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EC number: 234-091-5 | CAS number: 10528-67-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-13 to 2011-09-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- α-methylcyclohexanepropanol
- EC Number:
- 234-091-5
- EC Name:
- α-methylcyclohexanepropanol
- Cas Number:
- 10528-67-3
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-cyclohexylbutan-2-ol
Constituent 1
Method
- Target gene:
- Salmonella typhimurium strains had mutations in the histidine locus (histidine deficiency), rfa-minus (deficient lipopolysaccharide envelope), uvrB-minus (deficient excision repair) and TA 98 and TA 100 carried R-factor plasmid pKM 101 (ampicillin resistance marker).
The E. coli strain was deficient for tryptophan biosynthesis and had a mutation of uvrA leading to a deficient excision repair.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 0.3; 1; 3; 10; 33; 100; 333; 1000 and 2500 µg/plate
In the pre-experiment the concentration range of the test item was 3 - 5000 µg/plate. Since toxic effects were observed nine concentrations were tested in experiment II and 2500 µg/plate was chosen as maximal concentration. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- for TA 1535, TA 100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine,
- Remarks:
- for TA 1537, TA 98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- for WP2 uvrA without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- for TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: individual values from the plates for each concentration
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants - Evaluation criteria:
- A test item was considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control was observed.
A dose dependent increase was considered biologically relevant if the threshold was exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration was judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold was regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remained within the historical range of negative and solvent controls such an increase was not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data was not mandatory.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA1537, TA100, TA1535, TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting from 333 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- starting from 333 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: in the overlay agar in the test tubes from 1000 to 5000 ug/plate, in the overlay agar on the incubated agar plates from 1000 to 5000 µg/plate in experiment I with and without S9 mix, in the overlay agar on the incubated agar plates from 333 to 2500 µg/plate in the absence of metabolic activation and from 1000 to 2500 µg/plate in the presence of metabolic activation in experiment II. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDIES: yes, with all strains and 8 concentrations (3 - 5000 µg/plate)
COMPARISON WITH HISTORICAL CONTROL DATA: yes
Any other information on results incl. tables
Experiment 1 (range-finding test, plate incorporation)
Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli | ||||
TA1535 | TA1537 | TA98 | TA100 | WP2 uvrA | |
Results without S9 | |||||
DMSO | 18± 4 | 14 ± 2 | 33 ± 2 | 131 ± 18 | 57 ± 18 |
Untreated | 14 ± 3 | 9 ± 4 | 32 ± 4 | 130 ± 22 | 50 ± 5 |
3 | 17 ± 2 | 13 ± 3 | 30 ± 4 | 124 ± 12 | 61 ± 9 |
10 | 17 ± 1 | 17 ± 6 | 26 ± 5 | 126 ± 9 | 57 ± 6 |
33 | 19 ± 5 | 15 ± 4 | 22 ± 6 | 124 ± 1 | 53 ± 8 |
