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EC number: 840-567-9 | CAS number: 2247629-85-0
- 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:
- October-December 2019
- 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)
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement is included in attached full study report
Test material
- Reference substance name:
- Soil organic matter, alkaline extract, sodium salt
- EC Number:
- 840-567-9
- Cas Number:
- 2247629-85-0
- IUPAC Name:
- Soil organic matter, alkaline extract, sodium salt
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch #: 191016
Expiration Date: October 15, 2020
0.9% (9306 mg/L) mineral complexed organic matter (based on total organic carbon content of 0.51%)
1124 mg/L Fe
3333 mg/L Na
2187 mg/L total inorganic carbon
pH=7.28
Density: 1.011 g/mL at 25 degrees C
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Water Solubility Test
The water solubility of the test substance was determined prior to the beginning of the study. The test substance was determined to be water-soluble.
Range-finding Test
A preliminary range-finding test was conducted to determine the concentrations needed for the definitive test. The five concentrations used were 1 mg/L, 5 mg/L, 10 mg/L, 50 mg/L and 100 mg/L. There was one flask of test medium for each concentration. The algae were introduced to each concentration at an initial cell density of 10,000 cells/mL, and at 72 hours, the terminal density was measured. The range-finder indicated an EC50 (Median Effective Concentration) of >100 mg/L, so a limit test was conducted in lieu of a definitive.
Test Substance, Control and Positive Control Preparation
The limit test stock solution was prepared by dissolving 0.16 g of test substance in 800 mL of OECD medium and mixing for 15 minutes. A test substance control solution was made using only dilution water. A positive control solution was prepared using zinc chloride (Mfg: Acros, Lot: A0371487, Exp: 27 Feb 2022). Solutions for the limit test were prepared from the stock solution. All concentrations were double the desired final concentration until media containing algae cells was added in equal volume to prepared test concentration.
Limit Test
A limit test was conducted using a concentration of 100 mg/L of the test substance. The test cultures were divided into 250 mL flasks containing the appropriate concentration of test substance (four flasks for test concentration and six flasks for the control). A positive control group consisted of three flasks treated with 10 mg/L zinc chloride. The flasks were set on a shaker table for constant agitation at approximately 100 cycles/minute. At 24, 48, and 72 hours following dosing, observations of inhibition were made for each test container by measuring the mean cell density with a hemocytometer.
Test Validity
The test was considered valid if the 72-hour terminal control increased by a factor of at least 16 times. Additionally, the mean coefficient of variation (C.V.) among control replicates at 24, 48, and 72 hours should be less than 35%.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Experimental Organism
Species: Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum)
Justification for Species: One of the freshwater alga species specified in the regulations
Source: STILLMEADOW, Inc. cultures
Age: Mass culture initiated 3-7 ± 1 days prior to dosing
Density: Initial cell density was 10,000 cells/mL
OECD Media Preparation
Stock Solutions I-IV are prepared with the listed concentrations in deionized water, sterilized by membrane filtration (0.22 μm pore size), and stored in the dark at ~4°C for up to 6 months. The OECD Medium was prepared by combining 20 mL of Stock Solution I and 2 mL each of Stock Solutions II, III and IV for every 1000 mL of sterile deionized water.
Cultivation Method
Pseudokirchneriella subcapitata parent and daughter cultures are continuously maintained at STILLMEADOW, Inc. Prior to testing, 800 mL of sterile OECD medium was inoculated with 5-day old organisms. Autoclaved media was adjusted to a pH of 8.1 ±0.1 with 0.1 mL of 0.1 N sodium hydroxide (Mfg: Fluka, Lot: H053B, Exp: 05 Aug 2020). All procedures were conducted aseptically.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- N/A
- Test temperature:
- 24-26 degrees C
- pH:
- 8.1 (plus or minus 0.1)
- Dissolved oxygen:
- Test containers received constant agitation on shaker table set at approximately 100 cycles/minute.
