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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-556-2 | CAS number: 354-32-5
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 270
- Dose descriptor starting point:
- other: LC50
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 270
- Dose descriptor starting point:
- other: LC50
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
For the derivation of the Acute DNEL for local and systemic effects, the method for derivation of an acute DNEL as described by ECETOC (2003) has been applied. The point of departure was the 4 h-LC50 of 70 ppm in rats. Based on these results of this study, the DNEL value was calculated as follows:
Derivation of Acute DNEL for local and systemic effects based on an acute inhalation study
Worker | Acute DNEL/inhalation/local and systemic effects |
Step a : determination of the critical dose | |
Key study | Janssen (1996) |
Relevant dose descriptor | LC50 = 70 ppm |
Step b : Correct starting point – factor for uncertainties | |
Extrapolation to non-lethal level in animals | 3 |
Correct starting point = relevant dose descriptor | 23 ppm |
Step c : assessment factors | |
Extrapolation to non-lethal level in humans | 3 |
Extrapolation factor to non-toxic level in humans | 10 |
Quality of the whole database | 3 |
Overall assessment factor | 90 |
DNEL calculation | 0.3 ppm (corresponding to 1.6 mg/m3*) |
*DNEL(mg/m3) = 0.3 / (24.05/132.47)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.042 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 8.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification since same route of exposure fo rat and human
- AF for dose response relationship:
- 1
- Justification:
- Not required, starting point is NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
The gas Trifluoroacetyl chloride (TFAC) is extremely unstable in water. In contact with water or aqueous media it will react immediately to produce Trifluoroacetic acid and HCl, which are both considered as highly corrosive acids. The acute inhalation toxicity studies available on Trifluoroacetyl chloride demonstrate that the substance is fatal if inhaled and that the corrosive properties are the primary cause of the clinical symptoms. It can therefore be concluded that TFAC will induce local effects by all routes of exposure before systemic effects are expected. However, considering the low concentration exposure via the environment, local effects are very unlikely to occur. Therefore, only DNELs for systemic effects are considered. Moreover, as acute exposure is not relevant for the general population, only long-term DNEL for systemic effects are considered below.
DNEL for long-term toxicity - systemic effects
Dermal route
It is assumed that the general population is not exposed to TFAC via the dermal route.
Inhalation route
It is assumed that the general population is not exposed to TFAC vapours at ambient temperature.
Oral route:
Considering the rapid hydrolysis of TFAC in contact with water or air moisture, the hydrolysis product TFA is the relevant species for humans when exposed to TFAC by oral exposure.
The concentration descriptor has been obtained from a GLP compliant sub-chronic toxicity study according to OECD TG 408. In this study the neutral salt sodium trifluoroacetate was administered to male and female rats at 160, 1600 and 16000 ppm via dietary administration. Based on the observed effects (increase in liver weight, histopathological changes in the liver and changes in haematological parameters, clinical biochemistry and urinalysis), the NOAEL was set at 160 ppm in both sexes (equating approximately to 8.4 mg TFA/kg body weight/day in males and 10.1 mg TFA/kg body weight/day in females). The lowest NOAEL from the 90 -day study is taken forward for DNEL derivation.
Table: Calculation of long-term DNEL by oral route for systemic effects of Trifluoroacetic acid
General population | Long-term DNEL / oral / Systemic effects |
Step a : determination of the critical dose | |
Key study | Bayer, 2007 / rel. 1 (key study) |
Relevant dose descriptor | NOAEL = 8.4 mg/kg bw |
Step b : Correct starting point – factor for uncertainties | |
Differences in absorption depending on route of exposure (route-route extrapolation, human/animal) | - (same route of exposure rat/human) |
Modification for exposure (experiment in animal and human) | - |
Correct starting point = relevant dose descriptor / overall factor for uncertainties | 8.4 mg/kg bw |
Step c : assessment factors | |
Interspecies differences: - Differences in metabolic rate per b.w. (allometric scaling) - - Remaining differences (toxicokinetics and toxicodynamics) |
4
2.5 (remaining differences) |
Intraspecies differences | 10 (general population) |
Duration extrapolation | 2 (subacute to chronic) |
Issues related to dose-response | 1 (NOAEL) |
Quality of the whole database | 1 |
Overall assessment factor | 200 |
DNEL calculation | 0.042 mg/kg bw/d |
Hence, the long-term DNEL for systemic effects by oral route is 0.042 mg/kg bw/d for the general population.
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.