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EC number: 204-062-1 | CAS number: 115-07-1
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- minor modifications to the method as the test item is a gas at ambient temperature
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Propene
- EC Number:
- 204-062-1
- EC Name:
- Propene
- Cas Number:
- 115-07-1
- Molecular formula:
- C3H6
- IUPAC Name:
- prop-1-ene
- Reference substance name:
- Propylene
- IUPAC Name:
- Propylene
- Details on test material:
- - Batch No. U05278
- >99% purity
- gas at ambient temperature
- expiry date assigned by Inveresk: 01.10.03
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 prepared from liver of Aroclor 1254 induced male Fischer 344 rats.
- Test concentrations with justification for top dose:
- 0, 0.031, 0.063, 0.125, 0.25 and 1%.
- Vehicle / solvent:
- Air
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Air
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AAN), Ethylene oxide (ETHOX), 9-aminoacridine (9-AA), 2-nitrofluorene (2-NF) and N-ethyl-N-nitro-N-nitrosoguanidine (ENNG)
- Remarks:
- The positive control substances, except ethylene oxide, were dissolved in DMSO. Ethylene oxide was tested as a mixture in air.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) Vogel-Bonner Medium E agar with 2% glucose
DURATION
- Preincubation period: 3 days
- Exposure duration: 48 h
- Expression time (cells in growth medium): 24 h
NUMBER OF REPLICATIONS: 2 - Evaluation criteria:
- Positive mutagenic response if there was:
i) at least a 3-fold increase over the mean concurrent vehicle control values at some concentration of the test item (S. typhimurium strains TA 1535, TA 1537, TA 98, E. coli); or a 2-fold increase (S. typhimurium strain TA 100). If the mean colony count on the vehicle control plates was less than 10, then a value of 10 was assumed for assessment purposes. In such cases, a minimum count of 20 was required before a positive mutagenic response was registered.
And,
ii) a dose related response, although at high dose levels this relationship could be inverted because of, for example, (1) toxicity to the bacteria generally, (2) specific toxicity to the mutants and (3) inhibition of foreign compound metabolising enzymes where mutagens require metabolic activation by the liver
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- other: an increase was seen only in one strain, reaching 3-fold over background in one experiment and hence was considered of little biological relevance
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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:
- The weak positive response in the presence of S9 may be due to the generation of trace levels of propene oxide.
- Remarks on result:
- other: strain/cell type: weakly mutagenic in TA1535 only
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation with the exception of a weakly mutagenic response in TA1535 only
negative without metabolic activation
Propene was weakly mutagenic in strain TA1535 in the presence of S9 mix, when tested in air at a concentration of 1%. No mutagenic activity was observed with any of the other Salmonella strains tested or with Escherichia coli. - Executive summary:
In the main study, propene was tested for mutagenic activity according to the OECD 471 guideline protocol in Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli WP2uvrA (pKM101) at exposure levels ranging from 0.031% to 1.0% in air. The highest concentration was selected to be one half of the lower explosivity limit for propene, which is 2.2%
Two mutation assays were conducted on agar plates in the presence and absence of an Aroclor-1254 induced rat liver preparation and the co-factors required for mixed-function oxidase activity (S9 mix). Concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the S9 mix. The results obtained in the first and second mutation assays were similar. A weak, mutagenic response was observed with TA1535, in the presence of S9 mix only, and only at the highest concentration of propene (1%). In both assays, a 2-fold increase over the vehicle control group was observed at 0.5%. In the first mutation assay the mean colony number at the highest concentration of 1% met the required criterion for a positive result, namely a 3-fold increase over the concurrent vehicle control value. In the second mutation assay, the mean colony number of 38 was just below the 3-fold value of 39.
The weak positive response in the presence of S9 may be due to the generation of trace levels of propene oxide. No toxicity to the bacteria was observed in either mutation assay, in either the presence or the absence of S9 mix.
(Note: A sighting study, Inveresk 2003b, was carried out with exposure levels ranging from 3.125% to 100% propene. In this assay, TA1535 demonstrated a 3 -fold increase in the incidence of mutant colonies over the vehicle control group at all exposure levels below 100% in the presence of S9 mix. With the other four Salmonella strains tested, as well as Escherichia coli, propene was not mutagenic.)
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