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EC number: 200-839-4 | CAS number: 75-10-5
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment (SIDS score: 1b).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Difluoromethane
- EC Number:
- 200-839-4
- EC Name:
- Difluoromethane
- Cas Number:
- 75-10-5
- Molecular formula:
- CH2F2
- IUPAC Name:
- difluoromethane
- Details on test material:
- Name of test material: difluoromethane
Source: ICI Chemicals and Polymers
Batch number: 20764/1
CTL reference number: Y02105/004/001
Purity: 99.96%
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA1535, TA1537, TA98, TA100 and E.coli WP2P and WP2P uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9-mix prepared from Aroclor 1254-induced Alderley Park rats
- Test concentrations with justification for top dose:
- 0, 5, 10, 25, 50, 75 and 100% (v/v in air)
- Vehicle / solvent:
- air
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: acridine mutagen, 2-aminoanthracene, daunorubicine, N-methyl-N'-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION
The plate incorporation protocol was adapted for exposure of the test plates to a gaseous compound. This exposure regimen was validated by vinyl chloride as appropriate positive control showing that mutagenic activity was adequately detected in case of a gaseous compound.
DURATION
- Incubation time: 3 days
- Incubation temperature: 37°C
NUMBER OF REPLICATIONS: 3 (except 5 for negative controls and 2 for positive controls)
DETERMINATION OF CYTOTOXICITY
- determined by examination of background lawn growth
ANALYTICAL DEVICE
Colonies were counted electronically using an automatic colony counter AMS 40-10 Image Analyser.
POSITIVE CONTROLS
- Positive controls: prepared in DMSO
without S9-mix
. for TA1535: N-methyl-N'-nitro-N-nitrosoguanidine (5 µg/plate)
. for TA1537: acridine mutagen ICR191 (2 µg/plate)
. for TA98: daunorubicine (1 µg/plate)
. for TA100: N-methyl-N'-nitro-N-nitrosoguanidine (5 µg/plate)
. for WP2P: N-methyl-N'-nitro-N-nitrosoguanidine (2 µg/plate)
. for WP2P uvra: N-methyl-N'-nitro-N-nitrosoguanidine (2 µg/plate)
with S9-mix
. for TA1535: 2-aminoanthracene (2 µg/plate)
. for TA1537: 2-aminoanthracene (2 µg/plate)
. for TA98: (2 µg/plate) (1 µg/plate)
. for TA100: 2-aminoanthracene (1 µg/plate)
. for WP2P: 2-aminoanthracene (20 µg/plate)
. for WP2P uvra: 2-aminoanthracene (5 µg/plate) - Evaluation criteria:
- Result is considered as positive when the following criteria are observed:
- a statistically significant dose-related increase in revertant colony mean count
- the mean number of revertant colonies per plate with the test substance is at least more than twice that of the concurrent negative control. - Statistics:
- One-tailed Student's t-test.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA1535, TA1537, TA98, TA100 and E.coli WP2P and WP2P uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- CYTOTOXICITY:
No significant cytotoxicity was evidenced (no significant loss of background growth and/or reduction in colony numbers).
GENOTOXICITY:
No significant increases in the number of revertant colonies were observed in any experiment, whatever the strain and dose with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- HFC-32 did not show a mutagenic response under the conditions of the test.
- Executive summary:
Mutagenic activity of HFC-32 was evaluated by using 4 histididine dependent strains of Salmonella typhimurium (TA 98, TA 100, TA 1535 and TA 1537) and two tryptophan-dependent strains of Escherichia coli (WP2 and WP2 uvrA). Preliminary toxicity tests were carried out to select the maximal concentration for the main test. Tests were carried out in presence and in absence of Rat liver derived S-9 mix activation system. Cells were incubated with 0, 5, 10, 25, 50, 75 and 100% (v/v in air) HFC-32 for 3 days at 37°C.Suitable positive controls were used in the presence (2 -aminoanthracene) and in the absence (nitrosoguanidine, acridine, daunorubicine and aminoanthracene) of S-9 mix. No significant cytotoxicity was evidenced and no significant increases in the number of revertant colonies were observed in any experiment, whatever the strain and dose with and without metabolic activation.
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