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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-08-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- 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
- Details on test material:
- Aggregate State at RT: solid
Colour: white
Storage conditions: room temperature protected from light
Physical State: solid (crystalline powder)
Purity: > 99%
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: abattoir A. Moksel AG, Buchloe, Germany
- Number of animals: not specified
- Characteristics of donor animals (e.g. age, sex, weight): not specified
- Storage, temperature and transport conditions of ocular tissue: on the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories.
- Time interval prior to initiating testing: Immediately after arrival of the eyes, cornea preparation was initiated.
- indication of any existing defects or lesions in ocular tissue samples: The eyes were carefully examined for defects and any defective eyes were discarded.
- Indication of any antibiotics used: penicillin/streptomycin in HBSS during transport
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was administered directly and moistened with physiological saline 0.9% NaCl (B. Braun Melsungen, lot no. 17185401, expiry date: 04/2020).
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 mg - Duration of treatment / exposure:
- 4 hours ± 5 minutes at 32 ± 1 °C.
- Observation period (in vivo):
- n.a.
- Duration of post- treatment incubation (in vitro):
- 90 minutes at 32 ± 1 °C.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: eyes were carefully examined for defects and any defective eyes were discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS: corneas have been visually examined for defects and any defective cornea had been discarded.
NUMBER OF REPLICATES: three
NEGATIVE CONTROL USED: yes, 750 µL physiological saline
POSITIVE CONTROL USED: yes, 750 µL imidazole 20% in physiological saline
APPLICATION DOSE AND EXPOSURE TIME: Dose: 750 mg. Exposure time: 4 hours ± 5 minutes at 32 ± 1 °C.
TREATMENT METHOD: control substance: closed chamber. Test item: open chamber
REMOVAL OF TEST SUBSTANCE: epithelium was washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red).
POST-EXPOSURE INCUBATION: 90 minutes at 32 ± 1 °C.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: illuminance measurement.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490); Jenway 6405 UV/VIS.
- Others: each cornea was observed visually and pertinent observations were recorded.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: according to guideline.
For further details, see section “any other information on materials and methods incl. tables”.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 9.49
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- no prediction can be made
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values: for detailed information, see tables 4 and 5 in section “any other information on results incl. tables”.
Any other information on results incl. tables
The eye irritancy potential of the test substance was investigated in the bovine corneal opacity and permeability assay.
The test item was administered directly and moistened with physiological saline 0.9 % NaCl.
All 3 corneas treated with the test substance showed slight opacity of the tissue.
The following mean in vitro irritation score was calculated: 9.49
No prediction can be made regarding the classification of the test substance according to the evaluation criteria.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
For detailed data see tables 1-3 below.
INDIVIDUAL DATA
Table 1: Opacity. MV= mean value.
Cornea Nr. 1 |
Test item |
Initial opacity |
Final opacity |
Change of opacity value |
Corrected opacity value |
1 |
Negative control |
3.11 |
3.34 |
0.23 |
|
2 |
2.65 |
4.39 |
1.74 |
|
|
3 |
3.38 |
4.18 |
0.80 |
|
|
MV |
3.05 |
3.97 |
0.92 |
|
|
4 |
Positive control |
5.01 |
127.80 |
122.78 |
121.86 |
5 |
5.96 |
123.14 |
117.17 |
116.25 |
|
6 |
5.10 |
107.75 |
102.65 |
101.73 |
|
MV |
5.36 |
119.56 |
114.20 |
113.28 |
|
7 |
Test item |
1.94 |
12.13 |
10.19 |
9.27 |
8 |
2.05 |
8.24 |
6.18 |
5.26 |
|
9 |
1.94 |
10.91 |
8.97 |
8.04 |
|
MV |
1.98 |
10.43 |
8.45 |
7.52 |
Table 2: permeability. MV= mean value.
Cornea Nr. |
Test item |
OD490 |
Corrected OD490 value |
1 |
Negative control |
0.008 |
|
2 |
0.008 |
|
|
3 |
0.098 |
|
|
MV |
0.038 |
|
|
4 |
Positive control |
0.662 |
0.624 |
5 |
1.220 |
1.182 |
|
6 |
2.260 |
2.222 |
|
MV |
1.381 |
1.343 |
|
7 |
Test item |
0.160 |
0.122 |
8 |
0.190 |
0.152 |
|
9 |
0.157 |
0.119 |
|
MV |
0.169 |
0.131 |
Table 3: in vitro irritation score. MV= mean value.
Cornea Nr. |
Test item |
Corrected opacity |
Corrected OD490 value |
IVIS |
1 |
Negative control |
0.23 |
0.008 |
1.49 |
2 |
1.74 |
0.008 |
||
3 |
0.80 |
0.098 |
||
MV |
0.92 |
0.038 |
||
4 |
Positive control |
121.86 |
0.624 |
133.42 |
5 |
116.25 |
1.182 |
||
6 |
101.73 |
2.222 |
||
MV |
113.28 |
1.343 |
||
7 |
Test item |
9.27 |
0.122 |
9.49 |
8 |
5.26 |
0.152 |
||
9 |
8.04 |
0.119 |
||
MV |
7.52 |
0.131 |
Table 4: Historical mean in vitro irritation score of the positive control
|
IVIS Positive Control |
Mean value (MV) |
125.20 |
Standard deviation (SD) |
17.75 |
MV – 2xSD |
89.71 |
MV + 2xSD |
160.70 |
Number of replicates providing historical mean: 27 |
Table 5: Historical mean in vitro irritation score of the negative control
|
IVIS Positive Control |
Mean value (MV) |
1.23 |
Standard deviation (SD) |
0.79 |
MV – 2xSD |
-0.35 |
MV + 2xSD |
2.80 |
Number of replicates providing historical mean: 27 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Expert judgement: not Category 1
- Conclusions:
- The eye irritancy potential of the test substance was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated: 9.49. No prediction can be made regarding the classification of the test substance to the evaluation criteria. For safety reasons, the test substance is classified as Category 2.
- Executive summary:
In a primary ex vivo eye irritation guideline study (bovine corneal opacity and permeability assay) under GLP conditions,750 mg of neat potassium hexafluorophosphate was applied on corneas for 4 hours. Irritation was scored by the method recommended in guideline OECD 437.
In this study, the mean in vitro irritation score was 9.49. According to GHS, no prediction can be made using this value. For precautionary measures, potassium hexafluorophosphate is classified voluntarily as mildly irritating to eyes (GHS Category 2).
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.