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EC number: 417-060-2 | CAS number: 151006-61-0 1-DODECENE DIMER, HYDROGENATED; ALKANE 2
- 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:
- Between 05 Jan 1995 and 03 March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- The positive controls for the S9 series of plates with salmonella strains TA100, TA98 and TA1537 have been changed for Benzo(a)prene (BP) at 5µg/plate to 2-aminoantracene for Bacterial strains TA100-1µg/plate, TA98-0.5µg/plate and TA1537-2µg/plate.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection 31st Jan 1994 and Date of signing 16th March 1994
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alkane 2 (C1527-04-2)
- IUPAC Name:
- Alkane 2 (C1527-04-2)
- Details on test material:
- - Name of test material (as cited in study report): Alkane 2 (C1527-04-2)
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Storage condition of test material: At room temperature in a silver coloured metal cannister.
Constituent 1
Method
- Target gene:
- Histidine for Salmonella.
Tryptophan for E.Coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared in house from the livers of male Sprague Dawley. These had received a single i.p injection of Aroclor 1254 at 500mg/kg.
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
main test:
Experiment one: 0,15, 50, 150, 500, 1500 and 5000 µg/plate
Experiment two: 0,15,50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: The test material was fully soluble in Acetone in solubility checks performed in-house.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix
Migrated to IUCLID6: WP2uvrA- TA100 TA1535
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9 mix
Migrated to IUCLID6: TA1537
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix
Migrated to IUCLID6: TA 98
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene WP2uvrA-, TA100, TA1535, TA 1537 and TA 98
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 10h
- Exposure duration: 48 - 72 hrs
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 48 -72 hrs
SELECTION AGENT (mutation assays): Not applicable.
NUMBER OF REPLICATIONS: Triplicate plating.
NUMBER OF CELLS EVALUATED: Not applicable.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth and thinning of the bacterial background lawn.
OTHER EXAMINATIONS: None - Evaluation criteria:
- 1. Tester strain Integrity
The tester strain cultures must exhibit a characteristic number of spontaneous revertants per plate when plated along with the vehicle under selective conditions. These ranges may increase by as much as 25% if S9 concentrations of greater than 10% are used in the mutagenicity assay.
2. Tester Strain Culture Density
To demonstrate that appropriate numbers of viable bacteria have been plated, the viable count for each tester strain culture must be greater than or equal to 0.1 x 10^9 bacteria per ml.
3. Positive control Values.
All positive control chemicals must exhibit positive responses within the historical range for the dose levels used. Acceptable positive control values demonstrate both the intrinsic sensitivity of the tester strains to mutagen exposure and of the integrity of the S9 mix.
4.Cytotoxicity
A minimum of four non toxic dose levels will be required to evaluate assay data.
For a substance to be considered positive in this test system, it should have induced a dose related and statistically(5) significant increase in mutation rate (of at least twice the spontaneous reversion rate) in one or more strains of bacteria in the presence and/or absence of the S9 microsomal enzymes in both experiments at sub-toxic dose levels.
To be considered negative the number of induced revertants compared to spontaneous revertants should be less than two fold at each dose level employed, the intervals of which should be between 2 and 5 fold and extend to the limits imposed by toxicity or solubility or up to the maximum recommended dose of 5000µg/plate. - Statistics:
- All data are statistically analysed using the methods recommended by the UKEMS (5) and normally Dunnetts method of linear regression is used to evaluate this result.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Tested up to maximum recommended dose of 5000 micro.g/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Tested up to maximum recommended dose of 5000 micro.g/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test material was fully soluble in Acetone at 50 mg/ml in solubility checks performed in-house.
- Precipitation: A precipitate was observed at and above 500µg/plate, this however did not interfere with the scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES:
Preliminary Toxicity Test:
The test material was non-toxic to the strains of bacteria used (TA100 and WP2uvrA-). The numbers of revertant colonies for the toxicity assay are presented in Table 1 in Appendix 2.
The reults of the S9 optimisation study are presented in Table 2 of Appendix 2. No marked difference was observed between the four levels of S9 and therefore the default level of 10% S9 was selected for use in the mutation studies.
COMPARISON WITH HISTORICAL CONTROL DATA:
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory).
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY: None - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No toxicity was exhibited to any of the strains of bacteria used. A precipitate was observed at and above 500µg/plate, this however did not interfere with the scoring of revertant colonies.
No significant increase in the frequency of revertant colonies was recorded for any of the strains of bacteria used, at any dose level, either with or without metabolic activation.
The positive control substances all produced marked increases in the frequency of revertant colonies and the activity of the S9 fraction was found to be satisfactory.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
1. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escerichia coli strain WP2uvrA- were treated with the test material using the Ames plate incorporation method at six dose levels. In triplicate both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). This method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW, MOL and MAFF. It also meets the requirements of the OECD, EEC and USA, EPA (TSCA) guidelines. The dose range was determined in a preliminary toxicity assay and was 15 to 5000µg/plate in the first experiment. A second experiment was performed on a separate day using the same dose range as experiment 1, fresh cultures of the bacterial strains and fresh chemical formulations. The optimum concentration of S9 in the S9 -mix was also determined in a preliminary assay and was 10% for both experiments.
2. The vehicle (acetone) and untreated control plates produced counts of revertant colonies within the normal range.
3. All of the positive control chemicals used in the study induced marked increases in the frequency of revertant colonies, both with and without the metabolising system.
4. The test material caused no visible reduction in the growth of the bacterial lawn at any dose level either with or without metabolic activation. The test material was therefore, tested up to the maximum recommended dose level of 5000µg/plate, this however did not interfere with the scoring of revertant colonies.
5. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of this test.
The test material was considered to be non-mutagenic under the conditions of this test.
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