Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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:
- 2 001
- Report date:
- 2001
Materials and methods
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:
- Tetrafluoroethylene (TFE) 99%; CTL reference number Y00462/001/004 was supplied by Imperial Chemical Industries PLC.
S-(1,1,2,2-tetrafluoroethyl)glutathione (TFE-GSH), S-(1,1,2,2-tetrafluoroethyl)-L-cysteine (TFE-CYS) and N-acetyl-S-(1,1,2,2-tetrafluoroethyl)-L-cysteine (TFE-NAC) were synthesised as described previoiusly (Odum and Green, 1984).
[Acetyl-1-14C]-coenzyme A (40-60mCi per mmol) was obtained from Amersham-Pharmacia Cardiff
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Female F344 rats (150 - 180g) and femal B6C3F1 mice (18 -20g) were obtained from Harlan Olac UK. The clinical condition of all animals was monitored prior to the start of the experiments and any animal showing adverse clinical signs was removed.
The animals received Rat and Mouse Number 1 (RM1) pelleted diet from special Diet
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- S-(1,1,2,2-tetrafluoroethyl)-glutathione
S-(1,1,2,2-tetrafluoroethyl)-cysteine
N-acetyl-S-(1,1,2,2-tetrafluoro)-L-cysteine
Any other information on results incl. tables
Table A: Metabolism of TFE and its cysteine conjugates in liver and kidney fractions from rats, mice and humans
GSTa | C-S lyaseb | N-acetyl transferaseb | Acylasec | ||||
Organ/ | Vi | Km | Vmax | Km | Vmax | Km | Vmax |
Species | (nmol/min/ | (mM) | (nmol/min/ | (mM) | (nmol/min/ | (mM) | (nmol/min/ |
mg protein) | mg protein) | mg protein) | mg protein) | ||||
Liver | |||||||
Rat | 94 | 2.0 | 5.9 | 2.0 | 3.9 | 0.3 | 37 |
Mouse | 79 | 3.0 | 40 | 7.0 | 69 | 0.2 | 18 |
Human | 87 | 5.4 | 1.7 | 4.9 | 3.5 | 0.3 | 48 |
Kidney | |||||||
Rat | ND | 2.6 | 21.9 | 2.9 | 91 | 0.4 | 216 |
Mouse | ND | 5.9 | 4.0 | 9.0 | 48 | 1.0 | 248 |
Human | ND | 5.0 | 3.4 | 4.2 | 56 | 0.4 | 91 |
aGlutathione S-transferase (GST) activity was measured with TFE
bC-S lyase and N-acetyl transferase activities were measured with S-(1,1,2,2 -tetrafluoroethyl)-L-cysteine
cAcylase activity was measured with N-acetyl-S-(1,1,2,2 -tetrafluoroethyl)-L-cysteine
ND: not determined
Applicant's summary and conclusion
- Conclusions:
- The results suggest that the human kidney is at significantly less risk from the potentially adverse effects of TFE than the rat kidney. Comparisons of the same metabolic rates in mouse and human liver also leads to the conclusion that the risks to human liver are significantly lower than those to mouse liver following exposure to TFE.
- Executive summary:
Tetrafluoroethylene (TFE) is metabolised by glutathione conjugation and the ß-lyase and mercapturic acid pathways. The major metabolic steps in these pathways, the conjugation of TFE with glutathione, the metabolism of S-(1,1,2,2 -tetrafluoroethyl)-L-cysteine (TFE-Cys), by ß-Lyase, the N-acetylation of TFE-Cys by N-acyl transferases, and the de-acylation of N-acetyl-S-(1,1,2,2 -tetrafluoroethyl)-L-cysteine (TFE-NAC) by acylases, have been compared in vitro in rat, mouse and human liver and kidney fractions.
Glutathione conjugation of TFE in the liver was comparable in all three species. The highest ß-lyase activities were found in mouse liver and rat kidney, the target organs in the NTP cancer bioassay. Human ß-lyase activities were significantly lower, the rate in human liver being 23 -fold lower than that in mouse liver and in human kidney, 6 -fold lower than that in rat kidney. N-acetyl transferase activity was heavily localised in the kidney in rats and humans but in the mouse the liver had the highest activity. Acylase activity was also concentrated in the kidney with the activity in rodents approximately double that in the human kidney. Overall, these results suggest that the human kidney is at significantly less risk from the potentially adverse effects of TFE than the rat kidney. Comparisons of the same metabolic rates in mouse and human liver also leads to the conclusion that the risks to human liver are significantly lower than those to mouse liver following exposure to TFE.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.