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EC number: 700-184-9 | CAS number: 1000172-11-1
- 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
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline GLP study with full report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- not available. UVCB substance
- EC Number:
- 700-184-9
- Cas Number:
- 1000172-11-1
- Molecular formula:
- C28-80.H58-162
- IUPAC Name:
- not available. UVCB substance
- Reference substance name:
- Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated
- IUPAC Name:
- Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated
- Details on test material:
- - Name of test material (as cited in study report): Durasyn 124
- Lot/batch No.: J900-001-1
- Storage condition of test material: room temperature in the dark
Constituent 1
Constituent 2
Method
- Target gene:
- Target gene identity not required to characterise test system.
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (10% liver S9 in standard co-factors
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500, 5000 ug/plate
- Vehicle / solvent:
- Tetrahydrofuran
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: N-ethyl-n'-nitro-N-nitrosoguanidine (For TA100, TA1535, WP2uvrA-), 9-aminoacridine (TA1537), Ninitroquinoline-1-oxide (TA98). With metabolic activation: Benzo(a)opyrene (TA98), 2-aminoanthracene (all others).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours at 37C
NUMBER OF REPLICATIONS: 3 and experiment repeated a second time using fresh cultures of the bacterial strains and fresh test material formulations.
OTHER: Experimental phase: 23/1/08 - 13/2/08 - Evaluation criteria:
- Dose related increase in revertant frequency and/or a reproducible increase at one or more concentrations. Statistical significance and biological relevance of such findings taken into account. If such findings are found and considered relevant, the substance is considered mutagenic (positive.)
- Statistics:
- mean and standard deviation.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Globular precipitation observed at and above 1500ug/plate but this did not prevent scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES: Using E coli and TA100 at 10 doses up to 5000ug/plate. Negative
COMPARISON WITH HISTORICAL CONTROL DATA: All doses and controls within historic control ranges. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In experiment 1, the 1500ug/plate dose with TA100 showed statistically significantly raised reversion rates compared to the concurrent solvent control in a single replicate. Since this was not repeated in either of the other two replicates or in experiment 2 and was within historic control ranges, it was regarded as random and not of biological significance.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The substance is not mutagenic in bacteria. - Executive summary:
In a guideline GLP Ames study, the substance did not produce toxicologically significant elevated counts of revertant colonies in any of the five bacterial strains tested (TA98, TA100, TA1535, TA1537 and WP2uvra-) at doses up to 5000ug/plate, with and without S9 metabolic activation. At levels of 1500ug/plate and above there was evidence that the solubility limit had been exceeded in the system. All positive controls responded as expected.
Synopsis:
Not mutagenic
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