Registration Dossier
Registration Dossier
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: 206-581-9 | CAS number: 355-37-3
- 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:
- 2016-03-14 to 2016-03-21
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- The study integrity was not adversely affected by the deviation.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
- EC Number:
- 206-581-9
- EC Name:
- Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
- Cas Number:
- 355-37-3
- Molecular formula:
- C6HF13
- IUPAC Name:
- 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: AGC Chemicals Europe Ltd; Batch no. 41251
- Expiration date of the lot/batch: 01 March 2017 (nominal expiry date) (taken from label)
- Purity test date: Not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: until 01 March 2017 (nominal expiry date) (taken from label)
FORM AS APPLIED IN THE TEST (if different from that of starting material): Colourless liquid
OTHER SPECIFICS:
Purity/Composition: 100.00%
Molecular weight: 320
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: Preparation and preincubation: On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 21.5 hours at 37°C. Maintenance medium and Assay medium were supplied by Skinethic Laboratories, Lyon, France.
MTT medium: MTT concentrate (Sigma Aldrich, Zwijndrecht, The Netherlands; 3 mg/ml in PBS) diluted (10x) in Assay medium (final concentration 0.3 mg/ml).
Environmental conditions
All incubations, with the exception of the test item incubation of 15 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 67- 87%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.3- 37.3°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day.
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was [complete, e.g. 10 kΩ]
Application/Treatment of the test item
The test was performed on a total of 3 tissues per test item together with negative and positive controls. Twenty five µL of the undiluted test item was added into 12-well plates on top of the skin tissues. Three tissues were treated with 25 µL PBS (negative control) and 3 tissues with 25 µL 5% SDS (positive control) respectively. The positive control was re-spread after 7 minutes contact time. After the exposure period of 15 ± 0.5 minutes at room temperature the tissues were washed with phosphate buffered saline to remove residual test item. At the end of the exposure, it was noted that no test item was left on the tissue, possibly due to its volatility. After rinsing, the cell culture inserts were each dried carefully and moved to a new well on 2 ml pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 hours at 37°C. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test Material
- Value:
- ca. 119
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Asahiklin™ AC-2000 was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because no colour changes were observed it was concluded that Asahiklin™ AC-2000 did not interact with the MTT endpoint.
- Colour interference with MTT: Asahiklin™ AC-2000 was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because no colour changes were observed it was concluded that Asahiklin™ AC-2000 did not interact with the MTT endpoint.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline:
The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 44%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically with the positive and negative control was less than 8%, indicating that the test system functioned properly. The standard deviation of the viability of the test item treated tissues was 27% which is above acceptance criteria. But, since all individual viabilities were clearly >50%, this does not influence the outcome of the test (study plan deviation 1).
Any other information on results incl. tables
Table 2. Mean absorption in the in vitro skin irritation test with Asahiklin™ AC-2000 |
|||||
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
SD |
Negative control |
1.066 |
1.052 |
1.024 |
1.047 |
± 0.022 |
Asahiklin™ AC-2000 |
1.568 |
1.157 |
1.026 |
1.250 |
± 0.283 |
Positive control |
0.398 |
0.549 |
0.437 |
0.462 |
± 0.078 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table, the values are corrected for background absorption (0.0408). Isopropanol was used to
measure the background absorption.
Table 3. Mean tissue viability in the in vitro skin irritation test with Asahiklin™ AC-2000 |
|
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
Asahiklin™ AC-2000 |
119 |
Positive control |
44 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- GHS Criteria
- Conclusions:
- Asahiklin™ AC-2000 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
- Executive summary:
In a key in vitro skin irritation test using a human skin model, the test material (Asahiklin™ AC-2000; purity 100%) was applied undiluted (25 µL) directly on top of the skin tissue (human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM))) for 15 ± 0.5 minutes. After a 42-hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test item.
The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with Asahiklin™ AC-2000 compared to the negative control tissues was 119%. Since the mean relative tissue viability for Asahiklin™ AC-2000 was above 50% after 15 ± 0.5 minutes treatment, Asahiklin™ AC-2000 is considered to be non-irritant.
The positive control had a mean cell viability of 44% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically with the positive and negative control was less than 8%, indicating that the test system functioned properly.
It was concluded that Asahiklin™ AC-2000 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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.
