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Diss Factsheets
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EC number: 817-766-4 | CAS number: 91891-42-8
- 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:
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene
- EC Number:
- 817-766-4
- Cas Number:
- 91891-42-8
- Molecular formula:
- C6F12O
- IUPAC Name:
- 1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene
- 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:
3M Company
- Expiration date of the lot/batch:
No data
- Purity test date:
05 Feb, 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room temperature and humidity, protected from light and stored under enert gas
- Stability under test conditions:
Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
: None, dosed unchanged
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes
- Cell source:
- other: No data
- Source strain:
- other: NA
- Details on animal used as source of test system:
- SOURCE ANIMAL
: Human
- Source: MatTek - Justification for test system used:
- Test system validated in OECD 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm
- Tissue batch number(s): Lot 28838
- Production date: No data
- Shipping date: No data
- Delivery date: 17 July, 2018
- Date of initiation of testing: 18 July, 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Per the report the tissues were "thoroughly rinsed".
- Observable damage in the tissue due to washing: None reported.
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: μQuant Plate Reader, Bio-Tek Instruments, Winooski, VT
- Wavelength: 540 nm
- Filter: No data
- Filter bandwidth: No data
- Linear OD range of spectrophotometer: No data
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
Following the 60 minute exposure, the viability was then expressed as a percent of control values. If the mean tissue viability was 50% or less, the test material was classified as an irritant; if the mean tissue viability was more than 50%, the test material was classified as a non-irritant. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
VEHICLE : None
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 24 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 103.1
- 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: None
- Direct-MTT reduction: None
- Colour interference with MTT: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
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
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study (103.1% tissue viability) the test article is not irritating in the EpiDerm skin irritation model.
- Executive summary:
The skin irritation potential of the test article was evaluated in the 3D Reconstructed Human Epidermis model EpiDerm (MatTek). The study was conducted according to OECD 439 in compliance with OECD GLP principles. Tissues were dosed in triplicate with 30 uL test article, negative control (PBS) or positive control (5% SDS) and incubated at 37 C for 60 minutes. Following the 60 minute exposure period, tissues were rinsed with PBS, blotted to remove the test substance and dry the tissue and transferred to fresh medium. The rinsed tissues were then incubated for 24 hours, rinsed again and incubated for an additional 18 hours in fresh medium. At the end of the incubation period, each tissue was rinsed with PBS and transferred to a 24 -well plate containing 300 uL of MTT solution (1 mg/mL in DMEM). The tissues were incubated for 3 hours with MTT. Following MTT incubation, each tissue was rinsed with PBS and treated with 2.0 mL of extracant solution (isopropanol) for at least two hours with shaking. Two aliquots per tissue of the extracted MTT formazan were measured at 540 nm to determine viability when compared to control values. Tissues exposed to the test article for 60 minutes had a tissue viability of 103.1% with negative controls having 100% viability and positive controls having 2.3% viability. Based on the results of the study (103.1% tissue viability) the test article is not irritating in the EpiDerm skin irritation model.
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