100 | 19 ± 6 | 15 ± 0 | 25 ± 5 | 111 ± 6 | 57 ± 8 |
333 | 11 ± 3 | 8 ± 2 | 13 ± 3 | 83 ± 18 | 34 ± 6 |
1000 | 6 ± 2 | 3 ± 2 | 11 ± 5 | 34 ± 9 | 27 ± 3 |
2500 | 1 ± 1 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 13 ± 3 |
5000 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 4 ± 2 |
NaN3 (10) | 1906 ± 38 | 2085 ± 70 | |||
4-NOPD (10) | 306 ± 7 | ||||
4-NOPD (50) | 66 ± 12 | ||||
MMS (3.0 µL) | 1125 ± 66 | ||||
Results with S9 | |||||
DMSO | 23 ± 1 | 15 ± 3 | 43 ± 6 | 149 ± 10 | 69 ± 7 |
Untreated | 24 ± 5 | 24 ± 3 | 44 ± 2 | 167 ± 28 | 76 ± 4 |
3 | 24 ± 5 | 18 ± 2 | 38 ± 10 | 156 ± 12 | 74 ± 9 |
10 | 22 ± 3 | 22 ± 3 | 36 ± 8 | 147 ± 3 | 68 ± 13 |
33 | 21 ± 7 | 21 ± 3 | 46 ± 7 | 161 ± 16 | 62 ± 7 |
100 | 22 ± 2 | 20 ± 5 | 43 ± 4 | 156 ± 14 | 60 ± 4 |
333 | 22 ± 2 | 19 ± 3 | 35 ± 7 | 101 ± 15 | 61 ± 4 |
1000 | 1 ± 1 | 1 ± 1 | 2 ± 3 | 2 ± 1 | 12 ± 4 |
2500 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
5000 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
2-AA (2.5) | 349 ± 30 | 309 ± 24 | 1592 ± 281 | 1631 ± 73 | |
2-AA (10.0) | 398 ± 21 |
Experiment 2 (pre-incubation)
Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli | ||||
TA1535 | TA1537 | TA98 | TA100 | WP2 uvrA | |
Results without S9 | |||||
DMSO | 17 ± 4 | 15 ± 4 | 29 ± 6 | 120 ± 20 | 49 ± 1 |
Untreated | 14 ± 1 | 21 ± 2 | 32 ± 9 | 130 ± 13 | 49 ± 7 |
0.3 | 17 ± 4 | 123 ± 4 | 33 ± 3 | 112 ± 12 | 47 ± 11 |
1 | 15 ± 1 | 15 ± 1 | 31 ± 6 | 108 ± 11 | 44 ± 10 |
3 | 21 ± 6 | 13 ± 3 | 31 ± 9 | 103 ± 9 | 56 ± 8 |
10 | 17 ± 3 | 16 ± 3 | 28 ± 12 | 101 ± 5 | 40 ± 6 |
33 | 20 ± 1 | 15 ± 4 | 29 ± 3 | 113 ± 11 | 46 ± 4 |
100 | 16 ± 2 | 9 ± 3 | 28 ± 6 | 109 ± 5 | 48 ± 7 |
333 | 8 ± 2 | 3 ± 1 | 12 ± 0 | 74 ± 4 | 20 ± 2 |
1000 | 4 ± 1 | 1 ± 1 | 1 ± 1 | 16 ± 2 | 12 ± 3 |
2500 | 0 ± 0 | 0 ± 0 | 0 ± 1 | 0 ± 0 | 4 ± 1 |
NaN3 (10) | 1612 ± 101 | 1557 ± 128 | |||
4-NOPD (10) | 340 ± 14 | ||||
4-NOPD (50) | 94 ± 4 | ||||
MMS (2.0 µL) | 505 ± 62 | ||||
Results with S9 | |||||
DMSO | 23 ± 4 | 19 ± 6 | 42 ± 7 | 127 ± 6 | 51 ± 5 |
Untreated | 29 ± 5 | 17 ± 4 | 35 ± 2 | 129 ± 9 | 59 ± 12 |
0.3 | 21 ± 6 | 16 ± 3 | 40 ± 5 | 130 ± 20 | 50 ± 2 |
1 | 20 ± 6 | 20 ± 4 | 38 ± 4 | 125 ± 7 | 57 ± 8 |
3 | 23 ± 7 | 17 ± 5 | 38 ± 15 | 124 ± 14 | 55 ± 11 |
10 | 23 ± 5 | 20 ± 2 | 42 ± 7 | 118 ± 10 | 50 ± 11 |
33 | 20 ± 7 | 16 ± 4 | 38 ± 4 | 132 ± 10 | 52 ± 5 |
100 | 23 ± 4 | 15 ± 2 | 37 ± 5 | 130 ± 19 | 42 ± 3 |
333 | 7 ± 2 | 4 ± 1 | 7 ± 1 | 24 ± 6 | 39 ± 3 |
1000 | 3 ± 1 | 0 ± 1 | 1 ± 1 | 0 ± 1 | 15 ± 4 |
2500 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 3 ± 1 |
2-AA (2.5) | 191 ± 5 | 145 ± 11 | 1062 ± 43 | 1381 ± 37 | |
2-AA (10.0) | 212 ± 13 |
Applicant's summary and conclusion
- Conclusions:
- The test substance was determined to be non mutagenic but cytotoxic to the bacteria in high concentrations.
- Executive summary:
A bacterial reverse mutation assay (Ames test, OECD 471) was performed to investigate the potential of the test substance to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test substance was tested at several concentrations (Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000µg/plate; Experiment II: 0.3; 1; 3; 10; 33; 100; 333; 1000; and 2500µg/plate). The plates incubated with the test substance showed reduced background growth in all strains. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains at high concentrations. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used. Therefore the test substance is considered to be non-mutagenic.
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