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EC number: 241-143-0 | CAS number: 17084-13-8
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-11-18 to 2015-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 26 September, 2014
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation 440/2008, Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test”
- Version / remarks:
- 30 May, 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium hexafluorophosphate
- EC Number:
- 241-143-0
- EC Name:
- Potassium hexafluorophosphate
- Cas Number:
- 17084-13-8
- Molecular formula:
- F6P.K
- IUPAC Name:
- potassium hexafluoro-λ⁵-phosphanuide
- Test material form:
- solid: crystalline
- Details on test material:
- - State of aggregation: solid
- Other: crystalline powder,
Colour: white
hygroscopic
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- The EpiDermTM Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin. This in vitro method allows the identification of corrosive and non-corrosive substances and mixtures in accordance with UN GHS. It further allows a partial sub-categorisation of corrosives in a combination of optional sub-categories 1B and 1C.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was applied neat without addition of water to avoid potential hydrolytic degradation of the test item to hydrofluoric acid which is known to be severely corrosive.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM (MatTek)
- Tissue batch number(s): 23303 Kit E
- Production date: 2015-11-18
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper.
- Observable damage in the tissue due to washing: not reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution: 5 mg/mL MTT (Lot 3V005S-34; AppliChem) in PBS (Lot 1660068; Gibco). MTT medium: MTT stock solution was diluted 1 + 4 with assay medium (Lot 111215TMB; MatTek; final concentration 1 mg/mL)
- Incubation time: 3 hours
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: according to the manufacturer: MTT QC assay, 4 hours, n=3. Acceptance criteria: OD (540-570 nm) 1.0-3.0. Result: 1.764 ± 0.045. QA statement: pass.
- Barrier function: according to the manufacturer: ET-50 assay, 100 µL 1 % Triton X-100, 4 time-points, n=3, MTT assay. Acceptance criteria: ET-50 4.77-8.72 hours. Result: 8.33 hours. QA statement: pass.
- Morphology: Tissue viability and the barrier function test are within the acceptable ranges and indicate appropriate formation of the epidermal barrier, the presence of a functional stratum corneum, a viable basal cell layer and intermediate spinous and granular layers. Results obtained with this lot conform to the requirements of the OECD TG 431 and 439.
- Contamination: sterile; no contamination.
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL distilled water (Lot: RNBD8066, Sigma)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration: 8 N potassium hydroxide (KOH; Lot: 10357004; Neolab) - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min experiment
- Value:
- ca. 95.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min experiment
- Value:
- ca. 62.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: not reported.
- Direct-MTT reduction: no reduction of MTT compared to the solvent.
- Colour interference with MTT: no colouring detected.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The controls confirmed the validity of the study.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: mean absolute OD570 nm of two negative control tissues of the 3 min and 60 min treatment period between 0.8 and 2.8
- Acceptance criteria met for positive control: mean relative tissue viability of the two positive control tissues is ≤ 30 %
- Acceptance criteria met for variability between replicate measurements: coefficient of variation (CV) (at 20-100 % viability) between two tissues treated identically is ≤ 30 %.
Any other information on results incl. tables
Pre-Experiments
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, no determination of non-specific MTT-reduction by using killed tissues was necessary.
The mixture of 25 mg test item per 300 µL A. dest. showed no colouring as compared to the solvent. Therefore, no determination of non-specific colour by using additional viable tissues was necessary.
