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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Validated in vitro ocular irritation screening study. GLP compliant (FDA, EPA, OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The EpiOcular™ Human Cell Construct was used to assess the ocular irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure for various exposure times. The duration of exposure resulting in a 50% decrease in MTT conversion (ET50) in test article-treated EpiOcular™ human cell constructs, relative to control cultures, was determined.
The EpiOcular™ cultures were treated in duplicate with the test article at four exposure times of 0.33, 1, 2, and 4 hours. Duplicate cultures of the positive control, 100 µL of 0.3% Triton®-X-100, were exposed for 15 and 45 minutes. - 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 system
- Details on study design:
- The EpiOcular™ Human Cell Construct was used to assess the ocular irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure for various exposure times. The duration of exposure resulting in a 50% decrease in MTT conversion (ET50) in test article-treated EpiOcular™ human cell constructs, relative to control cultures, was determined.
The EpiOcular™ cultures were treated in duplicate with the test article at four exposure times of 0.33, 1, 2, and 4 hours. Duplicate cultures of the positive control, 100 µL of 0.3% Triton®-X-100, were exposed for 15 and 45 minutes.
Results and discussion
In vivo
- Irritant / corrosive response data:
- After 4 hours more than 50% of the cells (72.4%) treated with the test substance remained viable indicating the ET50 was greater than 4 hours, reflective of a low order of eye irritation potential. The ET50 of the positive control was 30.4 minutes, in the range of historical control values.
Any other information on results incl. tables
ET50 Data
Test Substance ET50 (hours) = > 4 hrs
Positive Control ET50 (minutes) = 30.4 minutes
Applicant's summary and conclusion
- Interpretation of results:
- other: Low order of eye irritation potential
- Conclusions:
- In this assay, the EpiOcular™ Human Cell Construct determined that the test substance has a low order of ocular irritation potential.
- Executive summary:
The EpiOcular™ Human Cell Construct was used to assess the ocular irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure for various exposure times. The duration of exposure resulting in a 50% decrease in MTT conversion (ET50) in test article-treated EpiOcular™ human cell constructs, relative to control cultures, was determined.
The EpiOcular™ cultures were treated in duplicate with the test article at four exposure times of 0.33, 1, 2, and 4 hours. Duplicate cultures of the positive control, 100 µL of 0.3% Triton®-X-100, were exposed for 15 and 45 minutes. After 4 hours more than 50% of the cells (72.4%) treated with the test substance remained viable indicating the ET50was greater than 4 hours, reflective of a low order of eye irritation potential.
The ET50of the positive control was 30.4 minutes, in the range of historical control values. The corrected mean OD550 value for the minimum negative control exposure time was within 20 % of the corrected mean OD550 value for the maximum negative control exposure time. Validity test criteria were therefore met.
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