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EC number: 888-364-4 | CAS number: 146569-48-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 February 2021 TO 24 June 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- As per OECD Guideline No. 442E
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As per OECD Guideline No. 442E
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- human Cell Line Activation Test (h-CLAT)
Test material
- Reference substance name:
- niobium trivanadium decamolybdenum tellurium dotetracontaoxide
- EC Number:
- 888-364-4
- Cas Number:
- 146569-48-4
- Molecular formula:
- Mo10V3Nb1Te1O42
- IUPAC Name:
- niobium trivanadium decamolybdenum tellurium dotetracontaoxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: EX.14402.600
- Purity test date: 87.6%
- Solubility and stability of the test substance in the solvent/vehicle: RPMI 1640 media
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: RPMI 1640 media
In vitro test system
- Details of test system:
- THP-1 cell line [442E]
- Details on the study design:
- Skin sensitisation (In vitro test system) - Details on study design: Frozen stock of cryovial was thawed immediately at 37±1°C in the water bath.
cells were transferred into 15 mL falcon tube with 5 mL culture media, cells were centrifuged at 125g for 10 minutes. Cells pellet were transferred in to a sterile flask with RPMI-1640 supplemented with 10% Fetal Bovine Serum, antibiotics (1% Penicillin-Streptomycin) and 0.05 mM 2-Mercptoethanol
incubated at 37±1°C and 5±1% CO2 for 4 days.
On the day of testing, cells harvested from culture flask were resuspended with fresh culture medium at 2 × 106 cells/mL.
Then, cells are distributed into a 24 well flat-bottom plate with 500 µL (1 × 106 cells/well). The cells were qualified by conducting a reactivity test using the positive controls,
2,4-dinitrochlorobenzene (DNCB) and nickel sulfate (NiSO4) and the negative control, lactic acid (LA), two weeks after thawing. Both DNCB and NiSO4 produced a positive response and LA produced a negative response for both CD86 and CD54 cell surface markers.
A dose finding assay was performed to determine the CV75. The 75% cell viability (CV) of test chemical concentration are compared with RPMI media control.
The test item was prepared on the day of testing. Test item was dissolved or stably dispersed in medium as solvent/vehicle to final concentrations of 500 mg/mL (in medium) or 500 mg/mL (in DMSO).
Starting from the 500 mg/mL (in medium) stock solutions of the test chemicals, the following dilution steps was taken:
For medium as solvent/vehicle: Eleven stock solutions (eleven concentrations) were prepared, by two-fold serial dilutions using the corresponding solvent/vehicle. These stock solutions are then further diluted 50-fold into culture medium (working solutions). The top final concentration in the plate was 5000 µg/mL. - Vehicle / solvent control:
- cell culture medium
- Negative control:
- DL-Lactic acid
- Positive control:
- dinitrochlorobenzene (DNCB) [442E]
Results and discussion
- Positive control results:
- DNCB was used as the positive control for CD86/CD54 expression measurement at a final single concentration in the plate was 4.0 μg/mL. To obtain a 4.0 μg/mL concentration of DNCB in the plate, a 2 mg/mL stock solution of DNCB in DMSO was prepared and further diluted 250-fold with culture medium to a 8 μg/mL working solution.
RFI values of CD86 for positive control is 412.55, 401.34 and of CD54 for positive control is 303.60, 364.43, for set 1 and set 2 respectively.
