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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 December 2020 To 29 March 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 439
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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Principles of method if other than guideline:
- To evaluate the skin irritation potential of Mo10V3TeNbO42 using Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200- SIT).
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- With GLP Certificate
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:
- Physical Appearance (with color): Solid (black)
Batch No.: EX.14402.600
Date of Manufacture: Oct 2017
Date of Expiry: No change of properties known over time (endless)
Storage Conditions: Ambient (21 to 29ºC)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In vitro Life Science Laboratories, s.r.o, MlynskéNivy 73, 821 05, Bratislava II, Slovak Republic, www.mattek.com; Phone: +421-2-3260-7401; Fax: +421-2-3260-7404.
- Justification for test system used:
- As recommended in OECD Guideline No. 439, Reconstructed Human Epidermal Model EpiDerm™ (EPI-200-SIT) has been selected as test system for in vitro skin irritation.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200-SIT) was used as test system
- Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- Quantity of 30 µL of DPBS (NC) and 5% SDS (PC) were dispensed directly atop the tissue at 1 minute intervals to facilitate rinsing of the NC and PC after exposure.
The tissues were exposed to 25 mg of test item. - Duration of treatment / exposure:
- 1 hour and 48 hours
- Duration of post-treatment incubation (if applicable):
- Percentage viability of tissues was measured by performing MTT assay after 60 minutes of treatment and post incubation of 43 hours and 7 minutes.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three replicates
- Value:
- 45.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- 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
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results obtained under the laboratory testing conditions, the test item is categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS (Category 2 or Category 1), as the mean percentage of tissue viability was less than 50% of the negative control after 60 minutes of exposure and 43 hours and 7 minutes post incubation.
Since a subsequent study performed according to OECD TG 431 (see chapter 7.3.1) did not justify a classification as Skin Corrosive Category 1, a justification as Skin Irritant Category in accordance with UN GHS is justified. - Executive summary:
The mean OD of the negative controltissues is 1.273 which is within the range of ≥0.8 and ≤2.8, hence the tissues were considered as viable after shipping and storing procedures and under specific conditions of use.Certificate of analysis, histology report and images of EpiDerm tissues of lot No. 33783 provided by MatTekwas provided as Annexures 3, 4 and 5 respectively. Percentage viability of tissues was measured by performing MTT assay after 60 minutes of treatment and post incubation of 43 hours and 7 minutes.The mean percentage viability of test item treated tissues was 45.7 which were <50% of the negative control, hence the test item is considered as irritantand the mean percentage viability of positive controltreated tissues was 4.4 which were <50% of the negative control clearly represents the irritation potential of positive control.
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