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EC number: 207-630-7 | CAS number: 486-25-9
- 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:
- 2017-10-24 to 2018-01-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 8 June 2000
- Deviations:
- no
- Principles of method if other than guideline:
- n.a.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fluoren-9-one
- EC Number:
- 207-630-7
- EC Name:
- Fluoren-9-one
- Cas Number:
- 486-25-9
- Molecular formula:
- C13H8O
- IUPAC Name:
- 9H-fluoren-9-one
Constituent 1
Method
- Target gene:
- HIS operon (S. thyphimurium)
TRP operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- his D 3052, uvrB-, rfa- + R-factor (pKM101)
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- his G 46, uvrB-, rfa- + R-factor (pKM101)
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- his G 46, uvrB-, rfa-
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- his C 3076, uvrB-, rfa-
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- E. coli WP2
- Details on mammalian cell type (if applicable):
- trp-, uvrA-
- Additional strain / cell type characteristics:
- other: mutations in the tryptophan operon
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from beta-Naphthoflavone/Phenobarbital-pretreated rats with standard co-factors
- Test concentrations with justification for top dose:
- The test material concentrations used were selected according to the EC, OECD and Japanese guidelines for this test system. The test material showed best solubility in DMSO and 5000 µg/plate was chosen as the appropriate maximum concentration.
1. Series: 5.00, 15.8, 50.0, 158, 500, 1580 and 5000 µg/plate
2. Series: 158, 281, 500, 889 and 1580 µg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: Daunomycin
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- Bacterial strains were tested in accordance with the plate incorporation method. 3 parallel plates were used for each concentration step of the test material. The incubation of plates was performed at 36-38°C for 2 days. Liver S9 mix from rats pre-treated with beta-Naphthoflavone/Phenobarbital was used as the metabolic activation system. Two experimental series were performed, containing 10% S9 ind the 1st and 20% S9 in the 2nd series.
- Rationale for test conditions:
- according to Guideline
- Evaluation criteria:
- A test material was to be defined as positive or mutagenic in this assay if
• the assay is considered valid and
• a biologically relevant increase in the mean number of revertants above a threshold of 2-fold (TA 98, TA 100, WP2 uvrA) or 3-fold (TA 1535, TA 1537) as compared to the con-current negative controls is observed
• an increase exceeding the threshold at only one concentration is considered as biologically meaningful if reproduced in a second independent experiment
• a concentration-dependent increase is considered biologically meaningful if the threshold is exceeded at more than one concentration
A test material is defined as negative or non-mutagenic in this assay if
• the assay is considered valid and
• none of the above-mentioned criteria are met
Whenever colony counts remain within the historical range of negative controls, such increases are considered as biologically not meaningful. In general, two series of experiments must be performed. However, there is no requirement for verification of a clear positive response (OECD TG 471, 1997).
Results which only partially satisfied the above criteria were dealt with on a case by case basis. Biological relevance was considered, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=1580 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=1580 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=889 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >=889 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- - Precipitation: >=500 µg/plate and >= 1580 µg/plate at the beginning and the end of the experiment, respectively
Applicant's summary and conclusion
- Conclusions:
- Under the conditions described, the test item induced relevant increases in revertant numbers (more than 3-fold of the negative control value) in TA1537 in both experimental series, indicating the potential of the test item to induce frameshift mutations in the absence of metabolic activation. Based on these results, it was concluded that the test item was mutagenic in this bacterial reverse mutation test under the described experimental conditions.
- Executive summary:
Objective
The present study was conducted to investigate the test material for mutagenic potential in a bacterial reverse gene mutation assay in the absence and presence of a rat liver metabolizing system (S9 mix).
Study Design
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coil WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from rats pre-treated with beta-Naphthoflavone/Phenobarbital was used. In this study, two independent experimental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series. The test item was dissolved in DMSO and tested at concentrations ranging from 5 to 5000 µg/plate.
Results
Precipitation of the test material on the agar plates occurred at concentrations >=500 µg/plate and >= 1580 µg/plate at the beginning and the end of the experiment, respectively. Toxicity to the bacteria, evident as a reduction of revertant numbers below 0.5 of the concurrent negative control, was observed in all tester strains at concentrations >=500 µg/plate (TA98), >=889 µg/plate (TA1537, WP2 uvrA) or >=1580 µg/plate (TA100, TA1535).
The mean numbers of revertant colonies were all within acceptable ranges for solvent control treatments, or were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
Under the conditions described, the test item induced relevant increases in revertant numbers (more than 3-fold of the negative control value) in TA1537 in both experimental series, indicating the potential of the test item to induce frameshift mutations in the absence of metabolic activation. Based on these results, it was concluded that the test item was mutagenic in this bacterial reverse mutation test under the described experimental conditions.
Conclusion
Based on these results for the described experimental conditions, it was concluded that the test item was mutagenic in this bacterial reverse mutation test .
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