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EC number: 206-557-8 | CAS number: 354-33-6
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Pentafluoroethane
- EC Number:
- 206-557-8
- EC Name:
- Pentafluoroethane
- Cas Number:
- 354-33-6
- Molecular formula:
- C2HF5
- IUPAC Name:
- 1,1,1,2,2-pentafluoroethane
- Details on test material:
- - Name of test material (as cited in study report): HFC-125
- Substance type: fluorinated alkane
- Physical state: gasseous
- Analytical purity: 99.558%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: pure substance
- Isomers composition: n/a
- Purity test date: not reported
- Lot/batch No.: BR131
- Expiration date of the lot/batch: not reported
- Stability under test conditions: Stability of the test material was confirmed by GC analysis on 3 days before and after the dosing day.
- Storage condition of test material: Sample stored for 3 days at room temperature in a gas cylinder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc.
- Age at study initiation: 6 week old
- Weight at study initiation: males 190-215 g; females 140-155 g
- Fasting period before study: no fasting before the dosing day
- Housing: Stainless steel cage (1 animal/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-2 (during quarantine, exposure period and recovery period)
- Humidity (%): 55 +/- 10% (during quarantine and recovery period); 22 +/- 2% (during the 4-h exposure period)
- Air changes (per hr): 15-17/hr (during quarantine and recovery period); 12/hr (during the 4-h exposure period)
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr
IN-LIFE DATES: From:8 Oct 1991 To: 29 Oct 1991
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure chamber (whole body exposure)
- Exposure chamber volume: 520 L
- Method of holding animals in test chamber: individual cages
- Source and rate of air: Room air filtered through an HEPA filter (control animals); Mixture of HFC-125/oxygen 80/20% (exposure group)
- Method of conditioning air:
- System of generating particulates/aerosols: HFC-125 released from the gas cylinder was diluted with oxygen in a line mixer and the mixture was
conveyed to the exposure chamber.
- Method of particle size determination: n/a
- Treatment of exhaust air: no information reported
- Temperature, humidity, pressure in air chamber: parameters were constantly monitored during the exposure period
TEST ATMOSPHERE
- Brief description of analytical method used: GC analysis:
Instrument: Shimadzu GC-8AIF
Column: CDC-200, 3m, 3mm diameter
Column oven temperature: 60°C
Carrier: N2, 1.5 kg/cm2
Detector: flame ionization, 60°C
Injection volume: 0.2 ml exhaust atmosphere from the exposure chamber
- Samples taken from breathing zone: yes
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Maximal applicable concentration - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- the exposure concentration was monitored via GC analysis during the exposure period.
- Duration of exposure:
- 4 h
- Concentrations:
- 800000 ppm (3,927,000 mg/m3)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Parameter evaluated: Observation of clinical signs and mortality were carried out during the exposure period, 1, 3 and 6 hours after the end of
exposure and more than once a day for 14 days. Body weights were measured prior the exposure and on day 1, 3, 7, 10 and 14. Gross pathology
examinations were carried out at the end of exposure period.
- Duration of observation period following administration: 14 days
- Frequency of observations: Quarantine period: more than once a day. Exposure period: every 15 minutes during the first hour and every hour
onward. Recovery period: 1, 3 and 6 hour after the exposure termination; more than once a day from day 1 to day 14.
- Body weight: 2 times during quarantine and adaptation period, on the exposure day and on day 1, 3, 7, 10 and 14 of the post exposure period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no
Results and discussion
- Preliminary study:
- No mortality was observed during the study. During the exposure clinical signs such as ataxic gait, and abnormal respiration were observed in all
exposed rats. The clinical signs disappeared one hour after the exposure. There was a slight decrease in mean body weight of exposed males in
comparison to control value. No findings were observed during pathology examinations.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LCLo
- Effect level:
- > 800 000 ppm
- Exp. duration:
- 4 h
- Mortality:
- No mortality observed
- Clinical signs:
- other: Signs of anesthesy (ataxic gait and abnormal respiration) observed during the exposure period.
- Body weight:
- No significant changes
- Gross pathology:
- No findings
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The lowest lethal dose (LDLo) was > 800,000 ppm (highest dose tested) for this study.
- Executive summary:
In an OECD guideline study (Nakayama et al., 1992a), 10 Sprague Dawley rats (5 males and 5 females) were exposed to 800,000 ppm (3,927,000 mg/m3) HFC-125 in atmosphere for 4 hours. Another 10 animals were exposed to normal air for control. No mortality was observed within 14 days after the exposure. During the exposure, clinical signs typical of an anaesthetic effect, such as abnormal respiration and ataxic gait, were observed. These effects disappeared within 1 hour after the end of the exposure period. A slight decrease in mean body weight was registered in the exposed males, in comparison with the control males. No findings were observed during the autopsy. The lowest lethal dose (LDLo) was > 800,000 ppm (highest dose tested) for this study.
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