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Diss Factsheets
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EC number: 700-737-4 | CAS number: 1220100-43-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Validated in vitro assay - the MTT Time Course Assay using the EpiDerm™ Skin Model (cited in OECD 439); GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The EpiDerm™ Skin Model was used to assess the dermal irritation potential of the substance. Reduction of MTT dye to a blue precipitate was used to
assess cellular metabolism after exposure to the test article for various exposure times. The time of exposure resulting in a 50% decrease in MTT
conversion (ET50) in test article-treated EpiDerm™ cultures, relative to control cultures, was determined. - GLP compliance:
- yes
- Remarks:
- FDA, EPA, OECD
Test material
- Reference substance name:
- N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride
- IUPAC Name:
- N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride
- Reference substance name:
- 1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride
- EC Number:
- 700-737-4
- Cas Number:
- 1220100-43-5
- Molecular formula:
- C18H34F8N2O4.2Cl
- IUPAC Name:
- 1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride
- Details on test material:
- - Physical state: Solid, white
- Storage condition of test material: Room temperature, protected from light
Constituent 1
Constituent 2
Test animals
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
Test system
- Details on study design:
- The EpiDermTM cultures were treated in duplicate with the test article at four exposure times of 4, 8, 16, and 24 hours. The positive control, 1% Triton®-X-100, was also exposed in duplicate for 4 and 8 hours. The negative control was exposed in duplicate for 4 and 24 hours.
Results and discussion
In vivo
- Irritant / corrosive response data:
- After 24 hours more than 50% of the cells (54.6%) treated with the test substance remained viable indicating the ET50 was greater than 24 hours, reflective of a very low order of skin irritation potential. The ET50 of the positive control was 5.83 hours, in the range of historical control values.
Any other information on results incl. tables
ET50 Data
Test Substance ET50 (hours) = > 24 hrs
Positive Control ET50 (hours) = 5.83 hrs
Applicant's summary and conclusion
- Interpretation of results:
- other: Very low order of skin irritation potential
- Conclusions:
- The ET50 result collected on the test article did not cause > 50 % relative toxicity to the tissues up to the longest prescribed exposure time of 24 hours (ET50 > 24 hours). This is indicative of a very low order of skin irritation potential.
- Executive summary:
The EpiDerm™ Skin Model was used to assess the dermal irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure to the test article for various exposure times. The time of exposure resulting in a 50% decrease in MTT conversion (ET50) in test article-treated EpiDerm™ cultures, relative to control cultures, was determined.
The EpiDermTMcultures were treated in duplicate with the test article at four exposure times of 4, 8, 16, and 24 hours. The positive control, 1% Triton®-X-100, was also exposed in duplicate for 4 and 8 hours. After 24 hours more than 50% of the cells (54.6%) treated with the test substance remained viable indicating the ET50was greater than 24 hours, reflective of a very low order of skin irritation potential.
The ET50of the positive control was 5.83 hours, in the range of historical control values.
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.
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