 4 | 4 | 4 |
Mean: | 4.852 | 4.657 | 5.269 | 5.165 | 4.747 | 4.961 |
Std.Dev.: | 0.47 | 0.49 | 0.96 | 0.47 | 0.25 | 0.62 |
CV: | 9.6 | 10.4 | 18.2 | 9 | 5.4 | 12.6 |
48 h | ||||||
Replicates: | 8 | 4 | 4 | 4 | 4 | 4 |
Mean: | 22.19 | 23.04 | 22.83 | 24.39 | 21.08 | 18.6 |
Std.Dev.: | 3.1 | 3.6 | 3.1 | 3.9 | 3.5 | 2.3 |
CV: | 14.1 | 15.5 | 13.8 | 15.8 | 16.8 | 12.6 |
72 h | ||||||
Replicates: | 8 | 4 | 4 | 4 | 4 | 4 |
Mean: | 119.63 | 103.88 | 113.01 | 104.53 | 74.37 | 56.01 |
Std.Dev.: | 25.8 | 4.2 | 11.9 | 10.9 | 12.1 | 5.4 |
CV: | 21.6 | 4.1 | 10.5 | 10.4 | 16.3 | 9.6 |
Mean: arithmetic mean; Std. Dev.: standard deviation; n: number of replicates; CV: coefficient of variation |
Table 4: Microscopic observation of the cell culture
Date | Observations | |
Test start, day 0 | Inoculum culture: normal appearance of intact cells | |
Test end, day 3 | Control – 25 mg/L | Normal appearance of intact cells, almost no cell debris |
50 – 100 mg/L | Less appearance of intact cells, almost no cell debris |
Validity criteria:
The test fulfils the validity criteria of the guideline:
· The cell number in the control cultures increased by a factor of 119.6 within the 72 h test period (validity criterion: > 16)
· Evaluation of the sectional growth rates of the controls: the mean of the replicate coefficients of variations (CV %) in the section-by-section growth rate of controls was 6.9% during the test period (validity criterion ≤ 35%)
· The coefficient of variation of average specific growth rate at test end in replicate control cultures was 4.8% (validity criterion ≤ 7%)
Applicant's summary and conclusion
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies