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EC number: 441-420-8 | CAS number: 113889-23-9
- 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:
- 7 November 2001 - 7 December 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- -
- EC Number:
- 441-420-8
- EC Name:
- -
- Cas Number:
- 113889-23-9
- Molecular formula:
- C14H20O2
- IUPAC Name:
- tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl butanoate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl butanoate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- His-gene and Trp-gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- PRELIMINARY TOXICITY STUDY
- Strains TA100 and -WP2uvrA‾ were tested
-Ten concentrations of the test material and a vehicle control (dimethyl sulphoxide) were tested (+/-S9): 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/plate
MUTATION STUDY - EXPERIMENT 1 (RANGE-FINDING STUDY)
-TA98, TA100, TA1535, TA1537 (-S9): 1.5, 5, 15, 50, 150, 500 µg/plate
-TA100, TA1535, TA98 (+S9): 5, 15, 50, 150, 500, 1500 µg/plate
-TA1537 ( +S9): 15, 50, 150, 500, 1500, 5000 µg/plate
-WP2uvrA‾ (+/-S9): 50, 150, 500, 1500, 5000 µg/plate
MUTATION STUDY - EXPERIMENT 2 (MAIN STUDY)
-TA98, TA100, TA1535, TA1537 (-S9): 1.5 to 500 µg/plate
-TA98, TA100, TA1535, TA1537 (-S9): 15 to 5000 µg/plate
-WP2uvrA‾ (+/-S9): 50 to 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulphoxide, prior to use dried using molecular sieves (sodium alumino-silicicate)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- benzo(a)pyrene and 2-Aminoanthracene are tested with S9, the other three substances without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT (mutation assays): agar containing Histidine and Tryptophan
NUMBER OF REPLICATIONS: Triplate for each bacterial strain and for each concentration of the test material both with and without S9.
DETERMINATION OF GENOTOXICITY
-number of revertants
OTHER:
- Temperature 37 °C
VALIDITY:
The reverse mutation assay was considered valid if the following criteria were met:
- All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls
- The appropriate characteristics for each tester strain have been confirmed
- Each mean positive control value should be at least two times the respective vehicle control value for each strain
- There should be a minimum of four non-toxic test material dose levels
- There should not be excessive loss of plates due to contamination - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met: The test material should have induced a reproducible, dose related and statistically (Dunnett's method of linear regression) significant increase in the revertant count in at least one strain of bacteria.
- Statistics:
- No data
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY STUDY
The test material caused a visible reduction in the growth of the bacterial background lawn to all of the Salmonella tester strains. The toxic responses were greater on plates dosed in the absence of S9-mix with weakened lawns initially observed at 150 µg/plate. Plates dosed in the presence of S9 exhibited variable toxicity at higher test material dose levels (1500 µg/plate). No toxicity was exhibited in Escherichia coli strain WP2uvrA‾ either with or without S9-mix.
MUTATION STUDY
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable. All of the positive control chemicals used in this test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of bacterial strains. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay performed according to OECD 471 (1997).
- Executive summary:
To determine the mutagenic potential of Cyclobutanate, a bacterial reverse mutation assays (Ames test) was performed according to OECD 471 using Salmonella thyphimurium strains TA1535, TA1537, TA98 and TA100, and Escherichia coli strain WP2uvrA. The bacterial cultures were treated according to the Ames plate incorporation method at up to six dose level, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9). The dose range was determined in a prelimitary toxicity assay and ranges between 1.5 and 5000 µg/plate, depending on bacterial tester strain type and presence or absence of S9 -mix.
The mean number of revertants observed in the negative controls (DMSO) for each of the test strains was within acceptable historical negative control ranges. Furthermore, all of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. All test strains demonstrated appropriate phenotypic characteristics.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. Therefore, the testing material was considered to be non-mutagenic under the conditions of this test. According to the criteria outlined in Annex VI of 67/548/ECC and Annex I of 1272/2008/EC, Cyclobutanate does not have to be classified as mutagenic.
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