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EC number: 627-872-0 | CAS number: 1514-82-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Feb 2012 - 16 Apr 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to official test guidelines and in compliance with GLP; on this basis the study is considered reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Health and Welfare. Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau, Notification No. 1604, 1 November 1999.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH GUideline S2A (1996) and S2B (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-bromo-3,3,3-trifluoroprop-1-ene
- EC Number:
- 627-872-0
- Cas Number:
- 1514-82-5
- Molecular formula:
- C3H2BrF3
- IUPAC Name:
- 2-bromo-3,3,3-trifluoroprop-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 2-Bromo-3,3,3-trifluoropropene
- Physical state: Liquid
- Analytical purity: Greater than 99%, Excluding stabilisers
- Lot/batch No.: KgF080
- Expiration date of the lot/batch: 01 August 2012
- Storage condition of test material: Ambient temperature, protected from light
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640, buffered with 2 mg/mL sodium bicarbonate, supplemented with 2.0 mM L-glutamine and 50 µg/mL gentamicin, supplemented with 0.1% v/v Synperonic F68, 1.0 mM sodium pyruvate and HiDHS at 10% v/v.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 3.42, 6.84, 13.67, 27.34, 54.69, 109.38, 218.75, 437.5, 875 and 1750 µg/mL
Mutation tests:
Without S9 mix (3 hours): 50, 100, 200, 225, 250, 275, 300, 325, 350, 375, 400 and 500 µg/mL
Without S9 mix (3 hours) - Additional levels: 50, 100, 125, 150, 175, 200, 225, 250, 275 and 300 µg/mL
With S9 mix (3 hours): 10, 50, 100, 150, 200, 225, 250, 275, 300, 350 and 400 µg/mL
Without S9 mix (24 hours): 200, 250, 300, 325, 350, 375, 400, 425, 450 and 500 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Osmolarity and pH of solutions prepared using DMSO as the solvent were assessed prior to the start of testing. DMSO was found not to cause fluctuations in osmolarity greater than 50 mOsm/kg, nor was it found to cause fluctuations in pH greater than 1.0 unit.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- methylmethanesulfonate
- Remarks:
- MMS used in the absence of S9 mix; BaP used in the presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: Preliminary test: 3 hours with or without S9 mix; 9 hours without S9 mix. Main test 1: 3 hours in the presence and absence of S9 mix. Main test 2: 24 hours in the absence of S9 mix.
- Expression time (cells in growth medium): Sampled at 24 and 48 hours
NUMBER OF REPLICATIONS: Duplicate cultures for each concentration; quadruplicate cultures for each vehicle control
NUMBER OF CELLS EVALUATED: 2 x 10^3 cells per well in selective medium on 96-well plates.
DETERMINATION OF CYTOTOXICITY
- Method: Relative suspension growth and relative total growth - Evaluation criteria:
- The test agent was regarded as negative if:
The mean mutant frequency of all test concentrations was less than the sum of the mean concurrent vehicle control mutant frequency and the GEF.
If the mutant frequency of any test concentrations exceeded the sum of the mean concurrent solvent control mutant frequency and the GEF, a linear trend test was applied:
If the linear trend test was negative, the result was regarded as negative.
If the linear trend test was positive, this indicated a positive, biologically relevant response.
The Global Evaluation Factor (GEF) applied was 126 x 10^-6 (Moore et al, 2006)
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No fluctuations in the pH of the medium of more than 1.0 unit were observed at 1750 µg/mL compared with the vehicle control
- Effects of osmolality: No fluctuations in the osmolarity of the medium of more than 50 mOsm/kg were observed at 1750 µg/mL compared with the vehicle control
- Precipitation: No precipitate (assessed visually at the end of treatment for each test) was observed
RANGE-FINDING/SCREENING STUDIES:
The preliminary toxicity test was conducted at concentrations between 3.42 to 1750 µg/mL. For a 3-hour exposure in the presence and absence of S9 mix, relative suspension growth (RSG) ranged from 113% to 1% in the absence of S9 mix and from 101% to 0% in the presence of S9 mix. Following continuous 24-hour exposure RSG ranged from 147% to 0% using the same concentration ranges as the 3-hour exposure. The main test concentrations were established on the basis of this preliminary work.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that 2-bromo-3,3,3-trifluoropropene did not demonstrate mutagenic potential in this in vitro cell mutation assay, under the experimental conditions described.
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