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EC number: 231-193-1 | CAS number: 7446-07-3
- 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:
- 2012-05-8 to 2012-06-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tellurium dioxide
- EC Number:
- 231-193-1
- EC Name:
- Tellurium dioxide
- Cas Number:
- 7446-07-3
- Molecular formula:
- O2Te
- IUPAC Name:
- tellurium dioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- lot/batch No.of test material: EK1008F023
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix; phenobarbital/β-naphthoflavone induced rat liver
- Test concentrations with justification for top dose:
- Range finding test: 5000; 2500; 1000; 316; 100; 31.6 and 10 μg/plate (TA 98 and TA 100 with and without metabolic activation)
Initial Test: 5000; 1581; 500; 158.1; 50; 15.81; 5 and 1.581 μg test item/plate
Confirmatory Test: 1581; 500; 158.1, 50; 15.81; 5; 1.581 and 0.5 μg test item/plate
Complementary Confirmatory Test: 5.81; 5; 1.581; 0.5; 0.1581; 0.05; 0.01581 and 0.005 μg test item/plate (TA1535; without metabolic activation)
Complementary Confirmatory Test: 5; 1.581; 0.5; 0.1581; 0.05; 0.01581; 0.005 and 0.001581 μg test item/plate (TA98, TA100 and TA1537 without metabolic activation) - Vehicle / solvent:
- 1 % (v/v) methyl cellulose solution was used
as vehicle to prepare the stock formulation of the test material. Test formulations were
freshly prepared at the beginning of the experiments in the testing laboratory by
diluting the stock formulation using the selected vehicle.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylenediamine (NPD); 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Preliminary and initial experiment: in agar (plate incorporation)
For confirmatory and complementary confirmatory tests preincubation method was used
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
SELECTION AGENT (mutation assays):
NUMBER OF REPLICATIONS: 3 plates/concentration - Evaluation criteria:
- Criteria for Validity:
The study was considered valid if:
- the number of revertant colonies of the negative (vehicle/solvent) and positive controls were in the historical control range in all strains of the main tests;
- at least five analyzable concentrations were presented in all strains of the main tests.
Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic
activation.
An increase was considered biologically relevant if:
- in all strains: the number of reversion was more than twice higher than the reversion rate of the vehicle control.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium 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 TA 98
- 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 TA 1537
- 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 TA 1535
- 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:
- E. coli WP2 uvr A
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Based on the results of the Preliminary Solubility Test, 1 % (v/v) methyl cellulose solution was selected for vehicle of the test item in the study. Concentrations of 5000; 2500; 1000; 316; 100; 31.6 and 10 μg/plate were examined in the Range Finding Test.
Based on the results of the Range Finding Test, the test item concentrations in the Initial Mutation Test were 5000; 1581; 500; 158.1; 50; 15.81; 5 and 1.581 μg test item/plate. Examined concentrations in the Confirmatory Mutation Test were 1581; 500; 158.1, 50; 15.81; 5; 1.581 and 0.5 μg test item/plate. Examined concentrations in the Complementary Confirmatory Mutation Test were 15.81; 5; 1.581; 0.5; 0.1581; 0.05; 0.01581 and 0.005 μg test item/plate (Salmonella typhimurium TA1535 strain without metabolic activation), and 5; 1.581; 0.5; 0.1581; 0.05; 0.01581; 0.005 and 0.001581 μg test item/plate (Salmonella typhimurium TA98, TA100 and TA1537 strains without metabolic activation).
In the Initial Mutation Test, Confirmatory Mutation Test and Complementary Confirmatory Mutation Test, none of the observed revertant colony numbers were above the respective biological threshold value. There were no consistent dose-related trends and no indication of any treatment effect. In all test item treated groups, the numbers of revertant colonies were below the biological relevance when compared with the solvent controls and were within the historical control range and were within the normal biological variability of the test system.
Inhibitory, cytotoxic effect of the test item was observed in the Initial Mutation Test in all tester strains with and without metabolic activation at the two or three highest concentration. Similar, but stronger cytotoxic effect was observed using the preincubation method (Confirmatory Mutation Test and Complementary Confirmatory Mutation Test) in all tester strains with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, the test item Tellurium dioxide had no mutagenic activity in the bacterium tester strains under the test conditions used in this study. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471, strains TA 1535, TA 1537, TA98 and TA100 of S. typhimurium and E. coli WP2 uvrA were exposed to Tellurium dioxide, (powder 99.9 % a.i.), at concentrations up to 5000 µg/plate in the presence and absence of mammalian metabolic activation, (S9 mix; phenobarbital/β-naphthoflavone induced rat liver).
The initial Mutation Test was performed as plate incorporation method; the confirmatory and complementary assays were performed according to the pre-incubation method.
In the Initial Mutation Test, Confirmatory Mutation Test and Complementary Confirmatory Mutation Test, none of the observed revertant colony numbers were above the respective biological threshold value. There were no consistent dose-related trends and no indication of any treatment effect. In all test item treated groups, the numbers of revertant colonies were below the biological relevance when compared with the solvent controls and were within the historical control range and were within the normal biological variability of the test system.
Inhibitory, cytotoxic effect of the test item was observed in the Initial Mutation Test in all tester strains with and without metabolic activation at the two or three highest concentration. Similar, but stronger cytotoxic effect was observed using the preincubation method (Confirmatory Mutation Test and Complementary Confirmatory Mutation Test) in all tester strains with and without metabolic activation.
The mean values of revertant colonies of the solvent control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was confirmed by a plating experiment in each test. At least five analyzable concentrations were presented in all strains of the main tests. The tests were considered to be valid.
In conclusion there was no evidence of induced mutant colonies over background.
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