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Diss Factsheets
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EC number: 700-052-0 | CAS number: 60046-50-6
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09/10 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out in accordance to Directive 92/69/EEC, Part B.13 and B.14, 1992, and the ninth amendment of OECD Guideline for Testing of Chemicals No. 471, 1997, with no deviations reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Jugend, Familie und Gesundheit
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (4R,6R)-4-hydroxy-2,2,6-trimethylcyclohexan-1-one
- EC Number:
- 700-052-0
- Cas Number:
- 60046-50-6
- Molecular formula:
- C9H16O2
- IUPAC Name:
- (4R,6R)-4-hydroxy-2,2,6-trimethylcyclohexan-1-one
- Details on test material:
- - Name of test material (as cited in study report): Actinol
- Physical state: crystalline white powder
- Analytical purity: 99.5 %
- Lot/batch No.: 410016
- Expiration date of the lot/batch: 31 July 2000
- Storage condition of test material: at room temperature, protected from sun light
- Other:
Constituent 1
Method
- Target gene:
- pKm 101
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- no applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500, 5000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated and solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA100 (10 ug/plate)
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 1537 (50 ug/plate), TA 98 (10 ug/plate)
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA (5 uL/plate)
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535, TA 1537, TA 98, TA 100 (2.5 ug/plate), WP2 uvrA (10 ug/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation): In the test, 100 uL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control), 500 uL S9 mix (for metabolic activation) or S9 mix substitution buffer (for test without metabolic activation), 100 uL bacterial suspension, and 2000 uL overlay agar were poured onto the minimal agar plates.
METHOD OF APPLICATION: preincubation: In the test, 100 uL test solution, 500 uL S9 mix or S9 mix substitution buffer and 100 uL bacterial suspension were mixed in a test tube and shaken at 37 °C for 60 minutes. After preincubation, 2.0 mL overlay agar (45 °C) was added to each tube. The mixture was poured on minimal agar plates.
After solidification, the plates were incubated upside down for at least 48 hours at 37 °C in the dark.
NUMBER OF REPLICATIONS: For each strain and dose level including the Controls, three plates were used. - Evaluation criteria:
- A test item is considered positive if either a dose related and reproducible increase in the number of revertants or a biologically relevant and reproducible increase for at least one test concentration is induced.
A test item producing neither a reproducible and dose related increase in the number of revertants, nor a biologically relevant and reproducibly positive response at any one of the test points is considered non-mutagenic in this system.
A mutagenic response is described as follows:
A test item is considered mutagenic if in the strains TA 98, TA 100, and WP2 uvrA the number of reversions will be at least twice as high and in the strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate (3,4). Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test item regardless whether the
highest dose induced the above described enhancement factors or not. - Statistics:
- No statistical evaluation has been applied.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
During the described mutagenicity test and under the experimental conditions, the test substance Actinol did not induce gene mutations by base pair changes or frameshifts of the strains used. - Executive summary:
A study was performed to investigate the potential of Actinol to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA
100, and the Escherichia coli strain WP2 uvrA in compliance with Directive 92/69/EEC, Part B.13 and B.14, 1992.
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: 33; 100; 333; 1000; 2500; and 5000 ug/plate
The plates incubated with the test item showed normal background growth up to 5000 pg/plate with and without metabolic activation in both independent experiments.
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Actinol 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, Actinol is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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