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EC number: 916-331-7 | 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:
- 23 February 2007 - 16 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- EC Number:
- 916-331-7
- Molecular formula:
- C14H20O2
- IUPAC Name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- Test material form:
- liquid
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 TEST
With and without metabolic activation. Tested concentrations 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/plate.
MUTATION TEST EXPERIMENT 1 (Range-finding test)
With and without metabolic activation.
-Salmonella strains: 1.5, 5, 15, 50, 150, 500, 1500 µg/plate
-E.coli strain WP2uvrA‾: 50, 150, 500, 1500, 5000 µg/plate
MUTATION TEST EXPERIMENT 2 (Main test)
-All Salmonella strains (-S9): 1.5, 5, 15, 50, 150, 500 µg/plate
-Salmonella strains TA98 & TA1537 (+S9): 15, 50, 150, 500, 1500, 5000 µg/plate
-Salmonella strains TA100 & TA1535 (+S9): 5, 15, 50, 150, 500, 1500 µg/plate
-E.coli strain WP2uvrA‾ (+/-S9): 50, 150, 500, 1500, 5000 µg/plate
For all experiments additional dose levels were included for the salmonella strains to allow for test material induced toxicity, ensuring that a minimum of four non-toxic doses were achieved. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulphoxide
- Justification for choice of solvent/vehicle: The test material was immiscible in sterile distilled water at 50 mg/ml but was fully micible in dimethyl sulphoxide at the same concentration in solubility checks performed in-house.
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 with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48hr (at 37°C)
SELECTION AGENT (mutation assays): agar containing Histidine and Tryptophan
NUMBER OF REPLICATIONS: triplicate for each bacterial strain and for each concentration of the test material both with and without S9.
VALIDITY: In accordance with OECD 471.
- Characteristic number of spontaneous revertants
- Confirmation of appropriate test strain characteristics
- All test strains in the approximate range of 1 to 9.9 * 10-9 bacteria per mL
- Mean positive control value at least twice vehicle control value
- Minimum of four non-toxic test material dose levels
- No excessive loss of plates due to contamination - Evaluation criteria:
- In accordance with OECD 471. There are several criteria for determining a positive result, such as a dose-related increase in revertant frequencyover the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: See text
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: See text
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: See text
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: See text
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: See text
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
A history profile of vehicle and positive control values is presented in appendix 2 of the study report.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
PRELIMINARY STUDY
The test material was toxic to TA100 from 500 µg/plate and non-toxic to WP2uvrA‾. The test material formulation and S9 -mix were shown to be sterile.
MUTATION STUDY
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9 -mix and the sensitivity of the bacterial strains.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
CYTOTOXICITY
The test material caused a visible reduction in growth of the bacterial background lawn of the majority of the Salmonella strains, initially from 150 and 500 ug/plate with and without S9, respectively. No cytotoxicity was observed in Salmonella strain TA98 (main test, +S9) and in the E. coli strain. - Remarks on result:
- other:
Applicant's summary and conclusion
- Conclusions:
- In a bacterial reverse mutation test in accordance with OECD 471, Cyclabute did not induce mutations and was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
A bacterial reverse mutation assay (Ames test) was performed with bacterial strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2uvrA‾. The test was performed under GLP conditions and according to OECD 471. A preliminary test was performed to determine the test range. The test item was dissolved in DMSO and applied once at test initiation with concentrations ranging from 1.5 -5000 µg/plate. The validity criteria of the test results were fulfilled. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9 -mix and the sensitivity of the bacterial strains. The test 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, cyclabute does not have to be classified as mutagenic.
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