Registration Dossier
Registration Dossier
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EC number: 206-556-2 | CAS number: 354-32-5
Toxicological Summary
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.
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