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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 microorganisms
Administrative data
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- Toxicity control from biodegradation study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Nov 2019 - 20 Jan 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data based on the inhibition control of a ready biodegradability study. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2012).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Nov 2019 - 20 Jan 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz; Wiesbaden; Germany
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: Aerobic activated sludge, microorganisms from a domestic waste water treatment plant was supplied by the sewage treatment plant Rossdorf, Germany.
- Storage conditions: aerobic
- Storage length: over night
- Preparation of inoculum for exposure: The activated sludge used for this study was deposited for 15 min before it was washed by centrifugation and the supernatant liquid phase decanted. The solid material was re-suspended in test water and centrifuged again. This procedure was performed three times. An aliquot of the final sludge suspension was weighed, dried and the ratio of wet sludge to its dry weight determined. Based on this ratio, calculated aliquots of washed sludge suspension, corresponding to 3.5 g dry material per L (± 10%) were mixed with test water and then aerated until use. This suspension was used for the experiment.
- Concentration of sludge: 3.5 g/L on dry matter base (final sludge concentration in test flasks: 27.5 mg sludge/L) - Duration of test (contact time):
- 60 d
- Initial conc.:
- 101.6 mg/L
- Based on:
- test mat.
- Initial conc.:
- 228.3 mg/L
- Based on:
- other: ThODNH4
- Initial conc.:
- 228.6 mg/L
- Based on:
- ThOD
- Remarks:
- ThODNO3
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Reconstituted Test Water, prepared from analytical grade salts.
- Test temperature: 22 ± 1 °C
- pH: 7.4 (at the start of the test), 7.4 - 7.6 (at the end of the test)
- Suspended solids concentration: 27.5 mg sludge/L
- Continuous darkness: Yes
TEST SYSTEM
- Culturing apparatus: BSB/BOD-Sensor-System, Aqualytic, Dortmund, Germany
- Number of culture flasks/concentration: 2
- Measuring equipment: BSB/BOD-Sensor-System, Aqualytic, Dortmund, Germany
- Test performed in open system: The test flasks were closed gas-tight by a measuring head.
- Details of trap for CO2 and volatile organics if used: A potassium hydroxide solution (45%) was used for trapping the produced carbon dioxide.
SAMPLING
- Sampling frequency: The change of pressure in the test flasks was measured by means of a manometric method each day. The temperature was recorded by means of the automated software AMR Wincontrol. pH-values were measured in procedure control, a separately prepared test flask with test item (to prevent loss of test item in the test flasks) and a separately prepared test flask without test item (control) at test start and in all flasks at the end of the test, except in the abiotic and toxicity control, using a pH-electrode WTW pH 340i.
CONTROL AND BLANK SYSTEM
- Inoculum blank (activated sludge in test water): 2 replicates
- Abiotic sterile control: 1 replicate: test item and CuSO4 in test water.
- Toxicity control: 1 replicate: test item, reference item and activated sludge in test water.
- Procedure control: 1 replicate: reference item and activated sludge in test water. - Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (O2 consumption)
- Value:
- 69
- Sampling time:
- 28 d
- Remarks on result:
- other: based on ThODNH4
- Parameter:
- % degradation (O2 consumption)
- Value:
- 91
- Sampling time:
- 60 d
- Remarks on result:
- other: based on ThODNH4
- Details on results:
- Biodegradation of test item:
The mean biodegradation after 28 days was 69% (ThODNH4). At the test end after 60 days the mean biodegradation was 91% (ThODNH4). Due to the fact that the substance is identified as an UVCB with structurally similar constituents, the 10-day window condition is not applicable and the pass level applied at 28 days is used according to section 4.1.2.9.5 of CLP Commission Regulation (EU) No 286/2011 of 10 March 2011.
Biodegradation in the Toxicity Control:
In the toxicity control containing both, the test item and the reference item sodium benzoate, 67% (ThODNH4) biodegradation was noted after 14 days and 28 days of incubation and 68% (ThODNH4) biodegradation was noted after 60 days. - Results with reference substance:
- Reference item: The reference item sodium benzoate was sufficiently degraded to 60% after 5 days, to 86% after 28 days and to 97% after 60 days of incubation.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
- Interpretation of results:
- readily biodegradable
Table 1. Validity criteria of OECD
Criterion from the guideline |
Study results |
Validity criterion fulfilled |
Difference of extremes of replicate values of the removal of the test chemical at the plateau, at the end of the test or at the end of the 10-d window, as appropriate, is less than 20%. |
The difference of duplicate values at day 28 differed by 2% and at day 60 by 0% (based on ThODNH4). |
Yes |
Percentage degradation of the reference compound has reached the pass levels by day 14. |
The reference item sodium benzoate was degraded to more than 60% after 5 days of incubation. |
Yes |
The oxygen uptake of the inoculum blank is normally 20-30 mg O2/L and should not be greater than 60 mg/L in 28 days. |
The oxygen demand of the inoculum control was 20 mg O2/L after 28 d and 27.5 mgO2/L after 60 d. |
Yes |
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:
- other: OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- GLP compliance:
- yes
- 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:
- no
Test solutions
- Vehicle:
- no
Test organisms
- Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- - Source of inoculum/activated sludge: Aerobic activated sludge, microorganisms from a domestic waste water treatment plant was supplied by the sewage treatment plant Rossdorf, Germany.
