Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-719-8 | CAS number: 5502-75-0
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study in compliance with guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Acceptable to the Japanese New Chemical Substance Law (METI)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- [(1r,4r)-4-(propan-2-yl)cyclohexyl]methanol; [(1s,4s)-4-(propan-2-yl)cyclohexyl]methanol
- EC Number:
- 939-719-8
- Cas Number:
- 5502-75-0
- Molecular formula:
- C10H20O
- IUPAC Name:
- [(1r,4r)-4-(propan-2-yl)cyclohexyl]methanol; [(1s,4s)-4-(propan-2-yl)cyclohexyl]methanol
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Mayol [Description: clear colourless liquid. Chemical name: Reaction mass of Cis-4-(isopropyl)cyclohexanemethanol and Trans-4-(isopropyl)cyclohexanemethanol]
- Physical state: liquid
- Analytical purity: 99.8% (Sum of 2 isomers)
- Lot/batch No.: 1000877823
- Expiration date of the lot/batch: 16 August 2013
- Storage condition of test material: Room temperature in the dark
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: human lymphocytes
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Cells were grown in Eagle's minimal essential medium with HEPES buffer (MEM), supplemented “in-house” with L-glutamine, penicillin/streptomycin, amphotericin B and 10% foetal bovine serum (FBS), at 37ºC with 5% CO2 in humidified air. The lymphocytes of fresh heparinised whole blood were stimulated to divide by the addition of phytohaemagglutinin (PHA).
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Microsomal fraction prepared from livers of male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- EXPERIMENT 1:
without S9 (μg/ml): 0, 12.5, 25, 50, 100, 150 and 200
with S9 (2%) (μg/ml): 0, 12.5, 25, 50, 100, 150 and 200
EXPERIMENT 2:
without S9 (μg/ml): 0, 3.13, 6.25, 12.5, 25, 50 and 100
with S9 (1%) (μg/ml): 0, 12.5, 25, 50, 100, 150 and 200 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulphoxide (DMSO)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DSMO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- other: cyclophosphamide (+S9)
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: 4 hours (± S9) in Experiment 1, 4 hours (+S9) and 24 hours (-S9) in Experiment 2
- Expression time (cells in growth medium): 20 hours (± S9) in Experiment 1, 20 hours (+S9) in Experiment 2
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 consecutive well-spread metaphases from each culture were counted
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: If greater than 44 chromosomes are scored and the number is a multiple of the haploid count then the cell is classified as a polyploid cell.
- Determination of endoreplication: If the chromosomes are arranged in closely apposed pairs, i.e., 4 chromatids instead of 2, the cell is scored as endoreduplicated (E). - Evaluation criteria:
- A positive response was recorded for a particular treatment if the % cells with aberrations, excluding gaps, markedly exceeded that seen in the concurrent control, either with or without a clear dose-relationship. For modest increases in aberration frequency a dose response relationship is generally required and appropriate statistical tests may be applied in order to record a positive response.
- Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells were compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Key result
- Species / strain:
- mammalian cell line, other: human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: >100 μg/ml (-S9) and >150 μg/ml (+S9); Experiment 2: >50 μg/ml (-S9) and >100 μg/ml (+S9).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The test item showed marked evidence of toxicity in all three exposure groups. Haemolysis was seen in the blood cultures at the end of the exposure period at and above 24.42 μg/ml in the 4(20)-hour exposure group in the absence of S9, and at and above 48.84 μg/ml in the 4(20)-hour exposure group in the presence of S9 and in the 24-hour continuous exposure group.
Microscopic assessment of the slides prepared from the treatment cultures showed that metaphase cells were present up to 97.69 μg/ml in the 4(20)-hour treatment in the absence of metabolic activation (S9) and in the 24-hour continuous exposure group in the absence of S9. The maximum dose with metaphases present in the 4(20)-hour exposure in the presence of S9 was 195.38 μg/ml.
EXPERIMENT 1:
The qualitative assessment of the slides determined that the toxicity was similar to that observed in the Preliminary Toxicity Test and that there were metaphases suitable for scoring present up to the test item dose level of 150 μg/ml in both the presence and absence of metabolic activation (S9). The toxicity curve was relatively sharp with no observed metaphases present at the higher dose level of 200 μg/ml in either exposure group. The ‘A’ replicate of the 150 μg/ml dose level in the presence of S9 was lost due to a technical error during the harvesting process and therefore extra scoring was performed on the ‘B’ culture to compensate. This is acceptable under the test guidelines.
