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EC number: 208-795-8 | CAS number: 541-91-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 25 to July 29, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on December 02, 2002/ signed on February 13, 2003
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-methylcyclopentadecan-1-one
- EC Number:
- 208-795-8
- EC Name:
- 3-methylcyclopentadecan-1-one
- Cas Number:
- 541-91-3
- Molecular formula:
- C16H30O
- IUPAC Name:
- 3-methylcyclopentadecan-1-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Physical state: Colourless slightly viscous liquid
- Storage condition of test material: Approximately 4 °C in the dark under nitrogen
Method
- Target gene:
- Histidine and tryptophan gene for Salmonella typhimurium and Escherichia coli, respectively
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:
- other: TA 100, TA1535 and E Coli WP2 sensitive to agents inducing base pair mutation. TA1537, TA1538 and TA98 sensitive to agents inducing frame-shift mutations.
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9 mix; S9 from liver of male Sprague- Dawley rats induced with phenobarbitone/β-naphthoflavone (oral)
- Test concentrations with justification for top dose:
- Preliminary toxicity study: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in TA 100 and WP2 uvr A strains, with or without S9-mix using the direct plate incorporation method.
Range finding study: 50, 150, 500, 1500 and 5000 µg/plate in S. typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and E. coli WP2 uvr A, with and without S9-mix using the direct plate incorporation method (up to maximum recommended concentration).
Main study: 50, 150, 500, 1500 and 5000 µg/plate in S. typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and E. coli WP2 uvr A, with and without S9-mix using the direct plate incorporation method (up to maximum recommended concentration). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulphoxide (DMSO)
- Preparation of test materials: The test material was accurately weighed and approximate half-log dilutions prepared in DMSO by mixing on a vortex mixer on the day of each experiment. Formulated concentrations were adjusted to allow for the stated water/impurity content (3 %) of the test material. Prior to use, the solvent was dried using molecular sieves (sodium alumino-silicate) i.e., 2 mm pellets with a nominal pore diameter of 4 x 10^-4 microns.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: Salmonella typhimurium strains were obtained from the University of California at Berkeley and Escherichia coli strain WP2uvrA- was obtained from the British Industrial Biological Research Association.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: Approximately 48 h at 37 °C
NUMBER OF REPLICATIONS:
- Preliminary toxicity study: One plate/dose
- Range finding study and mutation study: 3 plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: Evaluation of the toxicity was performed on the basis of growth of the bacterial background lawn.
OTHERS:
- After approximately 48 h incubation at 37 °C the plates were assessed for numbers of revertant colonies using a Domino colony counter. - Rationale for test conditions:
- Preliminary toxicity study: Maximum concentration was 5000 μg/plate (the maximum recommended dose level).
Range finding study: Maximum concentration was 5000 μg/plate (the maximum recommended dose level).
Main study: Maximum concentration was 5000 μg/plate (the maximum recommended dose level). - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically (Dunnett's method of linear regression) significant increase in the revertant count in at least one strain of bacteria. - Statistics:
- Dunnett' s method of linear regression
Results and discussion
Test results
- Key result
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not applicable
- Effects of osmolality: Not applicable
- Evaporation from medium: Not expected
- Water solubility: None
- Precipitation: An oily precipitate was observed at and above 1500 μg/plate, this did not prevent the scoring of revertant colonies.
- Other confounding effects: None
PRELIMINARY TOXICITY STUDY:
The test material was non-toxic to the strains of bacteria used (TA100 and WP2uvrA-).
COMPARISON WITH HISTORICAL CONTROL DATA:
All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the untreated controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Mutation test: The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 μg/plate.
OTHERS:
- Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory).
- The test material formulation and S9-mix used in this experiment were both shown to be effectively sterile.
Any other information on results incl. tables
Table 7.6.1/2: Preliminary toxicity study
S9 mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- S9 |
TA 100 |
131 |
114 |
111 |
124 |
122 |
125 |
132 |
109 |
123 |
128 P |
97 P |
+ S9 |
TA 100 |
123 |
126 |
98 |
109 |
117 |
121 |
109 |
110 |
90 |
89 P |
90 P |
- S9 |
WP2 uvr A |
34 |
19 |
16 |
22 |
12 |
18 |
15 |
18 |
19 |
26 P |
22 P |
+ S9 |
WP2 uvr A |
24 |
28 |
18 |
30 |
29 |
26 |
29 |
26 |
12 |
17 P |
20 P |
P: Precipitate
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test material is not mutagenic with and without metabolic activation in S. typhimurium (strains TA 1535, TA 1537, TA 98 and TA 100) and E. coli WP2 uvr A.
- Executive summary:
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and Escherichia coli WP2 uvr A were exposed to the test material diluted in DMSO both in the presence and absence of metabolic activation system (10% liver S9 in standard co-factors) using the plate incorporation method. The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5000 μg/plate. The experiment was repeated on a separate day using the same dose range as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations. Negative, vehicle (DMSO) and positive control groups were also included in mutagenicity tests.
The vehicle control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 μg/plate. An oily precipitate was observed at and above 1500 μg/plate, this did not prevent the scoring of revertant colonies. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
Under the test condition, the test material is not mutagenic with and without metabolic activation to S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli WP2 uvr A.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
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