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EC number: 248-471-3 | CAS number: 27458-94-2
- 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
- Study period:
- 8 July 1986 to 19 July 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study conducted to EWG 84/449/B.14. The study is comparable to current guideline study (EU Method B.14) with acceptable restrictions. A declaration by the original Study Director that the translation is accurate, although the study is not GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isononyl alcohol
- EC Number:
- 248-471-3
- EC Name:
- Isononyl alcohol
- Cas Number:
- 27458-94-2
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Isononanol
- Substance type: Technical material
- Physical state: Colourless liquid
- Stability under test conditions: No data
- Storage condition of test material: No data
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0 (water contol), 0 (vehicle control), 10, 50, 250, 1000 and 5000 µg Isononanol /plate with and without S9 metabolic activation. Test concentrations were half log intervals.
- Vehicle / solvent:
- Dimethylsulphoxide (DMSO)
A stock solution was prepared on the day of testing by dissolving isononanol in DSMO. All subsequent dilutions were made in the same solvent
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO with all strains
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- With TA 100 strain and S9 mix only
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- Plate incorporation test
0.1 ml of the solvent DMSO, 0.5 ml phosphate buffer or 0.5 ml S9 mix for metabolic activation, 2 ml of molten, trace histidine supplemented, top agar at 45ºC, and 0.1ml of the bacterial culture were mixed in sterile tubes. Mixing was done in triplicate for each bacterial strain and for each concentration of the test material. The mixture was then poured onto the surface of minimal agar plates . These plates were incubated at 37 degrees centigrade for 96 hours and then the number of revertant colonies counted.
Preincubation test
0.1ml of each bacterial culture was mixed with 0.5ml phosphate buffer or 0.5ml S9 mix for metabolic activation,. Then 50ul of cyclophosphamide, DMSO or test substance in DSMO were added and the tubes incubated at 30 degree celcius for 30 minutes with gentle agitation. At the end of the incubation period, 2ml of molten top agar was added to each tube and mixed briefly and poured onto minimal agar plates. These plates were incubated at 37 degrees centigrade for 96 hrs and then the number of revertant colonies were counted.
Three replicates for each treatment level.
- Evaluation criteria:
- For a test compound to be considered positive, it must (in two independent experiments),cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase must be accompanied by a dose response towards increasing concentrations of the test article. A test article
that does not meet these criteria will be called non-mutagenic in bacteria. Single increases in revertant frequencies, which are not dose-related and
not reproducible in two independent tests are considered non-relevant. If however these increases do occur in both tests, this will be taken as an
indication of a mutagenic effect. - Statistics:
- Not used
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1538
- 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:
- not applicable
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the plate incorporation assay as well as the preincubation assay, treatment with isononanol did not result in a dose-related significant increase in the revertant frequency of any of the five tester strains TA98, TA100, TA 535, TA1537 or TA1538.
The tables of results showing revertant colonies for each tester strain with and without S9 are included in the attached document:
Tables (Ames Test) from Report.pdf
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Isononanol did not induce a mutagenic effect in S typhimurium in two independent tests. It is not therefore considered to be a bacterial mutagen - Executive summary:
A study was performed at the Laboratories of Infracor GmbH, on behalf of Hüls Aktiengesellschaft Germany, to investigate the ability of the test substance Isononanol to induce reverse mutations in an in vitro bacterial system. Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were treated with Isononanol by the Ames test plate incorporation method as well as the pre-incubation method. Dose levels covered the range of 10 to 5000 µg/plate, in triplicate both with and without the addition of metabolising system (S9 mix), were employed using Study design reference EWG Directive 84/449 B.14. A reproducible mutagenic activity of the test substance to any of the tester strain was not observed with or without metabolic activation. Isononanol is therefore considered not to be a bacterial mutagen. This Ames Test study is considered to be 'reliable with restriction' and satisfies the guideline requirements of the bacterial reverse mutation assay.
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