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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Sep - 24 Oct 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- 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 and at the end of the test from all aged test media and the control of the actual test by pooling the contents of the 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
- Method: The highest loading rate of 100 mg test item/L was prepared by mixing 94.7 and 94.2 mg test item into 947 and 942 mL test water. For the loading rate of 40 mg test item/L, 39.0 and 37.0 mg test item were mixed into 975 and 925 mL test water, for the loading rate of 16 mg test item/L, 15.9 and 15.8 mg were mixed into 994 and 988 mL test water. The loading rate of 6.4 mg test item/L was prepared by mixing 6.3 and 6.1 mg into 984 and 953 mL test water, for 2.56 mg test item/L 5.26 and 5.08 mg were mixed into 2055 and 1984 mL test water and for the loading rate of 1.02 mg test item/L 2.09 and 2.14 mg were mixed into 2049 and 2098 mL test water. Each preparation was ultrasonicated for 15 min after 10 to 30 min stirring, total stirring time was 70 min. Non-dissolved fractions of the test item were separated from the test medium by membrane filtration (0.45 µm cellulose acetate filter).
The test media were prepared just before introduction of the daphnids (= start of the test) and the test medium renewal on Day 1.
- Controls: Medium without test item
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna (Straus), clone 5
- Age at study initiation (mean and range, SD): From 2.25 to 24.0 h old
- Method of breeding: The daphnids were bred in the laboratories of ibacon under similar temperature and light conditions as used in the test. The cultivation of the parental daphnids was performed in Elendt M4 medium. The test organisms were not first brood progeny.
- Source: The daphnids introduced in the test were taken from ibacon's in house laboratory culture
- Feeding during test : No
- Food type: The daphnids in the stock culture were with green algae (Desmodesmus subspicatus) freshly grown in the test facility.
- Frequency: Fed at least on all working days
ACCLIMATION : not necessary, since the test was performed in the same medium as the culturing.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 2.5 mmol/L (= 250 mg/L) as CaCO3
- Test temperature:
- 20.1 to 21.6 °C (Control)
20.2 to 21.2 °C (Test item concentrations) - pH:
- 7.9 to 8.0 (Control)
7.4 to 8.0 (Test item concentrations) - Dissolved oxygen:
- 8.5 to 8.9 mg/L (Control)
5.9 to 8.7 mg/L (Test item concentrations) - Nominal and measured concentrations:
- 100, 40, 16, 6.4, 2.56 and 1.02 mg/L (nominal concentrations)
0.483, 0.475, n.a., n.a., n.a., n.a. (based on the time weighted average measured concentration) - Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace, fill volume: 100 mL glass beakers; fill volume: 60 mL; headspace: 40 mL; covered with a lid to reduce evaporation
- Volume of solution: 60 mL
- Renewal rate of test solution: A semi-static test system with a test medium renewal on Day 1
- No. of organisms per vessel: 5 animals per test vessel
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt "M4" and analytical grade salts and additives were added:
Main components: CaCl2·2 H2O: 293.80 mg/L; MgSO4·7 H2O: 123.30 mg/L; KCl: 5.80 mg/L; NaHCO3: 64.80 mg/L; Na2SiO3·9 H2O: 10.00 mg/L; NaNO3: 0.27 mg/L; KH2PO4: 0.14 mg/L; K2HPO4: 0.18 mg/L
- Alkalinity: 0.9 mmol/L
- Culture medium different from test medium: No, medium was the same
- Intervals of water quality measurement: Daily and at every renewal of the test solution
OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark
- Light intensity: 420 to 880 lux (measured once during the test)
EFFECT PARAMETERS MEASURED: The mobility of the daphnids was determined by visual observation after 24 and 48 h. Those animals that are not able to swim within 15 sec after gentle agitation of the test beaker were considered to be immobile (even if they could still move their antennae).
RANGE-FINDING STUDY
- Test concentrations: performed under non-GLP, not reported
- Results used to determine the conditions for the definitive study: Based on the results of a non-GLP range-finding test the following test item concentrations for the main test were tested: 100, 40, 16, 6.4, 2.56 and 1.02 mg/L (spacing factor 2.5) - Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.483 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities:
No behavioural abnormalities were observed in any treatment group.
- Mortality of control: No mortality or immobility was observed.
