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EC number: 252-961-2 | CAS number: 36306-87-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone
- EC Number:
- 252-961-2
- EC Name:
- 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone
- Cas Number:
- 36306-87-3
- Molecular formula:
- C14H24O2
- IUPAC Name:
- 4-(1-ethoxyethenyl)-3,3,5,5-tetramethylcyclohexan-1-one
- Reference substance name:
- (3E,6E)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one
- Molecular formula:
- C14H24O2
- IUPAC Name:
- (3E,6E)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one
- Reference substance name:
- (E)-6-ethoxy-4,6,8-trimethylnona-3,7-dien-2-one
- IUPAC Name:
- (E)-6-ethoxy-4,6,8-trimethylnona-3,7-dien-2-one
- Reference substance name:
- (3E,6Z)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one
- IUPAC Name:
- (3E,6Z)-8-ethoxy-4,6,8-trimethylnona-3,6-dien-2-one
- Reference substance name:
- 1,3-diethoxy-5,7,7-trimethylbicyclo[3.3.1]non-2-ene
- IUPAC Name:
- 1,3-diethoxy-5,7,7-trimethylbicyclo[3.3.1]non-2-ene
- Reference substance name:
- 3,5-diethoxy-1,7,7-trimethylbicyclo[3.3.1]non-2-ene
- IUPAC Name:
- 3,5-diethoxy-1,7,7-trimethylbicyclo[3.3.1]non-2-ene
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
- Specific details on test material used for the study:
- Batch Number: 9000479770
Appearance: light yellow liquid
Storage: 1-10°C in the dark
Purity: 86.9%
Expiry Date: 4 Feb 2003
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian liver post--mitochondrial fraction (S-9) - prepared from male Sprague Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Range finding: 1.6, 8, 40, 200, 1000 and 5000 μg/plate
Experiment 1: 1.6, 8, 40, 200, 1000 and 5000 μg/plate
Experiment 2: perfromed up to an estimate of the lower limit of toxicity 1250 μg/plate for stain TA 1537 in the absence of S-9 and strain TA102 in the absence or presence of S-9) or up to 5000 μg/plate (all other treatments). Dose ranges of 78.13 to 5000 μg/plate and 19.52 to 1250 μg/plate were employed)
Controls
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: Glutaraldehyde (for TA102 without S-9), 2-aminoanthracene (for TA100, TA1535, TA1537, TA102 with S-9)
- Evaluation criteria:
- The test article was considered to be mutagenic if:
1. The assay was valid (see below)
2. Dunnett's test gave a significant response (p=<0.01) and the data set(s) showed a significant dose correlation
3. The positive responses described above were reproducible
Acceptance criteria
The assay was considered valid if the following criteria were met:
1. the mean negative control counts fell within the normal ranges as deinfined in Appendix 3
2. the positive control chemicals induced clear increases in revertant numbers confirming discrimination between different strains, and an active S-9 preparation
3. no more than 5% of the plates ere lost through contamination or some other unforeseen event
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:
- not specified
- 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:
- not specified
- 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:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- It was concluded that Kephalis did not induce mutation in five histidine-requiring strains of Salmonella typhimurium (TA98, TA100, TA1537 and TA102) when tested under the conditions of this study. The conditions included treatments at concentrations up to either 5000 μg/plate, or the lower limit of toxicity, in the absence and in the presence of a rat liver metabolic activation system (S-9).
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