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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 920-778-3 | CAS number: -
- 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:
- 09-Oct-2017 to 19-Oct-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(pentafluoroethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(trifluoromethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N,N-bis(heptafluoropropyl)propan-1-amine
- EC Number:
- 920-778-3
- Cas Number:
- 2176446-38-9
- Molecular formula:
- constituents: CnF(2n+3)N with n= 7-9
- IUPAC Name:
- Reaction mass of 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(pentafluoroethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(trifluoromethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N,N-bis(heptafluoropropyl)propan-1-amine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 50908
- Physical state: Colourless liquid
- Storage condition of test material: At room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0002712253
- Physical state: colorless liquid
- Expiration date of the lot/batch: 07 June 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: test substance stable in water, but extremely volatile
Sampling and analysis
- Analytical monitoring:
- no
- Remarks:
- The study was conducted as a limit test at 100 mg/L (nominal) loading level, which is above the water solubility of the test material
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance is poorly soluble and extremely volatile. Therefore, 42.5 mL air-tight vials were completely filled with medium and closed with a septum-sealed screw cap and parafilm. MTDID 50908 (2.4 μL) was then injected through the septum with gas-tight syringe. Vials were rotated slowly for seven days, and then centrifuged at 500g for 90 minutes to pull undissolved test substance into a single drop at the bottom of the vial.
- Controls: Blank only
- Evidence of undissolved material: Test solutions were clear and colorless, with a visible small droplet of undissolved test substance at the bottom.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Strain: NIVA CHL1
- Source: in-house laboratory culture.
- Age of inoculum (at test initiation): Three days
- Method of cultivation: Stock cultures were started by inoculating growth (M1) medium with algal cells from a pure culture on agar. The suspensions were continuously aerated in a climate room at a temperature of 21-24°C and light intensity of 60 to 120 μE/m²/s when measured in the photosynthetically effective wavelength range (400-700 nm). Growth (M1) medium (Nederlandse Praktijk Richtlijn no. 6505) was formulated using Milli-RO water (tapwater purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with the following composition.
NaNO3, 500 mg/l
K2HPO4∙3H2O, 52 mg/l
MgSO4∙7H2O, 75 mg/l
Na2CO3∙10H2O, 54 mg/l
C6H8O7∙H2O, 6 mg/l
NH4NO3, 330 mg/l
CaCl2∙2H2O, 35 mg/l
C6H5FeO7∙xH2O, 6 mg/l
H3BO3, 2∙9 mg/l
MnCl2∙4H2O, 1.81 mg/l
ZnCl2, 0.11 mg/l
CuSO4∙5H2O, 0.08 mg/l
(NH4)6Mo7O24∙4H2O, 0.018 mg/l
- Acclimation period: Three days before the start of the test, fresh (M2) medium was inoculated at a density of 1E4 cells/mL and was kept under the same conditions used in the test.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg/L as CaCO3
- Test temperature:
- 22°C - 23°C
- pH:
- 7.4 - 7.7
- Nominal and measured concentrations:
- Nominal: Control (0 mg/L), 100 mg/L
Measured: not evaluated - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass VOA vials closed with PTFE-faced septa, completely filled. Fill volume ca. 42.5 mL. To initiate the test, a 0.85-mL aliquot of algal suspension was injected by syringe through the septum. A vent needle temporarily placed through the septum allowed an equal volume of medium to be displaced, after which syringe and vent needle were removed.
- Agitation: No
- Initial cells density: 1E+04 cells/mL
- Control end cells density: 131E+04 cells/mL
- No. of vessels per concentration (replicates): Six replicates per day, sacrificed for cell counts. Three vials with saturated solution but without algae.
- No. of vessels per control (replicates): Six replicates per day, sacrificed for cell counts.
GROWTH MEDIUM
- Standard medium used: No
- Detailed composition if non-standard medium was used: Standard OECD TG 201 test medium was adjusted for use in a sealed test vessel by increase of NaHCO3 to 300 mg/L and addition of 6 mM HEPES buffer, final pH 7.1± 0.3. Formulated using Milli-RO water (tapwater purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA).
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Growth medium
- Culture medium different from test medium: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: Continuous
- Light intensity and quality: TLD lamps with a light intensity within the range of 75 to 82 μE/(m²∙s). Test vessels were placed randomly in the incubator, and repositioned daily.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Cells were counted using a microscope and a counting chamber to determine inoculum density. Thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with immersion probe (pathlength = 10 mm) against an algal medium blank and the extra replicates for the treated solutions.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: None
- Justification for using less concentrations than requested by guideline: Limit test - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- No effects on growth rate were observed at the single concentration tested.
- Key result
- 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 on result:
- other:
- Details on results:
- Under the conditions of the study with Pseudokirchneriella subcapitata exposed to MTDID 50908 no inhibition of growth rate or inhibition of yield was observed at a loading rate of 100 mg/L.
- Exponential growth in the control: yes.
- Observation of abnormalities: Microscopic observations at the end of the test revealed a normal and healthy appearance of the exposed cells when compared to the control.
- Other: The mean coefficient of variation for section-by-section specific growth rates in the control cultures exceeded 35% (i.e. 48%). These results were considered acceptable due to the unavoidable need to use sealed flasks with a volatile, low-soluble substance. The methodology was considered the best possible for MTDID 50908.
