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EC number: 231-927-0 | CAS number: 7779-31-9
- 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:
- February / April 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3,5-trimethylcyclohexyl methacrylate
- EC Number:
- 231-927-0
- EC Name:
- 3,3,5-trimethylcyclohexyl methacrylate
- Cas Number:
- 7779-31-9
- Molecular formula:
- C13H22O2
- IUPAC Name:
- 3,3,5-trimethylcyclohexyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- n/a
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA97a, TA98, TA100 and TA102
- Details on mammalian cell type (if applicable):
- n/a
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver
- Test concentrations with justification for top dose:
- Pre-experiment : 0.0031-0.01-0.3016-0.1-0.316-1.0-2.5-5.0 µl/plate
Main experiments : 0.0316-0.1-0.316-1.0-2.5-5.0 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine : TA97a + TA98 (without S9) ; 2-aminoanthracene : all strains with S9
- Details on test system and experimental conditions:
- -method of application : in agar plate incorporation (experiment 1) ; preincubation (experiment 3)
-triplicate (3 plates) by concentration in the main experiments
-Pre-experiment for toxicity: The toxicity of the test item was determined with strains TA98 and TA100. 8 concentrations were tested for toxicity and induction of mutations with 3 plates each, with plate incorporation method.
Toxicity may be detected by a reduction in the number of revertants, a clearing or diminution of the background lawn or by the degree of survival of treated cultures.
-triplicate (3 plates) by concentration in the main experiments
-Experiment 1 : For the plate incorporation method, the following materials were mixed in a test tube and poured over the surface of a minimal agar plate : test solution at each dose levels, solvent, S9 mix or S9 mix substitution buffer, bacteria suspension and overlay agar.
-Experiment 2: For pre-incubation method, the test item solution was preincubated with the tester strains and sterila buffer or the S9 for 60 minutes at 37 °C prior adding the overlay agar and pouring onto the surface of a minimal agar plate.
In the experiment 1 and 2, after the solidification the plates were inverted and incubated at 37°C for at least 48 hours in the dark. - Evaluation criteria:
- A test is considered acceptable if for each strain :
-the bacteria demonstrate their typical responses to crystal violet and ampicillin,
-the control plates without S9 are within the historical control data ranges,
-corresponding background growth on both negtaive control and test plate is observed,
-the positive controls show a distinct enhancement over te control plate.
A test item is considered as mutagenic if :
-a dose-related increase in the number of revertants occurs and/or
-a reproductible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
A biologically relevant increase is described as follow :
-if in strains TA97a, TA100 and TA102 the number of reversions is at least twice as high,
-if in strains TA1535 and TA98, the number of reversions is at least 3 times higher as compared ti the spontaneous reversion rate. - Statistics:
- no
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in TA98 and TA102 strains with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the experiment 1, no toxicity of the test item was observed in the tester strains TA1535, TA97a and TA102. In the tester strain TA98 a reduction of revertant colony numbers was noted at the highest dose group with S9. In tester strain TA100 a reduction of the background lawn was observed at the highest dose groups (with S9). In the experiment 2, no toxic effects of the test item were found in any tester strain used up to the highest dose group evaluated (+/-S9).
No substantial increases in revertant colony numbers of any of the five tester strains were observed following treatment with 3,3,5 -trimethyl cyclohexyl methacrylate at any concentration level, neither in the presence nor absence of metabolic activation in experiment 1 and 2.
Applicant's summary and conclusion
- Conclusions:
- The test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
In order to investigate the potential of 3,3,5 -trimethyl cyclohexyl methacrylate for its ability to induce gene mutations the plate incorporation test (experiment 1) and the pre-incubation test (experiment 2) were performed with the Salmonella typhimurium strains TA1535, TA97a, TA98, TA100 and TA102. The test item was tested in two independent experiments at several concentrations. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate.
In the experiment 1, no toxicity of the test item was observed in the tester strains TA1535, TA97a and TA102. In the tester strain TA98 a reduction of revertant colony numbers was noted at the highest dose group with S9. In tester strain TA100 a reduction of the background lawn was observed at the highest dose groups (with S9). In the experiment 2, no toxic effects of the test item were found in any tester strain used up to the highest dose group evaluated (+/-S9).
No substantial increases in revertant colony numbers of any of the five tester strains were observed following treatment with 3,3,5 -trimethyl cyclohexyl methacrylate at any concentration level, neither in the presence nor absence of metabolic activation in experiment 1 and 2.
In conclusion, it cas be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
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