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Diss Factsheets
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EC number: 266-047-6 | CAS number: 65997-18-4 Frit is a mixture of inorganic chemical substances produced by rapidly quenching a molten, complex combination of materials, confining the chemical substances thus manufactured as nonmigratory components of glassy solid flakes or granules. This category includes all of the chemical substances specified below when they are intentionally manufactured in the production of frit. The primary members of this category are oxides of some or all of the elements listed below. Fluorides of these elements may also be included in combination with these primary substances.@Aluminum@Manganese@Antimony@Molybdenum@Arsenic@Neodymium@Barium@Nickel@Bismuth@Niobium@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Cerium@Silver@Chromium@Sodium@Cobalt@Strontium@Copper@Tin@Gold@Titanium@Iron@Tungsten@Lanthanum@Vanadium@Lead@Zinc@Lithium@Zirconium@Magnesium
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Experimental guideline study, available in the peer reviewed literature. Minor restrictions in design and / or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Sodium ortho-vanadate
- Analytical purity: >90%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan s.r.l (Udine, Italy)
- Age at study initiation: 5-6 weeks
- Weight at study initiation: approx 14 g (+/- 2.2 g)
- Assigned to test groups randomly: yes
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C (+/- 2°C)
- Humidity (%): 55 (+/- 15 )
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Sodium ortho-vanadate was dissolved in distilled water and diluted with tap water to make up the dosing solutions. Tap water was used for the control.
DIET PREPARATION: No data - Duration of treatment / exposure:
- 5 weeks
- Frequency of treatment:
- Continous
- Post exposure period:
- Not applicable
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1500 mg/L
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
750 mg/L
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
75 mg/L
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
7.5 mg/L
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
0.75 mg/L
Basis:
nominal in water
- No. of animals per sex per dose:
- 5 males in each dose in the first experiment and 5 animals at the 0.75 mg/L, 7.5 mg/L, and 75 mg/L in the second experiment.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - methylmethanesulfonate (MMS)
- Route of administration: single intra peritoneal injection with MMS 24 h before sacrifice
- Doses / concentrations: 80 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A preliminary range finding experiment was carried out to select the maximum tolerated dose of 1500 mg/L. The first experiment used 7.5 mg/L, 75 mg/L, 750 mg/L, and 1500 mg/L. A second experiment had to be perfomed to clarify the results of the experiment and this was done with 0.75 mg/L, 7.5 mg/L, and 75 mg/L.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): no data
DETAILS OF SLIDE PREPARATION:
- Bone marrow cells were obtained by flushing both femurs with PBS.
- Drops of bone marrow cells suspension for each animal were spread on four slides.
- Air-dried smears were then fixed in absolute methanol at room temp for 5 min and stained with a 5% solution of Giemsa in 0.01 M phosphate buffer at pH 6.8 for 20 min to differentiate bone marrow polchromatic (PCE) from normochromatic erythrocytes (NCE).
METHOD OF ANALYSIS:
- Slides were coded and blind scored using a brightfield microscope.
- The frequency of micronucleated PCEs (MnPCEs) was evaluated by the analysis of 4000 cells for each animal by two scorers (2000 cells each).
- The vanadium content in the femour and tibia tissue collected was analysed by means of inductively coupled plasma emission spectrophotometry
OTHER:
- The percentage of PCEs among 1000 erythrocytes (PCEs+NCEs) was determined to assess bone marrow toxicity. - Evaluation criteria:
- No data
- Statistics:
- Significance of differences between treated and control groups was determined using one-tail Student's t-test. However, when data for the two experiments were pooled ANOVA was used to rule out heterogeneity between experiments.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- At the highest dosed tested (750 mg/L and 1500 mg/L)
- Toxicity:
- yes
- Remarks:
- At the highest dose tested (1500 mg/L) one animal died during the 3rd week of treatment. Mild signs of toxicity (viz. lethargy) were observed during the last two weeks of treatment in mice treated with 750 mg/L and 1500 mg/L.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Not reported
RESULTS OF DEFINITIVE STUDY
- At the end of the 5 week exposure period there was there was no indication of bone marrow toxicity.
- The incidence of micronucleated PCEs was significantly increased in mice treated with the two highest doses (750 mg/L and 1500 m/L).
- There was lower statistical significance in increase micronucleated PCEs observed at the lowest dose of 7.5 mg/L but not 75 mg/L.
- In the repeat clarification experiment no statistical significance deviation in the average incidence of micronucleated PCEs was observed.
- A clearcut positive response was observed in the positve control but no evidence of toxicity to bone marrow cells.
OTHER
- Vanadium concentration increased linearly with administered doe in femurs (r=0.97) and in tibias (r=0.99).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive at the two highest concentrations tested
The study results indicate that vanadium is able to exert significant genotoxic effect in somatic cells in vivo as demonstrated by the results of the induction of micronuclei in bone marrow. However, this effect was only seen at the two highest concentrations (750 mg/L and 1500 mg/L).
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