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EC number: 233-126-1 | CAS number: 10042-59-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-propylheptan-1-ol
- EC Number:
- 233-126-1
- EC Name:
- 2-propylheptan-1-ol
- Cas Number:
- 10042-59-8
- Molecular formula:
- C10H22O
- IUPAC Name:
- 2-propylheptan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Propylheptan-1-ol
- Physical state: Clear liquid
- Analytical purity: 96.20 area %
- Isomers composition: isomers of C10 alcohols 2.94 area %
- Lot/batch No.: 16.06.2008
- Test substance No.: 0649/82526
- Expiration date of the lot/batch: July 2009
- Storage condition of test material: Room temperature
Method
- Target gene:
- his- and trp-gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 5 - 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: 2-propylheptan-1-ol was insoluble in water. Its solubility was assessed at 50 mg/mL in dimethyl sulphoxide (DMSO) in which it was dissolved. DMSO was, therefore, used as the vehicle for this study.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see: Details on test system and conditions
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
First test:
Aliquots of 0.1 mL of the test substance solutions (seven concentrations up to 5000 μg/plate), positive control or negative control were placed in glass vessels. The negative control was the chosen vehicle, DMSO. S9 mix (0.5 mL) or 0.1 M pH 7.4 phosphate buffer (0.5 mL) was added, followed by 0.1 mL of a 10-hour bacterial culture and 2 mL of agar containing histidine (0.05 mM), biotin (0.05 mM) and tryptophan (0.05 mM). The mixture was thoroughly shaken and overlaid onto previously prepared Petri dishes containing 25 mL minimal agar. Each Petri dish was individually labelled with a unique code, identifying the contents of the dish. Three Petri dishes were used for each treatment. Plates were also prepared without the addition of bacteria in order to assess the sterility of the test substance, S9 mix and sodium phosphate buffer. All plates were incubated at approximately 37°C for ca 72 hours. After this period, the appearance of the background bacterial lawn was examined and revertant colonies counted using an automated colony counter. Any toxic effects of the test substance would be detected by a substantial reduction in mean revertant colony counts or by a sparse or absent background bacterial lawn. In the absence of any toxic effects, the maximum concentration selected for use in the second test would be the same as that used in the first. If toxic effects were observed, a lower concentration might be chosen, ensuring that signs of bacterial inhibition were present at this maximum concentration. Ideally, a minimum of four non-toxic concentrations should be obtained. If precipitate were observed on the plates at the end of the incubation period, at least four nonprecipitating concentrations should be obtained, unless otherwise justified by the Study Director.
Second test:
As a clear negative response was obtained in the first test, a variation to the test procedure was used for the second test. The variation used was the pre-incubation assay in which the tubes, which contained mixtures of bacteria, buffer or S9 mix and test dilution, were incubated at 37°C for 30 minutes with shaking before the addition of the agar overlay. The maximum concentration chosen was again 5000 μg/plate, and seven concentrations were
used in order to ensure that at least four non-toxic concentrations were tested.
Positive controls:
In the absence of S9 mix:
- Sodium azide (in DMSO): 2 μg/plate for strains TA100 and TA1535
- 9-Aminoacridine (in DMSO): 50 μg/plate for strain TA1537
- 2-Nitrofluorene ( in DMSO): 2 μg/plate for strain TA98
- 4-Nitroquinoline-1-oxide (in DMSO): 2 μg/plate for strain WP2 uvrA (pKM101)
In the presence of S9 mix:
- 2-Aminoanthracene (in DMSO): 5 μg/plate for strains TA100 and TA1535, 10 μg/plate for strain WP2 uvrA (pKM101)
- Benzo[a]pyrene: (in DMSO): 5 μg/plate for strains TA98 and TA1537 - Evaluation criteria:
- Acceptance criteria:
For a test to be considered valid, the mean of the vehicle control revertant colony numbers for each strain should lie within or close to the 99% confidence limits of the current historical control range of the laboratory unless otherwise justified by the Study Director. The historical range is maintained as a rolling record over a maximum of five years. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls. Mean viable cell counts in the 10-hour bacterial cultures must be at least 10^9/mL.
Criteria for assessing mutagenic potential
If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive dose-response relationship, it is considered to exhibit mutagenic activity in this test system. No statistical analysis is performed.
If exposure to a test substance does not produce a reproducible increase in revertant colony numbers, it is considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed.
