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Diss Factsheets
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EC number: 206-406-6 | CAS number: 335-99-9
- 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:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2,3,3,4,4,5,5,6,6,7,7-dodecafluoroheptan-1-ol
- EC Number:
- 206-406-6
- EC Name:
- 2,2,3,3,4,4,5,5,6,6,7,7-dodecafluoroheptan-1-ol
- Cas Number:
- 335-99-9
- Molecular formula:
- C7H4F12O
- IUPAC Name:
- 2,2,3,3,4,4,5,5,6,6,7,7-dodecafluoroheptan-1-ol
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany). The model used for this study has a functional stratum comeum with an underlying layer of living cells as recommended by the test guidelines. The barrier function of the stratum comeum is adequate, as has been shown by the supplier.
- Tissue batch number(s): Cat.-No.CS-1001
- Date of initiation of testing: 26 March 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: incubator (37 ± 2° C) for 20 min- exposure
- Temperature of post-treatment incubation (if applicable): 37 ± 2° C
PRE-CHECK FOR POTENTIAL OPTICAL INTERFERENCE OF THE TEST ITEM
Optical properties of the test item or its chemical action on MTT may interfere with the measurement of MTT formazan leading to a false estimate of tissue viability. The test item was therefore tested in advance for a potential direct influence on the test results not related to cytotoxic effects on tissue cells. For this pre-check the following parameters were tested:
1. Assessment of potential direct MTT-reduction of the test item
In case of a direct MTT-reduction of the test item a killed tissue control (inserts, which were killed by freezing) was used in the main assay.
2. Assessment of potential interference of colored or staining test items, which become colored after application to the tissues, with OD read out
In case of an influence of test item color on OD measurement, a color control was used in the main assay.
2.1. Assessment of the color reaction with water
2.2. Assessment of the color reaction with isopropanol
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
the optical density of the isopropanol-extracts of 3 insert was determined by duplicate per insert = 6 OD values.
ASSAY ACCEPTANCE CRITERIA:
The following acceptance criteria determined the validity of an assay:
- mean OD negative control is equal or greater 1.0 and equal or lower 2.8
- mean relative viability of the positive control is equal or lower 20 %
- If the mean viability of the 3 replicates is > 20% the coefficient of variation (CV) should not exceed 0.3.
PREDICTION MODEL / DECISION CRITERIA:
- The mean optical density (OD) value obtained with the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- Depending on the controls performed (see 4.4.6) the% Viability Final is calculated as follows (the values always refer to% viability)
% Viability Final = PG - (PG KC - NC KC)
- Thus the test item is identified as irritant and requiring classification according to UN GHS (Category 2 or Category 1) ifthe mean percent tissue viability after exposure and post-treatment incubation is less than or equal to 50 %. In case the test item was found to be non-corrosive (e.g. based on TG 431) and shows tissue viability after exposure and post-treatment incubation which is less than or equal to 50 %, the test item is considered to be irritant to skin in accordance with UN GHS Category 2.
The irritating potential of the test item is assessed by determination of its cytotoxic effect on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after exposure to the topically applied test item.
All tests were performed in triplets for each time point. The test item was applied for 20 min. Cell viability was measured by the amount of MTT reduction (calculated on the basis of optical density of the negative control). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- other:
- Amount/concentration applied:
- TEST MATERIAL APPLICATION
- Amount(s) applied: 30 µL of the test item, positive and negative control; a piece of nylon mesh was used as spreading aid
PROCEDURE FOR KILLED CONTROL
The test item was applied to two killed control tissue inserts and treated as described for the main assay (PG KC). In addition two killed control inserts were treated with 0.9 % NaCl (Negative control killed control, NC KC)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μl
- Concentration (if solution): 0.9% NaCl
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl
- Concentration (if solution): 5 % Sodium Dodecyl Sulfate (SDS) - Duration of treatment / exposure:
- 20 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- result for test material
- Value:
- 2.13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Reliability of the test was previously confirmed by interlaboratory validation
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative controls: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Sample No. | test item | cell viability (%) |
1 -3 | negative control (0.9% NaCl solution) | 100 |
6 -8 | positive control (5% SDS) | 1.87 |
18 -20 | test item | 2.13 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Executive summary:
An in vitro study for predicting non-specific irritating properties of the test item was conducted according to OECD TG 439. The liquid test item was applied topically to a reconstructed human epidermis model (RhE; epiCS) in an amount of 30µL. The cell viability was determined with 2.13 % for the test item as measured by MTT conversion. It is therefore concluded that according to the criteria of this assay the test item shows irritating properties to the skin and thus requires a classification according to UN GHS (Category 2).
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