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EC number: 811-734-3 | CAS number: 36097-07-1
- 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:
- 19 May, 2015 - 29 June, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2012)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]butane-1-thiol
- EC Number:
- 811-734-3
- Cas Number:
- 36097-07-1
- Molecular formula:
- C12 H13 F13 S2
- IUPAC Name:
- 4-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]butane-1-thiol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): IN-1000
- Appearance: Dark amber liquid
- Storage condition of test material: In refrigerator (2-8°C) container flushed with nitrogen
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 36.3 - 37.2
- Humidity (%): 73 - 91
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 25 μL (no correction for the purity)
NEGATIVE CONTOL:
- Amount applied: 25 µL Phosphate buffered saline
POSITIVE CONTROL
- Amount applied: 25 µL
- Concentration: 5% (aq) Sodium dodecyl sulphate - Duration of treatment / exposure:
- 15 minutes
- Details on study design:
- TEST SITE
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 15-EKIN-025). This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
TREATMENT
The test was performed on a total of 3 tissues per test substance together with negative and positive controls. Twenty five μl of the undiluted test substance 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. In addition three killed tissues treated with test substance and three killed non treated tissues were used for the cytotoxicity evaluation with MTT.
REMOVAL OF TEST SUBSTANCE
- Washing: phosphate buffered saline
- Time after start of exposure: 15 minutes
POST INCUBATION PERIOD
- 42 hours
SCORING SYSTEM:
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 106
- Remarks on result:
- other:
- Remarks:
- Basis: other: percentage of control. Time point: 15 minutes. Remarks: Negative control = 100%; Positive control = 7%. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with IN-1000 compared to the negative control tissues was 106%. Since the mean relative tissue viability for IN-1000 was above 50% IN-1000 is considered to be non-irritant.
Any other information on results incl. tables
Test for reduction of MTT by the test substance:
IN-1000 was checked for possible direct MTT reduction and colour interference in the Skin corrosion test using EpiDerm as a skin model (project 508547). Because solutions did turn blue / purple and/or a blue / purple precipitate was observed it was concluded that IN-1000 did interfere with the MTT endpoint.
In addition to the normal procedure, three killed tissues treated with test substance and three killed non treated tissues were used for the cytotoxicity evaluation with MTT.
The non-specific reduction of MTT by IN-1000 was 3.3% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test substance treated viable tissues.
Acceptability of the assay:
The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 7%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range (0.576 -1.352).
The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles.
It is concluded that this test is valid and that IN-1000 is not irritating in the in vitro skin irritation test. - Executive summary:
- In an in vitro skin irritation test using a human skin model ( EPISKIN Small Model) conducted according to OECD 439 guideline and GLP principles, the influence of IN-1000 on the viability of human skin was tested. The test substance (25 μL) was applied directly to 0.38 cm^2 cultured skin. Reliable positive and negative controls were included. After 15 minutes, the substance was removed and cells were cultured for 42 hours. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 7% whereas the test substance showed cell viability of 106%. Since the mean relative tissue viability after exposure to the test substance was above 50%, it can be concluded that IN-1000 is not irritating in the in vitro skin irritation test.
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