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EC number: 282-208-3 | CAS number: 84144-87-6 Flue dust and ash containing vanadium resulting from the combustion of vanadium-bearing fuel oil.
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- other: OECD 437 "Bovine Corneal Opacity and Permeability Test Method for Identifiying Ocular Corrosives and Severe Irritants"
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ashes (residues), vanadium-contg.
- EC Number:
- 282-208-3
- EC Name:
- Ashes (residues), vanadium-contg.
- Cas Number:
- 84144-87-6
- Molecular formula:
- Not available
- Reference substance name:
- Vanadium concentrate
- IUPAC Name:
- Vanadium concentrate
- Details on test material:
- - Name of test material (as cited in study report): vanadium concentrate
- Physical state: white powder
- Lot/batch No.: 14-45810
- Storage condition of test material: room temperature, protected from light
Constituent 1
Constituent 2
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- PREPERATION OF CORNEAS
The assay uses isolated corneas obtained as a by-product from an abattoir from freshly slaughtered animals
The eyes will be carefully examined for defects and any defective eyes is discarded.
The tissue surrounding the eyeball is carefully pulled away and the cornea is stored in a petri dish containing HBSS. Corneas are then mounted in corneal holders (MC2, Clermont, France) with the endothelial side against the O-ring of the posterior chamber. The anterior chamber is then positioned on top of the cornea and tightened with screws. The chamber of the corneal holder is then filled with RPMI (without phenol red) containing 1 % FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber is always filled first. The corneas are incubated for 1 h at 32 +-1 °C in a water bath.
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.8 g of the test item was diluted with 0.9 % NaCl ad 4 ml, to gain a 20 % concentration
- Controls:
- yes
- Amount / concentration applied:
- 750 µl
- Duration of treatment / exposure:
- 4 h +- 5 min
- Observation period (in vivo):
- none
- Number of animals or in vitro replicates:
- - 3 corneas for the test item
- 3 corneas as negative control treated with physiological saline 0.9 % NaCl
- 3 corneas as positive control treated with 20 % imidazole in physiological saline 0.9 % NaCl
The BCOP assay is considered to be valid if the in vitro score obtained with the positive control falls within the two standard deviations of the current historical mean. - Details on study design:
- TREATMENT OF THE CORNEAS
After the incubation period, the medium is removed from both chambers and replaced with fresh complete RPMI. An initial opacity measurement is performed on each of the corneas using an opacitometer (MC2, Clermont, France). Three corneas with opacity readings appproximately equivalent to the median opacity of all corneas are selected as negative-control corneas. The opacity of each cornea are read against an air-filled chamber and recorded. Corneas that have an initial opacity reading that is 7 or more units greater or lower then the average opacity from all used corneas are not dosed. The medium is removed from the anterior chamber and replaced with the test item or control.
750 µl of the test item preparation or the control substance are introduced into the anterior chamber. After 4 h +- 5 min incubation at 32 +- 1 °C either the test substance or control substance is removed and the epithelium is washed.
REMOVAL OF TEST SUBSTANCE
- Washing: at least 3x with MEM (containing phenol red). Once the medium is free of test substance, the cornea is finally rinsed with complete RPMI (without phenol red).
- Time after start of exposure: 4h +- 5 min
TREATMENT AFTER REMOVAL OF TEST SUBSTANCE
The anterior chamber is refilled with complete RPMI and an opacity measurement is performed. After the measurement, the medium is removed from both chambers of the holder. The posterior chamber is refilled with fresh complete RPMI. 1 ml of a 5 mg/ml sodium fluorescein solution is added to the anterior chamber and the corneas are incubated for 90 min at 32 +- 1 °C. Then the medium from the posterior chamber is removed and its optical density (OD490) is determined, using a spectrophotometer.
EVALUATION OF RESULTS
The change in opacity for each cornea is calculated by subtracting the initial opacity reading from the final opacity reading. These values are corrected by subtracting from each the average change in opacity observed for the negative-control corneas. The mean opacity value for each treatment is calculated by averaging the corrected opacity values of each cornea for a given treatment.