- Storage conditions: aerobic
- Storage length: overnight
- Preparation of inoculum for exposure: The activated sludge used for this study was deposited for 15 min before it was washed by centrifugation and the supernatant liquid phase decanted. The solid material was re-suspended in test water and centrifuged again. This procedure was performed three times.
An aliquot of the final sludge suspension was weighed, dried and the ratio of wet sludge to its dry weight determined. Based on this ratio, calculated aliquots of washed sludge suspension, corresponding to 3.5 g dry material per L (± 10%) were mixed with test water and then aerated until use. This suspension was used for the experiment.
- Concentration of sludge: 3.5 g/L on dry matter base (final sludge concentration in test flasks: 27.5 mg sludge/L)
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 14 d
Test conditions
- Test temperature:
- 22 ± 1 °C
- pH:
- 7.4 (at the start of the test), 7.4 - 7.6 (at the end of the test)
- Details on test conditions:
- TEST CONDITIONS
- Composition of medium: Reconstituted Test Water, prepared from analytical grade salts.
- Test temperature: 22 ± 1 °C
- pH: 7.4 (at the start of the test), 7.4 - 7.6 (at the end of the test)
- Suspended solids concentration: 27.5 mg sludge/L
- Continuous darkness: Yes
TEST SYSTEM
- Culturing apparatus: BSB/BOD-Sensor-System, Aqualytic, Dortmund, Germany
- Number of culture flasks/concentration: 2
- Measuring equipment: BSB/BOD-Sensor-System, Aqualytic, Dortmund, Germany
- Test performed in open system: The test flasks were closed gas-tight by a measuring head.
- Details of trap for CO2 and volatile organics if used: A potassium hydroxide solution (45%) was used for trapping the produced carbon dioxide.
SAMPLING
- Sampling frequency: The change of pressure in the test flasks was measured by means of a manometric method each day. The temperature was recorded by means of the automated software AMR Wincontrol. pH-values were measured in procedure control, a separately prepared test flask with test item (to prevent loss of test item in the test flasks) and a separately prepared test flask without test item (control) at test start and in all flasks at the end of the test, except in the abiotic and toxicity control, using a pH-electrode WTW pH 340i.
CONTROL AND BLANK SYSTEM
- Inoculum blank (activated sludge in test water): 2 replicates:
- Abiotic sterile control: 1 replicate: test item and CuSO4 in test water.
- Toxicity control: 1 replicate: test item, reference item and activated sludge in test water.
- Procedure control: 1 replicate: reference item and activated sludge in test water. - Reference substance (positive control):
- yes
- Remarks:
- benzoic acid, sodium salt
Results and discussion
Effect concentrations
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 101.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Result of toxicity control from ready biodegradability test
- Details on results:
- Biodegradation in the Toxicity Control:
In the toxicity control, the test item attained 67% (ThODNH4) biodegradation after 14 days. According to the test guidelines, the test item can be assumed to be not inhibitory to the aerobic activated sludge microorganisms because degradation was >25% within 14 days. Since the substance was degraded by 67% after 14 days it is with high probability not toxic to aquatic microorganisms. The test item concentration in the toxicity control of 101.6 mg/L can be used as NOEC value for the toxicity to aquatic microorganisms. - Results with reference substance (positive control):
- The reference item sodium benzoate was sufficiently degraded to 60% after 5 days, to 86% after 28 days and to 97% after 60 days of incubation, thus confirming the suitability of the aerobic activated sludge inoculum used.
Any other information on results incl. tables
The toxicity control attained 67% degradation after 14 days of incubation.
“If in a toxicity test, containing both the test and reference substance, less than 35% degradation (based on total DOC) or less than 25% (based on total ThOD or ThCO2) occurred within 14 days, the test substance can be assumed to be inhibitory.” (OECD guideline 301)
Since more than 25% degradation occurred in the toxicity control, the substance is with high probability not toxic to aquatic microorganisms. The test item concentration in the toxicity control of 101.6 mg/L can be used as NOEC value for the toxicity to aquatic microorganisms.
Applicant's summary and conclusion
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