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EC number: 212-833-9 | CAS number: 872-93-5
- 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
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Jan 2018 - 16 Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2011
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Dose Verification:
The concentration of the active ingredient, 3 methyl sulfolane, in the test item was determined in each new test solution at 0 hours and in each old test solution at 72 hours by validated standard analytical methods. A blank consisting of only dilution water was also analyzed. - Vehicle:
- no
- Details on test solutions:
- Test Item Preparation:
For the limit test, the stock solution of 200 mg/L concentration was prepared by dissolving 0.16 g of test substance into 800 mL of OECD medium and mixing for 15 minutes. An aliquot (600 mL) of the stock solution was then combined with 600 mL of algae to achieve the desired 100 mg/L concentration for testing. A positive control was prepared by combining 0.004 g of zinc chloride (Mfg: Acros, Lot: A0371487, Exp: 27 Feb 2022) with 200 mL of dilution water, to which was added 200 mL of algae, for a final concentration of 10 mg/L.
The definitive stock solution was prepared by dissolving 0.20 g of test item in 1000 mL of OECD medium and mixing for 15 minutes. This stock solution was diluted with dilution water to make five different test item solutions with five different concentrations for the definitive test. A test item control solution was made using only dilution water. A positive control solution was prepared using zinc chloride. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Experimental Organism
- Species: Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), also known as Raphidocelis subcapitata
- 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
Organism Husbandry
- Test Room:
- Range-Finder: Environmentally Controlled Chamber A
- Limit: Environmentally Controlled Chamber A
- Definitive: Algae Room
- 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. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- Limit: 22-24ºC
Definitive: 22-25ºC - pH:
- Limit: 8 - 7.9 (control)
Definitive: 8 - 8.6 (control) - Nominal and measured concentrations:
- Limit test
Nominal: 100 mg/L
Measured geometric mean: 88.8 mg/L
Definitive test
Nominal: 6.25 mg/L, 12.5, 25, 50 and 100 mg/L.
Measured geometric mean: 1.4, 4.9, 18.6, 44.8 and 89.9 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: sterile Erlenmeyer flasks with foam stoppers
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 250ml, filled with 100 mL of the appropriate solution
- Aeration: Test containers received constant agitation on shaker table set at approximately 100 cycles/minute
- Initial cells density:
Range-Finder: Initial cell density was 25,000 cells/mL
Limit: Initial cell density was 25,000 cells/mL
Definitive: Initial cell density was 50,000 cells/mL
- Control end cells density: Average 163.3 x 10^4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates):6 and 3 for positive control
GROWTH MEDIUM
- Standard medium used: yes (OECD media)
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: For the range-finding, limit and definitive test, the following measurements were made. The initial pH of each dosing solution and control solution were measured and recorded. The final pH of each treatment and control replicate was measured and recorded. Chamber temperature was measured at 0 hours and daily with a calibrated thermometer. Daily maximum and minimum temperatures were also recorded. Light intensity was measured daily in at least 5 locations in the test areas at the height of the test solution in the test chambers.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Continuous lighting (4440-8880 lux ±15%)
- Actual Light Intensity: Range-finding: 4020-4920 lux
Limit: 4000-4880 lux
Definitive: 3860-5310 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: observation of inhibition were made for each test container by measuring the mean cell density with a hemocytometer.
TEST CONCENTRATIONS
- Range finding study: A preliminary range-finding test was conducted to determine the concentrations needed for the definitive test. The five concentrations used were 1 mg/L, 10 mg/L, 100 mg/L, 500 mg/L and 1000 mg/L.
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- zinc chloride
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 4.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 11.2 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 90 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 4.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 90 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Details on results:
- Evaluation of Results for Limit Test
For the limit test, at 72 hours, the test concentration of 3-Methyl Sulfolane that resulted in EyC50 and ErC50 was determined to be > 88.8 mg/L. The yield and growth rate NOEC were <88.8 mg/L. The yield and growth rate LOEC were 88.8 mg/L.
For the definitive test:
the ErC10, at 72 hours, for 3-Methyl Sulfolane, was determined to be 11.2 mg/L. The ErC50 for 3-Methyl Sulfolane was determined to exceed the highest dose tested (90 mg/L). The growth rate NOEC for 3-Methyl Sulfolane was determined to 1.4 mg/L and the LOEC was 4.9 mg/L. For the definitive test, at 72 hours, the test concentration of 3-Methyl Sulfolane that resulted in EyC10 was determined to be 0.12 mg/L. The EyC50 was determined to exceed the highest dose tested (90 mg/L). At 72 hours, the cell density NOEC was determined to be 1.4 mg/L and the LOEC was 4.9 mg/L.
Test Validity
Per protocol, 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 for section-by-section specific growth rates in the control cultures was 17.5% in the definitive test and 9.9% in the limit test. Additionally, the coefficient of variation of average specific growth rates during the whole test period in replicate control cultures was 3.5% (<7.0% per OECD 201). Although initial cell density exceeded 10,000 cells/mL (recommended by OECD 201), this had no adverse effect on the exponential growth throughout the incubation period without risk of nutrient depletion or on the integrity of the study. - Results with reference substance (positive control):
- No growth occurred in the limit test or the definitive test.
