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EC number: 249-616-3 | CAS number: 29420-49-3
- 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 - 1 Feb 2001
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: L-7038 Lot 2
- Expiration date of the lot/batch: 17 Jan 2002
- Purity: 97.3%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient conditions
- Stability under test conditions: stable - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All concentrations monitored
- Sampling method: Three replicate test chambers were maintained for each treatment and control group. One additional replicate was also maintained for analytical sampling at 72 hours. Test solutions from the same concentration were pooled before sampling at 96 hours. The bulk test solution stocks fwere sampled at the initial time point. A sample was taken from all test concentrations and the control at test initiation, at approximately 72 hours, and at test termination.
- Sample storage conditions before analysis: samples stored in plastic vials and analyzed as soon as possible without storage
- Abiotic samples: To verify maintenance of the test substance concentration, two replicates were set up at the highest substance concentration but without algae. Measured test concentrations were determined at test initiation, at approximately 72 hours, and at test termination.
To verify maintenance of test substance concentration, a test vessel was set up at the highest substance concentration but without algae. Samples for analysis were taken at times zero, 24h and 72h. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 2-L primary stock solution was prepared in algal medium at a concentration of 10000 mg a.i./L. The primary stock solution was inverted at least 20 times to aid in the solubilization of the test substance. After mixing, the primary stock solution was proportionally diluted with algal medium to prepare 500 mL of the five other test concentrations (313, 625, 1250, 2500, 5000 mg a.i./L). All dilutions were inverted to mix.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none, test solutions were clear and colorless at start of test - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Selenastrum capricornutum
- Source (laboratory, culture collection): Internal stock at Wildlife International, Ltd. Inoculum originally obtained from University of Toronto, Canada.
- Age of inoculum: not reported
- Method of cultivation: Algal cells used in this test were obtained from Wildlife International, LtdCultures that had been actively growing in culture medium for at least two weeks prior to test initiation.
ACCLIMATION
- Acclimation period: none
- Culturing media and conditions: The algal cells were cultured and tested in freshwater algal medium. The pH of the medium was adjusted to 7.5 ± 0.1 using 10% HCl; the medium was sterilized by filtration (0.22 μm) prior to use.
MgCl2∙6H2O, 12.16 mg/L
CaCl2∙2H2O, 4.41 mg/L
H3BO3, 0.1855 mg/L
MnCl2∙4H2O, 0.4154 mg/L
ZnCl2, 3.27 mg/L
FeCl3∙6H2O, 0.1598 mg/L
CoCl2∙6H2O, 1.428 mg/L
Na2MoO4∙2H2O, 7.26 mg/L
CuCl2∙2H2O, 0.012 mg/L
Na2EDTA∙2H2O, 0.300 mg/L
NaNO3, 25.50 mg/L
MgSO4∙7H2O, 14.70 mg/L
K2HPO4, 1.044 mg/L
NaHCO3, 15.0 mg/L - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- The 9478 mg a.i./L treatment group was maximally inhibited at the end of the 96-hour exposure period. Aliquots of the test solution were diluted with algal medium and cultured for six days. Based on the growth observed in the recovery phase, the effect on algal growth was found to be algistatic.
- Test temperature:
- 23.8 - 24.7 °C
- pH:
- 0 hours: 6.9 - 7.1
96 hours: 7.5 - 8.7 - Nominal and measured concentrations:
- Nominal: 0 (negative control), 313, 625, 1250, 2500, 5000, and 10000 mg/L
Measured: < LOQ, 285, 563, 1077, 2216, 4561, and 9478 mg/L (see Table 1) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL polycarbonate Erlenmeyer flasks plugged with foam stoppers and 100 mL of test or control algal medium
- Type: closed
- Agitation: Yes, the test chambers were shaken continuously at 100 rpm
- Initial cells density: 1.0E+04 cells/mL
- Control end cells density: 3.56E+06 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes (ASTM Standard Guide 1218-90E)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified well water (reverse osmosis)
OTHER TEST CONDITIONS
- Photoperiod: Continuous cool-white fluorescent lighting (4300 ± 430 lux) measured using SPER Scientific Model 840006 light meter
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: cell counts were conducted using a hemacytometer and microscope at 24 hour intervals
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5 661 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 5230-6067 mg a.i./L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 734 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 0-2207 mg a.i./L
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5 733 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 5659-5817 mg a.i./L
- Duration:
- 96 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1 674 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 1482-1839 mg a.i./L
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities: After 96 hours of exposure, there were no signs of aggregation, flocculation, or adherence of the algae to the test flasks in the control or treatment groups. However, algal cells in the 2216, 4561, and 6478 mg a.i./L treatment groups appeared enlarged when compared to the negative control.
