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Diss Factsheets
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EC number: 905-013-3 | 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 cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Gl study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 487
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 2-isopropyl-5-methyl-cyclohexanone
- EC Number:
- 905-013-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 2-isopropyl-5-methyl-cyclohexanone
- Test material form:
- other: colourless to yellowish clear liquid
- Details on test material:
- - Name of test material (as cited in study report): 620103 Menthone / Iso menthone Racemic
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- primary culture, other: human blood lymphocytes
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- see attached document: Test concentrations MNT test
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen due to its solubility properties and its relative non-toxicity to the cell cultures
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Demecolcin
- Remarks:
- without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 40h
- Exposure duration: 4h ( with and without S9 mix) or 20 h ( with S9 mix) (for more details see attached document: Test concentrations MNT test)
- Expression time (cells in growth medium): 16h after 4h exposure, none after 20h exposure
- Selection time (if incubation with a selection agent): 20 h with Cytochalasin B
- Fixation time (start of exposure up to fixation or harvest of cells): harvest 40h after start exposure time
SPINDLE INHIBITOR (cytogenetic assays): Cytochalasin B (4ug/ml)
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS: 2 parallel cultures
NUMBER OF CELLS EVALUATED: 1000 binucleate cells per culture
DETERMINATION OF CYTOTOXICITY
- Method: % cytostasis
OTHER EXAMINATIONS:
- Determination of cytogenetic damage - Evaluation criteria:
- A test item can be classified as non-mutagenic - non-clasogenic and non-aneugenic if:
the number of micronucleated cells in all evaluated dose groups is in the range of the laboratory historical control data and/or
no statistically significant or concentration-related increase in the number of micronucleated cells is observed.
A test item can be classified as mutagenic clastogenic or aneugenic if:
the number of micronucleated cells is not in the range of the historical laboratory control data and
either a concentration-related increase of micronucleated cells in three test groups or a statistically significant increase of the number of micronucleated cells is observed. - Statistics:
- Statistical significance was confirmed by means of the Chi square test. However, both biological and statistical significance should be considered together. If the criteria for the test item mentioned above are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
Results and discussion
Test results
- Species / strain:
- primary culture, other: human lymphocytes
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Evaporation from medium: no
- Water solubility:
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: no
Phase separation was observed microscopically in Experiment I in the absence and presence of S9 mix and in Experiment IIA in the absence of S9 mix at 771.5 µg/mL and above at the end of treatment. In Experiment IIB in the presence of S9 mix phase separation was observed microscopically at 600.0 µg/mL and above at the end of treatment. - Remarks on result:
- other: other: primary culture
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions reported, the test item 620103 Menthone / Iso Menthone Racemic did not induce micronuclei in human lymphocytes in vitro when tested up to cytotoxic or the highest evaluable concentrations. - Executive summary:
The test item 620103 Menthone / Iso Menthone Racemic, dissolved in DMSO, was assessed for its potential to induce micronuclei in human lymphocytes in vitro in the absence and presence of metabolic activation by S9 mix.
Three independent experiments were performed.
In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were scored for cytogenetic damage on coded slides. To determine a cytotoxic effect the CBPI was determined in approximately 500 cells per culture and cytotoxicity is described as % cytostasis.
The highest treatment concentration in this study, 1543.0 µg/mL (approx. 10 mM) was chosen with regard to the molecular weight of the test item and with respect to the OECD Guideline 487 for the in vitro mammalian cell micronucleus test.
In Experiment I and IIB in the absence of S9 mix, clear cytotoxicity was observed at the highest evaluated concentration (74.2 and 60.5 % cytostasis). In Experiment I and IIB in the presence of S9 mix and in Experiment IIA in the absence of S9 mix concentrations showing clear cytotoxicity were not evaluable for cytogenetic damage. However, in Experiment IIB cytostasis was 44.1 % at the highest evaluable concentration.
In the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying micronuclei was observed. The micronucleus rates of the cells after treatment with the test item (0.10 – 1.00 % micronucleated cells) were slightly above the range of the solvent control values (0.15 – 0.50 % micronucleated cells) and within the range of the laboratory historical control data. In Experiment I in the absence of S9 mix one single statistically significant increase in the number of micronucleated cells (1.00 %) was observed at the highest evaluated concentration (1543.0 µg/mL). Since this value was clearly in the range of the laboratory historical solvent control data (0.15 – 1.40 % micronucleated cells), this observation is regarded as biologically irrelevant.
Either Demecolcin (125.0 or 150.0 ng/mL), MMC (2.0 µg/mL) or CPA (12.5 or 17.5 µg/mL) were used as positive controls and showed distinct increases in cells with micronuclei.
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