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EC number: 215-180-8 | CAS number: 1310-53-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- see section 13 in IUCLID for read-across justification report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21st July, 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Germanium dioxide
- EC Number:
- 215-180-8
- EC Name:
- Germanium dioxide
- Cas Number:
- 1310-53-8
- Molecular formula:
- GeO2
- IUPAC Name:
- Germanium dioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Product Name: Germanium Dioxide
CAS No.: 1310-53-8
Lot No./Batch No.: 1449
Colour / Form: White powder
Molecular formula: GeO2
Molecular weight: 104.59
Purity: 99.999%
Water Solubility: 4.5 g/L @ 25ºC
Storage: Room temperature (15-30°C), cool and dry place
Handling Precautions: As per MSDS (Appendix VIII)
Supplier: Teck Metals Ltd.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Teck Metals Ltd., batch n°: 1449
- Expiration date of the lot/batch: Not applicable
- Purity test date: 99.999 %
- Colour / Form: White powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:Room temperature (15 to 30ºC)
- Stability under test conditions:Stable under normal temperatures/pressures
- Solubility and stability of the test substance in the solvent/vehicle: Stable under normal temperatures/pressures
- Handling Precautions: Standard laboratory procedures
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9. Rat S9 corresponds to the 9,000 x g fraction of liver homogenate from male Sprague-Dawley rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 9.4, 19, 38, 75, 150 and 300 μg per plate for the S. typhimurium strains
0, 75, 150, 300, 600 and 1500 μg per plate for E. coli.
Once plated and at the end of the incubation period, precipitate was visible only at the highest concentration of 1500 μg per plate. Therefore at this concentration the test item was evaluated at the limit of solubility in the test system (OECD, 1997). For the S. typhimurium strains, Germanium dioxide was tested near the limit of toxicity (OECD,1997). For all strains and conditions, a minimum of 5 concentrations were analyzable for mutagenicity (OECD, 1997). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: It was determined that Germanium dioxide was limited in solubility in a number of solvents including water at concentrations required for testing. Thus water was selected as the vehicle for this study as it the solvent most compatible with the preincubation test
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- cyclophosphamide
- methylmethanesulfonate
- other: 2-aminoanthracene (2-AMA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; each in the presence and
absence of S9
DURATION
- Preincubation period: 20 minutes prior to adding the top agar and plating
- Exposure duration: All plates were incubated at 37 +/- 2°C for 48 to 72 hours
NUMBER OF REPLICATIONS: 3
SCORING OF PLATES: The number of revertant colonies per plate will then be manually counted. If scoring has to be delayed, the plates will be stored at 5 3oC. The background lawn will be evaluated for evidence of toxicity and test item precipitation. - Evaluation criteria:
- - Negative result (no evidence of genotoxicity) is concluded if there is no substantial increase in the number of colonies per plate; i.e. the results do not exceed the upper 98 percentile limit of the historical solvent/negative control range. A negative result indicates that the test item is non-mutagenic in S. typhimurium or E. coli.
- Positive result will be considered positive when there is a significant increase in the number of colonies per plate in comparison to the concurrent negative control and a concentration-related increase over the exposure range tested. For the cases that there is historical data available, a positive result has to present an increase in the number of revertant colonies per plate in comparison to the historical data for at least one experimental condition. Biological relevance of the results will be considered first. A statistical method may be used as an aid in evaluating the test results but it will not be the only determining factor. A positive result indicates that the test item induces point mutations in S. typhimurium or E. coli.
- Equivocal result: If no definite judgment can be made to fit the above criteria, even after repeated experiments, then the result will be described as equivocal. An equivocal result indicates that a definitive result cannot be made by performing the bacterial reverse mutation assay under the conditions described in this protocol. - Statistics:
- Statistical analysis was applied to the numbers suspected to be abnormally high or to have a dose-related increase in revertant counts. The colony counts were transformed (square root) to normalize the data prior to using the one-sided Dunnett’s test (Mahon, G.A.T., et al., 1989).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- not examined
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Germanium dioxide was not mutagenic to S. typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain, WP2 uvrA, under the test conditions.
- Executive summary:
Germanium dioxide was evaluated for its potential to induce point mutations in Salmonella typhimurium strains, TA98, TA100, TA1535, TA1537 and Escherichia coli strain WP2 uvrA. The experimental design followed the “OECD Guideline for Testing of Chemicals - 471, Bacterial Reverse Mutation Test” (OECD, 1997). In the plate incorporation experiment, both in the presence and absence of S9, the concentrations of Germanium dioxide investigated were 0, 9.4, 19, 38, 75, 150 and 300 μg per plate for the S. typhimurium strains and 0, 75, 150, 300, 600 and 1500 μg per plate for E. coli. Once plated and at the end of the incubation period, precipitate was visible only at the highest concentration of 1500 μg per plate. Therefore at this concentration the test item was evaluated at the limit of solubility in the test system (OECD, 1997). For the S. typhimurium strains, Germanium dioxide was tested near the limit of toxicity (OECD, 1997). For all strains and conditions, a minimum of 5 concentrations were analyzable for mutagenicity (OECD, 1997). For the plate incorporation test, with or without metabolic activation, Germanium dioxide did not produce any increases in revertants over the concurrent negative controls. In the preincubation experiment, both in the presence and absence of S9, the concentrations of Germanium dioxide investigated were identical to the plate incorporation test. Solubility and toxicity results were similar to those of the plate incorporation test. The preincubation test confirmed the negative results of the plate incorporation test. Germanium dioxide did not produce any statistically significant increases in revertants over the concurrent negative controls. The negative controls for each tester strain were within the historical negative control data. All concurrent positive controls induced at least a 2.9-fold increase in colony counts per plate when compared to the corresponding negative controls and were at levels similar to the historical positive control data. Thus, it was concluded that Germanium dioxide was not mutagenic to S. typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain, WP2 uvrA, under the test conditions.
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