Main experiments
Table 1: Resultsof 3 min experiment
* mean OD570≥ 0.8 and ≤ 2.8
** mean relative tissue viability of the 3 min positive control ≤ 30 %
*** coefficient of variation (CV) (at 20-100 % viability) between two tissues treated identically is ≤ 30 %.
Name |
Negative control |
Test item |
Positive control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570-values |
2.003 |
1.930 |
2.005 |
1.724 |
0.178 |
0.211 |
2.025 |
1.919 |
2.017 |
1.747 |
0.176 |
0.218 |
|
2.047 |
1.948 |
2.044 |
1.793 |
0.181 |
0.219 |
|
Mean OD570(mean of 3 aliquots) |
2.025 |
1.932 |
2.022 |
1.755 |
0.178 |
0.216 |
SD |
0.022 |
0.015 |
0.020 |
0.035 |
0.002 |
0.004 |
Total mean OD570 (mean of 2 replicate tissues) |
1.979 * |
1.888 |
0.197 |
|||
SD of mean of 2 replicate tissues |
0.066 |
0.189 |
0.027 |
|||
Mean relative tissue viability [%] |
100.0 |
95.4 |
10.0 ** |
|||
Coefficient of variation [%] *** |
3.3 |
10.0 |
13.5 |
Table 2: results of 60 min experiment
* mean OD570≥ 0.8 and ≤ 2.8
** coefficient of variation (CV) (at 20-100 % viability) between two tissues treated identically is ≤ 30
Name |
Negative control |
Test item |
Positive control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570-values |
1.885 |
1.991 |
1.405 |
1.017 |
0.149 |
0.124 |
1.866 |
1.942 |
1.404 |
1.008 |
0.150 |
0.126 |
|
1.936 |
2.013 |
1.436 |
1.049 |
0.156 |
0.127 |
|
Mean OD570 (mean of 3 aliquots) |
1.895 |
1.982 |
1.415 |
1.025 |
0.152 |
0.126 |
SD |
0.036 |
0.037 |
0.018 |
0.022 |
0.004 |
0.002 |
Total mean OD570 (mean of 2 replicate tissues) |
1.939 * |
1.220 |
0.139 |
|||
SD of mean of 2 replicate tissues |
0.061 |
0.276 |
0.018 |
|||
Mean relative tissue viability [%] |
100.0 |
62.9 |
7.1 |
|||
Coefficient of variation [%] ** |
3.2 |
22.6 |
13.3 |
Table 3: Test Acceptance Criteria
|
Value |
Cut off |
pass/fail |
Mean Absolute OD570 nmNK (3 min experiment) |
1.979 |
≥0.8 and ≤2.8 |
pass |
Mean Absolute OD570 nmNK (60 min experiment) |
1.939 |
≥0.8 and ≤2.8 |
pass |
Mean Relative Tissue Viability [%] of PC (3 min Experiment) |
10 |
≤ 30 % |
pass |
Max. CV of Viability[%] |
22.6 |
≤ 30 % |
pass |
Table 4: historical data. Historical data were generated from 2010 to 2015.
|
Mean |
SD |
n |
Absolute OD570nm NK (3 min experiment) |
1.984 |
0.365 |
33 |
Absolute OD570nm NK (60 min experiment) |
1.959 |
0.331 |
33 |
Relative Tissue Viability [%] of PC (3 min Experiment) |
17.6 |
4.65 |
33 |
Max. CV of Viability [%] |
18.5 |
13.10 |
33 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Expert judgement: not corrosive
- Conclusions:
- In this study under the given conditions the neat test item showed no corrosive effects. The relative mean tissue viability after 3 min treatment was ≥ 50 % and after 60 min treatment ≥ 15 %. It has to be pointed out that the test item was applied neat, without addition of water.
- Executive summary:
In this study according to OECD guideline 431, the potential of potassium hexafluorophosphate to induce skin corrosion was analyzed by using a three-dimensional human skin model (RhE). Neat potassium hexafluorophosphate was applied topically for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay.
All controls confirmed the validity of the study.
Neat potassium hexafluorophosphate showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 50 % (95.4 %) after 3 min treatment and ≥ 15 % (62.9 %) after 60 min treatment.
According to this guideline study, potassium hexafluorophosphate is classified as “non-corrosive”.It has to be pointed out that the test item was applied neat without addition of water to avoid potential hydrolytic degradation to hydrofluoric acid which is known to be severely corrosive. In consequence, this study was repeated under the same conditions with the exception that the surface of the RhE was moistened with a small amount of water to check whether this would have an impact on the test result “non-corrosive”.
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