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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: Range finder study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Dose range finding study for rat 28 day study (OECD 407). Performed according to the principles of GLP (OECD) using the same facilities and study procedures that were subject to routine inspection under the laboratory QA Programme. However, the study plan, experimental phases and final study report were not subject to Quality Assurance audit. Brief summary report providing only limited study details.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
- Principles of method if other than guideline:
- no guideline required
- GLP compliance:
- no
- Limit test:
- no
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:
- Substance received as a clear colourless liquid (substance in solution)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
330 mg/Kg/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
660 mg/Kg/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1320 mg/Kg/day
Basis:
nominal in water
- No. of animals per sex per dose:
- Groups 1-4. Each group consisted of 5 animals/sex.
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- All animals were observed twice daily for mortality and moribundity. Clinical examinations were performed daily and detailed physical examinations were performed on study days 0 and 7. Individual body weights and food consumption were recorded on study days 0 and 7. Gross necropsies were conducted on all animals; gross lesions were collected for possible future microscopic examination.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weights were unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption was unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.
- Details on results:
- SURVIVAL
All animals survived to the scheduled necropsy.
CLINICAL OBSERVATIONS
There were no test article related clinical observations.
BODY WEIGHTS
Body weights were unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.
FOOD CONSUMPTION
Food consumption was unaffected by test article administration. There were no statistically significant differences when the control and test article treated groups were compared.
ANATOMIC PATHOLOGY - MACROSCOPIC EXAMINATION
There were no test article related macroscopic findings at the scheduled necropsy. All macroscopic findings noted were considered to be spontaneous and/or incidental in nature and unrelated to test article administration.
Effect levels
- Dose descriptor:
- other: mortality
- Effect level:
- > 1 320 mg/kg bw/day (nominal)
- Based on:
- test mat.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, oral administration of the test substance to Crl:CD[SD] rats for 7 consecutive days at dosage levels of 330, 660, and 1320 mg/kg/day was well tolerated at all dosage levels. There were no treatment-related effects at 1320 mg/kg/day, the highest dosage level evaluated.
- Executive summary:
The objective of the study was to investigate the potential toxicity of the test substance when administered daily by oral gavage to Sprague Dawley rats for 7 consecutive days.
Based on the results of this study, oral administration of the test substance to Crl:CD[SD] rats for 7 consecutive days at dosage levels of 330, 660, and 1320 mg/kg/day was well tolerated at all dosage levels. There were no treatment-related effects at 1320 mg/kg/day, the highest dosage level evaluated.
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