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EC number: 433-470-4 | 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
- Study period:
- 30 October 2001 - 30 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study includes data generated according to generally valid and internationally accepted testing guidelines and performed according to GLP. The study was based on the following guidelines: -Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals; Guideline no. 471: "Genetic Toxicology: Bacterial Reverse Mutation Test". (Adopted July 21, 1997). - European Economic Community (EEC). Adapting to technical progress for the twenty-sixth time Annex V of the EEC Directive 67/548/EEC, Part B: Methods for the Determination of Toxicity; B.13/14: "Muta1~enicity: "Reverse Mutation Assay using bacteria". EEC Publication Commission Directive {Published June 8, 2000).
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP Statement date: 10/12/2001 and 21/12/2001
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,6-Bis(methoxybenzoyloxy)hexane
- Cas Number:
- 390359-18-9
- Molecular formula:
- C22H26O6
- IUPAC Name:
- 1,6-Bis(methoxybenzoyloxy)hexane
- Test material form:
- other: Yellowish solid
- Details on test material:
- - Name of test material (as cited in study report): SETAFIX X 11342
- Substance type: Organic
- Physical state: Solid
- Analytical purity: +/- 95%
- Lot/batch No.: PP02
- Expiration date of the lot/batch: 01 July2002
- Stability under test conditions: Not indicated
- Storage condition of test material: Stable
Constituent 1
Method
- Target gene:
- Salmonella typhimurium bacteria and Escherichia coli bacteria
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coIi WP2uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- DOSE RANGE FINDING TEST:
3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate in the absence and presence of 59-mix.
MUTATION ASSAY:
EXPERIMENT 1: 3, 10, 33, 100, 333 μg/plate in the absence and presence of 59-mix (Strains: TA 1535, TA 1537 and TA98)
EXPERIMENT 2: 3, 10, 33, 100, 333 μg/plate in the absence and presence of 59-mix (Strains: TA 1535, TA 1537, TA98, TA 100 and WP2uvrA) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO
- Justification for choice of solvent/vehicle:
Not specified but likely to be solubility of test substance
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Strain TA1535
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation(-S9-mix)
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Strain TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation(-S9-mix)
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Strain TA98
- Positive control substance:
- other: Daunomycine
- Remarks:
- Without metabolic activation(-S9-mix)
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Strain TA100
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation(-S9-mix)
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Strain WP2uvrA
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation(-S9-mix)
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Strains: TA1537, TA1535, TA98, TA100 and WP2uvrA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation (+S9-mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Preparation of Bacterial cultures:
Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth (Oxoid no. 2) and incubated in a shaking incubator (37°C, 150 spm), until the cultures reached an optical density of 1.0 ± 0.1 at 700 nm (109 cells/ml}. Freshly grown cultures of each strain were used for a test.
Permeabilization of the Escherichia coli strain:
WP2uvrA bacteria were washed twice in 0.25 the original volume of ice-cold 0.12 M Tris-HCL buffer pH 8.0, then gently resuspended in 0.2 vol. 0.12 M TrisHCL, 0.5 mM EDTA pH 8.0, and shaken for 2.5 min at 37°C. MgCl2 was then added to a final concentration of 10 mM. The cells were centrifuged and resuspended in the original volume of nutrient broth.
Agar Plates:
Agar plates (0 9 cm) contained 25 ml glucose agar medium. Glucose agar medium contained per liter: 18g purified agar (Oxoid, code L2) in Vogel-Bonner Medium E, 20 g glucose.
N.B. The agar plates for the test with the Salmonella typhimurium strains also contained 12.5 μg/plate biotin and 15 μg/plate histidine and the agar plates for the test with the Escherichia coli strain contained 15 μg/plate tryptophan.
Top Agar:
Top agar medium, containing 0.6% (w/v) purified agar and 0.5% (w/v) NaCl, was heated to dissolve the agar. Samples of 3 ml top agar were transferredinto 10 ml glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121 ± 1 °C.
Environmental conditions:
All incubations were carried out in the dark at 37 ± 1 °C. The temperature was monitored during the experiment. - Evaluation criteria:
- A test substance is consideried negative (not mutagenic) in the test if:
a) The total number of reveirtants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- No formal hypothesis testing was done.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coIi WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
DOSE RANGE FINDING TEST
SETAFIX X 11342 was testeid in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate in the absence and presence of 59-mix.
Precipitate:
The test substance precipitated in the top agar at concentrations of 100 μg/plate and upwards. Precipitation of SETAFIX X 11342 on the plates was observed at the start and at the end of the incubation period at concentrations of 333 μg/plate and upwards.
Toxicity:
To determine the toxicity of SETAFIX X 11342, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
MUTATION ASSAY
Based on the results of the close range finding test, SETAFIX X 11342 was tested up to concentrations of 333 μg/plate in the absence and presence of S9-mix in two mutation assays.
The first mutation experiment was performed with the strains TA 1535, TA 1537 and TA98 and the second mutation experiment was performed with the strains TA 1535, TA 1537, TA98, TA 100 and WP2uvrA.
Precipitate:
SETAFIX X 11342 precipitated in the top agar at concentrations of 100 and 333 μg/plate. Precipitation of SETAFIX X 11342 on the plates was observed at the start and at the end of the incubation period in all tester strains at the highest concentration tested.
Toxicity
The bacterial background lawn was not reduced at all concentrations tested and no biologically relevant decrease in the number of revertants was observed.
Number of revertants:
All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments.
The negative control values were within our laboratory background historical control data ranges. The strain-specific positive control values were within our laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly, except for TA1537 in the presence of S9 -mix (second experiment). However, since this value was just without the limit of the range, the validity of the test was considered to be not affected.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study it is concluded that SETAFIX X 11342 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
The objective of this study was to evaluate the test substance for its ability to induce reverse mutations in a gene of histidine-requiring Salmonella typhimurium bacterial strains resulting in histidine-independent strains, and in a gene of tryptophan-requiring Escherichia coli bacterial strain resulting in a tryptophan-independent strain.
SETAFIX X 11342 was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli WP2uvrA. The test was performed in two independent experiments in the presence and absence of S9-mix (Aroclor-1254 induced rat liver S9-mix).
In the dose range finding test, SETAFIX X 11342 was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. SETAFIX X 11342 precipita1ted on the plates at dose levels of 333 μg/plate and upwards. The bacterial background lawn was not reduced at all concentrations tested and no biologically relevant decrease in the number of revertants was observed.
In the first and in the second mutation assay, SETAFIX X 11342 was tested up to concentrations of 333 μg/plate in the absence and presence of S9-mix. SETAFIX X 11342 precipitated on the plates at this dose level. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
The presence of 5 and 10% (v/v) liver microsomal activation did not influence these findings.
SETAFIX X 11342 did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Based on the results of this study it is concluded that SETAFIX X 11342 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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