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EC number: 293-260-1 | CAS number: 91052-98-1
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Study dates not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Modified guideline study, GLP status unknown. Not all OECD required tester strains used , but main ones covered . Only illustrative data shown, sufficient for assessment of strains but not evaluation of any dose response or toxicity response.
- Justification for type of information:
- Justification for Category/Read-across approach:
See justification document for category approach and read-across to individual UVCB constituents in section 13.2.
Data source
Reference
- Reference Type:
- publication
- Title:
- In Vitro Microbiological Mutagenicity Studies Of Hydrocarbon Propellants
- Author:
- Kirwin CJ and Thomas WC.
- Year:
- 1 980
- Bibliographic source:
- J. Soc. Cosmet. Chem., 31, 367 - 370
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Not all OECD required tester strains used , but main ones covered .
- Principles of method if other than guideline:
- A modified procedure was used to enable testing of a gaseous chemical.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- n-Butane
- IUPAC Name:
- n-Butane
- Reference substance name:
- Butane
- EC Number:
- 203-448-7
- EC Name:
- Butane
- Cas Number:
- 106-97-8
- Molecular formula:
- C4H10
- IUPAC Name:
- butane
- Details on test material:
- The hydrocarbon propellant tested was composed as follows: n-butane 99.7Mole% and isobutane 0.3Mole%
Constituent 1
Constituent 2
Method
- Target gene:
- Not specified
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: All histidine auxotrophs.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9.
- Test concentrations with justification for top dose:
- 5, 10, 20, 30, 40 and 50%
- Vehicle / solvent:
- None.
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: methylene chloride
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Duplicate agar plates, with Salmonella were prepared. The plates, without Iids, were placed on a perforated shelf inside a 9-liter desiccator, the latter was then sealed. The air was evacuated, then a known volume of test gas was introduced into the desiccator. Air was then introduced through a sterile cotton plug to normalise the pressure inside. The desiccator was then sealed and placed on a magnetic stir plate in a room which was maintained at 37°C. Magnetic stirrer bars, placed inside the base of each desiccator, facilitated mixing of the gases.
DURATION
- Exposure duration: The plates were exposed to the test gas for 6 hours, then incubated for an additional 40 - 45 hours before scoring.
NUMBER OF REPLICATIONS: 2 - Evaluation criteria:
- The spontaneous mutation frequency of each Salmonella strain remains relatively constant, however the mutation frequency may be greatly increased by a mutagen being added to the agar. The number of his+ revertants on each plate is counted and compared to the negative control.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results from the highest non-toxic concentrations are shown.
Table 1: Summary of results:
Metabolic activation |
Conc of gas in the desiccators (v/v)% |
Average histidine revertants per plate |
||||
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
||
no |
50 |
24 |
6 |
18 |
22 |
122 |
yes |
50 |
26 |
4 |
37 |
48 |
134 |
no |
Negative control |
15 |
12 |
10 |
29 |
138 |
yes |
Negative control |
16 |
18 |
30 |
38 |
155 |
no |
Positive control (2%) |
34 |
10 |
16 |
234 |
900 |
yes |
Positive control (2%) |
52 |
12 |
52 |
237 |
1066 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Hydrocarbon propellant (containing 99.7% n-butane) was not toxic or mutagenic in any of the tested strains at concentrations up to 50%. - Executive summary:
In a modified Ames assay, hydrocarbon propellant (containing 99.7% n-butane) was not toxic or mutagenic in any of the tested strains at concentrations up to 50%. The positive control (methylene chloride) was mutagenic in strains TA98 and TA100 and was slightly mutagenic in TA1535.
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