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: undissolved test substance present throughout study. This was necessary to maintain saturation of the volatile and low-soluble test material.
- Effect concentrations exceeding solubility of substance in test medium: Yes. Undissolved test substance was observed throughout the test. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 1.1 mg/L (growth rate). Historical range for the reference substance at the contract lab lies between 0.82 and 2.3 mg/L
- Other: Reference substance toxicity assay conducted within one month of the test substance assay.
Any other information on results incl. tables
Table 1, Individual cell densities in the algal toxicity test (x 10^4 cells/mL)
Loading rate (mg/L) | Replicate | Time | |||
0 h | 24 h | 48 h | 72 h | ||
0 (Control) | 1 | 1 | 10.563 | 52.988 | 124.804 |
2 | 1 | 10.840 | 52.679 | 133.489 | |
3 | 1 | 11.776 | 53.828 | 130.787 | |
4 | 1 | 10.262 | 55.176 | 133.769 | |
5 | 1 | 10.773 | 57.636 | 133.208 | |
6 | 1 | 10.712 | 70.132 | 126.882 | |
Mean: | 1 | 10.8 | 57.1 | 130.5 | |
Std.Dev.: | 0 | 0.5 | 6.6 | 3.8 | |
CV: | 0 | 4.7 | 11.6 | 2.9 | |
100 | 1 | 1 | 11.049 | 54.988 | 129.765 |
2 | 1 | 10.166 | 62.392 | 131.595 | |
3 | 1 | 12.900 | 50.080 | 143.701 | |
4 | 1 | 11.702 | 51.700 | 118.790 | |
5 | 1 | 10.666 | 57.367 | 123.868 | |
6 | 1 | 9.170 | 59.101 | 141.467 | |
Mean: | 1 | 10.9 | 55.9 | 131.5 | |
Std.Dev.: | 0 | 1.3 | 4.6 | 9.7 | |
CV: | 0 | 11.7 | 8.3 | 7.4 |
Table 2, Growth rates (1/day) in the algal toxicity test
Loading rate (mg/L) | Replicate | Interval | |||
0-24 h | 24-48 h | 48-72 h | 0-72 h | ||
0 (Control) | 1 | 2.357 | 1.613 | 0.857 | 1.609 |
2 | 2.383 | 1.581 | 0.93 | 1.631 | |
3 | 2.466 | 1.52 | 0.888 | 1.625 | |
4 | 2.328 | 1.682 | 0.886 | 1.632 | |
5 | 2.377 | 1.677 | 0.838 | 1.631 | |
6 | 2.371 | 1.879 | 0.593 | 1.614 | |
Mean: | 2.381 | 1.659 | 0.832 | 1.624 | |
Std.Dev.: | 0.0462 | 0.124 | 0.1211 | 0.0098 | |
CV: | 1.9 | 7.5 | 14.6 | 0.6 | |
CV = 48% for all section-specific control growth rates | |||||
100 | 1 | 2.402 | 1.605 | 0.859 | 1.622 |
2 | 2.319 | 1.814 | 0.746 | 1.627 | |
3 | 2.557 | 1.356 | 1.054 | 1.656 | |
4 | 2.46 | 1.486 | 0.832 | 1.592 | |
5 | 2.367 | 1.682 | 0.77 | 1.606 | |
6 | 2.216 | 1.863 | 0.873 | 1.651 | |
Mean: | 2.387 | 1.634 | 0.856 | 1.626 | |
Std.Dev.: | 0.1173 | 0.1936 | 0.1092 | 0.0246 | |
CV: | 4.9 | 11.8 | 12.8 | 1.5 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Considered acceptable despite section by section coefficient of variation greater than 35% (i.e. 48%), because higher variation is expected with sealed-vessel methodology necessary for the test substance.
- Conclusions:
- The 72-hour EC50 and EC10 of MTDID 50908 to P. subcapitata exceeded a loading rate of 100 mg/L, a level which is greater than the maximum soluble concentration in the test medium, by OECD TG 201. No effects on growth were observed.
- Executive summary:
Toxicity of MTDID 50908 to the freshwater alga Pseudokirchneriella subcapitata was assessed in a limit test according to OECD201. The test substance is highly volatile. All tests were conducted in glass VOA vials, completely filled with medium and closed with a PTFE-faced septum cap. All transfers were made through the septum with gas-tight syringe. A water soluble fraction was made at a loading rate of 100 mg/L, with residual undissolved test material allowed to remain in the test vials. Analytical measurement of test substance concentrations was not done, but the loading rate was well above the solubility limit of the test material in water, and visible undissolved test substance was observed throughout the test. The 72-hour EC10 and EC50 were > 100 mg/L (nominal concentration), a level which was greater than the water solubility of MTID 50908 in the test medium. No effects on growth were observed.
The study was conducted according to internationally accepted test guidelines and in accord with GLP criteria. Variability in section-specific growth was above the limit given in OECD TG201, but is considered acceptable in a sealed-vessel protocol designed to contain a volatile and poorly-soluble test material. The test is considered reliable without restrictions. It is suitable for Risk Assessment, Classification & 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.