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EC number: 943-533-2 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- other: 'Commission Directive 2000/32/EC, L1362000, Annexe 4D', dated May 19, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
- Molecular formula:
- C11H22O
- IUPAC Name:
- Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
- Test material form:
- other: liquid
- Details on test material:
- Name: Super Muguet
Bathc Number: 9000408259
Aggregate state at Room Temperature: liquid
Colour: colourless to pale yellow
Stability in solvent: not indicated by the sponsor
Storage: room temperature
Expiry Date: 08 Dec 2002
Constituent 1
Method
- Target gene:
- Histidine [S. typhimurium]
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction obtained from male rats, strain Wistar Hanlbm
- Test concentrations with justification for top dose:
- In the pre-experiment the concentration range of the test item was 3 - 5000 μg/plate. Due to toxic effects 1000 μg/plate were chosen as the maximal concentration for TA 98 and TA 100, and 333 1000 μg/plate for the remaining strains.
Strains TA 98 and TA 100: 3, 10, 33, 100, 333 and 1000 μg/plate
Strains TA 1535, TA 1537 and TA 102: 1, 3, 10, 33, 100 and 333 μg/plate - Vehicle / solvent:
- Super Muguet was dissolved in DMSO, the solvent was chosen becuase of its solubility properties adn its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated and solvent controls were performed
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene (2-AA); 4-nitro-o-phenylene-diamine (4-NOPD)
- Details on test system and experimental conditions:
- The test item Super Muguet was assessed for tis potential to induce gene mutations according to the plate incorporation test and the pre-incubation test using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
The assay was performed in two independent experiments both with a dn without liver microsomal activation (S9). Each concentration and the controls, were tested in triplicate. The test item was tested at the following concentrations:
Strains TA 98 and TA 100: 3, 10, 33, 100, 333 and 1000 μg/plate
Strains TA 1535, TA 1537 and TA 102: 1, 3, 10, 33, 100 and 333 μg/plate - Evaluation criteria:
- A test item is considered positive if a biologically relevant and dose related increase in the number of revertants is induced.
A test item producing neither a dose related increase in the numberof revertants nor a biologically relevant positive response at any one of the test points is considered non-mutagenic in this system.
A biologically relevant response is described as follows:
A test item is considered mitagenic if in strains TA 98, TA 100 and TA 102 the number of reversions will be at least twice as high and in strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate (3, 4).
Also, a dose-dependant 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 will induce the above described enhamcement factors or not. - Statistics:
- A statistical analysis of the data is not required.
Results and discussion
Test results
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Irregular background growth was observed at 333 μg/plate in strain TA 1545 (with and without S9) and in strain TA 1537 (with and without S9).
No substantial increase in revertant colony numbers of any five tester strains was observed following treatment with Super Muguet at any concentration 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.
The positive controls in the strains TA 1537 and TA 102 (with S9 mix) did not reach the required factors thrice (TA 1537) or twice (TA 102) of the corresponding solvent control. Therefore, the positive controkl of the parallel project 696700 was used for this study.
Appropriate reference mutagens were used as positive cintrols. They showed a distinct increase in induced revertant colonies. - 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
In conclusion, Super Muguet did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Super Muguet is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
In a guideline study, conducted to GLP, Super Muguet was found to be non-mutagenic in the bacterial reverse mutation assay, tested in five strains of Salmonella typhimurium, in the presence and absence of metabolic activation.
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