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EC number: 234-809-7 | CAS number: 12034-59-2
- 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
No data is available for Niobium dioxide (target substance). Thus, Niobium oxide (source substance) is used to assess the skin and eye irritating/corrosive potential of Niobium dioxide in a read-across approach.
Niobium oxide was tested negative in an acute skin and in an acute eye irritation/corrosion study (EU methods B.4 & B.5).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key 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
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The treated and also the control skin area did not show any irritations at any observation time. After one hour the administration area was discoloured slightly black in all animals. This discolouration did not interfere with the evaluation of a possible erythema.
For detailed information on the individual results, please see Table 1 in box "Any other information on results". - Other effects:
- None of the animals died during the course of investigation and no clinical signs were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the acute dermal irritation/corrosion study according to Directive 67/548/EEC, Annex V, B.4, Niobium oxide is considered to be non-irritating to the skin.
- Executive summary:
In a primary dermal irritation study (EU method B.4), young adult male New Zealand White rabbits (3/sex) were dermally exposed to 0.5 g of Niobium oxide (>99% purity), moistened with 0.5% (m/v) solution of Tylose MH100 in deionised water, for 4 hours to a body surface area of 2 x 3 cm. Animals then were observed for 1, 24, 48 and 72 hours. Irritation was scored by the method of Draize.
Neither mortality nor any adverse clinical signs of toxicity were observed during the study. The treated and also the control skin areas did not show any irritations at any observation time. In this study, Niobium oxide is not a dermal irritant.
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
Table 1: Evaluation of alterations of the skin area after administration of the test item
Alteration | Animal No. | Observed grades of skin alteratioons of each observation time | |||||||
Hours after administration | |||||||||
1 | 24 | 48 | 72 | ||||||
Control | Test Item | Control | Test Item | Control | Test Item | Control | Test Item | ||
Erythema | 1 | 0 | 0* | 0 | 0* | 0 | 0 | 0 | 0 |
2 | 0 | 0* | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 0* | 0 | 0 | 0 | 0 | 0 | 0 | |
Oedema | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
* The administration area was discoloured slight black; this discolouring did not interfere with the evaluation of a possible erythema.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key 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
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The control eyes of the animals showed no alterations at any observation time. A slight redness of the conjunctivae and a serous lacrimation was observed in all animals on the day of instillation. The cornea and iris were not affected. After 24 hours no signs of irritation were observed. For details on the individual results please see Table 1 in box "Any other information on results".
- Other effects:
- None of the animals died or showed clinical signs during the course of testing.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in a primary eye irritation study Niobium oxide was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits for 24 hours. Based on the results, Niobium oxide can be considered as not eye irritating.
- Executive summary:
In a primary eye irritation study (EU method B.5), 0.1 g of Niobium oxide (> 99% purity) was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits for 24 hours. After the exposure period the treated eyes were rinsed with deionised water. Animals were observed for 1, 24, 48 and 72 hours after instillation. Irritation was scored by the method of Draize. In this study, none of the animals died or showed clinical signs of toxicity. A slight redness of the conjunctivae and a serous lacrimation was observed in all animals on the day of instillation. The cornea and iris were not affected. After 24 hours no signs of irritation were observed anymore. Based on the results, Niobium oxide is not an eye irritant to the eye.
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
Table 1: Evaluation of alterations of eyes after instillation of Niobium(II) oxide
Alteration | Animal No. | Observed grades of skin alterations of each observation time | |||||||
Hours after administration | |||||||||
1 | 24 | 48 | 72 | ||||||
Control | Test Item | Control | Test Item | Control | Test Item | Control | Test Item | ||
Cornea | 1 | 0 | 0 | 0 | 0* | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 1 | 0 | 1* | 0 | 0* | 0 | 0 | 0 | 0 |
2 | 0 | 1* | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 1* | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
* serous lacrimation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available for Niobium dioxide (target substance). Thus, Niobium oxide (source substance) is used to assess the skin and eye irritating/corrosive potential of Niobium dioxide in a read-across approach.
For justification of read-across please refer to the read-across report attached to IUCLID section 13.The source substance Niobium oxide (>99% purity) was tested negative for acute dermal irritating properties in a study conducted according to EU method B.4. After a dermal exposure period of 4 hours no skin effects were observed in rabbits.
In an acute eye irritation study (EU method B.5) a slight redness of the conjunctivae and a serous lacrimation was observed in all animals on the day of instillation after treatment with the source substance. The cornea and iris were not affected. After 24 hours no signs of irritation were observed anymore. Thus, Niobium oxide is not considered to be an eye irritant.
Justification for classification or non-classification
The read across partner Niobium oxide did not cause any skin and eye effects in an acute dermal and eye irritating study in accordance to EU method B.4 and EU method B.5. Based on these results, the target substance Niobium dioxide does not warrant classification for skin and eye irritation in accordance to CLP regulation (EC) No 1272/2008.
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