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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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Other information : Only secondary literature with no details on test conditions and on results.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- Only secondary literature with no details on test conditions and on results.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Subacute inhalation toxicity
- GLP compliance:
- no
- Remarks:
- Study performed before GLP compliance
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no details available
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- no details
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no details
- Duration of treatment / exposure:
- 6 hours/day for 4 weeks (5 days/week)
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 10 ppm
- Dose / conc.:
- 50 ppm
- Dose / conc.:
- 150 ppm
- No. of animals per sex per dose:
- no data
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data
- Rationale for selecting satellite groups: no data
- Post-exposure recovery period in satellite groups: the remaining males were allowed to recover from TFE exposure for about 10 days, and then each was supplied with a different female each week for 5 week, and conception rates were measured.
- Section schedule rationale (if not random): no data - Positive control:
- no data
- Observations and examinations performed and frequency:
- No data
CAGE SIDE OBSERVATIONS: No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: no data
BODY WEIGHT: Yes
- Time schedule for examinations: no data
FOOD CONSUMPTION: no data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY: no data
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: No data
- Time schedule for collection of blood:
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood:
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
URINALYSIS: No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
OTHER: effect on reproductive function (see details below) - Sacrifice and pathology:
- After 2 and 4 weeks exposure some of the males were sacrificed. All females were sacrificed after 4 weeks.
- Other examinations:
- effect on reproductive function: testis weight, spermatogenesis, ovary weight, histology of 26 tissues (no details on type of tissues examined), conception rate.
- Statistics:
- no data
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No differences in appearance or behavior among any of the four groups of animals were observed.
- Mortality:
- no mortality observed
- Description (incidence):
- No death during or after exposure and no differences in appearance or behavior among any of the four groups of animals were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Although there was no statistically significant decrease in body weight for any group of males after 4 weeks, subgroups exposed to 50 and 150 ppm of trifluoroethanol were significantly lighter than a control subgroup, which indicated that weight loss for the highly exposed groups was of borderline significance.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The male rats exposed to 150 ppm of Trifluoroethanol for 2 or 4 weeks had lowered mean testis weights and testis weight/body weight ratios. After 4 weeks of exposure to the test item, male rats exposed to 50 ppm also had decreased testis weights.
Treated females had elevated ovary weights relative to controls, but the difference was significant only for the group exposed to 10 ppm of test item. The ovary weight/body weight ratio increased by similar amounts for all non-control groups, but the increase for rats exposed to 150 ppm was not significant although it was nearly as high as for the other two non-control groups. Thus the gain in ovary weight due to test item appears to be of borderline statistical significance. It occurs rather sharply between 0 and 10 ppm and levels off for higher concentrations. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histology of ovary revealed no differences in apperance attributable to the test item. Other tissues (26 types in all) from both males and females did not appear different from those of controls.
Among males sacrificed after both 2 and 4 weeks, those exposed to 50 ppm showed impairment of spermatogenesis and those exposed to 150 ppm showed hypospermatogenesis - Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- In functional tests, the remaining males were allowed to recover from 2,2,2-trifluoroethanol for about 10 days, and then each was supplied with a different female each week for 5 weeks, and conception rates were measured. For group exposed to 10 ppm, the rate was the same as for controls; for the males exposed to 50 ppm, it was 72% that of controls; and for the group exposed to 150 ppm, no conception occured. For the group exposed to 50 ppm, conception rates were lower than for controls during the first 3 weeks, reaching a minimum during the second week, and preimplantation losses followed an analogous pattern. Males were sacrificed 2 weeks later (for a total recovery period of 57 days) and their testes examined. Males exposed to 50 ppm showed normal spermatogenesis. Males exposed to 150 ppm also showed some recovery and some normal spermatogenesis.
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 150 ppm
- System:
- male reproductive system
- Organ:
- seminiferous tubules
- testes
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- Under the test conditions, a repeated inhalation exposure to 50 and 150 ppm of 2,2,2 trifluoroethanol caused body weight loss of male rats. The treated animals presented also effects on the reproductive systems: decrease of testis weight in male rats, and increase of ovary weight in females. The conception rates were decreased in males exposed to 50 and 150 ppm.
- Executive summary:
In a subacute inhalation toxicity study, rats (male and female) were exposed to 0, 10, 50 and 150 ppm of 2,2,2-trifluoroethanol for 6 hours per day, for a period of 4 weeks (5 days/week). There is no detailed information on the exposure conditions, the number of animals in each group, the composition of the test item. The results are also not detailed (Kr.4).