The results of the mitotic indices (MI) from the cultures after their respective treatments show 69% and 31% growth inhibition was achieved at 150 μg/ml μg/ml in the absence and presence of S9 respectively.
No precipitate of the test item was observed at the end of the treatment period in either exposure group. Haemolysis was observed at the end of the exposure period in both exposure groups at and above 50 μg/ml.
Thus, the selection of maximum dose level selected for metaphase analysis was 150 μg/ml for both exposure groups and was the highest dose level with metaphases suitable for scoring in both exposure groups.
EXPERIMENT 2:
The qualitative assessment of the slides determined that there were metaphases suitable for scoring present at the maximum test item dose level of 100 μg/ml in both the presence and absence of S9.
The results of the mitotic indices (MI) from the cultures after their respective treatments show a dose related increase in toxicity in the 24-hour exposure group and 36% and 65% mitotic inhibition was achieved at 50 and 100 μg/ml respectively. In the presence of S9 the toxicity curve was very sharp with no toxicity being demonstrated up to the test item dose level of 100 μg/ml and no observed metaphases present at 150 μg/ml. The increase in toxicity in the 4(20)-hour exposure group in the presence of S9 when compared to the same Experiment 1 exposure group is considered to be due to the reduction in the S9 concentration and its protective effects.
No precipitate of the test item was observed at the end of the treatment period in either exposure group. Haemolysis was seen at the end of exposure at and above 50 μg/ml in both exposure groups.
Thus, the maximum dose level selected for metaphase analysis was the highest dose level with metaphases suitable for scoring and was 100 μg/ml for both exposure groups. Although optimum toxicity was not achieved in the 4(20)-hour exposure group in the presence of S9, due to the relative steepness of the toxicity curve, the test item was considered to have been adequately tested.
Any other information on results incl. tables
Experiment 1
The qualitative assessment of the slides determined that the toxicity was similar to that observed in the Preliminary Toxicity Test and that there were metaphases suitable for scoring present up to the test item dose level of 150 µg/ml in both the presence and absence of metabolic activation (S9).
The results of the mitotic indices (MI) from the cultures after their respective treatments show 69% and 31% growth inhibition was achieved at 150 µg/ml in the absence and presence of S9, respectively.
Thus, the selection of maximum dose level selected for metaphase analysis was 150 µg/ml for both exposure groups and was the highest dose level with metaphases suitable for scoring in both exposure groups.
All of the vehicle control cultures had frequencies of cells with chromosome aberrations within the expected range. The positive control items induced statistically significant increases in the frequency of cells with aberrations. The metabolic activation system was therefore shown to be functional and the test method itself was operating as expected.
The test item did not induce any statistically significant increases in the frequency of cells with aberrations either in the absence or presence of metabolic activation.
The test item did not induce a statistically significant increase in the numbers of polyploid cells at any dose level in either of the exposure groups.
Experiment 2
The results of the mitotic indices (MI) from the cultures after their respective treatments show a dose related increase in toxicity in the 24-hour exposure group and 36% and 65% mitotic inhibition was achieved at 50 and 100 µg/ml respectively.
Thus, the maximum dose level selected for metaphase analysis was the highest dose level with metaphases suitable for scoring and was 100 µg/ml for both exposure groups.
All of the vehicle control cultures had frequencies of cells with chromosome aberrations within the expected range. The positive control items induced statistically significant increases in the frequency of cells with aberrations. The metabolic activation system was therefore shown to be functional and the test method itself was operating as expected.
The test item did not induce any statistically significant increases in the frequency of cells with chromosome aberrations either in the absence or presence of metabolic activation.
The test item did not induce a significant increase in the numbers of polyploid cells at any dose level in either of the exposure groups.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
The test item did not induce any statistically significant increases in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments. Therefore the substance was considered to be non-clastogenic to human lymphocytes in vitro. - Executive summary:
The chromosome aberration test for the substance was conducted according to OECD Guideline No. 473 and under GLP conditions. The test substance did not induce any statistically significant increases in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments at test concentrations of either 100 or 200 µg/mL, depending on the test. Consequently, the substance was considered to be non-clastogenic to human lymphocytes in vitro.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.