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EC number: 612-179-8 | CAS number: 61597-98-6
- 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 / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-02-14 to 2008-04-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed under GLP conditions and according to OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Menthyl lactate
- IUPAC Name:
- Menthyl lactate
- Reference substance name:
- Methyl lactate
- EC Number:
- 208-930-0
- EC Name:
- Methyl lactate
- Cas Number:
- 547-64-8
- IUPAC Name:
- methyl 2-hydroxypropanoate
- Reference substance name:
- Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-
- EC Number:
- 612-179-8
- Cas Number:
- 61597-98-6
- Molecular formula:
- C13H24O3
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-
- Reference substance name:
- 5-methyl-2-(1-methylethyl)cyclohexyl lactate
- EC Number:
- 241-218-8
- EC Name:
- 5-methyl-2-(1-methylethyl)cyclohexyl lactate
- Cas Number:
- 17162-29-7
- IUPAC Name:
- 2-isopropyl-5-methylcyclohexyl 2-hydroxypropanoate
- Details on test material:
- Menthyl-lactate
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: obtained from blood of healthy donors
- Details on mammalian cell type (if applicable):
- - Type and identity of media: blood cultures
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Without S9 mix
Experiment I: 14.8, 25.9, 45.4, 79.4, 138.9, 243.1, 425.4, 744.5, 1302.9, 2280 µg/mL
Experiment II: 2.8, 4.8, 8.5, 14.8, 25.9, 45.4, 79.4, 138.9, 243.1, 425.4 µg/mL
With S9 mix
Experiment I: 14.8, 25.9, 45.4, 79.4, 138.9, 243.1, 425.4, 744.5, 1302.9, 2280 µg/mL
Experiment II: 138.9, 243.1, 425.4, 744.5, 1302.9, 2280 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO was chosen due to its solubility properties and its relative non-toxicity to the cell cultures
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethane sulfonate (without S9 mix) and cyclophosphamide (with S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
With S9 Mix: 4h / 22h for the Experiment I and 46h for the Experiment II
Without S9 Mix: 4h in Experiment I and II
- Fixation time (start of exposure up to fixation or harvest of cells): 22 and 46 hours after beginning of treatment
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa (MERCK, 64293 Darmstadt, Germany) or according to the Fluorescent plus Giemsa technique
NUMBER OF CELLS EVALUATED: 100 metaphase plates per culture, 1000 cells for determination of mitotic index
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: determination of polyploid cells in 250 metaphase cells
- Determination of endoreplication: not reported - Evaluation criteria:
- A test item is classified as non-mutagenic if:
− the number of induced structural chromosome aberrations in all evaluated dose groups is in the range of our historical control data (0.0 - 4.0% aberrant cells, exclusive gaps).
− no significant increase of the number of structural chromosome aberrations is observed.
A test item is classified as mutagenic if:
− the number of induced structural chromosome aberrations is not in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps)
and
− either a concentration-related or a significant increase in number of structural chromosome aberrations is observed.
Although the inclusion of the structural chromosome aberrations is the purpose of this study, it is important to include the polyploids and endoreduplications. The following criteria is valid:
A test item can be classified as aneugenic if:
- the number of induced numerical aberrations is not in the range of our historical control data (0.0 – 0.8% polyploid cells). - Statistics:
- Statistical significance was confirmed by means of the Fisher´s exact test (11) (p < 0.05). However, both biological and statistical significance should be considered together. If the above mentioned criteria for the test item 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:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic in Experiment I, at highest evaluated concentration in the absence of S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not reported
- Effects of osmolality: not reported
- Evaporation from medium: not reported
- Water solubility: 0.24g/L
- Precipitation: Precipitation was observed at the end of exposure to the test substance at dose levels above 425 µg/mL.
RANGE-FINDING/SCREENING STUDIES: A preliminary cytotoxicity test was performed to determine the concentrations to be used in the mutagenicity assay. Cytotoxicity is characterized by the percentages of mitotic suppression in comparison to the controls by counting 1000 cells per culture in duplicate. The experimental conditions in this pre-test phase were identical to those described for the mutagenicity assay.
The pre-test phase was performed with 10 concentrations of the test item and a solvent and positive control. All cell cultures were set up in duplicate. Exposure times were 4 hrs (with and without S9 mix) and 22 hrs (without S9 mix). The preparation interval was 22 hrs after start of the exposure. Additional solvent control cultures (with and without S9 mix) were used in the presence of BrdU (5-bromodeoxyuridine; 6 µg/mL) to reassure the replication time of the cultured lymphocytes.
Using reduced mitotic indices as an indicator for toxicity in Experiment I, clear toxic effects were observed after 4 hrs treatment with 425.4 µg/mL and above in the absence of S9 mix. In addition, 22 hrs treatment with 243.1 µg/mL and above in the absence of S9 mix induced strong toxic effects. In the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. Considering the toxicity data of the pre-test, 425.4 µg/mL (without S9 mix) and 2280.0 µg/mL (with S9 mix) were chosen as top concentrations in the second experiment
COMPARISON WITH HISTORICAL CONTROL DATA: The incidences of chromosome aberrations in the positive control and negative control were both within the range of the test laboratory's historical data, indicating that this study is valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Clear cytotoxicity was observed in Experiment I, after continuous treatment at the highest evaluated concentration of 243.1 µg/mL (44.1 % of control). In the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In experiment I, after pulse treatment in the absence of S9 mix, and in Experiment II, concentrations showing clear cytotoxic effects were not scorable for cytogenetic damage - Remarks on result:
- other: strain/cell type: human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not induce structural chromosomal aberrations as determined by the chromosome aberration test in human lymphocytes in vitro. - Executive summary:
This in vitro assay with human lymphocytes was performed to assess the potential of the test item Menthyl lactate to induce structural chromosomal aberrations in the absence and presence of an exogenous metabolic activation system (liver S9 mix from phenobarbital/ß-naphthoflavone treated male rats).The study was performed under GLP and followed the method described in OECD TG 473.
In each experimental group two parallel cultures were analysed. Per culture 100 metaphases were evaluated for structural chromosomal aberrations. The highest applied concentration in this study (2280 µg/mL of the test item) was chosen with regard to the molecular weight and the purityof the test item and with respect to the current OECD Guideline 473. Dose selection of the cytogenetic experiments was performed considering the toxicity data and test item precipitation.
In Experiment I, after continuous treatment in the absence of S9 mix, clear cytotoxicity was observed at the highest evaluated concentration. In the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In Experiment I, after pulse treatment, in the absence of S9 mix and in Experiment II, concentrations showing clear cytotoxic effects were not scorable for cytogenetic damage.
In both independent experiments, neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No relevant increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls. Appropriate mutagens were used as positive controls. They induced statistically significant increases (p < 0.05) in cells with structural chromosome aberrations.
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