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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 614-396-3 | CAS number: 68298-12-4
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
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:
- September 9th 2002- September 22nd 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, 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
Test material
- Reference substance name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
- EC Number:
- 614-396-3
- Cas Number:
- 68298-12-4
- Molecular formula:
- C5H4F9NO2S
- IUPAC Name:
- 1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M SMMD EHSR, Lot #3
- Purity: 97.25%
- Physical state: off white crystalline powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1.1, 2.3, 4.5, 9.0, 18, 36 mg/L
- Sampling method: Samples of exposure solution were collected at test initiation and exposure termination to measure dissolved concentrations of MeFBSA. Test initiation samples were taken from batch test solutions of each treatment concentration and control before distribution into test chambers. Exposure termination samples were collected from pooled replicates of each respective concentration and control group. All samples were placed in 20 mL plastic scintillation vials.
- Sample storage conditions before analysis: Samples were analyzed immediately
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 1L stock solution was prepared in algal medium at a concentration of 36 mg/L. The primary stock was mixed for 24 hours on a magnetic stir plate using a Teflon coated stir bar. After mixing, the primary stock solution was proportionally diluted with algal medium to prepare 500 mL stocks of the other test conditions. Test concentrations were not corrected for percent active ingredient of the test material. All secondary stocks were mixed via inversion. After mixing, 100 mL aliquots of each test solution were placed in each respective test vessel and placed in the environmental chamber for 24 hours for conditioning. The volumetric flasks used to prepare the exposure solutions were conditioned with the remaining solution. The procedure for preparing the primary stock and test solutions were repeated to prepare the exposure solutions using the volumetric flasks that were allowed to condition for a 24-hour period.
- Controls: Negative control (dilution water), test medium without substance or other additives.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): No vehicle
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None, solution appeared clear and colorless
- Other relevant information: None
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Source (laboratory, culture collection): Wildlife International Ltd. Cultures
- Method of propagation: Algal cells were grown in culture medium for two weeks prior to test initiation. Prior to test, the chambers were inoculated with algal cells and shaken continuously at 100 rpm.
- Growth medium: MgCl2.6H2O 12.164 mg/L, CaCl2.2H20 4.410 mg/L, H3BO3 0.1855 mg/L, MnCl2.4H2O 0.4154 mg/L, ZnCl2 3.27 ug/L, FeCl3.6H20 0.1598 mg/L, CoCl2.6H2O 1.428 ug/L, Na2MoO4.2H2O 7.26 ug/L, CuCl2.6H2O 0.012 ug/L, Na2EDTA.2H2O 0.300 mg/L, NaNO3 25.5 mg/L, MgSO4.7H2O 14.70 mg/L, K2HPO4 1.044 mg/L, NaHCO3 15.00 mg/L prepared with reverse osmosis purified water, sterilized via filtration (0.2 um) prior to use.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- At exposure termination, the 15 and 31 mg/L treatment groups exhibited no visual evidence of algal growth. A 0.5 mL aliquot of test solutions was taken from each replicate test chamber and pooled by treatment. The solution was diluted in 100 mL of culture medium to a concentration of test substance that was assumed would not hinder growth. The control flask was prepared for comparison by diluting 0.5 mL of solution from a single negative control replicate to 100 mL with culture medium. Growth of these subcultures was monitored for 9 days to determine if inhibition of growth observed at the test concentrations were reversible. Samples were collected for cell counts at recovery phase initiation, Days 3 and 6, and at termination of the recovery phase. The 15 mg/L treatment was terminated on Day 6 when algal growth was sufficient to indicate that the algal cells has recovered from effects of the test substance. The 31 mg/L treatment level was terminated on Day 9 after algal cells has recovered.
Test conditions
- Test temperature:
- 23.1-23.8
- pH:
- 7.2-8.8
- Nominal and measured concentrations:
- Nominal: 1.1, 2.3, 4.5, 9.0, 18, 36 mg/L
Mean measured: 0.92, 1.9, 3.8, 7.8, 15, 31 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL polycarbonate Erlenmeyer flasks
- Type: Closed with foam stoppers
- Fill volume: 100 mL
- Aeration: shaking at 100 RPM
- Renewal rate of test solution: None
- Initial cells density: 10,000 cells/mL (nominal)
- Control end cells density: 2,310,000 cells/mL (mean)
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: Yes, AAP medium per ASTM1218-E90
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Sterile test conditions: Yes
- Adjustment of pH: No
- Photoperiod: Continuous
- Light intensity and quality: 4300 ± 10 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Cell counts were performed using a hemacytometer with 10 grids and a microscope. Samples were diluted as needed using an electrolyte solution (Isoton) to maintain counting accuracy.
