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EC number: 246-929-7 | CAS number: 25383-99-7
- 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
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 Apr - 13 May 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- adopted March 23, 2006, corrected July 28, 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz; Wiesbaden; Germany
Test material
- Reference substance name:
- Sodium 2-stearoyllactate
- EC Number:
- 246-929-7
- EC Name:
- Sodium 2-stearoyllactate
- Cas Number:
- 25383-99-7
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, SMILES, InChI and structural formula cannot be given.
- IUPAC Name:
- sodium 2-hydroxy-2-methyl-3-oxoicosanoate
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and highest test item concentration (samples were taken from all test item concentrations but analytical measurements were performed only with the highest test item concentration)
- Sampling method: Duplicate samples from test media of all test concentrations and the controls were taken at test start. At test end (after 72 h) samples were taken in duplicate by pooling the content of the test beakers of all replicates for each treatment. Analytical measurements were performed for the highest test item concentration only, since no effects were observed up to the highest test item concentration.
- Sample storage conditions before analysis: All samples were stored in a freezer (≤ -20 °C), protected from light until analysis was performed. Afterwards the samples were again stored deep frozen and will be kept stored up to the date of the final report.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A supersaturated stock solution of nominal 100 mg test item/L was prepared by suspending 52.0 mg test item in 520 mL test water for preparing the test concentrations. The stock suspension was stirred for 2 hours at room temperature at approximately 100 rpm with subsequent ultrasonic treatment for 15 minutes to dissolve as much test item as possible. Then, non-dissolved fractions of the test item were separated from the test medium by membrane filtration (0.45 µm cellulose acetate filter). The solution with dissolved test item was used as the test medium of the highest test concentration and to prepare the desired 1:3, 1:9, 1:27 and 1:81 dilutions.
- Controls: Medium without test item
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: No. 61.81 SAG
- Source: Sammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göttingen, Göttingen, Germany
- Age of inoculum (at test initiation): 3 day old pre-culture
ACCLIMATION
- Acclimation period: 3 days
- Culturing media and conditions (same as test or not): same as test conditions
- Any deformed or abnormal cells observed: Not observed
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 0.24 mmol/L (= 24 mg/L) as CaCO3
- Test temperature:
- 22 - 23 °C
- pH:
- 8.1 - 9.4 (Control)
7.6 - 9.9 (Test item concentrations) - Nominal and measured concentrations:
- Nominal: Control, 1.23, 3.70, 11.1, 33.3 and 100 (corresponding to 0.0455 mg/L based on geometric mean measured concentration)
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open (loosely covered with watch glass)
- Material, size, headspace, fill volume: glass, Erlenmeyer flasks of 50 mL volume with nominal 50 mL of test medium
- Aeration: No aeration
- Initial cells density: 0.5 x 10E+04 cells/mL
- Control end cells density: 120.769 cells [10000/mL]
- 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: Analytical grade salts were added in deionised water.
- Culture medium different from test medium: No
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: continuous
- Light intensity and quality: 5263 lux (4840 to 5590 lux)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: The cell density on each observation time was determined by spectrophotometric measurement. The algal cell densities were calculated by subtracting the absorption of the blanks, from each of the measured absorption of the test media (with algae).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.0
Range finding study: non-GLP, not reported - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.045 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 0.045 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.045 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): No abnormalities were observed - Results with reference substance (positive control):
- 72-hour EC50: 0.858 mg/L
- Reported statistics and error estimates:
- Based on the calculated cell densities, the 72 hours ErL50 and the 72 hour EyL50 could not be calculated by a statistical analysis due to the lack of effects and were therefore determined directly from the raw data.
For the determination of the 72 hour LOEL and the 72 hour NOEC, the calculated growth rates and yields at each test concentration were tested for significant differences compared to the control values by Dunnett's t-test.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.3.0, ToxRatSolutions GmbH.
Any other information on results incl. tables
Biological Results
Table 1: Growth Rates µ and Percentage Inhibition of µ during the Test Period
Nominal loading rate |
Growth rates µ [1/day] and % inhibition of µ |
|||||
0 - 24 hours |
0 - 48 hours |
0 - 72 hours |
||||
[mg test item/L] |
µ |
% |
µ |
% |
µ |
% |
Control |
2.027 |
- |
1.937 |
- |
1.825 |
- |
1.23 |
2.043 |
-0.8 |
1.934 |
0.2 |
1.785 |
2.2 |
3.70 |
2.070 |
-2.1 |
1.972 |
-1.8 |
1.814 |
0.6 |
11.1 |
2.043 |
-0.8 |
1.964 |
-1.4 |
1.847 |
-1.2 |
33.3 |
2.097 |
-3.5 |
1.983 |
-2.4 |
1.841 |
-0.9 |
100 |
2.150 |
-6.1 |
2.147 |
-10.8 |
1.808 |
1.0 |
negative values in ‘% inhibition’ indicate an increase in growth
relative to that of the control
No statistically significant difference (tested with Williams t-test (24
and 48 h) and Dunnett's t-test (72h),a = 0.05, one-sided smaller)
Analytical Results
Table 2: Summary of Analytical Results
Sample Description |
Concentration nominal |
fresh (0h) |
aged (24h) |
aged (48h) |
aged (72h) |
Geometric mean² Concentration |
|||||
[mg test item/L] |
[mg test item/L]1 |
Concentration calculated [mg test item/L]1 |
n |
Concentration calculated [mg test item/L]1 |
n |
Concentration calculated [mg test item/L]1 |
n |
Concentration calculated [mg test item/L]1 |
n |
% |
[mg test item/L]1 |
Control |
0 |
n.a. |
2 |
n.a. |
2 |
n.a. |
2 |
n.a. |
2 |
n.a. |
n.a. |
1:81 dilution of filtrate |
1.23 |
n.m. |
- |
n.m. |
- |
n.m. |
- |
n.m. |
- |
n.a. |
n.a. |
1:27 dilution of filtrate |
3.70 |
n.m. |
- |
n.m. |
- |
n.m. |
- |
n.m. |
- |
n.a. |
n.a. |
1:9 dilution of filtrate |
11.1 |
n.m. |
- |
n.m. |
- |
n.m. |
- |
n.m. |
- |
n.a. |
n.a. |
1:3 dilution of filtrate |
33.3 |
n.m |
- |
n.m |
- |
n.m |
- |
n.m |
- |
n.a. |
n.a. |
Filtrate of 100 mg test item/L |
100 |
1.296 |
2 |
0.829 |
2 |
<LOD |
2 |
<LOQ |
2 |
0.05 |
0.0455 |
1 mean value of all measured samples per sampling date
2 Geometric mean calculated according to OECD Guidance Document No. 23, Annex 2 (2000)
Italic: Regarding these concentrations no biological effects were observed and only filtrate of 100 mg test item/L was analysed.
For values <LOQ, half the LOQ and for values <LOD, the LOD was used for calculating geometric mean concentrations according to OECD Guidance Document No. 23; LOD: Limit of Detection = 0.001 mg test item/L; LOQ: Limit of Quantification = 0.02 mg test item/L; n: number of analysed samples; n.a.: not applicable; ; n.m.: not measured because concentrations were below the NOEC determined in this test
Table 1: Validity criteria
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
241.5 |
Yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
12% |
Yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%. |
3% |
Yes |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
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