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Diss Factsheets
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EC number: 200-891-8 | CAS number: 75-68-3
- 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:
- genetic toxicity in vitro
- Remarks:
- Type of genotoxicity: other: in vitro indicator assay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant study, available as unpublished report, minor restrictions in design and reporting, but otherwise adequate for assessment (SIDS score: 2c)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Evaluation of the ability to induce malignant transformation of BALB/3T3 cells in vitro, according to the basic methodology developed by T. Kakunaga (1973)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell transformation assay
Test material
- Reference substance name:
- 1-chloro-1,1-difluoroethane
- EC Number:
- 200-891-8
- EC Name:
- 1-chloro-1,1-difluoroethane
- Cas Number:
- 75-68-3
- Molecular formula:
- C2H3ClF2
- IUPAC Name:
- 1-chloro-1,1-difluoroethane
- Details on test material:
- 1-chloro-1,1-difluoromethane: no data, purity not stated
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: BALB73T3
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Not determined; exposure to the test substance for 1, 2, 4, 6 and 24 h.
- Vehicle / solvent:
- None
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Details on test system and experimental conditions:
- Number of replicates: 10
- Evaluation criteria:
- Number of foci per set of replicate plates for each time exposure.
- Statistics:
- Not stated
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: BALB/3T3 Cell line
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Additional information on results:
- The positive control substance did not give usual response in this evaluation; it was low by 2-3 fold.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Test substance |
Concentration |
Number of plates scored |
Total number of foci |
Mean number of foci/plate |
Number of foci/plate corrected for spontaneous |
||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
|
|
|||
Negative control (media) |
- |
2 |
2 |
0 |
0 |
0 |
0 |
2 |
3 |
0 |
C |
9 |
1.0 |
- |
|
Positive control (3-MC) |
5 g/ml |
2 |
2 |
1 |
2 |
2 |
3 |
2 |
1 |
1 |
C |
16 |
1.7 |
0.7 |
|
Isotron 142-B |
1 h |
1 |
1 |
2 |
1 |
2 |
1 |
2 |
0 |
C |
C |
10 |
1.2 |
0.2 |
|
Isotron 142-B |
2 h |
1 |
2 |
0 |
1 |
1 |
1 |
0 |
1 |
0 |
1 |
8 |
0.8 |
- |
|
Isotron 142-B |
4 h |
2 |
2 |
1 |
0 |
1 |
2 |
1 |
2 |
1 |
C |
12 |
1.3 |
0.3 |
|
Isotron 142-B |
6 h |
1 |
1 |
1 |
0 |
1 |
0 |
C |
C |
C |
C |
4 |
0.6 |
- |
|
Isotron 142-B |
24 h |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
2 |
C |
C |
10 |
1.2 |
0.2 |
3 -MC = 3 -methylchloroanthrene
C = plate was contaminated and not scored
* data significant from the negative control at p = 0.05
** data significant from the negative control at p = 0.01
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Compound was not active in this BALB/3T3 cell transformation assay as it did not produce any significant increase in the transformed clones compared to the untreated control . - Executive summary:
The ability of 1-chloro-1,1-difluoroethane to induce malignant transformation in BALB/3T3 cell transformation assay in vitro was evaluated, by adding 10 s of gas into culture flasks and using 1 h, 2 h, 4 h, 6 h and 24 h exposure times. The substance was not active in the assay and did not produce any significant increased in transofrmed clones compared to the untreated control. It should however be noted that the positive control (3 -methylchloroanthrene) did not produce a usual responce in this evaluation, it was low by 2 -3 fold.
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