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EC number: 462-560-6 | CAS number: 832088-68-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study. Two deviations occured (quoted in the full test report) but they were judged as minor deviations and did not influence the quality and integrity so the reliability of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- FEXO-07
- IUPAC Name:
- FEXO-07
- Reference substance name:
- 4-( 4-( 4-(1-hydroxydiphenylmethyl)-1- piperinidyl)-1 butinyl)-a,a-dimethylbenzeneacetic acid
- IUPAC Name:
- 4-( 4-( 4-(1-hydroxydiphenylmethyl)-1- piperinidyl)-1 butinyl)-a,a-dimethylbenzeneacetic acid
- Test material form:
- other: liquid
- Details on test material:
- Name: FEX0-07
Chemical Name: 4-( 4-( 4-(1-hydroxydiphenylmethyl)-1-piperinidyl)-1 butinyl)-a,a-dimethylbenzeneaceticacid
Colour: colourless
Purity: >99%
Storage: at room temperature, protected from light
Constituent 1
Constituent 2
Method
- Target gene:
- uvrB gene, nitrate reductase (chl) and biotin (bio) genes
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:
- S9
- Test concentrations with justification for top dose:
- The test item was tested in the pre-experiment at the following concentrations:
3.16, 10, 31.6, 100,316, 1000,2500 and 5000 µg/plate.
The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment; two independent
experiments were performed at the following concentrations:
Experiment 1:
10, 31.6, 100, 316, 1000,2500 and 5000 µg/plate.
Experiment II:
50, 100, 190, 375, 750, 1500 and 3000 µg/plate (TA 98, TA 1535, TA 1537, TA 102)
250, 500, 700, l 000, 2000, 3000, 4000 and 5000µg/plate (only for TA 100)
Controls
- Untreated negative controls:
- yes
- Remarks:
- Solvent controls, consisting of solvent alone and treated in the same way as the treatment groups were included.
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Strain specific positive controls were inclnded in the assay, which demonstrated the effective performance of the test.
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- Pre-incubation method and the plate incorporation method were applyed.
- Evaluation criteria:
- A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs
and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains T A 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 98, TA 1535 and TA 1537 the number of reversions is at least three times higher as compared to the spontaneous reversion rate
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any ofthe dose groups is considered to be non-mutagenic in this system - Statistics:
- According to the OECD guidelines, the biological relevance ofthe results was the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA98 and TA102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects were observed at a dose of 1000 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 98 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects were observed at a dose of 2500 µg/plate and higher.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- Toxic effects were observed at a dose of 1000 µg/plate and higher.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- Toxic effects of the test item were found at a dose of 1000 µg/plate and higher. (No biologically relevant increases in revertant colony numbers were noted for these two strains).
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects of the test item were found at a dose of 1000 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects of the test item were found at a dose of 1500 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- Toxic effects of the test item were found at a dose of 750 µg/plate and higher
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Toxic effects of the test item were found at a dose of 2000 µg/plate and higher
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects of the test item were found at a dose of 750 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1537 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects of the test item were found at a dose of 750 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1537 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects of the test item were found at a dose of 1500 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- For the results relative to (i) pre-experiment, (ii) experiment I and (iii) experiment II see the file attached below.
- Remarks on result:
- other: strain/cell type: S. typhimurium TA98 and TA102 specifically
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No biologically relevant increases in revertant colony numbers were noted in tester strains TA 98, TA 1535, TA 1537 and TA 102. Biologically relevant increases of revertant colony numbers were observed in tester strain TA 100 at a dose of 1000 µg/plate (without metabolic activation) and at a dose of l000 µg/plate and higher (with metabolic activation) in experiment I.
In experiment II biologically relevant increases of revertant colony numbers were observed in the same tester strain at a dose of 1000 µg/plate (without metabolic activation) and at a dose of 750 µg/plate and higher (with metabolic activation). The threshold value of 2.0 was exceeded and a maximum mutation factor of 4.2 was reached at a dose of 1000 µg/plate (with metabolic activation) in experiment I.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
FEX0-07 caused gene mutations by base pair changes in the genome of the tester strain TA 100.
Therefore, FEX0-07 is considered to be mutagenic in this bacterial reverse mutation assay. - Executive summary:
In order to investigate the potential of FEX0 -07 for its ability to induce gene mutations the plate incorporation test (experiment I and II) was performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102. In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:
* Experiment I:
- 10, 31.6, l 00, 316, l 000, 2500 and 5000 µg/plate
* Experimcnt II:
-50, 100, 190, 375,750, 1500 and 3000 µg/plate (TA 98, TA 1535, TA 1537, TA 102)
-250, 500, 700, l 000, 2000, 3000, 4000 and 5000 µg/plate (only for TA 100) In experiment I toxic effects of the test item were observed at concentrations of 1000 µg/plate and higher (with and without metabolic activation), depending on the particular tester strain. In experiment II toxic effects of the test item were noted at concentrations of 750 µg/plate and higher (with and without metabolic activation), depending on the particular tester strain. No biologically relevant increases in revertant colony numbers were noted in tester strains TA 98, TA 1535, TA 1537 and TA 102. Biologically relevant increases of revertant colony numbers were observed in tester strain TA 100 at a dose of 1000 µg/plate (without metabolic activation) and at a dose of l000 µg/plate and higher (with metabolic activation) in experiment I. In experiment II biologically relevant increases of revertant colony numbers were observed in the same tester strain at a dose of 1000 µg/plate (without metabolic activation) and at a dose of 750 µg/platea and higher (with metabolic activation). The threshold value of 2.0 was exceeded and a maximum mutation factor of 4.2 was reached at a dose of l000 µg/plate (with metabolic activation) in experiment I. The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, FEX0-07 caused gene mutations by base pair changes in the genome of the tester strain TA 100. Therefore, FEX0-07 is considered to be mutagenic in this bacterial reverse mutation assay.
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