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Diss Factsheets
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EC number: 201-143-3 | CAS number: 78-79-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isoprene
- EC Number:
- 201-143-3
- EC Name:
- Isoprene
- Cas Number:
- 78-79-5
- Molecular formula:
- C5H8
- IUPAC Name:
- 2-methylbuta-1,3-diene
- Details on test material:
- - Name of test material (as cited in study report): Isoprene
- Physical state: Colourless liquid at room temperature
- Analytical purity: 99%
- Lot/batch No.: 0710MO
- Expiration date of the lot/batch: no data
- Molecular weight: 68.12
- Supplier: Aldrich Chemical Company
- Storage condition of test material: ca. 4°C in the dark
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 and microsomal fractions from uninduced B6C3F1 mice liver
- Test concentrations with justification for top dose:
- 0, 0.25 to 25% isoprene (2,500 to 250,000 ppm) in vapour phase
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used; DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: vinyl chloride (monomer)
- Remarks:
- with S9/microsome mix
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9/microsome mix Migrated to IUCLID6: 0.5 µg/plate for strains TA1535 and TA100
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9/microsome mix Migrated to IUCLID6: 50 µg/plate for strain TA1537
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9/microsome mix Migrated to IUCLID6: 1 µg/plate for strain TA98
- Positive control substance:
- other: 2-(2-Furyl)-3-5(5-nitro-2-furyl) acrylamide (AF-2). 0.05 µg/plate for strain WP2 uvrA (pKM101)
- Remarks:
- without S9/microsome mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- The tester strains were exposed to the test substance in stainless steel vessels.
- The untreated and vapour-phase positive controls were treated under identical conditions to the plates exposed to the test substance.
- The appropriate positive control compounds for confirmation of strain specificity were included using the conventional plate incorporation method.
- An aliquot of 0.1 mL of a 10 hour bacterial culture and 0.5 mL S9/microsome mix (or 0.5 mL 0.1 M phosphate buffer, pH 7.4, for the direct-acting positive controls) were placed in glass vessels. 2 mL of agar containing histidine (0.5 mM), biotin (0.5 mM) and tryptophan (0.5 mM) was then added, the mixture thoroughly shaken and overlaid onto previously prepared glass Petri dishes containing approximately 25 mL minimal agar.
- The seeded plates were placed in stainless steel vessels. The plates were supported, inverted with lids removed, on stainless steel racks inside the vessels, so as to permit circulation of the test substance. The plates containing S9/microsome mix and buffer were placed in separate vessels.
- The vessels were sealed, purged with nitrogen and partially evacuated. Appropriate volumes of the test substance were injected via a PTFE septum.
- The vessels were warmed to 37°C and the contents equilibrated to atmospheric pressure by admitting nitrogen.
DURATION:
- The plates were incubated for ca 48 hours in the vessels at 37°C and then removed under air extraction.
- The lids were replaced and the plates incubated for a further period of ca 24 hours at 37°C to permit the growth of revertant colonies.
- Further sets of plates were prepared for the liquid positive control compounds. An aliquot of 0.1 mL of the positive control solution was added to the plates together with the bacteria, buffer and agar overlay. These plates were not placed in stainless steel vessels and were incubated at 37°C for 72 hours.
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- A positive response is defined as reproducible, dose-related increase in revertant colonies in any one strain. An increase of 2x over background is required for a positive response in Salmonella strains TA98 & TA100 and for E. coli bacteria, and 3x background for Salmonella TA1535 & TA1537.
- Statistics:
- None performed.
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:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle 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:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Isoprene vapour exposures above 25% produced significant cytotoxicity based upon a pilot study with exposures up to 100% isoprene.
The concurrent positive controls, including Vinyl Chloride monomer at 2% v/v in vapour phase, demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. Increases obtained with Vinyl Chloride in the presence of mouse S9 were consistently higher than those obtained with mouse microsomes at the same percentage volume in the cofactor mix (i.e. the S9 was more active per unit volume than the microsomes). - Remarks on result:
- other: other: Enclosed static vapour phase exposure chambers
Any other information on results incl. tables
Revertant colony counts appeared to be slightly increased (between 1.3 and 1.7 x untreated control counts) in strains TA1535 and WP2uvrA (pKM101) following exposure to Isoprene at 2.5% v/v in the presence of mouse liver S9, but these were not of sufficient magnitude to be considered evidence of mutagenic activity.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Isoprene was not mutagenic in the Ames bacterial mutagenicity test. - Executive summary:
In an in vitro assessment of the mutagenic potential of Isoprene, histidine-dependent auxotrophic mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA (pKM101) were exposed to Isoprene in vapour phase. Revertant colony counts appeared to be slightly increased (between 1.3 and 1.7 x untreated control counts) in strains TA1535 and WP2uvrA (pKM101) following exposure to Isoprene at 2.5% v/v in the presence of mouse S9, but these were not of sufficient magnitude to be considered evidence of mutagenic activity.
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