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Diss Factsheets
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EC number: 940-803-1 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- other: in vitro human cell line activation test (h-CLAT)
- Version / remarks:
- The h-CLAT method is supposed to address the third key event of the skin sensitisation process as defined by the adverse outcome pathway (AOP) for skin sensitisation, which is the activation of dendritic cells (DC) typically accompanied by expression of specific cell surface markers, chemokines and cytokines. The h-CLAT quantifies the expression of the two surface markers CD86 and CD54 which are considered to be associated with the process of DC activation by using the human monocytic leukemia cell line THP-1 as a surrogate. The expression level of CD86 and CD54 following exposure to test chemicals are used for supporting the discrimination between sensitisers and non-sensitisers
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
- EC Number:
- 940-803-1
- Molecular formula:
- This is a multi-constituent susbstance there is no molecular formula or molecular weight range available
- IUPAC Name:
- Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name: Thetawet FS-8250
Batch No.: W17033003
Compounds Substituted alkyl phosphate esters, ammonium salt (EPA accession numbers 278978, 263128, 265259; 25-30 %) Water (70-75 %)
Molecular Weight: 211.55 g/mol
Physical State: liquid
Colour: beige
The test item was freshly prepared immediately prior to use.
The test item was not soluble in 0.9% NaCl at a concentration of 100 mg/mL, it was dissolved in 0.9% NaCl solution at a concentration of 1.00 mg/mL.
Vortex mixing was used to aid solubilisation.
Stock solutions were prepared by diluting the highest soluble concentration seven times with a constant dilution factor of 1:2.
The working stock solutions were prepared by diluting each stock solution 50 times with cell culture medium.
No precipitation, turbidity or phase separation was observed when diluted 1:50 in cell culture medium. Vortex mixing and/or sonication and/or warming to 37 °C were be used to aid solubilisation.
In vitro test system
- Details on the study design:
- A medium control, a solvent control, and a positive control were set up in parallel in order to confirm the validity of the test.
The test was carried out using THP-1 cells (ATCC® TIB-202TM), an acute human monocytic leukemic cell line used as a surrogate for DC. Cells from frozen stock cultures, tested routinely for mycoplasma, were seeded in culture medium at an appropriate density and subcultured at least 2 weeks before they were used in the in vitro h-CLAT test. Cells at passage number (<30) were used. Cells are routinely passaged every 2-3 days at a density of 0.1 – 0.2 x 106 cells/mL.
Cells were cultured in 75 cm2 culture flasks (Greiner) in Roswell Park Memorial Institute medium (RPMI-1640, Gibco Life Science; Cat. No.: 31870-025) supplemented with 10% fetal bovine serum, 25 mM HEPES, L-glutamine, 0.05 mM 2-mercaptoethanol and 100 U/ml penicillin/ 100 μg/mL streptomycin at 37 +/- 1°C and 5% CO2.
Results and discussion
- Positive control results:
- Positiive control: 2,4-dinitrochlorobenzene (DNCB) at a final concentration of 4 μg/mL (alternatively at the concentration of the CV75) was tested concurrently with the test item. DNCB was dissolved in DMSO and diluted according to the procedure, resulting in a final DMSO concentration of 0.2% (v/v).
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: First experiment
- Parameter:
- other: Relative cell viability
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No cytotoxic effects were observed for the cells treated with the test item. Relative cell viability at the highest test item concentration was reduced to 91.8% (CD86), 91.6% (CD54) and 92.3% (isotype IgG1 control)
- Key result
- Run / experiment:
- other: Second experiment
- Parameter:
- other: Relative cell viability
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No cytotoxic effects were observed for the cells treated with the test item. Relative cell viability at the highest test item concentration was reduced to 95.4% (CD86), 94.6% (CD54) and 94.9% (isotype IgG1 control) i
- Other effects / acceptance of results:
- Due to a lack of cytotoxicity, no CV75 could be derived. Therefore, the main experiments were performed covering the following concentration steps:
10.00, 8.33, 6.94, 5.79, 4.82, 4.02, 3.35 and 2.79 μg/mL
In all experiments no precipitation or turbidity of the test item was observed for all the concentration steps when mixing the test item stock solutions with cell culture medium.
Cells were incubated with the test item for 24 h at 37°C. After exposure cells were stained and cell surface markers CD54 and CD86 were measured by FACS analysis. Cell viability was assessed in parallel using propidium iodide staining.
No cytotoxic effects were observed for the cells treated with the test item. Relative cell viability at the highest test item concentration was reduced to 91.8% (CD86), 91.6% (CD54) and 92.3% (isotype IgG1 control) in the first experiment and to 95.4% (CD86), 94.6% (CD54) and 94.9% (isotype IgG1 control) in the second experiment.
The test meets acceptance criteria if:
the cell viability of the solvent controls is >90%,
the cell viability of at least four tested doses of the test item in each run is >50%,
the RFI values of the positive control (DNCB) is ≥150% for CD86 and ≥200% for CD54 at a cell viability of >50%,
the RFI values of the solvent control is not ≥150% for CD86 and not ≥200% for CD54,
the MFI ratio of CD86 and CD54 to isotype IgG1 control for the medium and DMSO control, is >105%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No cytotoxic effects were observed for the cells treated with the test item. Relative cell viability at the highest test item concentration was reduced to 91.8% (CD86), 91.6% (CD54) and 92.3% (isotype IgG1 control) in the first experiment and to 95.4% (CD86), 94.6% (CD54) and 94.9% (isotype IgG1 control) in the second experiment.
The expression of the cell surface marker CD86 was not upregulated above the threshold of 150% in any of the experiments. The expression of cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments. Therefore, the test item is considered to be a non-sensitiser.
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