- Other: The 9478 mg a.i./L treatment group was maximally inhibited at the end of the 96-hour exposure period. Aliquots of the test solution were diluted with algal medium and cultured for six days. Based on the growth observed in the recovery phase, the effect on algal growth was found to be algistatic. - Reported statistics and error estimates:
- After 72 hours of exposure, Dunnett’s test showed that growth rate was significantly reduced in all treatment groups (p ≤ 0.05). After 96 hours of exposure, Dunnett’s test showed that growth rate was significantly reduced in the 2216, 4561, and 9478 mg a.i./L treatment groups (p ≤ 0.05).
- Validity criteria fulfilled:
- yes
- Remarks:
- Control cell density increased by an average factor of >16 within 2 days, the mean CV for section specific growth rates in the control was < 35% (29%), and the CV of average specific growth rates during the whole test period in control was < 7% (4.4%).
- Conclusions:
- The 72-hour EC50 (growth rate) of PFBSK+ to Pseudokirchneriella subcapitata was 5661 mg a.i./L. The corresponding 72-hour EC10 (growth rate) was 734 mg a.i./L. Test conducted per OECD 201.
- Executive summary:
The toxicity of PFBSK+ to the green algae, Pseudokirchneriella subcapitata, was assessed according to the OECD 201 method. An exponential growth was observed during the entire period of exposure in the control vessel and the validity criteria were met.
The 72-hour ErC50 of PFBSK+ to Pseudokirchneriella subcapitata for growth rate was 5661 mg a.i./L (5230-6067 mg a.i./L). The corresponding 72-hour ErC10 was 734 mg/L (95% CI: 0-2207 mg/L). Based on the growth observed in the recovery phase, the effect on algal growth was found to be algistatic.
The study was performed in accordance with internationally-accepted test guidelines under GLP. The study is deemed reliable without restriction and suitable for use in Risk Assessment, Classification & Labeling, and PBT Analysis.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 18 - 21 Mar 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: K100
- Sample no./year: 1069024/2002
- Purity: 98.7%
- Expiration date of the lot/batch: August 12, 2004 - Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples taken at 0 and 72 hours (all concentrations). Samples for the 0 hour time point were stored one working day before analysis.
- Abiotic samples: In order to check whether or not significant amounts of the test item are incorporated into the algal biomass during the test period, a test flask at the highest test concentration without algae is run in parallel to the geometric series of test concentrations. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 125.2 mg of the test item were added to 1 liter of dilution water and treated for 1 hour in an ultrasonic bath and then stirred for 24 hours on a magnetic stirrer. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmus subspicatus
- Strain: Non-axenic strain
- Source (laboratory, culture collection): The Collection of Algal Cultures' of the Institute of Plant Physiology at the University of Göttingen (Germany). Exponentially-growing stock cultures are maintained in the test facility under constant temperature conditions (23 ± 2°C) at a light intensity in the range 60 - 120 µE. x m-2 x s-1.
ACCLIMATION
- Culturing media and conditions (same as test or not): Pre-cultures are set up three days before the start of a test. They are grown under identical exposure conditions as the stock cultures, except from the use of a different nutrient medium. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 23 ± 2 °C
- pH:
- Control:
8.1 at 0 hours
10.3 at 72 hours
Test:
8.1 at 0 hours
10.5 at 72 hours - Nominal and measured concentrations:
- Nominal: 100 mg/L
Measured: 105 mg/L at 0 hours; 98-126 mg/L at 72 hours - Details on test conditions:
- TEST SYSTEM
- Test vessel: 300 mL Erlenmeyer flasks with stoppers
- Type: closed
- Initial cells density: 1.0E+04 cells/mL
- Control end cells density: 3.4E+05 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, OECD medium
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Light intensity and quality: light intensity in the range 60 - 120 11E. x m-2 x s-1 (measured in the range 400 to 700 nm using a spherical quantum flux meter)
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: microcell counter or microscopic counting chamber - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 115.5 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.:
- 115.5 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control: yes
- Validity criteria fulfilled:
- yes
- Remarks:
- The cell density in the control cultures increased by a factor of at least 16 within 72 hours. The concentration of the test item was maintained to within 80% of the initial concentration throughout the study (DOC analysis).
