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EC number: 205-459-2 | CAS number: 141-12-8
- 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:
- weight of evidence
- Study period:
- 12-28 July 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:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-yl acetate
- 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.: 171893
Purity: 90.9%
Name of test material (as cited in study report): neryl acetate
Physical state: colourless to slightly amber liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 9 December 2017
Constituent 1
impurity 1
impurity 2
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
Additional experiment 2 (pre-incubation method) without S9:
- 0.05, 0.15, 1.5, 5, 15, 50, 150, 500 μg/plate without S9-mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
The solubility of Neryl acetatet 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. The highest concentration of neryl acetate tested in this study was 50 mg/mL in the chosen vehicle, which provided a final concentration of 5000 µg/plate.
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:
- plate incorporation method: at 1500 µg/plate and above with S9 and in pre-incubation method: at 50 µg/plate and above without S9 and 500 µg/plate and above with 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:
- plate incubation method: at 1500 µg/plate and above without S9 and at 5000µg/plate with S9, in pre-incubation method: at 150 µg/plate and above without and at 500 µg/plate without 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:
- plate incorporation method: at 1500 µg/plate and above with and without S9, in pre-incubation method: at 50 µg/plate and above without S9 and 500 µg/plate and above with 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:
- plate incorporation method: at 1500 µg/plate and above with and without S9, in pre-incubation method: at 150 µg/plate and above without S9 and at 500 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:
- cytotoxicity
- Remarks:
- in pre-incubation method at 1500 µg/plate with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- First Test
In the absence of S9 mix, toxicity (observed as thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98, TA100 and TA1537 at 1500 µg/plate and above. In the presence of S9 mix, toxicity (observed as thinning or complete absence of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98 at 5000 µg/plate and in strains TA100, TA1535 and TA1537 at 1500 µg/plate and above.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to Neryl acetate at any concentration up to and including 5000 µg/plate in either the presence or absence of S9 mix.
Second Test
In the absence of S9 mix, toxicity (observed as thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98 and TA1537 at 150 µg/plate and above, and in strains TA100 and TA1535 at 50 µg/plate and above. In the presence of S9 mix, toxicity (observed as thinning or complete absence of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98, TA100, TA1535 and TA1537 at 500 µg/plate and above, and in strain WP2 uvrA (pKM101) at 1500 µg/plate and above.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to Neryl acetate at any concentration up to and including 5000 µg/plate in either the presence or absence of S9 mix.
As there were an insufficient number of non-toxic concentrations in strains TA98, TA100, TA1535 and TA1537 in the absence of S9 mix these were repeated in an additional test using modified dose concentrations.
Additional Second Test
In the additional second test, toxicity (observed as thinning or complete absence of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in all strains at 50 µg/plate and above.
Toxicity (observed as a reduction in revertant colony numbers 0.5 x fold those of the concurrent vehicle control values) was also seen in strain TA98 at 0.5 µg/plate. These reductions in colony numbers would, however, appear to be anomalous when considered with the remaining cultures in the exposure condition and were likely an effect of experimental variation.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to Neryl acetate at any concentration up to and including 500 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Neryl acetate showed no evidence of mutagenic activity in this bacterial system at doses up to 5000 μg/plate.
- Executive summary:
In an in vitro bacterial reverse mutation test performed according to OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and Escherichia coli, strain WP2 uvrA (pKM101), were exposed to neryl acetate 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 concentration of the test item was used: 5, 15, 50, 150, 500, 1500 and 5000 μg/plate, with and without S9-mix, in experiment 1 and 0.05, 0.15, 1.5, 5, 15, 50, 150, 500 μg/plate without S9-mix in experiment 2 .
In the first test, in the absence of S9 mix, toxicity (observed as thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98, TA100 and TA1537 at 1500 µg/plate and above. In the presence of S9 mix, toxicity (observed as thinning or complete absence of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98 at 5000 µg/plate and in strains TA100, TA1535 and TA1537 at 1500 µg/plate and above.
In the second test, in the absence of S9 mix, toxicity (observed as thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98 and TA1537 at 150 µg/plate and above, and in strains TA100 and TA1535 at 50 µg/plate and above. In the presence of S9 mix, toxicity (observed as thinning or complete absence of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strains TA98, TA100, TA1535 and TA1537 at 500 µg/plate and above, and in strain WP2uvrA (pKM101) at 1500 µg/plate and above. As there were an insufficient number of non-toxic concentrations in strains TA98, TA100, TA1535 and TA1537 in the absence of S9 mix these were repeated in an additional test using modified dose concentrations.
In the additional test, toxicity (observed as thinning or complete absence of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in all strains at 50 µg/plate and above.
No evidence of mutagenic activity was seen at any concentration of neryl acetate in any 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, neryl acetate showed no evidence of mutagenic activity in this bacterial system with and without metabolic activation at doses up to 5000 μg/plate.
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