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EC number: 272-447-1 | CAS number: 68845-00-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al. (1975)
- Qualifier:
- according to guideline
- Guideline:
- other: Reports on the international collaborative program in de Serres and Ashby (1981), Levin et al. (1982), Marin and Ames (1983), McCann and Ames (1976)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Cas Number:
- 125673-86-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Reference substance name:
- rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Reference substance name:
- 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- EC Number:
- 250-657-4
- EC Name:
- 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- Cas Number:
- 31499-72-6
- Molecular formula:
- C13H22O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- Code: RO 84-3360/000
Name: Boisiris (2-Ethoxy-9-methylene-2,6,6-trimethyl-bicyclo-[3.3.1]nonane
Batch No.: 149135
Storage conditions: cooled
Stability: 6 months
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix was prepared from the livers of phenobarbital/beta-napththoflavone treated male albino rats
- Test concentrations with justification for top dose:
- Concentrations range was 0.05 - 5.0 mg/plate
- Vehicle / solvent:
- Ethanol. Upon addition to the aqueous medium concentration of 0.5 mg/plate and above formed milky suspension and starting at 2.5 mg/plate white threads were visible. Therefore 50 μl of Tween 80 solution [10% (v/v)] were added in the tests performed, to increase the solubility of the test compound.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- mitomycin C
- other: ICR 191 (with strains TA 1537 and TA 97), 2-aminoanthracene was used with all strains
- Rationale for test conditions:
- Toxicity of the test substance was determined in a preliminary toxicity assay by evaluating the growth on NB- and/or minimal-medium (determination of the growth of the background lawn and/or frequency of spontaneous revertants). Each test substance dose, as well as the appropriate solvent control was evaluated in duplicate in strain TA 100.
- Evaluation criteria:
- A postive result is defined as a reproducible, dose-related increase in the number of his+ revertants. The increase should reach at least a soubling of the number of spontaneous revertants for Salmonella typhimurium strains TA 1535, TA1537, TA 1538 and TA98. For strains TA 97, TA 100 and TA 102 a 1.5-fold increase over control values might be indicative of a mutagenic effect provided the negative control values fall within the historical control data. Other investigators have set higher limits for a mutagenic response (factor 3 and 2 for the respective groups of strains). These rules of thumb have a questionable scientific foundation (Claxton et al. 1987) and biological relevance should always be taken into account. A negative result is defined as the absence of a reproducible increase in the number of his+ revertant colonies.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 1538, TA 97, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Boisiris showed distinct toxic effects in all strains except TA 1535 (+/- S9) and TA 97 (+/- S9) in the preincubation assay. In the standard assay only strain TA 1538 (+/- S9) showed toxic effects.
Boisiris did not produce a mutagenic effect in any of the seven tester strains used.
Applicant's summary and conclusion
- Conclusions:
- Boisiris did not induce an increase of the frequency of revertant colonies in any of the seven tester strains while the positive controls verified the sensitivity of the strains and the activity of the S9-mix.
Thus it can be concluded that neither Boisiris per se nor any of its metabolites formed under the described experimental conditions induced genetic damage in the Ames Test nor in the preincubation modification.
Therefore, Boisris is not mutagenic in the Ames Test. - Executive summary:
Boisris is not mutagenic in the in vitro Ames Test.
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