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EC number: 209-578-0 | CAS number: 586-62-9
- 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:
- 06 December 2000 - 12 January 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD Guideline No 471 without any deviation
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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- p-mentha-1,4(8)-diene
- EC Number:
- 209-578-0
- EC Name:
- p-mentha-1,4(8)-diene
- Cas Number:
- 586-62-9
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexene
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Name of test material (as cited in study report): Terpinolene
Colour: colourless to yellowish
Analytical purity: 91.2 %
Lot/batch No.: 290600015
Storage Conditions: Refrigerator 7 ± 2 °C, protected from light and moisture
Expiration Date: 31 January 2001
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: the genotypes of the tested strains were checked at each study by histidine auxotrophy, ampicillin resistance, tetracycline resistance (only TA 102), UV-sensitivity (except TA 102) and growth inhibition with crystal violet (rfa-mutation)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction prepared from liver homogenates of male Wistar rats induced with phenobarbital (intraperitoneal route) and ß-Naphthoflavone (oral route)
- Test concentrations with justification for top dose:
- Study 1:
- TA 97a, TA 100 and TA 1535 (- S9): 0.5, 1.6, 5, 16 and 50 µg/plate
- TA 98 (± S9), TA 97a and TA 100 (+ S9): 5, 16, 50, 160 and 500 µg/plate
- TA 102 (± S9) and TA 1535 (+ S9): 50, 160, 500, 1600 and 5000 µg/plate
Study 2:
- TA 97a, TA 100 and TA 1535 (- S9): 0.5, 1.6, 5, 16 and 50 µg/plate
- TA 100 (+ S9) and TA 98 (± S9): 16, 50, 160, 500 and 1600 µg/plate
- TA 102 (± S9), TA 97a and TA 1535 (+ S9): 50, 160, 500, 1600 and 5000 µg/plate - Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191 (0.5 µg/plate in TA 97a); 4-Nitro-1,2-phenylenediamine (0.5 µg/plate in TA 98); Nitrofurantoine (0.2 µg/plate in TA 100); sodium azide (0.25 µg/plate in TA 1535); cumene hydroperoxide (100 µg/plate in TA 102)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2 µg/plate in TA 97a, TA 98, TA 100 and TA 1535); danthron (30 µg/plate in TA 102)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: University of California, Berkeley Division of Biochemistry and Molecular Biology, USA
METHOD OF APPLICATION: In agar (plate incorporation method)
DURATION
Incubation period: Plates for confirmation of the genotypes were incubated for 24 h and plates of the mutagenicity test for 48 h, respectively, at 37± 1 °C.
NUMBER OF REPLICATIONS: 3 plates/dose (3 replicates per concentration level and control)
DETERMINATION OF CYTOTOXICITY
Method: Evaluation of the toxicity was performed on the basis of the observation of a reduced background lawn.
OTHER: Revertants were scored with colony counter (manual counting). - Evaluation criteria:
- Test item is to be interpretated mutagenic if there is a concentration effect relationship and the induction rate is ≥ 2.
- Statistics:
- none
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- 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:
Study 1:
- Reduced background lawn was observed in TA 97a, TA 100 and TA 1535 strains at 50 µg/plate (- S9)
- Reduced background lawn was observed in TA 1535 strain at 5000 µg/plate (+ S9)
Study 2:
- Reduced background lawn was observed in TA 98 strain at 1600 µg/plate (± S9)
- Reduced background lawn was observed in TA 100 strain at 1600 µg/plate (+ S9) and 50 µg/plate (- S9)
- Reduced background lawn was observed in TA 1535 strain at 50 µg/plate (- S9) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Terpinolene monoconstituent is not considered as mutagenic in S. typhimurium strains (TA 97a, TA 98, TA 100, TA 102 and TA 1535). - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline No 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535) were exposed to terpinolene monoconstituent at the following concentrations:
Study 1:
- TA 97a, TA 100 and TA 1535 (- S9): 0.5, 1.6, 5, 16 and 50 µg/plate
- TA 98 (± S9), TA 97a and TA 100 (+ S9): 5, 16, 50, 160 and 500 µg/plate
- TA 102 (± S9) and TA 1535 (+ S9): 50, 160, 500, 1600 and 5000 µg/plate
Study 2:
- TA 97a, TA 100 and TA 1535 (- S9): 0.5, 1.6, 5, 16 and 50 µg/plate
- TA 100 (+ S9) and TA 98 (± S9): 16, 50, 160, 500 and 1600 µg/plate
- TA 102 (± S9), TA 97a and TA 1535 (+ S9): 50, 160, 500, 1600 and 5000 µg/plate
S9 mix was used in the experiments conducted with metabolic activation. S9 fraction was prepared from liver homogenates of male Wistar rats induced with phenobarbital (intraperitoneal route) and ß-Naphthoflavone (oral route). Vehicle and positive control groups were also included in these experiments.
Test substance induced cytotoxicity in the form of background lawn inhibition in TA 97a, TA 100 and TA 1535 strains at 50 µg/plate (- S9); TA 1535 strain at 5000 µg/plate (+ S9) in study 1. In study 2, cytotoxicity was observed in TA 98 strain at 1600 µg/plate (± S9); TA 100 strain at 1600 µg/plate (+ S9) and 50 µg/plate (- S9); TA 1535 strain at 50 µg/plate (- S9). The positive and negative (vehicle) controls induced the appropriate responses in the corresponding strains. Terpinolene monoconstituent showed no substantial increases in revertant colony numbers over control count obtained with any of the tester strains at any concentrations in either presence or absence of S9 mix.
Therefore, terpinolene monoconstituent is not considered as mutagenic in this bacterial system.
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