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Diss Factsheets
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EC number: 930-690-7 | 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
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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
- Study period:
- 18th February - 26th April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 68308-34-9
- Cas Number:
- 68308-34-9
- IUPAC Name:
- 68308-34-9
- Reference substance name:
- Shale oils
- EC Number:
- 269-646-0
- EC Name:
- Shale oils
- IUPAC Name:
- 269-646-0
- Reference substance name:
- Shale oil
- IUPAC Name:
- Shale oil
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Histidine is the target gene for S. typhimurium strains.
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 100, TA 98, TA 97, TA 1535, TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from the livers of adult Sprague-Dawley male rats
- Test concentrations with justification for top dose:
- 0.0001, 0.001, 0.01, 0.05 0.1, 0.25, 0.5, 1 and 5 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (for test substance, vehicle control, 2-nitrofluorene, 9-aminoacridine, 2-acetamidofluorene and water (for sodium azide and mitomycin C)
- Justification for choice of solvent/vehicle: NDA
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 and TA 100 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 97 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- TA 102 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-acetamidofluorene
- Remarks:
- TA 98 and TA 100 with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes - 1 hour
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATIONS: 3 plates
NUMBER OF CELLS EVALUATED: 10^9 cells per ml
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertants
RANGE-FINDING/SCREENING STUDIES:
A preliminary range-linding assay was performed using live tested strains (TA 102, TA 100. TA 98. TA 97 and TA 1535) to determine the optimal non toxic test doses of Shale oils, heavy fraction.
Shale oils, heavy was freshly prepared in DMSO and seven concentrations from range 0.001 - 5.0 mg/plate were tested without and with metabolic activation. An aliquot of the culture was added to 2 ml of molten top agar, along with 0.1 ml ml of the test substance. For the assay with metabolic activation, 0.5 ml of metabolic activation mixture containing 10 % of postmitochondrial traction (S9) together with the bacteria and the test substance were used. The contents were then mixed and poured onto the surface of minimum agar plate. The plates were incubated at 37 ºC for 48-72 hours. Alter the incubation period, the number of revertant colonies per plate was counted.
Cultures were set up in triplicate: negative control and positive control were also included. - Evaluation criteria:
- Positive results: concentration-related increase oxer the tested range and reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation. Mf>2. Student's t-test was used for evaluation of statistical significance of mutation frequency increasing against solvent control value.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of 0.5 mg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of 0.5 mg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of 0.5 mg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of 0.1 mg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of 1 mg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Shale oils, heavy in range-finding experiments performed using strains Salmonella typhimurium TA 97, TA 98, TA 1535, TA 102 and TA 100 was tested up to a maximum dose 5.0 mg/plate with and without metabolic activation. This dose was selected according to OECD 471 guideline as the highest tested dose. The concentrations, 5, 1 and 0.5 mg/plate caused reduction of spontaneous revertant counts of all strains of Salmonella typhimurium. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Raw data from the bacterial mutagenicity tests (Tables 1 to 15) are presented in the attached documents.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In the Ames test, with use of live strains of Salmonella Typhimurium (TA 97, TA 98, TA 100, TA 102 and TA 1535) Shale oils, heavy fraction was tested with and without the addition of activation system (S9) for mutagenicity in concentration range from 5 to 0.0001 mg/plate.
The Shale oils heavy fraction produced neither a statistically significant dose-related increase in the number of revertants nor a statistically significant and reproducible positive response at any one of the test points and according these results is considered non mutagenic in this system. - Executive summary:
In the Ames test, with use of live strains of Salmonella Typhimurium (TA 97, TA 98, TA 100, TA 102 and TA 1535) Shale oils, heavy fraction was tested with and without the addition of activation system (S9) for mutagenicity in concentration range from 5 to 0.0001 mg/plate. The experiment was conducted according to OECD guideline 471 and to GLP standard.
The Shale oils heavy fraction produced neither a statistically significant dose-related increase in the number of revertants nor a statistically significant and reproducible positive response at any one of the test points and according these results is considered non mutagenic in this system.
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