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EC number: - | CAS number: -
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): EXP1200078
- Physical state: dark brown viscous liquid
- Storage condition of test material: at room temperature in the dark
- Analytical purity: 100%
- Lot/batch No.: E00275-350
- Expiration date of the lot/batch: 31 Dec 2013
Method
- Target gene:
- The tester strains used were the Salmonella typhimurium histidine auxotrophs TA98, TA100,
TA1535 and TA1537 as described by Ames et al. (1975) and Escherichia coli WP2 uvrA as
described by Green and Muriel (1976). Salmonella tester strains were derived from Dr. Bruce
Ames’ cultures; E. coli tester strains were from the National Collection of Industrial and Marine
Bacteria, Aberdeen, Scotland.
Tester strains TA98 and TA1537 are reverted from histidine dependence (auxotrophy) to
histidine independence (prototrophy) by frameshift mutagens. Tester strain TA1535 is reverted
by mutagens that cause basepair substitutions. Tester strain TA100 is reverted by mutagens that
cause both frameshift and basepair substitution mutations. Specificity of the reversion
mechanism in E. coli is sensitive to basepair substitution mutations, rather than frameshift
mutations (Green and Muriel, 1976).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 was used as the metabolic activation system.
- Vehicle / solvent:
- EXP1200078 - tetrahydrofuran (CAS 109-99-9)
Positive controls - dimethyl sulfoxide (CAS 67-68-5)
Water (Sodium Azide control)
Controls
- Untreated negative controls:
- yes
- Remarks:
- Water, dimethyl sulfoxide, ethanol, acetone
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water, dimethyl sulfoxide, ethanol, acetone
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Table of Positive Controls for Study AD63KG.503.BTL included below.
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene (CAS 613-13-8)
- Details on test system and experimental conditions:
- Overnight cultures were prepared by inoculating from the appropriate frozen permanent stock
into a vessel, containing 30 to 50 mL of culture medium. To assure that cultures were harvested
in late log phase, the length of incubation was controlled and monitored. Following inoculation,
each flask was placed in a shaker/incubator programmed to begin shaking at 125 to 175 rpm and
incubating at 37±2°C for approximately 12 hours before the anticipated time of harvest. Each
culture was monitored spectrophotometrically for turbidity and was harvested at a percent
transmittance yielding a titer of greater than or equal to 0.3x109 cells per milliliter. The actual
titers were determined by viable count assays on nutrient agar plates.
Metabolic Activation System
Aroclor 1254-induced rat liver S9 was used as the metabolic activation system. The S9 was
prepared from male Sprague-Dawley rats that were injected intraperitoneally with Aroclor™
1254 (200 mg/mL in corn oil) at a dose of 500 mg/kg, five days before sacrifice. The S9 (Lot
No. 3017, Exp. Date: 17 October 2014) was purchased commercially from Moltox (Boone,
NC). Upon arrival at BioReliance, the S9 was stored at -60°C or colder until used. Each bulk
preparation of S9 was assayed for its ability to metabolize benzo(a)pyrene and
2-aminoanthracene to forms mutagenic to Salmonella typhimurium TA100.
Metabolic Activation System
Aroclor 1254-induced rat liver S9 was used as the metabolic activation system. The S9 was
prepared from male Sprague-Dawley rats that were injected intraperitoneally with Aroclor™
1254 (200 mg/mL in corn oil) at a dose of 500 mg/kg, five days before sacrifice. The S9 (Lot
No. 3017, Exp. Date: 17 October 2014) was purchased commercially from Moltox (Boone,
NC). Upon arrival at BioReliance, the S9 was stored at -60°C or colder until used. Each bulk
preparation of S9 was assayed for its ability to metabolize benzo(a)pyrene and
2-aminoanthracene to forms mutagenic to Salmonella typhimurium TA100. - Evaluation criteria:
- Initial Toxicity-Mutation Assay
The initial toxicity-mutation assay was used to establish the dose-range for the confirmatory
mutagenicity assay and to provide a preliminary mutagenicity evaluation. Vehicle control,
positive controls and eight dose levels of the test article were plated, two plates per dose, with
overnight cultures of TA98, TA100, TA1535, TA1537 and WP2 uvrA on selective minimal
agar in the presence and absence of Aroclor-induced rat liver S9.
Confirmatory Mutagenicity Assay
The confirmatory mutagenicity assay was used to evaluate and confirm the mutagenic potential
of the test article. Five dose levels of test article along with appropriate vehicle control and
positive controls were plated with overnight cultures of TA98, TA100, TA1535, TA1537 and
WP2 uvrA on selective minimal agar in the presence and absence of Aroclor-induced rat liver
S9. All dose levels of test article, vehicle control and positive controls were plated in triplicate. - Statistics:
- means and standard deviations
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, test article EXP1200078 was concluded to be negative in the
Bacterial Reverse Mutation Assay. The increase observed with tester strain TA1537 in the
presence of S9 activation in the initial toxicity-mutation assay was not considered indicative of
mutagenic activity because (1) the increase was non-dose responsive and not reproducible and
(2) all of the plate counts for each treated dose level were within the historical vehicle control
range. Therefore, the test article was concluded to be negative in this assay.
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