Under the test conditions, a repeated inhalation exposure to 50 and 150 ppm of 2,2,2 trifluoroethanol caused body weight loss of male rats. The treated animals presented also effects on the reproductive systems: decrease of testis weight in male rats, and increase of ovary weight in females. The conception rates were decreased in males exposed to 50 and 150 ppm.
No other information
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a functional tests derived from a repeated dose study inhalation, in which male rats were exposed to 0, 10, 50 and 150 ppm concentations of TFE for 6h/day, 5d/week for 4 weeks, some males were allowed to recover from 2,2,2-trifluoroethanol for about 10 days, and then each was supplied with a different non exposed female each week for 5 weeks and then the conception rates were measured.
- GLP compliance:
- no
- Remarks:
- Study performed before GLP compliance
- Limit test:
- no
Test material
- Reference substance name:
- 2,2,2-trifluoroethanol
- EC Number:
- 200-913-6
- EC Name:
- 2,2,2-trifluoroethanol
- Cas Number:
- 75-89-8
- Molecular formula:
- C2H3F3O
- IUPAC Name:
- 2,2,2-trifluoroethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Trifluoroethanol, Fluorinol-85 or Fluorinol-50
- Physical state: colorless liquid
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: assumed to be stable during the test (sponsor responsibility)
- Storage condition of test material: no data
- Other: manufactured by Halocarbon Products Corporation
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no detail availbale
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Remarks on MMAD:
- No data
- Vehicle:
- not specified
- Details on exposure:
- No details
- Details on mating procedure:
- Male rats were exposed to 0, 10, 50 and 150 ppm concentations of TFE for 6h/day, 5d/week for 4 weeks. Some males were allowed to recover from 2,2,2-trifluoroethanol exposure for about 10 days, and then each was supplied with a different non exposed female each week for 5 weeks and then the conception rates were measured.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No details
- Duration of treatment / exposure:
- 6h/day, 5day/week for 4 week
- Frequency of treatment:
- 5 day/week
- Details on study schedule:
- No data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 10 ppm
- Dose / conc.:
- 50 ppm
- Dose / conc.:
- 150 ppm
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- In a functional tests derived from a repeated dose study inhalation, in which male rats were exposed to 0, 10, 50 and 150 ppm concentations of TFE for 6h/day, 5d/week for 4 weeks, some males were allowed to recover from 2,2,2-trifluoroethanol for about 10 days, and then each was supplied with a different non exposed female each week for 5 weeks and then the conception rates were measured.
- Positive control:
- No
Examinations
- Parental animals: Observations and examinations:
- Conception rate
- Oestrous cyclicity (parental animals):
- see Robust study summary "Rep. Dose tox. Inh. V4 1978b SILB" in Section 7.5.2.
- Sperm parameters (parental animals):
- see Robust study summary "Rep. Dose tox. Inh. V4 1978b SILB" in Section 7.5.2.
- Litter observations:
- no data
- Postmortem examinations (parental animals):
- see Robust study summary "Rep. Dose tox. Inh. V4 1978b SILB" in Section 7.5.2.
- Postmortem examinations (offspring):
- no
- Reproductive indices:
- Conception rate
- Offspring viability indices:
- Not examined
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- For group exposed to 10 ppm, the conception rate was the same as for controls; for the males exposed to 50 ppm, it was 72% that of controls; and for the group exposed to 150 ppm, no conception occured. For the group exposed to 50 ppm, conception rates were lower than for controls during the first 3 weeks, reaching a minimum during the second week, and preimplantation losses followed an analogous pattern. Males were sacrificed 2 weeks later (for a total recovery period of 57 days) and their testes examined. Males exposed to 50 ppm showed normal spermatogenesis. Males exposed to 150 ppm also showed some recovery and some normal spermatogenesis.
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Effect level:
- 10 ppm
- Based on:
- not specified
- Sex:
- male
- Basis for effect level:
- reproductive function (sperm measures)
- reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 50 ppm
- System:
- male reproductive system
- Organ:
- seminiferous tubules
- testes
- Treatment related:
- yes
- Dose response relationship:
- yes
Applicant's summary and conclusion
- Conclusions:
- Conception rate was impaired in male rats pre-treated by repeated inhaltion of TFE at 50 ppm. When male rats were exposed to 150 ppm 6h/day, 5day/week for 4 weeks, no conception occured. When males were sacrificed after a total recovery period of 57 days post exposure for testis examination, rats exposed to 50 ppm showed normal spermatogenesis while rats exposed to 150 ppm showed some recovery and some normal spermatogenesis.
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