- Conclusions:
- The 72-hour EC50 (growth rate) of PFBSK+ to Desmodesmus subspicatus was beyond the range tested (measured concentration of 115.5 mg/L). The corresponding 72-hour NOEC (growth rate) was 115.5 mg/L. Test conducted per EU Method C.3.
- Executive summary:
The toxicity of PFBSK+ to the green algae, Desmodesmus subspicatus, was assessed in a 72-hour toxicity test conducted according to the EU Method C.3. An exponential growth was observed during the entire period of exposure in the control vessel and the validity criteria were met. Nominal concentrations were confirmed by analytical measurement (98-106%).
The 72-hour ErC50 of PFBSK+ to Desmodesmus subspicatus for growth rate was beyond the range tested (measured concentration of 115.5mg/L). The corresponding 72-hour NOEC (growth rate) was 115.5 mg/L. The study was performed in accordance with internationally-accepted test guidelines under GLP. The study is deemed reliable without restriction and suitable for use in Risk Assessment, Classification & Labeling, and PBT Analysis.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- Draft revised guideline of 2002
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: purchased from Tokya Kasei Kogyo (Tokyo, Japan)
OTHER SPECIFICS:
- Other substances tested in parallel: perfluorohexanoic acid ([PFHxA], CAS# 307-24-4); perfluorooctanoic acid (PFOA, CAS# 335- 67-1); perfluorododecanoic acid ([PFDoA], CAS# 307-55-1); perfluorooctane sulfonate (PFOS, CAS# 1763-23-1) and perfluorotetradecanoic acid ([PFTeA], CAS# 376-06-7). - Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- other: Scenedesmus obliquus
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Source: Freshwater Algae Culture Collection, Institute of Hydrobiology, Chinese Academy of Sciences (Beijing)
ACCLIMATION
- Acclimation period: not reported
- Culturing media and conditions: The algal cells were cultured and tested in freshwater algal medium. The pH of the medium was adjusted to 7.5 ± 0.2. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 50 mL flask
- Material, size, headspace, fill volume: 20 mL
- Initial cells density: 1.0E+04 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes, OECD medium
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Light intensity and quality: Illumination was provided by cool-white fluorescent lights (6000 lux) at a 14:10-h light:dark cycle.
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: optical density at 650 nm (UV-Vis spectrometer (Xinmao Instrument, Shanghai, China)) and in vitro chlorophyll fluorescence (Hitachi F-4500 fluorescence spectrophotometer (Tokyo, Japan) after 24-hour extraction in a 1:1 (v:v) mixture of dimethyl sulphoxide and acetone).
- Other:
- Flow cytometry: Cell viability was studied using propidium iodide staining to distinguish between live nonfluorscent cells and nonviable fluorescent cells. Mitochondrial membrane potential was measured by the incorporation of a cationic fluorescent dye, rhodamine 123. Cell membrane permeability was tested using fluorescein diacetate. - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- IC50
- Effect conc.:
- > 676 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Reported as > 2 mM
- Key result
- Duration:
- 72 h
- Dose descriptor:
- IC10
- Effect conc.:
- > 676 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Reported as > 2 mM
- Details on results:
- PFBSK+ showed no effects on membrane characteric during the flow cytometry section of the study.
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 72-hour IC50 (growth rate) of PFBSK+ to Scenedesmus obliquus was beyond the range tested (nominal concentration of 676 mg/L). The corresponding 72-hour IC10 (growth rate) was also beyond the range tested. Test conducted per OECD 201.