In vitro / in chemico
Resultsopen allclose all
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- EC150, CD86 [442E]
- Value:
- 1.13 µg/mL
- Cell viability:
- 94.75 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- EC150, CD86 [442E]
- Value:
- 1.4 µg/mL
- Cell viability:
- 94.18
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- EC200, CD54 [442E]
- Value:
- 1.51 µg/mL
- Cell viability:
- 93.19 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- EC200, CD54 [442E]
- Value:
- 2.07 µg/mL
- Cell viability:
- 89.96 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Viability of 75 % was observed at 3.3105 µg/mL. All concentrations below showed respective higher viabilities.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: YES
- Acceptance criteria met for positive control: YES
- Acceptance criteria met for variability between replicate measurements: YES
- Range of historical values if different from the ones specified in the test guideline: NO
Any other information on results incl. tables
Test Item Concentrations (µg/mL) | RFI Values of test item: Set 1 | RFI Values of test item: Set 2 | ||
CD86 | CD54 | CD86 | CD54 | |
3.973 | 426.39 | 363.70 | 350.05 | 360.46 |
3.311 | 392.37 | 423.64 | 389.83 | 344.84 |
2.759 | 366.24 | 350.54 | 320.97 | 269.20 |
2.299 | 366.36 | 141.58 | 345.22 | 337.42 |
1.916 | 282.28 | 216.51 | 335.66 | 106.80 |
1.597 | 209.31 | 233.28 | 175.13 | 31.07 |
1.331 | 213.97 | 125.31 | 140.90 | 77.93 |
1.109 | 141.79 | 137.05 | 142.03 | 193.73 |
TABLE 1. EC150 (CD86), EC200 (CD54) AND PREDICTION OF THE TEST ITEM
Sl. No. | Details | CD86 | CD54 | EC150 (CD86) µg/mL | EC200 (CD54) µg/mL |
1 | Set-1 | RFI>150 | RFI>200 | 1.13 | 1.51 |
2 | Set-2 | RFI>150 | RFI>200 | 1.40 | 2.07 |
3 | Prediction | Positive | Positive | - | - |
Refer Appendix 2 and 3
ND: Not Determined, EC: Effective Concentration.
TABLE 2. CV-75 CONCENTRATION AND OVERALL PREDICTION OF THE TEST ITEM
CV-75 (µg/mL) | 3.3105 |
Prediction | Positive |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- The data generated with this method may not be sufficient to conclude in isolation on skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA. Since further in vitro studies were not feasible, no conclusion on the sensitising properties via in vitro studies can be made. Hence, a subsequent in vivo study was performed (see Chapter 7.4.1).
- Conclusions:
- Based on the expression levels of CD86 and CD54, the test item in h-CLAT prediction is considered as “Sensitiser”.
The data generated with this method is however not sufficient to conclude in isolation on the skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA. Since further in vitro studies were not feasible, no conclusion on the sensitising properties via in vitro studies can be made. Hence, a subsequent in vivo study was performed (see Chapter 7.4.1). - Executive summary:
The test item was evaluated in the “In Vitro Skin Sensitization by Human Cell Line Activation Test (h-CLAT) Method” as per the OECD guideline for testing of chemicals, No.: 442E. The measured expression levels of CD86 and CD54 cell surface markers are used for supporting the discrimination between skin sensitisers and non-sensitisers. Study was conducted to determine the cell viability (CV-75), expression level of CD86 and CD54 cell surface markers expression using human monocytic leukaemia cell line THP-1 in the h-CLAT method. Solubility test was conducted by RPMI 1640 media and dimethyl sulphoxide. Test item formed suspension in RPMI 1640 media at 500 mg/mL. On the day of testing, test item was prepared. Eleven concentrations were prepared for dose finding assay, RPMI media was used as solvent/vehicle, the final concentrations in plate was 4.883, 9.766, 19.531, 39.063, 78.125, 156.25, 312.5, 625, 1250, 2500 and 5000µg/mL. The CV75 value of the test item was determined at 3.3105 µg/mL. Based on the CV75 of dose finding assay, eight test concentrations of 1.109, 1.331, 1.597, 1.916, 2.299, 2.759, 3.311 and 3.973µg/mL were selected for CD86/CD54 expression measurement. Upregulation of the biomarkers CD86 and/or CD54 was observed in some of the tested concentration of the test item. EC150 value for CD86 was 1.13 and 1.4 µg/mL for run 1 and 2 respectively. EC200 for CD 54 was 1.51 and 2.07 µg/mL for run 1 and 2 respectively.
Hence, the test item can be consideres as "sensitiser" in the h-CLAT assay. However, the data generated with this method may not be sufficient to conclude in isolation on skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA. Since further in vitro studies were not feasible, no conclusion on the sensitising properties via in vitro studies can be made. Hence, a subsequent in vivo study was performed (see Chapter 7.4.1).
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