- Other adverse effects control: No
- Immobilisation of control: No - Results with reference substance (positive control):
- For the evaluation of the quality of the Daphnia clone and the consistency of the experimental conditions, the reference item potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions (EC50 (24 h): 0.6 - 2.1 mg potassium dichromate/L).
- Reported statistics and error estimates:
- No statistical analysis was performed. The EL50 could not be quantified due to the absence of toxicity of the test item and were determined to be higher than the highest test concentration. The NOEL and the LOEL were determined directly from the raw data.
Any other information on results incl. tables
Biological Results:
Table 1: Biological Results of the test item on the mobility of Daphnia magna and sublethal effects
|
Abbreviations for observations:
0: No abnormalities
Table 2. Summary of Biological Results
Endpoints |
Test item concentration [mg/L] |
EL50 [mg test item/L]: EC50 [mg test item/L]: |
> filtrate of 100 |
95 % CI [mg test item/L]: |
n.d. |
EL20 [mg test item/L]: EC20 [mg test item/L]: |
> filtrate of 100
|
95 % CI [mg test item/L]: |
n.d. |
EL10 [mg test item/L]: EC10 [mg test item/L]: |
> filtrate of 100
|
95 % CI [mg test item/L]: |
n.d. |
NOEL [mg test item/L]: NOEC [mg test item/L]: |
≥ filtrate of 100
|
LOEL [mg test item/L]: LOEC [mg test item/L]: |
> filtrate of 100
|
Values refer to nominal loading rates; the values in brackets
refer to time weighted average concentrations
CI: Confidence interval; n.d.: not determinable; NOEC and LOEC were
determined directly from the raw data
Analytical Results
Table 3: Results for the Determination of the Test Item in the Test Samples
Sample Description |
Sampling Age |
Concentration found |
Concentration Calculated |
Concentration Nominal |
% of nominal |
Time weighted average concentration |
|
[mg test item/L] |
[day] |
[h] |
[mg test item/L] |
[mg test item/L] |
[mg test item/L] |
|
[mg test item/L] |
Control (untreated) |
0 |
0 |
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
24 |
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
0 |
<LOD |
n.a. |
0.000 |
n.a. |
|
|
2 |
24 |
<LOD |
n.a. |
0.000 |
n.a. |
|
Control |
0 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
0 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
1 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
2 |
|
<LOD |
n.a. |
0.000 |
n.a. |
|
|
2 |
|
|
n.a. |
0.000 |
n.a. |
|
Filtrate of 40 |
0 |
0 |
0.067 |
0.671 |
40.000 |
2 |
|
Filtrate of 40 |
0 |
0 |
0.056 |
0.562 |
40.000 |
1 |
|
Filtrate of 40 |
1 |
24 |
0.045 |
0.454 |
40.000 |
1 |
|
Filtrate of 40 |
1 |
24 |
0.048 |
0.482 |
40.000 |
1 |
|
Filtrate of 40 |
1 |
0 |
0.059 |
0.587 |
40.000 |
1 |
|
Filtrate of 40 |
1 |
0 |
0.057 |
0.566 |
40.000 |
1 |
|
Filtrate of 40 |
2 |
24 |
0.027 |
0.266 |
40.000 |
1 |
|
Filtrate of 40 |
2 |
24 |
0.029 |
0.239 |
40.000 |
1 |
|
|
|
|
|
|
Time weighted average (n=8) |
0.475 |
|
Filtrate of 100 |
0 |
0 |
0.031 |
0.615 |
100.00 |
1 |
|
Filtrate of 100 |
0 |
0 |
0.032 |
0.634 |
100.00 |
1 |
|
Filtrate of 100 |
1 |
24 |
<LOD |
n.a. |
0.00 |
n.a. |
|
Filtrate of 100 |
1 |
24 |
<LOD |
n.a. |
0.00 |
n.a. |
|
Filtrate of 100 |
1 |
0 |
0.032 |
0.633 |
100.00 |
1 |
|
Filtrate of 100 |
1 |
0 |
0.032 |
0.633 |
100.00 |
1 |
|
Filtrate of 100 |
2 |
24 |
0.017 |
0.332 |
100.00 |
0.3 |
|
Filtrate of 100 |
2 |
24 |
0.020 |
0.391 |
100.00 |
0.4 |
|
|
|
|
|
|
Time weighted average (n=6) |
0.483 |
Table 4: Validity criteria
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
0% |
Yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
7.8 mg O2/L |
Yes |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
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.