- Executive summary:
The toxicity of PFBSK+ to the green algae, Scenedesmus obliquus, was assessed in a 72-hour toxicity test conducted according to the OECD 201 method. The 72-hour IC50 of PFBSK+ for growth rate was beyond the range tested (nominal concentration of 2mM (676 mg/L)). The corresponding 72-hour IC10 was also beyond the range tested. Cell viability, mitochondrial membrane potential, and cell permeability were assessed after exposure was complete using flow cytometry and fluorescent stains. PFBS-exposed organisms showed no effects up to 2 mM. The regulatory implications of the flow cytometry results are not clear, but with further research the approach may be useful for determining adverse outcome pathways. The study was well-documented and followed a national standard method but was not conducted under GLP; therefore, the study is deemed reliable with restrictions and suitable for use in Risk Assessment, Classification & Labeling, and PBT Analysis.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- test completed in a microplate at a volume of 200 µg/L
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: provided by the 3M Company
OTHER SPECIFICS:
- Other substances tested in parallel: Perfluorooctane sulfonate (PFOS) potassium salt, perfluorooctanoic acid (PFOA), docusate sodium, triclosan, 2,4,6-trichlorophenol (TCP), and Polyfox 656 (PF-656). - Analytical monitoring:
- not specified
- Remarks:
- The authors report that nominal and measured exposure concentrations did not show significant deviations, indicating analytical monitoring was conducted; however, no further details or data were available.
- Vehicle:
- no
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 250 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- not specified
- Remarks on result:
- other: 37% growth inhibition at 20250 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 72-hour EC50 (growth inhibition) of PFBSK+ to Pseudokirchneriella subcapitata was > 20250 mg/L.
- Executive summary:
The toxicity of PFBSK+ to the green algae, Pseudokirchneriella subcapitata, was assessed in a 72-hour toxicity test conducted using a method equivalent or similar to the OECD 201 method. The 72-hour EC50 of PFBSK+ for growth inhibition was > 20250 mg/L. The study was conducted using a method similar to a guideline study; therefore, the study is deemed reliable with restrictions and suitable for use in Risk Assessment, Classification & Labeling, and PBT Analysis.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Inhibition of constitutive luminescence in an engineered bioluminescent organism Anabaena CPB4337
- Short description of test conditions: Cells were grown in batch culture, transferred to 96-well microtiter plates, and exposed to substances up to an hour. CuSO4 was reference substance
- Parameters analysed / observed: Luminescence recorded every 5 min during exposure period. - GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: provided by the 3M Company
OTHER SPECIFICS:
- Other substances tested in parallel: Perfluorooctane sulfonate (PFOS) potassium salt, perfluorooctanoic acid (PFOA), docusate sodium, triclosan, 2,4,6-trichlorophenol (TCP), and Polyfox 656 (PF-656). - Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Anabaena sp.
- Details on test organisms:
- TEST ORGANISM
- Strain: PCC 7120 CPB4337 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 30 min
- Details on test conditions:
- - Principle of test: The bioassays using the recombinant bioluminescent cyanobacterium Anabaena CPB4337 were based on the inhibition of constitutive luminescence caused by the presence of any toxic substance.
- Short description of test conditions: Anabaena CPB4337 was routinely grown at 28 °C in the light, ca. 65 mmol photons m2/s on a rotary shaker in 50 mL AA/8 supplemented with nitrate (5 mM) in 125 ml Erlenmeyer flasks and 10 mg/mL of neomycin sulphate (Nm). Luminescence inhibition-based toxicity assays were performed as follows: 160 mL from five to seven serial dilutions of each tested toxicant or toxicant mixture plus a control (ddH2O buffered with MOPS at pH 5.8) were disposed in an opaque white 96-well microtiter plates. Cells were washed twice in MOPS buffer and added in 40 µL MOPS buffer to obtain an optical density (750 nm) of 0.5.
- Parameters analysed / observed: The luminescence of each sample was recorded every 5 min for up to 1 h in the Centro LB 960 luminometer. Three independent experiments with duplicate samples were carried out for all Anabaena toxicity assays. CuSO4 has been used as toxicity standard and all tests have been replicated to ensure reproducibility. - Reference substance (positive control):
- yes
- Remarks:
- CuSO4
- Key result
- Duration:
- 30 min
- Dose descriptor:
- EC50
- Effect conc.:
- 8 386 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: luminescence inhibition
- Remarks on result:
- other: 95% CI: 7752-8693 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 30-min EC50 (luminescence inhibition) of PFBSK+ to Anabaena CPB4337 was 8386 mg/L (95% CI: 7752 - 8693 mg/L).
