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EC number: 204-126-9 | CAS number: 116-14-3
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- male animals only used
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Tetrafluoroethylene
- EC Number:
- 204-126-9
- EC Name:
- Tetrafluoroethylene
- Cas Number:
- 116-14-3
- Molecular formula:
- C2F4
- IUPAC Name:
- tetrafluoroethene
- Details on test material:
- A single 600 lb sample of d-limonene stabilised production grade TFE, 99.3% minimum purity, was provided by EI du Pont de Nemours and Company and was used for all studies. The d-limonene present at approximately 4 ppm, was removed prior to atmosphere generation by in-line silica gel traps.
Impurities detected in the TFE sample by gas chromatographic analysis are summarised in table 1.
Constituent 1
Test animals
- Species:
- hamster
- Strain:
- other: Lak:LVG (SYR)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Lak:LVG (SYR) hamsters (Charles River Breeding Laboratories, Wilmington MA) were housed in suspended stainless steel, wire-mesh cages which were separate from the exposure rooms. They were caged singly in compartmentalised modules during exposure. Control animals were housed in separate rooms from the TFE-exposed animals. The animal rooms were maintained on a 12-hour photoperiod with temperature and relative humidity averaging 23 +/- 3 °C and 55 +/- 5% respectively.
Certified Purina Rodent Chow® 5002 and tap water were available ad libitum. All animals were monitored for overt manifestation of disease during a pre-test period of 1 week.
During exposure, chamber temperatures were monitored hourly and ranged 21 - 25 °C.
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- During exposure , hamsters were housed in compartmentalized modules and placed in 150 litre glass and stainless-steel chambers.
The TFE was piped from the cylinder manifold through a single ¼” O.D. stainless steel line to a single stage regulator. TFE was carried from the regulator through ¼” O.D. Teflon® lines and metered through a brooks R2-15A flowmeter to the exposure chamber. The stream entered the chamber through a port located in the top of the chamber. Samples were taken from the ports in the side of the chamber.
D-limonene, a stabilizer in the TFE sample, was removed from the TFE with a silica gel trap located between the regulator and flowmeter.
Gas samples were collected from the inhalation exposure chamber every 15 minutes using a 1 ml gas tight Tekmar syringe and analysed by gas chromatography. The TFE concentrations were calculated by comparison with standards. A mean concentration and standard deviation were calculated for each 4 hour exposure.
Chamber temperature was monitored hourly using a mercury thermometer. Oxygen was monitored hourly with a Biomarine Industries Model 225 Oxygen analyser. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Exposure atmospheres were analysed by a Hewlett Packard Model 5710A Gas Chromatograph (CD) equipped with a Flame Ionisation Detector (FID). Samples and standards were chromatographed on a 6 ft x 1/4 in OD glass coil packed with 10% SE 30 on 60/80 mesh Chr
- Duration of exposure:
- 4 h
- Concentrations:
- 0, 10200, 20700, 25000, 30000, 40100 or 78100 ppm
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Groups of ten 7-week old male hamsters were exposed, whole body, to TFE atmospheres for single 4-hour periods. Hamsters were observed for toxic signs during the exposure period and survivors were weighed and observed daily during a 14-day post-exposure period. Tissue and clinical pathology examinations were not performed.
- Statistics:
- The LC50 was determined by the probit method of Finney.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 28 500 ppm
- Exp. duration:
- 4 h
- Mortality:
- 1/10 died at 25000ppm; 7/10 at 30000ppm; 10/10 at 40100 and 78100ppm
- Clinical signs:
- other: Lethargy at 40100 and 78100ppm
- Body weight:
- Post exposure weight loss wa s mild at 10 200 ppm but moderate at 20 700 ppm or more.
Any other information on results incl. tables
Male hamsters exposed to TFE vapours for single 4 -hour exposure periods exhibited no signs of toxicity at 30 000ppm or less, salivation and lethargy at 40 000ppm, and a clear nasal discharge and lethargy at 78 000 ppm. Post-exposure weight loss was mild at 10 200 ppm but moderate at 20 700 ppm or more. Clear nasal and ocular discharges and lethargy were noted in hamsters exposed to 30 000 ppm or more during the post-exposure period. All deaths occurred from 1 to 10 days after exposure at the highest and lowest lethal concentrations, respectively. The LC 50 of TFE in the hamster was calculated to be 28 500 ppm (116 500 mg/m3) with confidence limits of 26 400 - 31 500 ppm.
Table 2: Mortality of Hamsters vs 4 hour exposure concentrations of TFE
Concentration (ppm) |
S.D. |
Fractional Mortality No. Deaths / No. Exposed |
Time of Death No. Hamsters / No. of Days |
10 200 |
852 |
0/10 |
- |
20 700 |
1239 |
0/10 |
- |
25 000 |
1449 |
1/10 |
1@7 |
30 000 |
1233 |
7/10 |
3@6 2@7 2@8 |
40 100 |
1945 |
10/10 |
6@4 3@5 1@10 |
78 700 |
4914 |
10/10 |
1@1 2@2 2@3 5@4 |
Table 3: Observations in Hamsters vs 4 hour exposure concentrations.
Concentration (ppm) |
Observations during exposure |
Observations post exposure |
10 200 |
None |
Slight weight loss 1 day post exposure, normal weight gain thereafter |
20 700 |
None |
Moderate weight loss 1-3 days post exposure, normal weight gain thereafter |
25 000 |
None |
Moderate weight loss 1-6 days post exposure, normal weigh gain thereafter |
30 000 |
None |
Moderate weight loss 1-11 days post exposure, normal weight gain thereafter |
40 100 |
Salivation, lethargy |
Moderate weigh loss until death, sluggishness, discharge from eyes |
78 700 |
Reduced response to sound, clear discharge from eyes |
Moderate weight loss until death, sluggishness, clear discharge from eyes and nose, and eyes closed. |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classifiable for acute toxicity based on the LC50 of 116 508 mg/m3 (28 500 ppm) ie. LC 50 > 20 mg/l
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LC 50 of TFE in the hamster was calculated to be 28 500 ppm (116 500 mg/m3).
- Executive summary:
The toxic effects of inhaled tetrafluoroethylene (TFE) were investigated in an acute study with male Lak: LVG (SYR) hamsters.
The LC 50 of TFE in the hamster was calculated to be 28 500 ppm (116 500 mg/m3) with confidence limits of 26 400 - 31 500 ppm.
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