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EC number: 266-841-2 | CAS number: 67662-96-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted similarly to OECD 471 Guideline with deviations: strains E. coli WP2 or S. typhimurium TA102 not used; purity of test item, evaluation and acceptance criteria and individual plate counts not reported
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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- strains E. coli WP2 or S. typhimurium TA102 not used; purity of test item, evaluation and acceptance criteria and individual plate counts not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenethyl pivalate
- EC Number:
- 266-841-2
- EC Name:
- Phenethyl pivalate
- Cas Number:
- 67662-96-8
- Molecular formula:
- C13H18O2
- IUPAC Name:
- 2-phenylethyl 2,2-dimethylpropanoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Phenethyl pivalate (Fenethylpivalinaat)
- Physical state: Clear colourless liquid
- Date received: 20 March 1980
Constituent 1
Method
- Target gene:
- None
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: examined for the number of spontaneous revertants, histidine requirement and sensitivity to ampicillin, crystal violet and UV radiation.
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9 mix; S9 fraction prepared from liver homogenates of male Wistar rats intraperitoneally induced with Aroclor 1254 (500 mg/kg bw) as a 20 % (w/v) dilution in soya bean oil
- Test concentrations with justification for top dose:
- Preliminary toxicity test with strain TA 98:
- Approximately 0.009, 0.09, 0.9 and 9 mg/plate
Mutagenicity test:
- 3.7, 11.1, 33.3, 100 and 300 µg/plate, with and without S9 mix in TA 1535, TA 1537, TA 1538, TA 98 and TA 100 strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Methanol
- Test substance preparation: Appropriate test solutions in methanol (0, 37, 111.1, 333.3, 1000 and 3000 µg/mL) were prepared immediately before use.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (0.5 µg/plate (in 0.1 mL water)) for strains TA 1535 and TA 100 ; hycanthone methanesulphonate (12.5 µg/plate (in 0.1 mL water)) for strains TA 1537, TA 1538 and TA 98
- Remarks:
- without S-9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (0.5 µg/plate (in 0.1 mL DMSO) for all strains
- Remarks:
- with S-9 mix
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: - All Salmonella typhimurium strains received from Dr. B.N. Ames, Berkeley, California, U.S.A.
METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Incubation period: Plates were incubated at 37 °C for three days
NUMBER OF REPLICATIONS:
- 3 plates/dose for treatment, vehicle and positive controls
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was determined based on background lawn of bacterial growth.
OTHER:
- Colony counting: After incubation, the colonies (revertants which are histidine independent) were counted and the background lawn of bacterial growth was examined microscopically. - Evaluation criteria:
- None
- Statistics:
- None
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- CYTOTOXICITY:
- In a preliminary toxicity test, 0.9 mg/plate was still toxic whereas 0.09 mg/plate did not show a growth-inhibiting effect. Therefore 0.3 mg/plate was chosen as the highest dosage level for the mutagenicity study.
MUTAGENICITY TEST:
- The toxicity of the test substance for the bacteria appeared not to prevent adequate mutagenicity testing: at the higher dosage levels Phenethyl pivalate was clearly toxic for the bacteria, but at lower levels the background lawn of bacterial growth in control and test plates was comparable. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See the attached document for information on tables of results
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, Phenethyl pivalate is not considered as mutagenic in S. typhimurium (TA1535, TA1537, TA1538, TA98 and TA100) strains. - Executive summary:
In a reverse gene mutation assay in bacteria, performed similarly to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98 and TA100) were exposed to Phenethyl pivalate at the following concentrations:
Preliminary toxicity test with strain TA 98:
- Approximately 0.009, 0.09, 0.9 and 9 mg/plate
Mutagenicity test:
- 3.7, 11.1, 33.3, 100 and 300 µg/plate, with and without S9 mix in TA 1535, TA 1537, TA 1538, TA 98 and TA 100 strains
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of male Wistar rats intraperitoneally induced with Aroclor 1254 (500 mg/kg bw) as a 20 % (w/v) dilution in soya bean oil. Vehicle and positive control groups were also included in mutagenicity tests.
In a preliminary toxicity test, 0.9 mg/plate was still toxic whereas 0.09 mg/plate did not show a growth- inhibiting effect. Incorporation of the test product with the bacteria at levels up to 300 µg/plate did not increase the numbers of his+ revertants with any of the five tester strains, either in the presence or in the absence of S-9 mix. The toxicity of the test substance for the bacteria appeared not to prevent adequate mutagenicity testing: at the higher dosage levels Phenethyl pivalate was clearly toxic for the bacteria, but at lower levels the background lawn of bacterial growth in control and test plates was comparable. The positive and vehicle controls induced the appropriate responses in the corresponding strains indicating the validity of the study.
Under the test conditions, Phenethyl pivalate is not considered as mutagenic in this bacterial system.
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