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EC number: 204-435-9 | CAS number: 120-92-3
- 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
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:
- from 2014-11-28 to 2015-04-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 471 guideline study in compliance with the GLP. No deviation from the protocol of the study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cyclopentanone
- EC Number:
- 204-435-9
- EC Name:
- Cyclopentanone
- Cas Number:
- 120-92-3
- Molecular formula:
- C5H8O
- IUPAC Name:
- cyclopentanone
- Test material form:
- other: liquid stored at controlled room temperature
- Details on test material:
- - Name of test material (as cited in study report): Cyclopentanone
- Physical state: colourless liquid
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- - Histidine: TA 1535, TA 100, TA 1537 and TA 98
-Tryptophan: Escherichia coli WP2 uvr A
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:
- other: see Table 7.6.1/1
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: see Table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from induced phenobarbital/Beta-naphthoflavone rat liver.
- Test concentrations with justification for top dose:
- - Range finding test: 10; 100; 500; 1000; 2500 and 5000 µg/plate
- First experiment (Direct plate incorporation method, with and without metabolic activation): 312.5, 625, 1250, 2500 and 5000 µg/plate
- Second experiment (Direct plate incorporation method, without metabolic activation) (Pre-incubation method, with metabolic activation): 312.5, 625, 1250, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injections, batch No. 4F1081 (CDM Lavoisier)
- Justification for choice of solvent/vehicle: the substance was soluble in water (solubility: 301 g/l at 20°C)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- methylmethanesulfonate
- other: 4-nitroquinoline 1-oxide (4NQO); 2-anthramine (2AM)
- Remarks:
- see Table 7.6.1/2
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The preliminary test, both experiments without S9 mix and the first experiment with S9 mix were performed according to the direct plate
incorporation method in agar. The second experiment with S9 mix was performed according to the pre-incubation method.
DURATION
- Incubation period: at 37°C for 48 to 72 hours.
- Preincubation period: 60 min at 37ºC.
NUMBER OF REPLICATIONS: 3 plates/dose/strain. Two independent experiments were performed.
DETERMINATION OF CYTOTOXICITY
- Method: The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a
thinning of the bacterial lawn.
OTHER: SCORING METHOD: the number of revertants per plate was scored for each strain and for each experimental point using an automatic counter (Sorcerer Automatic Colony Counter for the scoring of colonies and Ames Study Manager for the data management, Perceptive Instruments Ltd, Bury St Edmunds IP33 3TA, UK). - Evaluation criteria:
- Acceptance criteria :
Each main experiment was considered valid if the following criteria are fully met:
- the mean number of revertants in the vehicle controls is consistent with our historical data, in each strain and test condition (Appendix 2),
- at least five analyzable dose-levels (i.e. including at least three non-cytotoxic dose-levels) are obtained for each strain and test condition,
- the mean number of revertants in the positive controls is higher than that of the vehicle controls (at least 2-fold increase (for the TA 98, TA 100 and WP2 uvrA strains) or at least 3-fold increase (for the TA 1535 and TA 1537 strains)).
When these criteria were not met for one strain or test condition, the corresponding results were invalidated and the experiment was repeated.
Evaluation criteria :
In all cases, biological relevance (such as reproducibility and reference to historical data) was taken into consideration when evaluating the results.
The test item is considered to have shown mutagenic activity in this study if:
- a reproducible 2-fold increase (for the TA 98, TA 100 and WP2 uvrA strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the mean number of revertants compared with the vehicle controls is observed, in any strain, at any dose-level,
- and/or a reproducible dose-response relationship is evidenced.
The test item is considered to have shown no mutagenic activity in this study if:
- neither an increase in the mean number of revertants, reaching 2-fold (for the TA 98, TA 100 and WP2 uvrA strains) or 3-fold (for the TA 1535 and TA 1537 strains) the vehicle controls value, is observed at any of the tested dose-levels,
- nor any evidence of a dose-response relationship is noted. - Statistics:
- No data
Results and discussion
Test results
- 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
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES:
To assess the toxicity of the test item to the bacteria, six dose-levels (one plate/dose-level) were tested in the TA 98, TA 100 and WP2 uvrA strains, both with and without S9 mix.
Using a test item concentration at 50 mg/mL in the vehicle and a treatment volume of 100 µL/plate, the highest recommended dose-level of 5000 µg/plate was achievable. Thus, the dose-levels selected for the preliminary test were 10, 100, 500, 1000, 2500 and 5000 µg/plate. The evaluation of the
toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose levels. No noteworthy toxicity was noted towards the three strains used, either with or without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: The control data reported in these report are in the range of the historical control data observed in the laboratory. The study was therefore considered valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxicity was noted towards all the strains used. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See attached document
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Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative (with and without metabolic activation)
Under the experimental conditions of this study, the test item Cyclopentanone did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli strains, either in the presence or in the absence of a rat liver metabolizing system. - Executive summary:
This study was performed to investigate the potential of the test item, Cyclopentanone, to induce reverse mutations in Salmonella typhimurium and Escherichia coli. The study was performed according to OECD guideline no. 471 and EC guideline n° B13/14 and in compliance with the Principles of Good Laboratory Practice.
A preliminary toxicity test was performed to define the dose-levels of Cyclopentanone to be used for the mutagenicity study. The test item was then tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C).
Four strains of bacteria Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100) and one strain of Escherichia coli (WP2 uvrA) were used. Each strain was exposed to five dose-levels of the test item (three plates/dose‑level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item was dissolved in water for injections.
The test item was freely soluble in the vehicle at 50 mg/mL. Consequently, with a maximum dose-volume of 100 µL/plate, the dose-levels for the preliminary toxicity test were 10, 100, 500, 1000, 2500 and 5000 µg/plate.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose‑levels, and no noteworthy toxicity was noted towards the three strains used, either with or without S9 mix.
Since the test item was freely soluble and non-toxic in the preliminary test, the highest dose-level selected for the main experiments was 5000 µg/plate, according to the criteria specified in the international guidelines.
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
The selected treatment-levels were 312.5, 625, 1250, 2500 and 5000 µg/plate, for both mutagenicity experiments with and without S9 mix.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose‑levels, and no toxicity was noted towards all the strains used.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, either with or without S9 mix. These results met thus the criteria of a negative response.
Under the experimental conditions of this study, the test item Cyclopentanone did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli strains, either in the presence or in the absence of a rat liver metabolizing system.
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