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EC number: 244-479-6 | CAS number: 21615-47-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Mar 2018
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium undecafluorohexanoate
- EC Number:
- 244-479-6
- EC Name:
- Ammonium undecafluorohexanoate
- Cas Number:
- 21615-47-4
- Molecular formula:
- C6H4F11NO2
- IUPAC Name:
- 2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™ (EPI-200)
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™(EPI-200) (MatTek Corporation, Ashland, MA, USA)
- Tissue batch number: 28302
- Production date: 22 Mar 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 min exposure); 37 °C (60 ± 1 min exposure)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were rinsed with PBS 20 times in order to remove any residual test material.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mL/well
- Incubation time: 180 ± 5 min
- Spectrophotometer: microplate reader (FLUOstar OPTIMA, BMG LABTECH)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm™ tissue was assessed by undertaking an MTT cell viability test. The determined OD (540 - 570 nm) was 1.708 ± 0.063 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 6.42 h (acceptance criteria: 3.68-8.02 h).
- Contamination: The cells used to produce the EpiDerm™ tissue were screened for the presence of viruses, bacteria, yeast and other fungi.
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test substance showed no reducing capacity 1 h after MTT incubation, no additional test with freezekilled tissues had to be performed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if the viability after 3 min exposure is greater than 50% and the viability after 1 h exposure is greater than 15%.
- The test substance is considered to be corrosive to skin if the viability after 3 min exposure is less than 50%, or if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is less than 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg moistened with 25 µL distilled water
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration : 8 N - Duration of treatment / exposure:
- 3 min and 60 ± 1 min
- Number of replicates:
- duplicates for each treatment and control group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 94.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: The test substance showed no reducing capacity 1 hour after MTT incubation.
- Colour interference with MTT: The test substance did not change colour, when mixed with deionised water and thus passed the colour interference pre-test.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD of the tissue replicates treated with the negative control was ≥ 0.8 and ≤ 2.8 for every exposure time (1.941 and 2.047).
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control for 1 hour, was < 15% (1.4%) compared to the negative control.
- Acceptance criteria met for variability between replicate measurements: The Coefficient of Variation (CV) in the range 20 - 100% viability between tissue replicates was ≤ 30% (values between 0.1% and 11.74%)
Any other information on results incl. tables
Table 1. Results of skin corrosion test
3-min exposure | 60-min exposure | ||||||||||||||
OD a) | Cell viability (%) b) | SD c) | CV | OD a) | Cell viability (%) b) | SD c) | CV | ||||||||
Group | Tissue no. | Mean | Mean | Mean | Mean | ||||||||||
Negative control (Distilled water) | 1 | 1.937 | 1.939 | 1.941 | 99.9 | 100 | 0.14 | 0.1 | 2.026 | 2.03 | 2.047 | 99.2 | 100 | 1.13 | 1.1 |
1.937 | 2.031 | ||||||||||||||
1.942 | 2.032 | ||||||||||||||
2 | 1.938 | 1.942 | 100.1 | 2.07 | 2.063 | 100.8 | |||||||||
1.945 | 2.063 | ||||||||||||||
1.942 | 2.056 | ||||||||||||||
Positive control (KOH 8N) | 1 | 0.113 | 0.112 | 0.111 | 5.8 | 5.7 | 0.14 | 2.5 | 0.029 | 0.029 | 0.028 | 1.4 | 1.4 | 0.07 | 5.1 |
0.111 | 0.029 | ||||||||||||||
0.113 | 0.03 | ||||||||||||||
2 | 0.108 | 0.109 | 5.6 | 0.025 | 0.026 | 1.3 | |||||||||
0.111 | 0.025 | ||||||||||||||
0.109 | 0.027 | ||||||||||||||
Test substance (APFHx) | 1 | 1.68 | 1.671 | 1.833 | 86.1 | 94.4 | 11.74 | 12.4 | 0.103 | 0.103 | 0.102 | 5 | 5 | 0.07 | 1.4 |
1.669 | 0.104 | ||||||||||||||
1.665 | 0.103 | ||||||||||||||
2 | 1.983 | 1.994 | 102.7 | 0.095 | 0.1 | 4.9 | |||||||||
1.997 | 0.109 | ||||||||||||||
2.002 | 0.096 |
OD: optical density; SD: standard deviation; CV: coefficient of variation
a) OD value corrected by mean blank OD
b) Cell viability of negativ control was regarded as 100%.
c) The SD was calculated from the cell viabilities of each tissue insert (n=2).
Table 2. Historical control data (Jan 2016 - Feb 2018)
OD | ||||
3- min exposure | 60-min exposure | |||
Negative control | Positive control | Negative control | Positive control | |
Mean | 1.9 | 0.2006 | 1.852 | 0.065 |
SD | 0.192 | 0.069 | 0.191 | 0.031 |
Max | 2.331 | 0.371 | 2.176 | 0.113 |
Min | 1.635 | 0.028 | 1.573 | 0.024 |
Number of tests | 20 | 20 |
OD: optical density
SD: standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Corr. 1B/C according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the reconstructed human epidermis test cell viability after 3-min and 60-min exposure to the test substance were 94.4% and 5.0%, respectively.
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