- 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 item 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. Probit analysis was used for ErCx and EyCx determination for the definitive test.
- Validity criteria fulfilled:
- yes
- Remarks:
- > 16-fold increase in controls, mean of coefficients of variation < 35%, specific coefficient of variation < 7%
- Conclusions:
- Under the conditions of the present study with Pseudokirchneriella subcapitata, 3-Methyl Sulfolane reduced growth rate and inhibited the yield of this fresh water algae species significantly at the 4.9 mg/L, 18.6 mg/L, 44.8 mg/L and 89.9 mg/L concentrations tested.
The EC50 for growth rate inhibition (72h-ERC50) exceeded 90 mg/L, the highest dose tested, based on analytically confirmed concentrations.
The EC50 for yield inhibition (72h-EYC50) exceeded 90 mg/L, the highest dose tested, based on analytically confirmed concentrations.
The 72h-NOEC for growth rate and yield inhibition based on statistical significance was 1.4 mg/L. - Executive summary:
A full OECDTG201 GLP test was performed with Pseudokirchneriella subcapitata based on the results of a preceding range-finding test. Initially, a limit test was conducted using 100 mg/L concentration. To determine a No Observed Effect Concentration (NOEC), a definitive test was conducted. Six exponentially growing algal cultures were exposed to an untreated control, whereas three replicates per group were exposed to nominal concentrations of 6.25, 12.5, 25, 50 and 100 mg 3-Methyl Sulfolane per litre under static conditions. A positive control group consisted of three flasks treated with 10 mg/L zinc chloride. Dose verification was conducted by gas chromatography (GC) and performed during the study on new test solutions sampled at 0 and on old test solutions at 72 hours. In the definitive test, the dose verified concentrations were calculated using geometric means and were determined to be 1.4 mg/L, 4.9 mg/L, 18.6 mg/L, 44.8 mg/L and 89.9 mg/L for 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L and 100 mg/L, respectively.
The study met the acceptability criteria prescribed by the study plan and was considered valid. Under the conditions of the present study 3-Methyl Sulfolane reduced growth rate and inhibited the yield of this fresh water algae species significantly at the 4.9 mg/L, 18.6 mg/L, 44.8 mg/L and 89.9 mg/L concentrations tested.
For the definitive test, the ErC10, at 72 hours, for 3 Methyl Sulfolane, was determined to be 11.2 mg/L. The ErC50 for 3 Methyl Sulfolane was determined to exceed the highest dose tested (> 90 mg/L) based on geometric mean concentration. The growth rate No Observed Effect Concentration (NOEC) for 3 Methyl Sulfolane was determined to 1.4 mg/L.
For the definitive test, at 72 hours, the test concentration of 3 Methyl Sulfolane that resulted in EyC50 was determined to exceed the highest dose tested (> 90 mg/L) based on geometric mean concentration. At 72 hours, the cell density NOEC was determined to be 1.4 mg/L. The EyC10 was determined to be 0.12 mg/L.
Reference
Description of key information
A full OECDTG201 GLP test was performed with Pseudokirchneriella subcapitata based on the results of a preceding range-finding test. Initially, a limit test was conducted using 100 mg/L concentration. To determine a No Observed Effect Concentration (NOEC), a definitive test was conducted. Six exponentially growing algal cultures were exposed to an untreated control, whereas three replicates per group were exposed to nominal concentrations of 6.25, 12.5, 25, 50 and 100 mg 3-Methyl Sulfolane per litre under static conditions. A positive control group consisted of three flasks treated with 10 mg/L zinc chloride. Dose verification was conducted by gas chromatography (GC) and performed during the study on new test solutions sampled at 0 and on old test solutions at 72 hours. In the definitive test, the dose verified concentrations were calculated using geometric means and were determined to be 1.4 mg/L, 4.9 mg/L, 18.6 mg/L, 44.8 mg/L and 89.9 mg/L for 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L and 100 mg/L, respectively.
The study met the acceptability criteria prescribed by the study plan and was considered valid. Under the conditions of the present study 3-Methyl Sulfolane reduced growth rate and inhibited the yield of this fresh water algae species significantly at the 4.9 mg/L, 18.6 mg/L, 44.8 mg/L and 89.9 mg/L concentrations tested.
For the definitive test, the ErC10, at 72 hours, for 3 Methyl Sulfolane, was determined to be 11.2 mg/L. The ErC50 for 3 Methyl Sulfolane was determined to exceed the highest dose tested (> 90 mg/L) based on geometric mean concentration. The growth rate No Observed Effect Concentration (NOEC) for 3 Methyl Sulfolane was determined to 1.4 mg/L.
For the definitive test, at 72 hours, the test concentration of 3 Methyl Sulfolane that resulted in EyC50 was determined to exceed the highest dose tested (> 90 mg/L) based on geometric mean concentration. At 72 hours, the cell density NOEC was determined to be 1.4 mg/L. The EyC10 was determined to be 0.12 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 90 mg/L
- EC10 or NOEC for freshwater algae:
- 11.2 mg/L
Additional information
The ErC50 value was higher than the highest dose tested (nominally 100 mg/L).
Based on geomean measured concentrations this equals > 90 mg/L.
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