The mean OD490 for the blank wells is calculated. The mean blank OD490 is subtracted from the OD490 of each well (corrected OD490). Any dilutions that are made to bring the OD490 values into the linear range of the spectrophotometer (OD490 should be less than 1500), are taken into account by multiplying the OD490 value of the dilution by the dilution factor. The final-corrected OD490 of the test artivle and the positive control is calculated by subtracting the average-corrected OD490 of the negative control corneas from the corrected OD490 value of each treated cornea:
Final-corrected OD490 = (OD490 - mean blank OD490) - average-corrected negative control OD490
The mean OD490 value of each treatment group is calculated by averaging the final-corrected OD490 values of the treated corneas for that treatment condition.
The following formula is used to determine the in vitro score:
In vitro score = mean opacity value + (15x mean OD490 value)
The results are evaluated according to Table 1.
SCORING SYSTEM:
see Table 1.
Results and discussion
In vivo
Results
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- in vitro
- Time point:
- other: 4 h
- Score:
- 9.048
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The mean in vitro score was calculated to be 9.048. Therefore the test item was classified as mild irritant. The in vitro score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
Any other information on results incl. tables
Table 1: Opacity
Cornea-No. |
Test item |
Opacity blank value |
Opacity post dose |
Change of opacity values |
Corrected opacity values |
1.000 |
Negative Control |
5 |
3 |
-2 |
|
2.000 |
3 |
3 |
0 |
|
|
3.000 |
6 |
4 |
-2 |
|
|
MV |
4.667 |
3.333 |
-1.333 |
|
|
4.000 |
Positive Control Imidazole |
6 |
170 |
164 |
165.333 |
5.000 |
6 |
185 |
179 |
180.333 |
|
6.000 |
6 |
153 |
147 |
148.333 |
|
MV |
6.000 |
169.333 |
163.333 |
164.667 |
|
7.000 |
Test item Vanadium concentrate |
3 |
9 |
6 |
7.333 |
8.000 |
4 |
14 |
10 |
11.333 |
|
9.000 |
3 |
11 |
8 |
9.333 |
|
MV |
3.333 |
11.333 |
8.000 |
9.333 |
Table 2: Permeability
Cornea-No. |
Test item |
OD490 |
Corrected OD490 values |
1.000 |
Negative Control |
0.012 |
|
2.000 |
0.017 |
|
|
3.000 |
0.033 |
|
|
MV |
0.021 |
|
|
4.000 |
Positive Control Imidazole |
2.107 |
2.086 |
5.000 |
2.115 |
2.094 |
|
6.000 |
2.110 |
2.089 |
|
MV |
2.111 |
2.090 |
|
7.000 |
Test item Vanadium concentrate |
0.001 |
-0.020 |
8.000 |
0.008 |
-0.013 |
|
9.000 |
-0.004 |
-0.025 |
|
MV |
0.002 |
-0.019 |
Table 3: in vitro Score
Cornea-No. |
Test item |
Corrected opacity value |
Corrected OD490 value |
in vitroscore |
1.000 |
Negative Control |
-2.000 |
0.012 |
|
2.000 |
0.000 |
0.017 |
|
|
3.000 |
-2.000 |
0.033 |
|
|
MV |
-1.333 |
0.021 |
|
|
4.000 |
Positive Control Imidazole |
165.333 |
2.086 |
|
5.000 |
180.333 |
2.094 |
|
|
6.000 |
148.333 |
2.089 |
|
|
MV |
164.667 |
2.090 |
196.017 |
|
7.000 |
Test item Vanadium concentrate |
7.333 |
-0.020 |
|
8.000 |
11.333 |
-0.013 |
|
|
9.000 |
9.333 |
-0.025 |
|
|
MV |
9.333 |
-0.019 |
9.048 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the evaluation criteria the test item Vanadium concentrate is classified as mild eye irritant.
- Executive summary:
In a Bovine Corneal Opacity and Permeabiliy Assay (BCOP) 750 µl of 20% Vanadium concentrate was exposed in vitro to 3 corneas for 4 h. The mean in vitro score was calculated to be 9.048. Therefore, Vanadium concentrate is mildly irritating to the eye.
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