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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-396-3 | 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 18 February - 07 April 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- 2 014
- Report date:
- 2014
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- cis-α,α,4-trimethylcyclohexanemethanol
- EC Number:
- 230-795-1
- EC Name:
- cis-α,α,4-trimethylcyclohexanemethanol
- Cas Number:
- 7322-63-6
- Molecular formula:
- C10H20O
- IUPAC Name:
- cis-2-(4-methylcyclohexyl)propan-2-ol
- Reference substance name:
- trans-α,α,4-trimethylcyclohexanemethanol
- EC Number:
- 225-844-9
- EC Name:
- trans-α,α,4-trimethylcyclohexanemethanol
- Cas Number:
- 5114-00-1
- Molecular formula:
- C10H20O
- IUPAC Name:
- trans-2-(4-methylcyclohexyl)propan-2-ol
- Reference substance name:
- cis-4-isopropyl-1-methylcyclohexanol
- Cas Number:
- 3901-95-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- cis-4-isopropyl-1-methylcyclohexanol
- Reference substance name:
- trans-4-isopropyl-1-methylcyclohexanol
- Cas Number:
- 3901-93-7
- Molecular formula:
- C10H20O
- IUPAC Name:
- trans-4-isopropyl-1-methylcyclohexanol
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No. MP8 du 29/10/2013
Purity: 98.8% (sum of the 4 main constituents)
Name of the test item (as cited in the study report): DIHYDROTERPINEOL MULTICONSTITUENT
IUPAC Name of the test item: Reaction mass of cis-2-(4-methylcyclohexyl) propan-2-ol and trans-2-(4-methylcyclohexyl) propan-2-ol and
cis- 4-isopropyl-1-methylcyclohexanol and trans- 4-isopropyl-1-methylcyclohexanol
Synonym: Reaction mass of cis-α,α-4-trimethyl-cyclohexanemethanol and trans-α,α-4-trimethyl-cyclohexanemethanol and cis-1-methyl-4-(1-methylethyl)-cyclohexanol and trans-1-methyl-4-(1-methylethyl)-cyclohexanol
Physical state: colourless – slightly amber liquid
Storage Conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry Date: 28 October 2015
Constituent 1
Constituent 2
Constituent 3
Constituent 4
impurity 1
Method
- Target gene:
- None
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1 (plate-incorporation method):
- TA1535, TA1537, TA98, TA100 and TA102: 5, 16, 50, 160, 500, 1600 and 5000 μg/plate, with and without S9-mix
Experiment 2 (plate-incorporation method without S9 mix; preincubation method with S9 mix):
- TA1535, TA1537, TA98, TA100 and TA102: 8.192, 20.48, 51.20, 128, 320, 800 and 2000 μg/plate, without S9-mix
- TA100, TA1537 and TA102: 8.192, 20.48, 51.20, 128, 320, 800 and 2000 μg/plate, with S9-mix
- TA98 and TA1535: 20.48, 51.20, 128, 320, 800, 2000 and 5000 μg/plate, with S9-mix
Experiment 3 (preincubation method):
- TA98 and TA1535: 3.277, 8.192, 20.48, 51.2, 128, 320 and 800 μg/plate, with S9-mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Preliminary solubility data indicated that Dihydroterpineol multiconstituent was soluble in anhydrous analytical grade dimethyl sulphoxide (DMSO) at concentrations up to at least 100 mg/mL.Therefore, DMSO was selected as vehicle.
- Test substance preparation: Test substance stock solutions were prepared by formulating Dihydroterpineol multiconstituent under subdued lighting in DMSO, to give the maximum required treatment concentration. Subsequent dilutions were made using DMSO. The test article solutions were protected from light and used within approximately 3.5 h of initial formulation.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- 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:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM:
Strains TA98, TA1535 and TA1537 were originally obtained from the UK NCTC. Strains TA100 and TA102 were derived from cultures originally obtained from Covance Laboratories Inc., USA.
METHOD OF APPLICATION: In agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 minutes at 37 ± 1 °C, with shaking
- Incubation period: Plates were inverted and incubated at 37 ± 1 °C in the dark for 3 days in both direct plate and preincubation methods.
NUMBER OF REPLICATIONS:
- Vehicle and positive controls were included in quintuplicate and triplicate plates, respectively.
- Treatment (test item) groups were included in triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: The background lawns of the plates were examined for signs of toxicity. Other evidence of toxicity may have included a marked reduction in revertants compared to the concurrent vehicle controls and/or a reduction in mutagenic response. Where mutation data from fewer than five treatment concentrations was obtained, an evaluation of the mutation data for the study as a whole was made. If the mutation data for any strain treatment was considered insufficient to provide a thorough and robust assessment of mutagenicity then additional testing was conducted.