- Executive summary:
The toxicity of PFBSK+ to Anabaena CPB4337 was assessed in a 30-min toxicity test. The 30-min EC50 (luminescence inhibition) of PFBSK+ was 8386 mg/L (95% CI: 7752 - 8693 mg/L). The study did not follow a national standard method and did not include sufficient documentation; therefore, the reliability of the report could not be assigned.
Referenceopen allclose all
Table 2. Cell Densities over 96-Hour Exposure Period
|
Cell Densities (cells/mL) |
||||
Mean Measured Concentration (mg a.i./L) |
Replicate |
24 hours |
48 hours |
72 hours |
96 hours |
Negative Control |
A |
21000 |
168000 |
1200000 |
3735000 |
|
B |
25000 |
184000 |
1045000 |
3420000 |
|
C |
47000 |
185000 |
800000 |
3525000 |
285 |
A |
29000 |
157000 |
625000 |
4005000 |
|
B |
26000 |
152000 |
730000 |
3930000 |
|
C |
36000 |
178000 |
710000 |
3825000 |
563 |
A |
25000 |
136000 |
645000 |
3120000 |
|
B |
30000 |
126000 |
625000 |
3195000 |
|
C |
26000 |
154000 |
750000 |
3480000 |
1077 |
A |
24000 |
133000 |
720000 |
3750000 |
|
B |
17000 |
106000 |
465000 |
3180000 |
|
C |
21000 |
118000 |
530000 |
3150000 |
2216 |
A |
19000 |
88000 |
430000 |
2025000 |
|
B |
14000 |
97000 |
330000 |
1845000 |
|
C |
19000 |
101000 |
395000 |
1920000 |
4561 |
A |
12000 |
51000 |
171000 |
850000 |
|
B |
17000 |
80000 |
188000 |
870000 |
|
C |
17000 |
56000 |
167000 |
860000 |
9478 |
A |
17000 |
13000 |
16000 |
19000 |
|
B |
4000 |
15000 |
16000 |
15000 |
|
C |
15000 |
20000 |
12000 |
12000 |
Table 3. Mean Growth Rates and Percent Inhibition at 24-hour Time Intervals
|
Growth Rate |
||||||
Mean Measured Concentration (mg a.i./L) |
Replicate |
0-24 hours |
24-48 hours |
48-72 hours |
72-96 hours |
0-72 hours |
0-96 hours |
Negative Control |
A |
0.0309 |
0.0866 |
0.0819 |
0.0473 |
0.0665 |
0.0617 |
|
B |
0.0382 |
0.0832 |
0.0724 |
0.0494 |
0.0646 |
0.0608 |
|
C |
0.0645 |
0.0571 |
0.0610 |
0.0618 |
0.0609 |
0.0611 |
285 |
A |
0.0444 |
0.0704 |
0.0576 |
0.0774 |
0.0574 |
0.0624 |
|
B |
0.0398 |
0.0736 |
0.0654 |
0.0701 |
0.0596 |
0.0622 |
|
C |
0.0534 |
0.0666 |
0.0576 |
0.0702 |
0.0592 |
0.0619 |
563 |
A |
0.0382 |
0.0706 |
0.0649 |
0.0657 |
0.0579 |
0.0598 |
|
B |
0.0458 |
0.0598 |
0.0667 |
0.0680 |
0.0574 |
0.0601 |
|
C |
0.0398 |
0.0741 |
0.0660 |
0.0639 |
0.0600 |
0.0610 |
1077 |
A |
0.0365 |
0.0713 |
0.0704 |
0.0688 |
0.0594 |
0.0617 |
|
B |
0.0221 |
0.0763 |
0.0616 |
0.0801 |
0.0533 |
0.0600 |
|
C |
0.0309 |
0.0719 |
0.0626 |
0.0743 |
0.0551 |
0.0599 |
2216 |
A |
0.0267 |
0.0639 |
0.0661 |
0.0646 |
0.0522 |
0.0553 |
|
B |
0.0140 |
0.0807 |
0.0510 |
0.0717 |
0.0486 |
0.0544 |
|
C |
0.0267 |
0.0696 |
0.0568 |
0.0659 |
0.0511 |
0.0548 |
4561 |
A |
0.0076 |
0.0603 |
0.0504 |
0.0668 |
0.0394 |
0.0463 |
|
B |
0.0221 |
0.0645 |
0.0356 |
0.0638 |
0.0407 |
0.0465 |
|
C |
0.0221 |
0.0497 |
0.0455 |
0.0683 |
0.0391 |
0.0464 |
9478 |
A |
0.0221 |
-0.0112 |
0.0087 |
0.0072 |
0.0065 |
0.0067 |
|
B |
0.000 |
0.0551 |
0.0027 |
