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EC number: 200-913-6 | CAS number: 75-89-8
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 620
- Dose descriptor starting point:
- NOAEC
- Value:
- 62 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 31.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Differences in metabolic rate per b.w. (allometric scaling) : not relevant for dose level from inhalation study
- 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) : 6/8 (different conditions of exposure human/animal)
- Modification for the respiratory volume : 6,7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours)
=> Correct starting point = relevant dose descriptor / overall factor for uncertainties = 31.2 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not necessary same effects observed in several species
- AF for other interspecies differences:
- 1
- Justification:
- not necessary same effects observed in several species
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- several studies showing same effect
- AF for remaining uncertainties:
- 10
- Justification:
- Issues related to dose-response: severity
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.06 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 033
- Dose descriptor starting point:
- NOAEL
- Value:
- 62 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 18 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Conversion into dermal NOAEL (in mg/kg bw/day) by using a 6 h respiratory volume of 0.29 m3/kg bw for the rat.
- Conservative default for route to route: 100% for inhalation and 100% for dermal absorption
=> corrected strating point = relavant dose descriptor / overall factor for uncertainties = 18 mg/kg/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not necessary same effects observed in several species
- AF for other interspecies differences:
- 1
- Justification:
- not necessary same effects observed in several species
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- several studies showing same effects
- AF for remaining uncertainties:
- 10
- Justification:
- Issues related to dose-response: severity
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
2,2,2 Trifluoroethanol is self-classified:
- in category 3, Toxic by ingestion (T, H301), in category 3, Toxic if inhaled (T, H331), in Category 1 (Irreversible effects to eyes ; H318:), as Specific Target Organ Toxicants following Repeated Exposure (STOT-RE 2 ; H373), as Presumed human reproductive toxicant, May damage fertility (Repr. 1B; H360F) according to the criteria of Regulation No 1272/2008 (CLP).
1. DNEL for long-term exposure – fertility effects:
1.1 Dermal route
Regarding the self-classification of TFE as Presumed human reproductive toxicant, May damage fertility (Repr. 1B; H360F), qualitative assessment is performed following the approach described in the dossier to define the risk management measures (RMMs) and operational conditions (OCs).
1.2 Inhalation
The concentration descriptor has been obtained from the repeated dose toxicity study by inhalation considered as a key-study according to the Klimisch scoring (see § 7.5.3).
a) systemic effects - hematological effects
The Lowest Observed Adverse Effect Concentration (LOAEC) is considered to be 51.1 ppm (approximately 213 mg/m3 at 20°C) based on the decrease in the mean corpuscular volume and the decrease in the mean corpuscular hemoglobin in the hematological analysis which were irreversible during the two-week recovery period for the rat group exposed at this dose level.
At the middle level (14.9 ppm corresponding to 62 mg/m3), observed hematological effects were reversible during the 2 -week recovery period. Hence the 62 mg/m3 exposure was considered as the No Observed Adverse Effect concentration (NOAEC) while the No Observed Effect Concentration (NOEC) was assumed to be 5.26 ppm (approximately 22 mg/m3) regarding the absence of effects after 28-day repeated exposure.
b) systemic effect - reprotoxic effects
Toxicity to the reproduction as spermatogenesis alteration was observed at the highest concentration (LOEAC) of 51.1 ppm (213 mg/m3). No such effects were observed at mid concentration 14.9 ppm (62 mg/m3) and this concentration was considered as NOEC.
The DNELs were derived for both types of effects in order to determine the lowest DNEL which is protecting from both types of effects (systemic effects and effects on the fertility).
The following Tables 1.2 and 1.3 indicate the calculations for the long-term DNELby inhalation for fertility and hematologic effects.
Table 1.2: Calculation of long-term DNEL by inhalation for fertility effects of Trifluoroethanol
Worker |
Long-term DNEL / inhalation / fertility (male) |
Step a : determination of the critical dose |
|
Key study |
Yoshitake 2000 / OECD 412, K1 |
Relevant dose descriptor |
NOEC = 62 mg/m3 based on damages on testis, male rat, inhalation |
Step b : Correct starting point – factor for uncertainties |
|
Differences in metabolic rate per b.w. (allometric scaling) |
- (not relevant for dose level from inhalation study) |
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) |
- (available inhalation data) |
Modification for exposure (experiment in animal and human) |
6/8 (different conditions of exposure human/animal) |
Modification for the respiratory volume |
6.7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours) |
Correct starting point = relevant dose descriptor / overall factor for uncertainties |
31.2 mg/m3 |
Step c : assessment factors |
|
Interspecies differences |
- not necessary same effects observed in several species |
Intraspecies differences |
5 (worker) |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
6 |
Issues related to dose-response: severity |
10 |
Quality of the whole database |
1 |
Overall assessment factor |
300 |
DNEL calculation |
0.10 mg/m3 |
0.025 ppm* |
*DNELppm= 0.10 * 24.05 / 100.06 at 20°C
The long-term DNEL by inhalation for fertility effects is 0.10 mg/m3 in the workercorresponding to 0.025 ppm.
Table 1.2: Calculation of long-term DNEL by inhalation for hematological effects of Trifluoroethanol
Worker |
Long-term DNEL / inhalation / systemic effects (male/female) |
Step a : determination of the critical dose |
|
Key study |
Yoshitake 2000 / OECD 412, K1 |
Relevant dose descriptor |
NOAEC = 62 mg/m3 based on hematological effects, male rat, inhalation |
Step b : Correct starting point – factor for uncertainties |
|
Differences in metabolic rate per b.w. (allometric scaling) |
- (not relevant for dose level from inhalation study) |
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) |
- (available inhalation data) |
Modification for exposure (experiment in animal and human) |
6/8 (different conditions of exposure human/animal) |
Modification for the respiratory volume |
6.7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours) |
Correct starting point = relevant dose descriptor / overall factor for uncertainties |
31.2 mg/m3 |
Step c : assessment factors |
|
Interspecies differences |
2.5 (remaining differences) |
Intraspecies differences |
5 (worker) |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
6 |
Quality of the whole database |
1 |
Overall assessment factor |
75 |
DNEL calculation |
0.42 mg/m3 |
0.10 ppm* |
*DNEL ppm= 0.42 * 24.05 / 100.06 at 20°C
The long-term DNEL by inhalation for systemic effects by inhalation is 0.42 mg/m3 in the workercorresponding to 0.10 ppm.
Finally, the lowest obtained DNEL is assumed protecting for both hematological effects and effects on male fertility (damage on the testes) i.e. 0.10 mg/m3 or 0.025 ppm. No short term DNEL calculation is proposed considering that the exposure seems more important than time and is covered by the long term DNEL.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2 480
- Dose descriptor starting point:
- NOAEC
- Value:
- 62 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 15.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Differences in metabolic rate per b.w. (allometric scaling) : not relevant for dose level from inhalation study
- 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) : 6/24 (different conditions of exposure human/animal)
=> Corrected starting point = relevant dose descriptor / overall factor for uncertainties = 15.5 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- same effect observed in different species
- AF for other interspecies differences:
- 1
- Justification:
- same effect observed in different species
- AF for intraspecies differences:
- 10
- Justification:
- default factor general public
- AF for the quality of the whole database:
- 1
- Justification:
- several studies showing same effects
- AF for remaining uncertainties:
- 10
- Justification:
- severity of the effect
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - 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.
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