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EC number: 227-561-6 | CAS number: 5888-33-5
- 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:
- 2012-07-10 - 2012-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted May 26, 1983
- 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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
- EC Number:
- 227-561-6
- EC Name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
- Cas Number:
- 5888-33-5
- Molecular formula:
- C13H20O2
- IUPAC Name:
- (1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Isobornyl acrylate
- 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
- Additional strain / cell type characteristics:
- other:
- Remarks:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix fraction of Aroclor 1254-induced, male Sprague-Dawley rats and male Syrian hamster livers
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II; Salmonella typhimurium
without S9 mix: 0.3; 1; 3, 10, 33; 100; 333; and 1000 µg/plate
with S9 mix 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Escherichia coli
with and without S9 mix: 33: 100; 333; 1000; 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. 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, Merck, Darmstadt, purity > 99 %)
- 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 with 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 azide (purity: >= 99.0%, supplier: Serva, D-69042 Heidelberg, Germany) dissolved in aqua dest.; concentration: 10 µg/plate Migrated to IUCLID6: without metabolic activation
- Positive controls:
- yes
- Remarks:
- for TA 1537, TA 98
- Positive control substance:
- other: 4-nitro-o-phenylenediamine, without metabolic activation
- Remarks:
- 4-nitro-o-phenylenediamine (purity: > 99.9%, supplier: Fluka (Sigma Aldrich), 82024 Taufkirchen/Germany, dissolved in DMSO; concentration: 10 µg/plate
- Positive controls:
- yes
- Remarks:
- for E. coli WP2 uvr A
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- methylmethanesulfonate, MMS (purity: > 99.0%, Supplier: Sigma Aldrich, 82024 Taufkirchen/Germany Migrated to IUCLID6: without metabolic activation
- Positive controls:
- yes
- Remarks:
- for TA 1535, TA 1537, TA 98, TA 100, E. coli WP2 uvr A
- Positive control substance:
- other: 2-aminoanthracene, with metabolic activation
- Remarks:
- 2-aminoanthracene (purity: 97.5%, supplier: Sigma-Aldrich, D-82024 Taufkirchen, Germany) dissolved in DMSO; concentration: 2.5 µg/plate (10 µg/plate in TA 102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation assay as described by Haworth et al. 1983, with some differences.
- Salmonella typhimurium strains were obtained from Dr. Bruce Ames (University of California, Berkeley, U.S.A.) and were stored as recommended (Maron and Ames, 1983).
- Cultures were grown overnight with shaking at 37 °C in Oxoid No. 2 broth, and their phenotypes were analyszed prior to their use for mutagenicity assays.
Test conditions:
System of testing:
-Metabolic activation system: S9 from rat liver, induced with phenobarbital and 5,6-benzoflavone.
Administration:
-Number of replicates: 2
-Plate per test: 3
-Application: pre-incubation - Evaluation criteria:
- Validity of the data is confirmed by the laboratory´s historical control data from January 2011 until December 2011 representing approx.550 experiments (WP2 uvrA the historical data are based on approx. 200 experiments).
- Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was not observed below 100 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was not observed below 100 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was not observed below 100 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was not observed below 100 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was not observed below 100 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the decribed mutagenicity test with Salmonella typhimurium and Escherichia coli and under the experimental conditions reported, Isobornyl acrylate did not induce gene mutations by base pair changes or frame shifts 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. - Executive summary:
The study was performed to investigate the potential of Isobornyl acrylate to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment /Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II; Salmonella typhimurium
without S9 mix: 0.3; 1; 3, 10, 33; 100; 333; and 1000 µg/plate
with S9 mix 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Escherichia coli
with and without S9 mix: 33: 100; 333; 1000; 2500; and 5000 µg/plate
Reduced background growth was observed at higher concentrations with and without
metabolic activation in strains TA 1535, TA 1537, TA 98, and TA 100 in both independent
experiments.
Toxic effects, evident as a reduction in the number of revertants (below the indication
factor of 0.5), were observed at higher concentrations in strains TA 1535, TA 1537, TA 98,
and TA 100 with and without metabolic activation in both independent experiments.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Isobornyl acrylate at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, Isobornyl acrylate is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia colireverse mutation assay.
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