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EC number: 231-403-1 | CAS number: 7534-94-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Principles of method if other than guideline:
- The bacterial reverse mutation test is able to identify substances that cause point mutations, by substitution, addition or deletion of one or a few
DNA base-pairs. Mutagenic substances can induce reversion in histidine-(for Salmonella typhimurium) or tryptophan-(for Escherichia coli)
deficient strains which are then able to grow and form colonies in a histidine- or tryptophan limited medium, while non-reverted strains cannot. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 7-8 March 2007
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate
- EC Number:
- 231-403-1
- EC Name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate
- Cas Number:
- 7534-94-3
- Molecular formula:
- C14H22O2
- IUPAC Name:
- 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Supplier : Rhodia Inc. (Cranbury, NJ USA)
- Name of test material: Isobornyl Methacrylate (IBOMA)
- CAS Registry No. : 7534-94-3
- Molecular weight : 222 g/mol
- Substance type: organic
- Physical state at room temperature: liquid
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix fraction of Aroclor 1254-induced rats
- Test concentrations with justification for top dose:
- Main experiment:
+/-S9 mix; 0, 156.3 (2nd experiment only), 312.5, 625, 1250, 2500 and 5000 µg/plate
According to the results of the pre-experiment the concentrations applied in the main experiments were chosen.
The maximum concentration was 5000.0 µg/plate. The concentration range include two logarithmic decades. Five to six adequately spaced
concentrations were tested. Two independent experiments were performed.
Each chemical was tested initially at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one which was toxic in
the preliminary toxicity test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulfoxide (DMSO)
- Justification for choice of solvent/vehicle: The solvent was chosen because of its relative nontoxicity for the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Concurrent untreated and solvent control: DMSO were performed
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle: DMSO
- True negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- for TA 1535, TA 100
- Positive control substance:
- sodium azide
- Remarks:
- sodium acide concentration: 1 µg/plate Migrated to IUCLID6: without metabolic activation
- Positive controls:
- yes
- Remarks:
- for TA 1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 9-aminoacridine concentration: 50 µg/plate Migrated to IUCLID6: without metabolic activation
- Positive controls:
- yes
- Remarks:
- for TA 98
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 2-nitrofluorene concentration: 0.5 µg/plate Migrated to IUCLID6: without metabolic activation
- Positive controls:
- yes
- Remarks:
- for WP2 uvrA strain
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 4-nitroquinoline-N-oxide concentration: 2.0 µg/plate Migrated to IUCLID6: without metabolic activation
- Positive controls:
- yes
- Remarks:
- for TA 1535, TA 1537 and TA 98
- Positive control substance:
- other: 2-Anthramine; with metabolic activation
- Remarks:
- 2-Anthramine concentration: 2 µg/plate
- Positive controls:
- yes
- Remarks:
- for TA 100
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- benzo(a)pyrene concentration: 5 µg/plate Migrated to IUCLID6: with metabolic activation
- Positive controls:
- yes
- Remarks:
- for WP2 uvrA strain
- Positive control substance:
- other: 2-Anthramine; with metabolic activation
- Remarks:
- 2-Anthramine concentration: 10 µg/plate
- Details on test system and experimental conditions:
- EXPERIMENTAL DESIGN
Treatment
The test item was tested in a preliminary test and two mutagenicity experiments. The preliminary test and the first experiment were performed
according to the direct plate incorporation method. The second experiment with and without S9 mix was performed according to the preincubation
method.
Salmonella typhimurium and E. coli strains were treated with Isobornyl methacrylate using the direct plate incorporation method with at least five dose levels, plated in triplicate, for the preliminary test and the first mutagenicity experiment with and without S9. The second experiment tested six dose levels with and without S9 mix and was performed according to the preincubation method. The dose range was determined in a preliminary toxicity assay in which the highest dose tested was 5000 µg/plate. Moderate toxicity was observed in the TA 100 stran at 5000 µg/plate dose level with and without S9 mix. For the plate incorporation method, 0.1 mL bacterial suspension and 2 mL of overlay agar were mixed with 0.05 mL S9 mix (when required) or phosphate buffer (pH 7.4). Following homogenization, the mixture was on minimal medium. Once solidified, the plates were inverted and incubated for 48 to 72 hours at 37 ± 2 °C.
In the preincubation method, 0.05 mL of IBOMA solution, vehicle control or positive control solution and 0.05 mL S9 mix (when required) or phosphate buffer (pH 7.4) were mixed with 0.1 mL bacterial suspension and added to a glass culture tube. The mixture was incubated for 60 ± 3 minutes at 37 ± 2 °C under shaking. After incubation, 2 mL of overlay agar were added and the mixture was poured onto minimum agar plate. Once solidified, the plates were inverted and incubated for 48 to 72 hours at 37 ± 2°C. - Evaluation criteria:
- A significant response is described as follows:
A test article is considered mutagenic if in strain TA 100 and TA 98 and WP2 uvrA the number of reversions is at least twice as high and in strains TA 1535 and TA 1537 it is at least three times higher as compared to the vehicle controls. Also, a dose-dependent and reproducible
increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the
highest dose induced the above described enhancement factors or not. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic concentration: >= 5000 µg/plate for TA 1535
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic concentration: >= 5000 µg/plate for TA 1537
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic concentration: >= 5000 µg/plate for TA 98
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic concentration: >= 2500 µg/plate for TA 100
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic concentration: >= 5000 µg/plate for WP2 uvrA
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
In conclusion, it can be stated that during the decribed mutagenicity test and under the experimental conditions reported, Isobornyl methacrylate did not induce gene mutations by base pair changes or frameshifts in the genome of the strains tested.
Therefore, the test substance has to be judged as nonmutagenic up to 5000 µg/plate in the presence and absence of mammalian metabolic activation according to the Ames test results. - Executive summary:
In a reverse gene mutation assay (according to OECD 471) in bacteria (Ames test), strains TA1535, TA1537, TA98, TA100, and TA102 of Salmonella typhimurium and Escherichia coli WP2 uvrA were exposed to Isobornyl methacrylate (99.07 % stabilised with 143 ppm MEHQ) at concentrations of up to 5000 µg/plate in the presence and absence of mammalian metabolic activation S9 -mix.
With the direct plate incorporation method, moderate to marked toxicity was noted in the TA 1535 strain at 5000 µg/plate and in the TA 100 strtain at dose levels of >= 2500 µg/plate with metabolic activation. Moderate toxicity was noted for TA 100 at 5000 µg/plate with metabolic activation. Exposure to graded doses of Isobornyl methacrylate in either the presence or the absence of metabolic activation. Exposure to graded doses of the test substance in either the presence or the absence of metabolic activation did not increase the reversion rates in any of the tester strains in either experiment.
Appropriate reference mutagens were used as positive controls.
The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for tests for in vitro mutagenicity (bacterial reverse gene mutation) data.
Conclusion:
Under the conditions of this study Isobornyl Methacrylate (IBOMA; CAS: 7534-94-3), did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli at the concentrations tested with and without metabolic activation.
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