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EC number: 406-700-6 | CAS number: 78531-61-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- there was no strain tested with main DNA target AT (trpE gene) in the first study. Two other studies were conducted with E.coli only.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- there was no strain tested with main DNA target AT (trpE gene) in the first study. Two other studies were conducted with E.coli only.
- Principles of method if other than guideline:
- there was no strain tested with main DNA target AT (trpE gene) in the first study. Two other studies were conducted with E.coli only.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(trans-4-propylcyclohexyl)acetophenone
- EC Number:
- 406-700-6
- EC Name:
- 4-(trans-4-propylcyclohexyl)acetophenone
- Cas Number:
- 78531-61-0
- Molecular formula:
- Hill formula: C17H24O CAS formula: C17H24O
- IUPAC Name:
- 1-[4-(4-propylcyclohexyl)phenyl]ethan-1-one
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Aroclor-induced male rats
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50, 250, 500, 1000, 2000, 3000, 4000, 5000, 7500, 10000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 250, 500, 1000, 2000, 3000, 4000, 5000, 7500, 10000 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- methylmethanesulfonate
- other: 2-Aminoanthracene; Daunomycin;
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1250 µg/plate
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Remarks:
- at precipitating concentrations only; Batch No. 315
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Remarks:
- at precipitating concentrations only; Batch No. 315
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Batch No. HE 227/92
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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
- Remarks:
- Batch No. HE 227/92
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Please refer to the attached background material.
The test item dose-dependently increased the number of revertants of both, E. coli WP2 and WP2 uvrA. The effects were reproduced in the repeat experiments performed. Maximal increases of 3- to 5-fold over the respective solvent controls were induced. These
effects however occurred at high test material concentrations which strongly precipitated on the agar plates.
This weak mutagenic effects were re-produced in another independent study conducted with the test item in E. coli strains. However, testing a purified batch of the test item negative results were obtained. Therefore, the weak mutagenicity observed is highly likely related to an impurity and not to the test item itself.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test item was not mutagenic in S. typhimurium strains but weakly mutagenic in E. coli.
- Executive summary:
Mutagenic potential of the test item was investigated using Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537, and TA 1538 as tester strains. The plate incorporation test with and without addition of rat liver S-9 fraction (Aroclor-induced) was used. The test item was tested in two series of experiments at the following concentrations: 50, 250, 1250, 2500, 5000, and 10000 µg/plate.
In another study, mutagenic potential of the test item was investigated using Escherichia coli WP2 and WP2 uvrA as tester strains. Again, the plate incorporation test with and without addition of rat liver S-9 fraction (Aroclor-induced) was used. The test item was tested in four series of experiments at the following concentrations: 50, 250, 1250, 2500, 5000, and 10000 µg/plate.
A third study was conducted using Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 and Escherichia coli WP2 and WP2 uvrA as tester strains. The plate incorporation test with and without addition of liver S9-Mix from Aroclor 1254-pretreated rats was used. The test item was tested in two series of experiments at the following concentrations: 25, 50, 250 1250, 2500, 5000, and 10000 µg/plate.
9-Aminoacridine, daunomycin, 1 -ethyl-2 -nitro-3 -nitrosoguanidine, methyl methanesulfonate, 2-nitrofluorene, 4-nitro-1,2 -phenylene diamine, and sodium azide served as positive control compounds for testing the bacteria in all three studies. 2-Aminoanthracene was used for testing the bacteria and the activity of the S-9 preparation. The positive controls showed normal reversion properties of all strains and good metabolic activity of the S-9 mix used. Thus, all three studies are considered to be valid.
With and without addition of S-9 as the metabolizing system, did not show any mutagenic activity in the Salmonella typhimurium strains at the concentration range used.
The test item dose-dependently increased the number of revertants of both, E. coli WP2 and WP2 uvrA. The effects were reproduced in the repeated experiments performed. Maximal increases of 3- to 5-fold over the respective solvent controls were induced. These effects however occurred at high test material concentrations which strongly precipitated on the agar plates.
In the third study conducted, this weak mutagenicity in E. coli strains was confirmed. However, with and without addition of S9-Mix as the external metabolizing system, no increases in the number of revertants over the respective solvent controls occurred with the purified test material. Thus, the test item was not mutagenic under the experimental conditions described. It is therefore very likely that chemical impurities are responsible for the mutagenic effects seen with the earlier tested batch.In conclusion, the test item was weakly mutagenic in Escherichia coli WP2 and WP2 uvrA. Since the effects occurred at precipitating test material concentrations, it should however be noted that not the test item itself but, more likely, impurities may be responsible for the weak mutagenic effects found in this finding. This is confirmed by negative findings obtained with a purified batch tested.
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