RANGE FINDING STUDY
- Results used to determine the conditions for the definitive study: A range finding study was conducted and used to establish definitive test concentrations. However, details were not provided. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 3.6 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% CI: 2.1-4.7 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EC10
- Effect conc.:
- 6.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% CI: 5.7-8.2 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 12 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% CI: 10-14 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% CI: 12-14 mg/L
- Details on results:
- - Exponential growth in the control (for algal test): Yes
- Observation of abnormalities: The morphology of the cells of all treatment groups appeared normal when compared to the negative control. There was no evidence of aggregation, flocculation of cells, nor evidence of algal cells adhering to the test chambers.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: No
- Recovery Test Results: Based on the growth observed in the recovery phase, the effect on algal growth was found to be algistatic at 15 to 31 mg/L treatrments. See Table 3. - Results with reference substance (positive control):
- No reference substance test run
- Reported statistics and error estimates:
- Statistics run: Levene's test for homogeneity, Shapiro-Wilk's Test for normality, Dunnett's Multuple Comparison Test for comparing the treatment groups to the negative control. EC10 and EC50 growth rates were calculated using non-linear regression or linear interpolation using TOXSTAT v3.5 software.
Any other information on results incl. tables
Table 1. Measured concentrations of MeFBSA in Freshwater
Concentration (mg/L) |
Sampling Time (Day) |
Measured concentration MeFBSA (mg/L) |
% of Nominal |
Mean Measured concentration (mg/L) |
Mean Measured % of Nominal |
|||||
Negative control |
0 |
<LOQ |
- |
<LOQ |
- |
|||||
|
4 |
<LOQ |
- |
|
|
|||||
1.1 |
0 |
1.3 |
114 |
0.92 |
84 |
|||||
|
4 |
0.59 |
54 |
|
|
|||||
2.3 |
0 |
2.4 |
103 |
1.9 |
83 |
|||||
|
4 |
1.3 |
58 |
|
|
|||||
4.5 |
0 |
4.8 |
106 |
3.8 |
84 |
|||||
|
4 |
2.7 |
61 |
|
|
|||||
9 |
0 |
9.8 |
109 |
7.8 |
87 |
|||||
|
4 |
5.8 |
65 |
|
|
|||||
18 |
0 |
19 |
104 |
15 |
83 |
|||||
|
4 |
11 |
64 |
|
|
|||||
36 |
0 |
38 |
107 |
31 |
86 |
|||||
|
4 |
23 |
64 |
|
LOQ was 0.200 mg/L, calculated as the product of the lowest calibration standard (0.1 mg/L) and the dilution factor of the matric blanks (2.00)
Table 2. Mean Growth Rates
Mean Measured Test Concentration (mg/L) |
72 hour Mean Growth Rate |
72 hour % Inhibition |
96 hour Mean Growth Rate |
96 hour % Inhibition |
||||
Negative control |
0.0568 |
-- |
0.0567 |
-- |
||||
0.92 |
0.0553 |
2.7 |
0.0553 |
2.4 |
||||
1.9 |
0.0547 |
3.7 |
0.0563 |
0.75 |
||||
3.8 |
0.0507* |
11 |
0.0520* |
8.3 |
||||
7.8 |
0.0380* |
33 |
0.0441* |
22 |
||||
15 |
0.0214* |
62 |
0.0227* |
60 |
||||
31 |
0.0019* |
97 |
0.0020* |
97 |
There were statistically significant differences (p<0.05) at 72 and 96 hours when compared to the negative control replicates using Dunnett's test.
Table 3. Cell Densities During the Nine-Day Recovery Phase
Mean Measured Test Concentration (mg/L)* |
Cell Densities (Cells/ml) Day 0 |
Cell Densities (Cells/ml) Day 3 |
Cell Densities (Cells/ml) Day 6 |
Cell Densities (Cells/ml) Day 9 |
||||
Negative control |
15000 |
870000 |
5280000 |
6480000 |
||||
15 |
2000 |
121000 |
5280000 |
-- |
||||
31 |
0 |
3000 |
79000 |
4395000 |
* The treatment group was diluted to a concentration of the test substance that theoretically would not inhibit growth. Due to the method used to prepare recovery phase test solutions, initial cell densities were not equivalent between the groups.
