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EC number: 419-330-5 | 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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD compliant GLP study without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: FAT 40543/A
Description: Red powder
Batch: TV RN 196-200
Purity: 90%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: November 01, 2000
Stability in vehicle: Dimethylsulfoxide: not indicated
Constituent 1
Method
- Target gene:
- 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
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98 , TA 100 Escherichia coli WP2 uvrA
- Additional strain / cell type characteristics:
- other: histidine-requiring and tryptophan-requiring
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate
(all tested in triplicates)
Concentration range in the main test (without metabolic activation): 3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate (all tested in triplicates) - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- for TA1535 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- for TA1537 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: duanomycin
- Remarks:
- for TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- for TA100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- for WP2uvrA without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains with metabolic activation
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 100 µg/plate
- Evaluation criteria:
- No formal hypothesis testing was done. A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants 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 at least a 2-fold, dose related increase in the number of revertants with respect to the number 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.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- TA1537 only at concentrations with precipitation
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation as of 100 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation as of 100 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- only at concentrations with precipitation
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation as of 100 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- only at concentrations with precipitation
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation as of 100 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation as of 100 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation as of 100 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
Significant increases in revertants were observed in the precipitating range only (>=100 micrograms/plate) in strains TA 1537, TA 98, in the absence of S9 and strain TA 1537 in the presence of S9.
At non-precipitating concentrations (<100 micrograms/plate), significant increases in revertants were observed in strains TA 1535, TA 98, TA 100 and WP2 uvrA in the presence of S9.
No toxicity was observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the absence of S9-mix, FAT40543/A induced in strain TA1537 5- and 4-fold dose-related increases in the number of revertant (His+) colonies, in experiment 1 and 2 respectively. In strain TA98 the test substance induced 7-and 6-fold dose-related increases, in experiment 1 and 2 respectively. These increases were observed only at precipitating concentrations. In the tester strains TA1535, TA100 and WP 2 uvrA, FAT40543/A did not induce a dose-related increase in the number of revertant colonies in both independent experiments. In the presence of S9-mix, FAT40543/A induced in strain TA1535 14- and 7-fold dose-related increases in the number of revertant (His+) colonies, in experiment 1 and 2 respectively. In strain TA1537 the test substance induced 6- and 9-fold dose-related increases, in experiment 1 and 2 respectively. In. TA98 the test substance induced dose related 4-fold increases in both experiments. FAT 40543/A induced in strain TA100 12- and 8-fold dose-related increases, in experiment 1 and 2 respectively. In WP 2 uvrA the test substance induced dose related 2-fold increases in the number of revertant (Trp+) colonies in both experiments. The increases in tester strain TA1537 were observed only at precipitating concentrations. The increases in the four other strains were observed at non-precipitating concentrations also.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation
Based on the results of this study it is concluded that FAT 40543/A is mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
FAT 40543/A 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 the tryptophan-requiring strain WP2 uvrA in two independent experiments. FAT 40543/A was tested up to and including concentrations of 5000 µg/plate in the absence and presence of S9-mix. In the absence of S9-mix, FAT 40543/A induced in strain TA1537 5- and 4-fold dose-related increases in the number of revertant (His+) colonies, in experiment 1 and 2 respectively. In strain TA98 the test substance induced 7-and 6-fold dose-related increases, in experiment 1 and 2 respectively. These increases were observed only at precipitating concentrations. In the tester strains TA1535, TA100 and WP2 uvrA, FAT 40543/A did not induce a dose-related increase in the number of revertant colonies in both independent experiments. In the presence of S9-mix, FAT40543/A induced in strain TA1535 14- and 7-fold dose-related increases in the number of revertant (His+) colonies, in experiment 1 and 2 respectively. In strain TA1537 the test substance induced 6- and 9-fold dose-related increases, in experiment 1 and 2 respectively. In. TA98 the test substance induced dose related 4-fold increases in both experiments. FAT 40543/A induced in strain TA100 12- and 8-fold dose-related increases, in experiment 1 and 2 respectively. In WP2 uvrA the test substance induced dose related 2-fold increases in the number of revertant (Trp+) colonies in both experiments. The increases in tester strain TA1537 were observed only at precipitating concentrations. The increases in the four other strains were observed at non-precipitating concentrations also.
Based on the results of this study it is concluded that FAT 40543/A is mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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