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EC number: 272-745-1 | CAS number: 68910-55-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-10 to 2013-06-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Substance type: UVCB
- Physical state: powder
Constituent 1
Method
- Target gene:
- histidin and tryptophan operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver
- Test concentrations with justification for top dose:
- Preliminary toxicity assay (all strains): 6.7, 10, 33, 67, 100, 333, 667, 1000, 3333, or 5000 µg per plate, ± S9
Mutagenicity assay (all strains): 50, 150, 500, 1500, or 5000 µg per plate, ± S9
Mutagenicity assay (positive controls): 1 µg per plate of 2-nitrofluorene (2NF); 1 µg per plate of sodium azide (SA); 75 µg per plate of 9-aminoacridine; and 1000 µg per plate of methylmethanesulfonate (MMS) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tetrahydrofuran (THF)
- Justification for choice of solvent/vehicle: THF was selected based on its ability of form a workable suspension with the test material and its compatibility with the target bacteria
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
SELECTION AGENT (mutation assays): None
NUMBER OF REPLICATIONS: Three - Evaluation criteria:
- A response was considered positive for the test material if a dose-related increase in mean revertants per plate in at least one tester strain was observed over a minimum of two increasing concentrations of test material. For the tester stains, a positive response was considered if an increase in mean revertants at the dose-response peak was observed at greater than or equal to 2 (strains TA98, TA100, or urA) or 3 (strains TA1525 and TA1527) times the mean vehicle control value. An equivocal response was considered to be an increase in revertant count that partially met the criteria for a positive response. A negative response was considered if the response with neither positive or equivocal.
The following must be demonstrated for a test to be considered valid:
• The presence of deep rough mutation and the deletion in the uvrB gene for all Salmonella tester stain cultures
• The deletion in the uvrA gene for all WP2 urA cultures
• The presence of pKM101 plasmid R-factor for strains TA98 and TA100
• The following spontaneous revertants in vehicle control: TA98, 10-50; TA100, 80-240; TA1535, 5-45; TA1537, 3-21; and WP2 uvrA, 10-60.
• Tester strain cultures titers greater or equal to 0.3x109 cells/mL
• Evaluation of a minimum of three non-toxic dose levels. A dose was considered toxic if: a
> 50% reduction in the mean number of revertants per plate as compared to the vehicle control, along with an abrupt dose-dependent drop in revertant count, was observed ; and/or at lease a moderate reduction in background lawn was observed. - Statistics:
- None performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 100, TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation.
Under the conditions of this study, test article Organolignite was concluded to be negative in the Bacterial Reverse Mutation Assay. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535, TA1537 of S. typhimurium and WP2 uvrA of E. coli were exposed to organolignite in tetrahydrofuran at concentrations up to 5000 μg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method.
Organolignite was not cytotoxic at any dose level. Based on these findings, the maximum dose used in the mutagenicity assay was 5000 μg/plate. There were no positive mutagenic responses for any tester strain at any dose level, both with and without metabolic activation. The positive controls induced the appropriate responses in the corresponding strains.
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