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EC number: 240-458-0 | CAS number: 16409-44-2
- 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:
- 31 May 2000 - 28 July 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This information is used for read-across to Neryl acetate multi
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse 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:
- (2Z)-3,7-dimethylocta-2,6-dien-1-yl acetate
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix from rats that had been induced with Aroclor 1254 (500 mg/kg body weight).
- Test concentrations with justification for top dose:
- Experiment 1 (Strains TA1535, TA1537, TA98, TA100, and TA102).
(without S9) All tester strains: 5, 15, 50, 150, 500, 1500 µg/plate
(with S9) All tester strains: 5, 15,50, 150, 500, 1500, 5000 µg/plate
Experiment 2 (Strains TA1535, TA1537, TA98, TA100, and TA102).
(without S9) All tester strains: 5, 15, 50, 150, 500, 1500 µg/plate
(with S9) All tester strains: 5, 15,50, 150, 500, 1500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for vehicle: the vehicle is according to OECD guideline 471
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene (2-AA)
- Remarks:
- For more details on positive controls, see 'additional details on methods'
- Details on test system and experimental conditions:
- Two individual experiments were performed. The first experiment was a direct plate assay and included a dose-range finding test, the second experiment was a pre-incubation assay.
METHOD OF APPLICATION: To each culture tube containing 2 ml of top agar 0.1 mL of bacteria was added followed by the test solution and 0.5 ml of S9-mix or phosphate buffer in the assays without metabolic activation. The test components were mixed thoroughly with a vortex and immediately poured onto coded minimal agar plates and carefully spread to achieve an uniform distribution of the top agar on the surface of the plate. The minimal agar plates contain 20 to 25 mL of 1.5 % agar in Vogel-Bonner medium E with 2 % glucose. Three parallel plates were prepared for each experimental point. Plates were kept for 48 to 72 h at 37°C in the dark and then examined. Besides the counting of the number of revertant colonies, the plates were examined for the existence of a normal background lawn and/or precipitates and
microscopically for microcolony growth.
DURATION
- Exposure duration: 48 - 72 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain.
NUMBER OF CELLS EVALUATED: >1E8 per plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 1500 (μg/plate) , without S9 and from 5000 (μg/plate) with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- upwards from 1500 (μg/plate) , without and with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- upwards from 1500 (μg/plate) , without and with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- upwards from 500 (μg/plate) without and with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- from 1500 (μg/plate) , without S9 and from 5000 (μg/plate) with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No precipititation occurred.
Historical control data: The controls were close to the laboratory historical control data range.
Applicant's summary and conclusion
- Conclusions:
- In an Ames test, performed according to OECD guideline 471 and GLP principles, Nerylacetate was found not to be mutagenic in the Salmonella typhimurium strains TA1535, TA1537, TA98, TA100,
and TA102, in the absence and in the presence of metabolic activation. - Executive summary:
The mutagenic activity of Neryl Acetate (‘mono’) was evaluated in a study according to OECD TG 471 and in compliance with GLP criteria. The test was performed in two independent experiments. The substance was dissolved in DMSO and tested in concentrations of 5 to 1500 μg/plate in the absence and of 5 to 5000 μg/plate in the presence of S9. In the absence of S9-mix the substance was bacteriotoxic towards the strain TA1535 at 500 μg/plate and towards the strains TA98, TA100, TA102, and TA1537 at 1500 μg/plate. In the presence of S9-mix the substance was bacteriotoxic towards the strain TA1535 at 500 μg/plate, towards the strains TA100 and TA102 at 1500 μg/plate and towards the strains TA98 and TA1537 at 5000 μg/plate. Precipitation of the test compound in the plates was not observed. Adequate negative and positive controls were included.
The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
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