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EC number: 206-922-1 | CAS number: 400-38-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 22nd to June 22nd 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- September 22nd, 2015
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Isopropyl trifluoroacetate
- EC Number:
- 206-922-1
- EC Name:
- Isopropyl trifluoroacetate
- Cas Number:
- 400-38-4
- Molecular formula:
- C5H7F3O2
- IUPAC Name:
- propan-2-yl 2,2,2-trifluoroacetate
- Test material form:
- liquid
- Details on test material:
- Name: Isopropyl trifluoroacetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks old
- Weight at study initiation: 206 - 234 g
- Fasting period before study: yese
- Housing: Type II polypropylene/polycarbonate
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes, at least 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 – 24.0°C
- Humidity (%): 33 – 73 %
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: April 7th, 2016 To: May 17th, 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): SZBF3070V
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: The test item was freshly formulated at a concentration of 200 mg/mL in the vehicle, in the Pharmacy of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed:
* clinical signs: Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
* necropsy: Macroscopic examination was performed on all animals. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Statistics:
- Not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Isopropyl trifluoroacetate did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: At the dose level of 2000 mg/kg bw incoordination was observed in 6/6 animals on the day of treatment, decreased activity in 4/6 animals during the first three days after treatment, distended abdomen on Day 2 in 1/6 animal were noted. 2/6 animals showed p
- Gross pathology:
- No macroscopic observations were seen in animals dosed at 2000 mg/kg bw terminated on Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Isopropyl trifluoroacetate was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
- Executive summary:
The single-dose oral toxicity of Isopropyl trifluoroacetate was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in CRL:(WI) rats.
Two groups of 3 female CRL:(WI) rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was formulated in dimethyl sulfoxide (DMSO) at a concentration of 200 mg/mL at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
The results of the study were summarized as follows:
Mortality: Isopropyl trifluoroacetate did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical Observations: At the dose level of 2000 mg/kg bw incoordination was observed in 6/6 animals on the day of treatment, decreased activity in 4/6 animals during the first three days after treatment, distended abdomen on Day 2 in 1/6 animal were noted. 2/6 animals showed piloerection up to Day 5 after treatment and hunched back was observed in 6/6 animals up to Day 5 after treatment. Body Weight and Body Weight Gain There were no effects on body weights or body weight gains that could be attributed to treatment with of Isopropyl trifluoroacetate.
Macroscopic Findings: No macroscopic observations were seen in animals dosed at 2000 mg/kg bw terminated on Day 14.
Conclusion: Under the conditions of this study, the acute oral LD50 value of the test item Isopropyl trifluoroacetate was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
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