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EC number: 910-388-1 | 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:
- 2010-05-07 to 2010-05-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of silicon dioxide and zirconium dioxide
- EC Number:
- 910-388-1
- Molecular formula:
- not applicable (multi-constituent substance)
- IUPAC Name:
- Reaction mass of silicon dioxide and zirconium dioxide
- Details on test material:
- - Name of test material (as cited in study report): Silica-Zirkonia Filler
- Physical state: White powder
- Batch: IT-253
- Analytical purity of components: 72.4% silicon dioxide (CAS No. 7631-86-9) and 26.0% zirconium dioxide (CAS No. 1314-23-4) and a not stated percentage of disodium oxide (CAS No. 1313-59-3)
- Storage: at room temperature in the dark
- Stability: stable under storage conditions
- Expiry date: 20 Nov 2010
- not soluble in water
Constituent 1
Method
- Target gene:
- S. typhimurium: Histidine operon
E. coli: Tryptophan operon
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:
- Phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg bw) induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 3330, and 5000 µg/plate with and without 3.6% S9-mix for dose range finding test
3, 10, 33, 100, 333, 1000, 3330, and 5000 µg/plate with and without 5% S9-mix for experiment 1
33, 100, 333, 1000 and 3330 µg/plate with and without 10% S9-mix for experiment 2 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2 aminoanthracene: 2.5 µg/plate for TA 1535 and TA 1537, 1 µg/plate for TA 98 and TA 100 and 10 µg/plate for WP2 uvrA
- Remarks:
- with 5% S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2 aminoanthracene: 2.5 µg/plate for TA 1535 and TA 100, 1 µg/plate for TA 98, 5 µg/plate for TA 1537 and 10 µg/plate for WP2 uvrA
- Remarks:
- with 10% S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9-mix Migrated to IUCLID6: 5 µg/plate for TA 1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix Migrated to IUCLID6: 60 µg/plate for TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9-mix Migrated to IUCLID6: 10 µg/plate for TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9-mix Migrated to IUCLID6: 650 µg/plate for TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9-mix Migrated to IUCLID6: 10 µg/plate for WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 ± 4 hours
NUMBER OF REPLICATIONS: triplicate
NUMBER OF CELLS EVALUATED: if less than 40 colonies/plate were present they were counted manually, if more than 40 colonies were present, they were counted automatically with a Biocount 4000 Pro-S colony counter.
DETERMINATION OF CYTOTOXICITY
- Method: reduction of the bacterial background lawn, increase in the size of the microcolonies and reduction of the revertant colonies - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA1OO is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
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) The total number of revertants in tester strain TA1OO is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, 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 results
- Species / strain:
- other: E. coli WP2uvrA and S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at concentrations of 3330 and 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 pg/plate in the absence and presence of S9-mix.
COMPARISON WITH HISTORICAL CONTROL DATA: In range of historical control data from the laboratory.
Any other information on results incl. tables
Table 1: Maximum number of revertants from experiment 1
|
Maximum number of revertants |
|||||
Solvent control |
Positive control |
Treatment (at dose level [µg/mL]) |
||||
Strain |
With S9 |
Without S9 |
With S9 |
Without S9 |
With S9 |
Without S9 |
TA 1535 |
6 |
5 |
332 |
960 |
10 (100) |
9 (333) |
TA 1537 |
3 |
4 |
364 |
268 |
4 (333) |
5 (33) |
TA 98 |
19 |
13 |
1027 |
1131 |
25 (1000) |
18 (100) |
TA 100 |
93 |
95 |
1197 |
603 |
104 (5000) |
101 (33) |
WPA2uvrA |
20 |
18 |
376 |
1082 |
23 (1000) |
25 (333) |
Table 2: Maximum number of revertants from experiment 2
|
Maximum number of revertants |
|||||
Solvent control |
Positive control |
Treatment (at dose level [µg/mL]) |
||||
Strain |
With S9 |
Without S9 |
With S9 |
Without S9 |
With S9 |
Without S9 |
TA 1535 |
6 |
12 |
224 |
942 |
10 (333) |
13 (33) |
TA 1537 |
3 |
4 |
283 |
296 |
4 (33) |
5 (100) |
TA 98 |
25 |
15 |
694 |
1098 |
27 (3330) |
22 (100) |
TA 100 |
64 |
106 |
1239 |
1097 |
74 (3330) |
109 (333) |
WPA2uvrA |
17 |
10 |
331 |
1045 |
20 (1000) |
20 (333) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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