If the results obtained fail to satisfy the criteria for a clear “positive” or “negative” response, even after additional testing, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers. The statistical procedures used are those described by Mahon et al (1989) and are usually Dunnett’s test followed, if appropriate, by trend analysis. Biological importance should always be considered along with statistical significance. In general, treatment-associated increases in revertant colony numbers below two or three times the vehicle controls (as described above) are not considered biologically important. - Statistics:
- The mean number and standard deviation of revertant colonies were calculated for all groups. The “fold-increases” relative to the vehicle controls were calculated in order to compare the means for all treatment groups with those obtained for the vehicle control groups.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium: strains TA1535, TA1537, TA98 and TA100; Escherichia coli: strain WP2 uvrA (pKM101)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (in all strains at one or more concentrations in both tests)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: yes
Any other information on results incl. tables
1st experiment:Standard plate test (5 - 5000 µg/plate) | |||||||
Strain | Metabolic activation system | mean his+revertant colonies (negative control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) | comments |
TA 98 | no | 36.7 | 1.1 (50 / 500) | no | negative | 9 (2NF) | Thinning of background lawn at 5000 µg/plate |
yes | 9.3 | 1.0 (5 / 500 / 1500) | no | negative | 3.3 (B[a]P) | Slight thinning of background lawn at 5000 µg/plate | |
TA 100 | no | 150 | 1.0 (15 / 50) | no | negative | 4.3 (NaN3) | Slight thinning of background lawn at 5000 µg/plate |
yes | 178 | 1.0 (50) | no | negative | 15.7 (AAN) | Slight thinning of background lawn at 5000 µg/plate | |
TA 1537 | no | 8.7 | 1.4 (150) | no | negative | 40.3 (AAC) | Slight thinning of background lawn at 1500 µg/plate; Thinning of background lawn at 5000 µg/plate; |
yes | 32 | 0.9 (15 / 50 / 150 / 500) | no | negative | 4.6 (B[a]P) | Slight thinning of background lawn at 1500 µg/plate; Severe thinning of background lawn at 5000 µg/plate; |
|
TA 1535 | no | 26.7 | 1.2 (50) | no | negative | 43.6 (NaN3) | Slight thinning of background lawn at 1500 µg/plate; Thinning of background lawn at 5000 µg/plate; |
yes | 28 | 0.9 (15) | no | negative | 14.8 (AAN) | Thinning of background lawn at 5000 µg/plate | |
WP2 uvrA | no | 117.3 | 1.3 (500) | no | negative | 26.6 (NQO) | Thinning of background lawn at 5000 µg/plate; |
yes | 171 | 1.2 (500) | no | negative | 2.5 (AAN) | Slight thinning of background lawn at 5000 µg/plate | |
2nd experiment:Preincubation test (5 - 5000 µg/plate) | |||||||
Strain | Metabolic activation system | mean his+revertant colonies (negative control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) | comments |
TA 98 | no | 36.7 | 1.0 (5 / 15 / 50 / 150) | no | negative | 7.5 (2NF) | Slight thinning of background lawn at 500 µg/plate; Severe thinning of background lawn at 1500 µg/plate; Lawn absent at 5000 µg/plate; |
yes | 48.7 | 1.1 (50) | no | negative | 8.2 (B[a]P) | Slight thinning of background lawn at 500 µg/plate; Severe thinning of background lawn at 1500 µg/plate; Lawn absent at 5000 µg/plate; |
|
TA 100 | no | 174.7 | 1.1 (5) | no | negative | 5.1 (NaN3) | Slight thinning of background lawn at 500 µg/plate; Severe thinning of background lawn at 1500 µg/plate; Lawn absent at 5000 µg/plate; |
yes | 197 | 0.9 (5 / 15) | no | negative | 14.6 (AAN) | Slight thinning of background lawn at 500 µg/plate; Severe thinning of background lawn at 1500 µg/plate; Lawn absent at 5000 µg/plate; |
|
TA 1537 | no | 12 | 0.9 (5) | no | negative | 87.2 (AAC) | Thinning of background lawn at 500 µg/plate; Lawn absent at 1500 and 5000 µg/plate; |
yes | 30.7 | 1.0 (5) | no | negative | 7.6 B[a]P) | Thinning of background lawn at 500 µg/plate; Lawn absent at 1500 and 5000 µg/plate; |
|
TA 1535 | no | 22 | 1.2 (15) | no | negative | 54.5 (NaN3) | Thinning of background lawn at 500 µg/plate; Lawn absent at 1500 and 5000 µg/plate; |
yes | 26 | 1.1 (15) | no | negative | 13.1 (AAN) | Thinning of background lawn at 500 µg/plate; Lawn absent at 1500 and 5000 µg/plate; |
|
WP2 uvrA | no | 178.3 | 1.0 (5) | no | negative | 18 (NQO) | Thinning of background lawn at 1500 µg/plate; Lawn absent at 5000 µg/plate; |
yes | 206.3 | 1.0 (5 / 50) | no | negative | 2.9 (AAN) | Thinning of background lawn at 1500 µg/plate; Lawn absent at 5000 µg/plate; |
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance is not mutagenic in the Ames test under the experimental conditions chosen here.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce back mutations in selected loci in several strains of Salmonella typhimurium and one Escherichia coli strain in the Ames test.
Strains: TA 1535, TA 100, TA 1537, TA 98, Escherichia coli WP2 uvrA
Dose range: 15 µg - 5,000 µg/plate (SPT); 15 µg - 250 µg/plate (PIT)
Test conditions: Standard plate test (SPT) and pre incubation test (PIT) both with and without metabolic activation (Aroclor induced rat liver S-9 mix).
Solubility: No precipitation of the test substance was found.
Toxicity: A bacteriotoxic effect was observed depending on the strain and test conditions from about 120 µg - 250 µg/plate onward.
Mutagenicity:
An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
Mutagenicity:
An increase in the number of his• revertants was not observed both in the standard plate test
andin the preincubation test either without S-9 mix or after the addition of a metabolizing system.
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