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EC number: 244-479-6 | CAS number: 21615-47-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 - 24 Apr 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium undecafluorohexanoate
- EC Number:
- 244-479-6
- EC Name:
- Ammonium undecafluorohexanoate
- Cas Number:
- 21615-47-4
- Molecular formula:
- C6H4F11NO2
- IUPAC Name:
- 2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)
- Test material form:
- solid
- Remarks:
- White powder
Constituent 1
- Specific details on test material used for the study:
- - storage: at room temperature in a shaded and air-tight container in a desiccator
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Remarks:
- SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hino Breeding Centers (Charles River Laboratories), Hino, Japan
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 189.1 g (first sighting study), 193.2 g (second sighting study) and 196.3 – 200.0 g (main study)
- Fasting period before study: animals were fasted overnight prior to administration (17 – 19 h)
- Housing: Group housing of 4 females per cage in stainless steel cages (260 x 380 x 180 mm) with mesh-floor
- Diet: MF pelleted diet (Oriental Yeast), ad libitum
- Water: chlorinated tap water (chloric level maintained from 3 to 5 ppm by addition of sodium hypochloride (Purelox) to tap water), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 Mar 2018 To: 24 Apr 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Administration /exposure:
VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle: 10 mL/kg bw
- Lot/batch No.: PC171219
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION:
Dosing formulation was prepared freshly on each administration day. The test substance was weighed and mixed with purified water to be dissolved. The solution was filled up to the prescribed volume with purified water to prepare the dosing formulation. The dosing formulations were administered within one hour after the preparation. - Doses:
- 300 mg/kg bw
(300 mg/kg bw for 1st sighting, 2000 mg/kg bw for 2nd sighting) - No. of animals per sex per dose:
- 300 mg/kg bw: 5 (incl. sighting study)
2000 mg/kg bw: 4 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality and clinical signs continuously for 10 min after the administration, 30 min and 3 h after the administration and once daily during Days 1 to 14 after the administration. Individual body weights were recorded before dose administration and 1, 7 and 14 days post-dose.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw: 0/4 (main study), 0/1 (1st sighting study)
2000 mg/kg bw: 1/1 (2nd sighting study) within 24 h after administration - Clinical signs:
- 300 mg/kg bw: No clinical signs of toxicity were observed up to the end of the 14 day observation period
2000 mg/kg bw: decreased spontaneous locomotion, decreased respiratory rate, incomplete eyelid opening and moist hair (abdomen) in 1/1 animals 3 h after administration. Lacrimation was observed 5 h after administration. - Body weight:
- One animal dosed at 300 mg/kg bw showed a low body weight gain of 4.5 g one day after administration. The effect was not considered toxicologically significant, because no abnormalities were observed in the general clinical observation or necropsy.
- Gross pathology:
- 300 mg/kg bw: Necropsy and histopathological examination revealed no substance-related findings.
2000 mg/kg bw: edematous change of limiting ridge of the forestomach was observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- CLP: Acute Oral (4), H302
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