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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,6R)-4,6-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,6R)-4,6-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
EC number: 700-927-7 | 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:
- key study
- Study period:
- September 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed equivalent or similar to OECD 471 guideline, but predating GLP. A fifth strain to detect certain oxidising mutagens, cross-linking agents and hydrazines was not included.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No fifth strain was tested (E. coli or TA102).
- GLP compliance:
- no
- Remarks:
- Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
- EC Number:
- 700-927-7
- Molecular formula:
- C17H30O2
- IUPAC Name:
- Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): PM 968
- Physical state: liquid
- Storage condition of test material: no data available
Constituent 1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary toxicity assay (all strains):
Without and with S9-mix: 0, 0.5, 5, 50, 500 and 5000 µg/plate
Main study 1 and 2:
TA1535 (without and with S9-mix) and TA1537 (without S9-mix): 0, 5, 15, 50, 150 and 500 µg/plate
TA1537 (with S9-mix) and TA100 (without and with S9-mix): 0, 15, 50, 150, 500 and 1500 µg/plate
TA98 (without and with S9-mix): 0, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO is accepted and approved by authorities and international guidelines.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without S9-mix: 10 µg/plate in water for TA1535 and TA100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9-mix: 40 µg/plate in DMSO for TA1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without S9-mix: 10 µg/plate in DMSO for TA98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 2 µg/plate in DMSO for all tester strains
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 or 72 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the revertant colonies. - Evaluation criteria:
- The average number of mutant colonies per plate is compared with the average number of spontaneous revertants in the control. A dose-related
increase in the number of colonies which reaches at least a doubling of the control values is usually considered to be a positive response.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- of 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535, TA1537 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No information on precipitation in doses tested.
RANGE-FINDING/SCREENING STUDIES:
- Toxicity was observed at the top dose of 5000 µg/plate in strain TA1535 (with and without S9-mix), TA1537 (without S9-mix) and TA100 (without S9-mix)
COMPARISON WITH HISTORICAL CONTROL DATA:
- The positive control substances produced the expected mutagenic results.
ADDITIONAL INFORMATION ON CYTOTOXICITY MAIN STUDY:
- No toxicity or mutagenicity was observed up to and including the top dose of 5000 µg/plate in strain TA98.
- No toxicity or mutagenicity was observed up to and including the top dose of 500 µg/plate in strain TA1535 (with and without S9-mix), TA1537 (without S9-mix).
- No toxicity or mutagenicity was observed up to and including the top dose of 1500 µg/plate in strain TA1537 (with S9-mix) and TA100 (with and without S9-mix).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance was tested in the Salmonella typhimurium assay with strains TA1535, TA1537, TA98 and TA100 equivalent or similar to OECD 471 guideline. The substance is not mutagenic in strain TA1535, TA1537, TA98 and TA100 with and without S9-mix. - Executive summary:
The substance was tested in the Salmonella typhimurium assay with strains TA1535, TA1537, TA98 and TA100 equivalent or similar to OECD 471 guideline. In a preliminary toxicity test all four strains were tested up to 5000 ug/plate with and without metabolic activation. In the mutagenicity assay concentrations used were chosen on data obtained in the preliminary toxicity assay. In the mutagenicity assay no toxicity and no increase in the number of revertant colonies was observed in strain TA98 up to and including the top dose of 5000 µg/plate, with and without S9 -mix. No toxicity and no increase in the number of revertant colonies was observed up to and including the top dose of 500 µg/plate in strain TA1535 (with and without S9-mix), TA1537 (without S9-mix), and no toxicity and no increase in the number of revertant colonies was observed up to and including the top dose of 1500 µg/plate in strain TA1537 (with S9 -mix) and TA100. From this it can be concluded that the substance is not mutagenic in strains TA1535, TA1537, TA98 and TA100 with and without S9-mix in two main experiments.
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.