Registration Dossier
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EC number: 200-896-5 | CAS number: 75-73-0
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Perfluoroethane
- EC Number:
- 200-939-8
- EC Name:
- Perfluoroethane
- Cas Number:
- 76-16-4
- Molecular formula:
- C2F6
- IUPAC Name:
- hexafluoroethane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air and supplemental oxygen
- Analytical verification of doses or concentrations:
- yes
- Remarks:
- gas chromatography
- Duration of treatment / exposure:
- approximately 20 days of exposure followed by approximately 28 days of no-exposure (recovery)
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 2 500 ppm
- Dose / conc.:
- 10 000 ppm
- Dose / conc.:
- 50 000 ppm
- No. of animals per sex per dose:
- 5 rats/sex/dose (subchronic with recovery subset)
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Body weight, clinical signs, food consumption were recorded throughout the study (during the treated period and the recovery period). Two ophtalmology evaluations were conducted by a veterinary ophtalmologist. Both eyes were examined by focal illumination and indirect ophtalmoscopy after mydriasis was produced.
On test day 29, blood and urine samples were collected from 5 male and 5 female rats per group for measurement of hematology, clinical chemistry and urinalysis parameters and again near the end of the recovery period on test day 57.
An abbreviated neurobehavioral evaluation was conducted on the 5 males and 5 females prior to test substance administration in order to obtain baseline measurements. This neurobehavioral evaluation was conducted again following approximately 4 weeks of exposure for the animals. - Sacrifice and pathology:
- Following collection of terminal blood samples from the rats, the rats were euthanized, selected organs were weighed and selected tissues were evaluated microscopically.
The following organs were weighed fresh at necropsy from all adult animals: adrenals, brain, heart, kidneys, liver, lungs, spleen, thymus, ovaries, uterus, testes, epididymides, prostate, seminal vesicles, accessory sex organs. - Statistics:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test substance-related clinical signs of toxicity were observed in males or females.
Incidental clinical signs common to the age and strain of rat were occasionaly observed during the exposure and/or recovery periods. - Mortality:
- no mortality observed
- Description (incidence):
- Unscheduled deaths did not occur in the animals.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No adverse test substance-related effects on body weight or weight gain occurred in males or females.
The body weight changes observed at 10000 ppm (females) and 2500 ppm (females) were not dose-dependent and were considered to be spurious. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No test substance-related effects or statistically differences in food consumption were observed for males or females.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- No test substance-related effects or statistically differences in food efficiency were observed for males or females.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No adverse test substance-related ophtalmologic effects occurred in males or females.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No exposure-related changes in any group mean hematology parameter in male or female rats.
The following statistically significant difference was not considered to be related to exposure to the test substance: absolute large unstained cells were statistically significantly higher in female rats exposed to 50000 ppm. There were no other statistically significant differences in other white blood cell parameter in any subsets of male or female rats at any concentration tested. Therefore, this change was considered unrelated to exposure and non-adverse. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No exposure-related changes in group mean clinical chemistry parameters in male or female rats.
The following statistically significant difference was not considered to be related to exposure to the test substance: blood urea nitrogen (BUN) was minimally lower in female rats exposed to 50000 ppm. However, there were no statistically significant differences in other kidney-related clinical pathology parameters and no exposure-related changes in renal histopathology in this group. Therefore, the lower BUN in the 50000 ppm females was considered unrelated to exposure and non-adverse. - Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- There were no statistically significant differences in group mean urinalysis parameters in male or female rats at any concentration tested.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No test substance-related or statistically significant effects occurred on :
- on forelimb or hindlimb grip strength
- on any behavioral parameter evaluated
- on motor activity
for males and females exposed to the substance. - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test substance-related organ weight effects. All individual and mean organ weight differences were considered spurious and unrelated to test substance exposure.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No test substance-related gross observations in either male or female rats.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Microscopic findings: no test substance-related microscopic findings in either male or female rats in the 50000 ppm inhalation exposure group.
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 50 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- food efficiency
- gross pathology
- haematology
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the NOAEC of perfluoroethane for systemic toxicity in male and female rats was 50000 ppm, the highest concentration tested, based on the absence of effects in all endpoints.
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