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EC number: 234-808-1 | CAS number: 12034-57-0
- 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
Endpoint summary
Administrative data
Description of key information
The dermal sensitization potential of the source substance Diniobium pentaoxide (> 98.5% purity) was tested in a murine local lymph node assay (LLNA) conducted according to OECD 429. Neither mortality nor any other adverse effects were observed during the study. The maximum SI was 1.3 %.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- Reliability checks with a positive control substance was performed periodically in the performing laboratory. The mean SI-value of the latest reliability check was 13.8 (see table 2 in box "Any other information on results incl. tables).
- Parameter:
- SI
- Value:
- 0.7
- Variability:
- SD = 0.3
- Test group / Remarks:
- 12% Diniobium pentaoxide
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- SD = 0.4
- Test group / Remarks:
- 25 % Diniobium pentaoxide
- Parameter:
- SI
- Value:
- 0.9
- Variability:
- SD = 0.4
- Test group / Remarks:
- 50 % Diniobium pentaoxide
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
For detailed results please refer to table 3 presented in box "Any other information on results incl. tables".
EC3 CALCULATION
The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
CLINICAL OBSERVATIONS:
All animals survived throughout the test period without showing any clinical signs.
BODY WEIGHTS
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Diniobium pentaoxide is not sensitizing under the conditions of this LLNA study (OECD 429).
- Executive summary:
In a dermal sensitization study conducted according to OECD 429 with Diniobium pentaoxide (> 98.5 % purity) suspended in AOO (3 +1 v/v acetone/olive oil), young adult female CBA/OlaHsd mice (5 per dose group) were tested at concentrations of 12.5% (w/v), 25 % (w/v) and 50 % (w/v) in a local lymph node assay (LLNA). Due to animal welfare reasons a periodically performed positive control (Phenylenediamine in AOO (3 +1 v/v) was used. There was no mortality nor clinical observations nor effects on body weights observed. None of the tested concentrations of the test substance reached the stimulation index threshold of 3. Therefore no EC3 value could be determined. In this study, Diniobium pentaoxide is not a dermal sensitizer.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
Reference
Results of the preliminary test:
Table 1: Ear Thickness - Preliminary test
Group | Animal No. | Day 1 [mm] | Day 2 [mm] | Day 3 [mm] | Day 4 [mm] |
50% Diniobium Pentaoxide | 1 | 0.18 | 0.17 | 0.17 | 0.18 |
2 | 0.17 | 0.17 | 0.17 | 0.18 | |
100 % AOO (3+1) Negative control |
3 | 0.17 | 0.17 | 0.18 | 0.17 |
Neither signs of systemic toxicity nor signs of irritation at the application site could be detected in the animals.
Results of the Reliability Check (Positive Control)
Table 2: Stimulation indices of the Positive-Control Group of the Recent Study
Test Item | Concentration [%] |
Animal Number | Stimulation Index |
AOO (3+ I (v/v) Acetone/Olive Oil) | 100 | 16 | |
17 | |||
18 | |||
19 | |||
20 | |||
MV | 1.0 | ||
SD | |||
Phenylenediamine | 1 | 81 | 10.2 |
82 | 11.0 | ||
83 | 14.0 | ||
84 | 17.1 | ||
85 | 16.8 | ||
MV | 13.8 | ||
SD | 2.9 |
Results of the Main Study
Table 3: Stimulation Indices obtained in the main study
Test Item | Concentration [%] |
Animal Number | Stimulation Index |
AOO (3+ I (v/v) Acetone/Olive Oil) | 100 | 16 | |
17 | |||
18 | |||
19 | |||
20 | |||
MV | 1.0 | ||
SD | |||
Diniobium Pentaoxide | 12.5 | 1 | 1.0 |
2 | 1.0 | ||
3 | 0.4 | ||
4 | n.d.* | ||
5 | 0.5 | ||
MV | 0.7 | ||
SD | 0.3 | ||
Diniobium Pentaoxide | 25 | 6 | 1.0 |
7 | 1.0 | ||
8 | 1.7 | ||
9 | 0.7 | ||
10 | 1.8 | ||
MV | 1.3 | ||
SD | 0.4 | ||
Diniobium Pentaoxide | 50 | 11 | 0.3 |
12 | 0.9 | ||
13 | 1.3 | ||
14 | 1.0 | ||
15 | n.d.* | ||
MV | 0.9 | ||
SD | 0.4 |
* = outlier, failed Grubbs, Nalimov and Dixon; n.d. = not determined
If not noted individually, the results include both lymph nodes of an animal.
SD = standard deviation; MV = mean value
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on skin sensitisation is available for the target substance Niobium oxide. Thus, available data from Niobium pentaoxide (source substance) is used to assess the skin sensitisation potential of Niobium oxide. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
In a dermal sensitization study according to OECD 429 Diniobium pentaoxide (source substance) was tested at concentrations of 12.5% (w/v), 25 % (w/v) and 50 % (w/v). There was no mortality and no adverse clinical signs of toxicity or adverse effects on body weights were observed. None of the tested concentrations of the test substance reached the stimulation index threshold of 3. Based on the results Diniobium pentaoxide can be considered as not dermal sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a dermal sensitization study according to OECD 429, female mice were tested negative for the source substance Diniobium pentaoxide. Based on the results from the read-across partner, no classification of the target substance Niobium oxide is warranted.
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