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EC number: 212-377-0 | CAS number: 811-97-2
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Human safety and pharmacokinetics of the CFC alternative propellants HFC 134a (1,1,1,2-tetrafluoroethane) HFC 227 (1,1,1,2,3,3,3-heptafluorpropane) following whole body exposure.
- Author:
- Emmen HH et al
- Year:
- 2 000
- Bibliographic source:
- Regul Toxicol Pharmacol 32:33-35
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- basic toxicokinetics
- repeated dose toxicity: inhalation
Test material
- Reference substance name:
- Norflurane
- EC Number:
- 212-377-0
- EC Name:
- Norflurane
- Cas Number:
- 811-97-2
- Molecular formula:
- C2H2F4
- IUPAC Name:
- 1,1,1,2-tetrafluoroethane
Constituent 1
Method
- Subjects:
- - Number of subjects exposed: 8
- Sex: 4 makes / 4 females
- Known diseases: none - healthy
- Other: - Route of exposure:
- inhalation
- Reason of exposure:
- intentional
- Details on exposure:
- 1 hour / week whole body exposure to air alone for first week and then during 7 suceeeding weeks to ascending concentrations of 1000, 2000, 4000, 8000 ppm HFC 134a.
- Examinations:
- clinical observation, pulse, blood pressure, electrocardiogram, lung function
Results and discussion
- Clinical signs:
- No observed adverse effects
- Results of examinations:
- No evidence of effects on the central nervous system, no symptoms of respiratory irritation, no adverse effects on pulse, blood pressure or lung function.
HFC 134a blood concentrations increased rapidly and in an exposure-dependent manner. They approached steady state within 30 minutes and tended to be higher in males than in females. Following the end of exposure, blood concentrations declined rapidly, predominantly biphasically and independent of exposure concentration.
The alpha elimination half-life (t½α) was less than 11 minutes, while the beta elimination half-life (t½β) was 42 minutes. The mean residence time was 44 minutes.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that, under the text conditions, human exposure to HFC-134a did not result in any adverse effects on pulse, blood pressure, electrocardiogram or lung function .
- Executive summary:
A clinical study was conducted in which HFC-134a vapour was administered (1 h/wk, whole-body exposure) for 8 weeks to healthy volunteers (4 male, 4 female) by inhalation first to air alone and then to ascending concentrations of 1,000, 2,000, 4,000 and 8,000 ppm (4,170, 8,340, 16,700, 33,400 mg/m3) interspersed with a second air exposure and two exposures to CFC-12 at 1,000 and 4,000 ppm. Blood pressure, blood levels of HFC-134a, pulse, cardiac function, respiratory function and effects on the CNS were measured and evaluated. There were no notable adverse effects, no evidence of effects on the central nervous system, and no symptoms of upper respiratory tract irritation. HFC-134a blood concentrations increased rapidly and in an exposure-dependent manner. They approached steady state within 30 minutes and tended to be higher in males compared to females. Following the end of the exposure period, blood concentrations declined rapidly, predominantly biphasically and independent of exposure concentration. The alpha elimination half-life (t1/2a) was less than 11 minutes, while t1/2ß was 42 minutes. The mean residence time was 44 minutes. It was concluded that, under these text conditions, human exposure to HFC-134a did not result in any adverse effects on pulse, blood pressure, electrocardiogram or lung function
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