- Salinity:
- N/A
- Conductivity:
- N/A
- Details on test conditions:
- Organism Husbandry
Test Room: Environmentally controlled chamber (Chamber A)
Test Chambers: 250 mL sterile Erlenmeyer flasks with foam stoppers; filled with 100 mL of the appropriate solution
Dissolved Oxygen Concentrations: Test containers received constant agitation on shaker table set at approximately 100 cycles/minute
Test/Nutrient Medium: OECD media with a pH of 8.1 ± 0.1.
Environmental Controls
Set to Maintain: Temperature of 24 ± 2°C
Continuous lighting (4300 ± 645 lux)
Actual Temperature: Range-finding: 23-26ºC
Limit: 24-26ºC
Actual Light Intensity: Range-finding: 3680-4650 lux
Limit: 3940-4810 lux - Reference substance (positive control):
- yes
- Remarks:
- A positive control solution was prepared using zinc chloride (Mfg: Acros, Lot: A0371487, Exp: 27 Feb 2022).
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and cell density
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and cell density
- Details on results:
- Test Validity
The test was considered valid because the 72 hour terminal control increased by a factor of at least 16 times. The mean coefficient of variation was 16.845% at 72 hours.
Chemical and Physical Monitoring
Chemical and physical monitoring data (chamber temperature and light intensity) of test chambers for the limit test are presented in Appendix C of the attached report.
Limit Test
Initial cell density was 10,000 cells/mL. The only observation recorded was that the cells in the test substance group were clumping at 48 and 72 hours. Results presented are based on nominal concentrations. Daily cell counts, terminal pH and average growth rate are presented in Table 2 below and in the attached report.
Evaluation of Results
At 72 hours, the test concentration of FBS Transit that resulted in cell density and growth rate EC50 was determined to be >100 mg/L. At 72 hours, the cell density and growth rate NOEC was determined to be 100 mg/L. Results presented are based on nominal concentrations. Statistics are presented in Appendix D. - Results with reference substance (positive control):
- See Table 2 below and in the attached report.
- Reported statistics and error estimates:
- The mean cell counts of the test concentration containers were compared to the control counts to determine the concentration of the test substance which resulted in a Median Effective Concentration (EC50) and the No Observed Effect Concentration (NOEC). The NOEC and EC50 were determined by a commercially available statistical program (ToxCalc Version 5.0™). Linear Interpolation was used for EC50 determination. See Appendix D in the attached report.
Any other information on results incl. tables
Table 2a: Limit Test Average Growth Rate Results
Test Conc. | Rep | Cell Density x 10^4 cells/mL | Initial pH | Terminal pH | Average Growth Rate | ||
mg/L | 24 hr | 48 hr | 72 hr | ||||
A | 6 | 18 | 78 | 7.2 | 0.061 | ||
B | 4 | 12 | 4 a | 7.1 | NA | ||
Control | C | 6 | 16 | 80 | 8.1 | 7.2 | 0.061 |
D | 4 | 12 | 13 a | 7.1 | NA | ||
E | 6 | 27 | 82 | 8.3 | 0.061 | ||
F | 4 | 20 | 86 | 8.3 | 0.062 |
Table 2b- Limit Test Average Growth Rate Results
Test Conc. | Rep | Cell Density x 10^4 cells/mL | Initial pH | Terminal pH | Average Growth Rate | ||
mg/L | 24 hr | 48 hr | 72 hr | ||||
A | 5 | 18 b | 80 b | 8.2 | 0.061 | ||
100 | B | 4 | 30 b | 86 b | 8.1 | 8.3 | 0.062 |
C | 4 | 20 b | 70 b | 8.3 | 0.059 | ||
D | 6 | 24 b | 79 b | 8.2 | 0.061 | ||
C2 | A | 1 | 2 | 0 | 7.8 | 0.000 | |
10 mg/L | B | 1 | 1 | 1 | 7.8 | 7.9 | 0.000 |
ZnCl2 | C | 1 | 1 | 1 | 7.9 | 0.000 |
a- Replicate was considered an outlier and was not included in any statistical analysis.
b- Cells clumping
NA- not applicable as replicate was an outlier
Note: all organisms had no observable abnormalities unless otherwise noted.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- FBS Transit does not inhibit algal growth.
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