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Diss Factsheets
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EC number: 201-911-8 | CAS number: 89-48-5
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2012-09-11 to 2013-
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 487
- Deviations:
- yes
- Remarks:
- To get proper responses of statistical significance when using the specified positive controls the test design, specifically for the treatment, the expression phase and harvest time, was slightly modified compared to the OECD Guideline 487.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- - Type and identity of media: DMEM:F12 (Dulbecco's modified eagle medium/Ham's F12 medium, mixture 1:1) supplemented with 200 mM GlutaMax
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- pre-test on cytotoxicity: up to 1983.0 µg/mL (approx. 10 mM)
Further concentrations please see Table 1 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol; final concentration of ethanol in the culture medium was 0.5 % (v/v)
- Justification for choice of solvent/vehicle: The solvent was chosen due to its solubility properties and its relative non-toxicity to the cell cultures. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without metabolic activation
- Positive control substance:
- mitomycin C
- other: Demecolcin
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- With metabolic activation
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 h
- Exposure duration: 4 h with and without S9 mix (experiment I) or 4 h with S9 mix and 20 h without S9 mix (experiment II: A and B) (see Table 1)
- Expression time (cells in growth medium): cells exposed for 4 h have 16 h recovery period before fixation (expression phase), no recovery period for 20 h exposure cells
- Selection time (if incubation with a selection agent): 20 h with Cytochalasin B (4 µg/mL)
- Cells were prepared 40 h after start of the exposure
SPINDLE INHIBITOR (cytogenetic assays): Cytochalasin B (4 µg/mL)
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED:
cytotoxic effect the CBPI: ca 500 cells per culture and cytotoxicity is expressed as % cytostasis
micronuclei effects: 1000 - 2000 binucleate cells per culture. The frequency of micronucleated cells was reported as % micronucleated cells
DETERMINATION OF CYTOTOXICITY
- percentages of reduction in the CBPI (cytokinesis-block proliferating index) in comparison with the controls (% cytostasis) by counting 500 cells per culture in duplicate - Evaluation criteria:
- A test item can be classified as non-clastogenic 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 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.
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 211.4 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes:
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 180.0 µg/mL
- 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 data
- Water solubility: phase separation in Experiment I and IIA at and above 211.4 µg/mL with and without S9 mix; in Experiment IIB at and above 220.0 µg/mL without S9 mix.
- Precipitation: no
- Other confounding effects: no
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes - Remarks on result:
- other: other: Experiment I
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions reported, the test item did not induce micronuclei as determined by the in vitro micronucleus test in human lymphocytes. Therefore, Menthyl Acetate Racemic is considered to be non-aneugenic and non-clastogenic when tested upto cytotoxic, the highest evaluable or the highest required concentration. - Executive summary:
The study was conducted according to OECD Guideline 487. The expression phase and harvest time were slightly modified compared to the OECD Guideline 487. The test item Menthyl Acetate Racemic, dissolved in ethanol, was assessed for its potential to induce micronuclei in human lymphocytes in vitro in three independent experiments. The following study design was performed:
Without S9-Mix
With S9-Mix
Exp. I
Exp. IIA & IIB
Exp. I and IIA
Exposure period
4 hrs
20 hrs
4 hrs
Recovery
16 hrs
-
16 hrs
Cytochalasin B exposure
20 hrs
20 hrs
20 hrs
Preparation interval
40 hrs
40 hrs
40 hrs
Total culture period
88 hrs
88 hrs
88 hrs
In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were evaluated for cytogenetic damage. The highest applied concentration in this study (1983.0 µg/mL of the test item, approx. 10 mM) was chosen with regard to the molecular weight of the test item and with respect to the guideline. Dose selection of the cytogenetic experiment was performed considering the toxicity data in accordance with the guideline. The evaluated experimental points and the results are summarised in Table 2 (see Attached document). In Experiment I the absence and presence of S9 mix and in Experiment IIA in the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In Experiment IIA in the absence of S9 mix concentrations showing clear cytotoxicity were not evaluable for cytogenetic damage. In Experiment IIB in the absence of S9 mix clear cytotoxicity was observed at the highest evaluated concentration. In the absence and the presence of S9 mix, no increase in the number of micronucleated cells was observed after treatment with the test item. One single statistically significant increase in micronucleated cells was observed in Experiment IIA after continuous treatment with 120.8 µg/mL in the absence of S9 mix (0.85 %). The value was clearly within the laboratory historical control data range (0.05 – 1.45 % micronucleated cells) and thus considered as being biologically irrelevant. Appropriate mutagens were used as positive controls. They induced statistically significant increases in cells with micronuclei. Under the experimental conditions reported, the test item did not induce micronuclei as determined by the in vitro micronucleus test in human lymphocytes. Therefore, Menthyl Acetate Racemic is considered to be non-aneugenic and non-clastogenic in this in vitro micronucleus test, when tested up to cytotoxic, the highest evaluable or the highest required concentration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Three genetic toxicity in vitro assays were conducted with the substance covering different modes of action of genetic toxicity. The substance did not produce significant genetic toxicity in a reliable bacterial reverse mutation assay with S. typhimurium and E. coli, in an in vitro Gene Mutation Assay in Chinese Hamster V79 Cells (V79/HPRT) and in an in vitro micronucleus assay with human lymphocytes. It is therefore concluded that the substance is not genotoxic. Further testing on the genetic toxicity of Menthyl Acetate is not required.
Justification for selection of genetic toxicity endpoint
GLP and guideline study performed in mammalian cells to detect the activity of clastogenic and aneugenic chemicals.
Justification for classification or non-classification
Based on the above stated assessments on genotoxicity the test substance Menthyl Acetate is not considered to be genotoxic and does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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