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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 915-768-0 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1st August to 09 October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 261-020-5
- EC Name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 57934-97-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Reference substance name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 278-776-7
- EC Name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 77851-07-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test material name: Givescone
Batch No.: 9000375280
Appearance: colourless to yellow pale liquid
Expiration date: March 10, 2002
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 33; 100; 333; 1000; 2500; and 5000 microg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phylene-diamine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA1535, TA1537, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Distinct toxic effects, evident as a reduction in the number of revertants, occured in the test groups with and without metabolic activation at the following concentrations:
Experiment I (microg/plate) | Experiment II (microg/plate) | |||
without S9 mix | with S9 mix | without S9 mix | with S9 mix | |
TA1535 | 5000 | 5000 | 333, 2500 -5000 | 2500 - 5000 |
TA1537 | 100, 1000 - 5000 | 2500 - 5000 | 333 - 5000 | 1000 - 5000 |
TA98 | / | / | 333 - 5000 | 333 - 5000 |
TA100 | 333 - 5000 | 1000 - 5000 | 33 - 5000 | 333 - 5000 |
TA102 | 333 - 5000 | / | 100 -5000 | 333 - 5000 |
/ : no toxic effect received
The plates incubated with the test item showed irregular background growth at 1000 microg/plate and above with and without S9 mix in all strains.
No substancial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Givescone at any dose level, neither in the presence nor in absence of metabolic activation (s9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledge border of biological relevance.
Appropriate reference mutagens were used as postive controls and showed a disctinct increase of induced revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- In conlusion it can be stated that during the described mutagenicity test an under the experimental conditions, the test item did not induce gene mutations by base pair of changes or framesshifts in the genome of strains used.
Therefore the Givescone is considered to be non mutagenic in the Salmonella Typhimurium reverse mutation assay. - Executive summary:
This study was perfomred to investigate the potential of Givescone to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experimemt II) using the Salmonella Typhimurium strains TA1535, TA1537, TA98, TA100 and TA102.
The assay was performed in two independant experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate.
The plates incubated with the test item showed irregular background growth at 1000 microg/plate and above with and without S9 mix in all strains.
No substancial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Givescone at any dose level, neither in the presence nor in absence of metabolic activation (s9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledge border of biological relevance.
Appropriate reference mutagens were used as postive controls and showed a disctinct increase of induced revertant colonies.
In conlusion it can be stated that during the described mutagenicity test an under the experimental conditions, the test item did not induce gene mutations by base pair of changes or framesshifts in the genome of strains used. Therefore the Givescone is considered to be non mutagenic in the Salmonella Typhimurium reverse mutation assay.
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.