-- The treatment group was fully recorded and terminated on Day 3
Table 4. Cell Densities By Replicate Over the 96-hour Exposure Period
Mean Measured Test Concentration (mg/L)* |
Replicate |
Cell Densities (Cells/ml) 24 hours |
Cell Densities (Cells/ml) 48 hours |
Cell Densities (Cells/ml) 72 hours |
Cell Densities (Cells/ml) 96 hours |
|||||
Negative control |
A |
32000 |
101000 |
610000 |
2360000 |
|||||
|
B |
34000 |
121000 |
595000 |
2440000 |
|||||
|
C |
19000 |
123000 |
585000 |
2130000 |
|||||
0.92 |
A |
22000 |
100000 |
510000 |
2030000 |
|||||
|
B |
31000 |
101000 |
565000 |
1950000 |
|||||
|
C |
30000 |
98000 |
530000 |
2080000 |
|||||
1.9 |
A |
30000 |
87000 |
470000 |
1950000 |
|||||
|
B |
28000 |
142000 |
580000 |
2390000 |
|||||
|
C |
28000 |
118000 |
495000 |
2330000 |
|||||
3.8 |
A |
25000 |
111000 |
410000 |
1740000 |
|||||
|
B |
26000 |
55000 |
320000 |
1220000 |
|||||
|
C |
21000 |
86000 |
435000 |
1490000 |
|||||
7.8 |
A |
8000 |
63000 |
147000 |
660000 |
|||||
|
B |
10000 |
55000 |
185000 |
650000 |
|||||
|
C |
18000 |
64000 |
135000 |
770000 |
|||||
15 |
A |
18000 |
22000 |
46000 |
77000 |
|||||
|
B |
10000 |
19000 |
38000 |
80000 |
|||||
|
C |
9000 |
25000 |
58000 |
111000 |
|||||
31 |
A |
6000 |
7000 |
7000 |
16000 |
|||||
|
B |
10000 |
12000 |
15000 |
11000 |
|||||
|
C |
9000 |
11000 |
8000 |
7000 |
Prior to the test initiation, the cell density of the stock culture was determined and an inoculum volume was administered to each test chamber to yield a cell density of approximately 10,000 cells/mL at test initiation (0 hours).
Table 5. Specific Growth Rates
|
24 HRS |
48 HRS |
72 HRS |
(0-72 H) |
CV (%) |
|||||
|
(0-24H) |
(24-48H) |
(48-72H) |
|
|
|||||
Rep A |
1.16 |
1.15 |
1.80 |
1.37 |
27.06 |
|||||
Rep B |
1.22 |
1.27 |
1.59 |
1.36 |
14.77 |
|||||
Rep C |
0.64 |
1.87 |
1.56 |
1.36 |
47.01 |
|||||
|
|
|
|
|
|
|||||
Mean |
1.01 |
1.43 |
1.65 |
1.36 |
29.61 |
|||||
Std Dev |
0.32 |
0.38 |
0.13 |
0.01 |
|
|||||
CV (%) |
31.69 |
26.93 |
7.84 |
0.51 |
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- control biomass increase >16x (61x), CV for section-by-section growth rates <35% (30.7%), CV for average specific growth rates <7% (0.51%)
- Conclusions:
- 72 hour EC50 of 12 mg/L (OECD 201 and EPA 850.5400) in Pseudokirchneriella subcapitata.
72 hour EC10 of 3.6 mg/L (OECD 201 and EPA 850.5400) in Pseudokirchneriella subcapitata. - Executive summary:
The 72 hour and 96 hour EC50, EC10 and NOEC, of MeFBSA to Pseudokirchneriella subcapitata was determined according to OECD 201 and EPA 850.5400 guidelines. Nominal concentrations of 1.1, 2.3, 4.5, 9.0, 18, 36 mg/L and a blank control, were run with three replicates for each treatment level and the negative control. A 72 hour EC50 of 12 mg/L and a 72 hour EC10 of 3.6 mg/L (measured concentrations) were determined. Percent of nominal concentrations of the test material ranged from 104-114% on Day 0 to 54-65% on Day 4. A 9 day recovery test was run at 15 and 31 mg/L and demonstrated algistatic effects on the population.
The study was well-documented, followed a international standard methods and was GLP compliant. The study is considered reliable without restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)