-0.0027 |
0.0065 |
0.0042 |
|
C |
0.0169 |
0.0120 |
-0.0213 |
0.0000 |
0.0025 |
0.0019 |
The mean CV for section specific growth rates in the control was 29%, and the CV of average specific growth rates during the whole test period in control was 4.4%
Table 1. Control: Cell Density, Growth (Biomass) and Growth Rate
Replicate |
Cell Density (cells/mL) |
|
|
Growth (b) |
Growth rate (r) |
24 h |
48 h |
72 h |
|||
I |
40000 |
170000 |
330000 |
350000 |
1.17 |
II |
43333 |
170000 |
336667 |
356667 |
1.17 |
III |
50000 |
176667 |
343333 |
373333 |
1.18 |
IV |
40000 |
170000 |
340000 |
355000 |
1.18 |
V |
43333 |
173333 |
346667 |
365000 |
1.18 |
VI |
40000 |
170000 |
340000 |
355000 |
1.18 |
mean |
42778 |
171667 |
339444 |
359167 |
1.17 |
Table 2. Test (100 mg/L): Cell Density, Growth (Biomass), and Growth Rate
Replicate |
Cell Density (cells/mL) |
|
|
Growth (b) |
Growth rate (r) |
24 h |
48 h |
72 h |
|||
I |
40000 |
170000 |
366667 |
368333 |
1.20 |
II |
43333 |
170000 |
370000 |
373333 |
1.20 |
III |
40000 |
170000 |
363333 |
366667 |
1.20 |
mean |
41111 |
170000 |
366667 |
369444 |
1.20 |
Description of key information
The 72-hour EC50 (growth rate) of PFBSK+ to Pseudokirchneriella subcapitata was 5661 mg a.i./L. The corresponding 72-hour EC10 (growth rate) was 734 mg a.i./L.
Key value for chemical safety assessment
Additional information
In the key study, the toxicity of PFBSK+ to the green algae, Pseudokirchneriella subcapitata, was assessed according to the OECD 201 method. The study was performed in accordance with internationally-accepted test guidelines under GLP. The study is deemed reliable without restriction and suitable for use in Risk Assessment, Classification & Labeling, and PBT Analysis. In a supporting study, the 72-hour ErC50 of PFBSK+ to Pseudokirchneriella subcapitata for growth rate was beyond the range tested (measured concentration of 115.5mg/L). The study was performed in accordance with internationally-accepted test guidelines under GLP. The study is deemed reliable without restriction. A second supporting study reported the 72-hour IC50 (growth rate) of PFBSK+ to Scenedesmus obliquus was beyond the range tested (nominal concentration of 2mM (676 mg/L)). The study was well-documented and followed a national standard method but was not conducted under GLP; therefore, the study is deemed reliable with restrictions. Another supporting study reported a 72-hour EC50 (growth inhibition) to Pseudokirchneriella subcapitata > 20250 mg/L in a study equivalent or similar to the OECD 201 method and considered reliable with restrictions. The 30-min EC50 (luminescence inhibition) of PFBSK+ to Anabaena CPB4337 was 8386 mg/L (95% CI: 7752 - 8693 mg/L). The final study did not follow a national standard method and did not include sufficient documentation; therefore, the reliability of the report could not be assigned.
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