OTHER:
- Strain characteristics: The inocula were taken from master plates or vials of frozen cultures, which had been checked for strain characteristics (histidine dependence, rfa character, uvrB character and resistance to ampicillin or ampicillin plus tetracycline). Checks were carried out according to Maron and Ames, 1983 and De Serres and Shelby, 1979.
- Colony counting: Colonies were counted electronically using a Sorcerer Colony Counter (Perceptive Instruments). The background lawn was inspected for signs of toxicity. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
A concentration related increase in revertant numbers was ≥1.5-fold (in strain TA102), ≥2-fold (in strains TA98 and TA100) or ≥3-fold (in strains TA1535 and TA1537) the concurrent vehicle control values.
The test article was considered positive in this assay if the above criterion was met.
The test article was considered negative in this assay if the above criterion was not met.
Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and between experiments. - Statistics:
- The presence or otherwise of a concentration response was checked by non-statistical analysis, up to limiting levels (for example toxicity, precipitation or 5000 μg/plate). However, adequate interpretation of biological relevance was of critical importance (OECD, 1997; ICH S2(R1), 2011).
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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
- Precipitation: None
- Other confounding effects: None
COMPARISON WITH HISTORICAL CONTROL DATA: Mean vehicle control counts fell within the laboratory’s historical ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Experiment 1: Following the treatment, evidence of toxicity ranging from a diminution of the background bacterial lawn, with or without a concurrent marked reduction in revertant numbers, to a complete killing of the test bacteria was observed at 500 μg/plate and/or 1600 μg/plate and above in all strains in the absence and presence of S-9.
- Experiment 2: Following the treatment, evidence of toxicity ranging from a slight thinning of the background bacterial lawn, to a complete killing of the test bacteria was observed at 800 μg/plate and/or at 2000 μg/plate and/or 5000 μg/plate in the absence and presence of S-9 in all strains. In addition, complete toxicity was observed at 320 μg/plate on a single plate for strain TA1537 in the presence of S-9 only. Since mutation data were only available for four concentrations in the presence of S-9 for strains TA98 and TA1535 due to toxicity, a further Experiment (Experiment 3) was performed.
- Experiment 3: Following the treatment, evidence of toxicity ranging from a slight thinning of the background bacterial lawn to a complete killing of the test bacteria was observed at 320 μg/plate and above in both strains.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- The test item is not considered as mutagenic in S. typhimurium (TA1535, TA1537, TA98, TA100 and TA102) strains in a study conducted according to OECD Guideline 471.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were exposed to test item dihydroterpineol multiconstituent at the concentrations below.
Experiment 1 (plate-incorporation method)
- TA1535, TA1537, TA98, TA100 and TA102: 5, 16, 50, 160, 500, 1600 and 5000 μg/plate, with and without S9-mix
Experiment 2 (plate-incorporation method without S9 mix; preincubation method with S9 mix)
- TA1535, TA1537, TA98, TA100 and TA102: 8.192, 20.48, 51.20, 128, 320, 800 and 2000 μg/plate, without S9-mix
- TA100, TA1537 and TA102: 8.192, 20.48, 51.20, 128, 320, 800 and 2000 μg/plate, with S9-mix
- TA98 and TA1535: 20.48, 51.20, 128, 320, 800, 2000 and 5000 μg/plate, with S9-mix
Experiment 3 (preincubation method)
- TA98 and TA1535: 3.277, 8.192, 20.48, 51.2, 128, 320 and 800 μg/plate, with S9-mix
Metabolic activation system used in this test is 10% S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats induced with Aroclor 1254. Vehicle and positive control groups were also included in mutagenicity tests.
In Experiment 1, following the treatment, evidence of toxicity was observed at 500 μg/plate and/or 1600 μg/plate and above in all strains in the absence and presence of S-9. In Experiment 2, evidence of toxicity was observed at 800 μg/plate and/or at 2000 μg/plate and/or at 5000 μg/plate in the absence and presence of S-9 in all strains. In addition, complete toxicity was observed at 320 μg/plate on a single plate for strain TA1537 in the presence of S-9 only. Since mutation data were only available for four concentrations for strains TA98 and TA1535 in the presence of S-9 due to toxicity, a further experiment (Experiment 3) was performed. In Experiment 3, evidence of toxicity was observed at 320 μg/plate and above in both strains.
The mean numbers of revertant colonies fell within acceptable ranges for vehicle control treatments, and were elevated by positive control treatments.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Therefore, the test item is not considered as mutagenic in this bacterial system.
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.