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EC number: 947-215-4 | CAS number: -
- 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:
- 15 August - 26 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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:
- 2 016
- Report date:
- 2016
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:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- (R*,R*)-7-methoxy-3,7-dimethyl-2-octanol
- Cas Number:
- 87605-57-0
- Molecular formula:
- C11H24O2
- IUPAC Name:
- (R*,R*)-7-methoxy-3,7-dimethyl-2-octanol
- Reference substance name:
- (R*,S*)-7-methoxy-3,7-dimethyl-2-octanol
- Cas Number:
- 87605-61-6
- Molecular formula:
- C11H24O2
- IUPAC Name:
- (R*,S*)-7-methoxy-3,7-dimethyl-2-octanol
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No.: 171894
Purity: 99.7% (sum of the two main constituents)
Name of test material (as cited in study report): 7-METHOXY-3,7-DIMETHYLOCTAN-2-OL MULTICONSTITUENT
Physical state: colourless - slightly yellow liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 14 December 2017
Constituent 1
Constituent 2
impurity 1
Method
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:
- S9 fraction prepared from liver homogenates of male Sprague Dawley rats
- Test concentrations with justification for top dose:
- Experiment 1 (plate-incorporation method):
-TA1535, TA1537, TA98, TA100 and WP2 uvra 5, 15, 50, 150, 500, 1500 and 5000 μg/plate, with and without S9-mix
Experiment 2 (preincubation method with and without S9 mix):
- 5, 15, 50, 150, 500, 1500 and 5000 μg/plate, with and without S9-mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
The solubility of 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent was assessed at 50 mg/mL in dimethyl sulphoxide (DMSO) in which it dissolved. DMSO (ACS reagent grade) was, therefore, used as the vehicle for this study.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: Benzo[a]pyrene
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM:
The strains of S. typhimurium and E. coli were obtained from Moltox Inc.
METHOD OF APPLICATION: In agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 minutes at 37 ± 1 °C, with shaking
- Incubation period: Plates were inverted and incubated at 37 ± 1 °C in the dark for 3 days in both direct
plate and preincubation methods.
NUMBER OF REPLICATIONS:
- Vehicle, treatment (test item) and positive controls were included in triplicate plates, - Evaluation criteria:
- Criteria for Assessing Mutagenic Potential:
If exposure to a test item produces a reproducible increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) that of the concurrent vehicle controls, with some evidence of a positive concentration-response relationship, it is considered to exhibit mutagenic activity in this test system.
If exposure to a test item does not produce a reproducible increase in mean 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 will be considered along with statistical significance. In general, treatment-associated increases in mean revertant colony numbers below two or three times those of the vehicle controls (as described above) are not considered biologically important. It should be noted that it is acceptable to conclude an equivocal response if no clear results can be obtained.
Occasionally, these criteria may not be appropriate to the test data and, in such cases, the Study Director would use his/her scientific judgment. - Statistics:
- The mean number and standard deviation of revertant colonies will be calculated for all groups. The means for all treatment groups will be compared with those obtained for the vehicle control groups
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:
- cytotoxicity
- Remarks:
- pre-incubation method: at 5000 µg/plate with and without S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- pre-incubation method: at 5000 µg/plate with and without S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- pre-incubation method: at 1500 µg/plate and above without S9 and at 5000 µg/plate with S9
- Vehicle controls validity:
- valid
- 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:
- pre-incubation method: at 1500 µg/plate and above without S9 and at 5000 µg/plate with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- First Test
No evidence of toxicity was obtained following exposure to 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent in either the absence or presence of S9 mix. No precipitate was observed on any plates containing 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent. A maximum exposure concentration of 5000 µg/plate was, therefore, selected for use in the second test.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent at any concentration up to and including 5000 µg/plate in either the presence or absence of S9 mix.
Second Test
Toxicity, observed as a thin or absent background lawn of non-revertant colonies and/or a reduction in the number of revertant colonies, was seen in strains TA100, TA1537 and WP2 uvrA (pKM101) at 1500 µg/plate and above and in strains TA98 and TA1535 at 5000 µg/plate in the absence of S9 mix. In the presence of S9 mix, toxicity, observed as a thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers, was seen in all strains at 5000 µg/plate. No precipitate was observed on any plates containing 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent at any concentration up to and including 5000 µg/plate in either the presence or absence of S9 mix.
Applicant's summary and conclusion
- Conclusions:
- 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent showed no evidence of mutagenic activity in this bacterial system [strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and Escherichia coli, strain WP2 uvrA (pKM101)] at concentrations up to 5000 µg/plate.
- Executive summary:
In an in vitro bacterial reverse mutation test performed according to Guideline OECD 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and Escherichia coli, strain WP2 uvrA (pKM101), were exposed to 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent diluted in dimethyl sulphoxide (DMSO).
Two independent mutation tests were performed in the presence and absence of liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone. The first test was a standard plate incorporation assay; the second included a pre-incubation stage.
The following concentrations of test item were used: 5, 15, 50, 150, 500, 1500 and 5000 μg/plate, with and without S9-mix, in experiment 1 and 2.
In the first test, no evidence of toxicity towards the tester strains was observed following exposure to 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent in either the absence or presence of S9 mix.
In the second test, toxicity (observed as a thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA100, TA1537 and WP2uvrA (pKM101) at 1500 µg/plate and above and in strains TA98 and TA1535 at 5000 µg/plate in the absence of S9 mix.In the presence of S9 mix, toxicity (observed as a thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in all strains at 5000 µg/plate.
No evidence of mutagenic activity was seen at any concentration of 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent in either mutation test.
The concurrent positive controls verified the sensitivity of the assay and the metabolizing activity of the liver preparations. The mean revertant colony counts for the vehicle controls were within or close to the current historical control range for the laboratory.
Therefore, it was concluded that 7-methoxy-3,7-dimethyloctan-2-ol multiconstituent showed no evidence of mutagenic activity in this bacterial system at concentrations up to 5000 µg/plate.
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