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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
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-02 to 2003-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, 97320 Sulzfeld, Germany
- Hygiene status upon supply: SPF
- Weight at study initiation: 2800 - 3310 g
- Housing: Cages of stainless steel with bottom grid of oval steel and with tub for faeces, dimensions of cages: 50 x 55 x 40 cm
- Diet (e.g. ad libitum): ad libitum, ALTROMIN 2123, standard diet for rabbits
- Water (e.g. ad libitum): ad libitum, tap water
- Bedding: ALTROMIN Type S8/15, granulated soft wood bedding
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 0.5% (m/v) solution of Tylose MH 1000 in deionised water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): test item was moistened
- Concentration (if solution): 0.5 % (m/v) Tylose MH 1000 in deionised water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL of the vehicle 0.5% (m/v) Tylose MH 1000 in deionised water
- Concentration (if solution): 0.5% (m/v) Tylose MH 1000 in deionised water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm
- coverage: one layer of gauze patch (2.5 x 3.5 cm) and aluminium foil (3 x 4 cm)
- Type of wrap if used: occlusive (Elastoplast, Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with deionised water after patch removal
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS (indicate if minutes, hours or days)
1, 24, 48, and 72 h after patch removal
SCORING SYSTEM:
- Method of calculation:
Erythema and Eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar formation preventing
grading of erythema 4
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extended beyond area
of exposure) 4
Evaluation criteria:
The evaluation of results was carried out according to Appendix 6 to Directive 2001/59/EU of August 06, 2001.
The following criteria should be fulfilled within 72 hours after patch removal in a test using three test animals for the classification of a substance as a skin irritant and for labelling with R 38:
In at least two animals Erythema and Eschar formation: ≥2.0 or Oedema formation: ≥2.0, which persist for at least 24 hours.
All responses scored at 24, 48 and 72 hours after patch removal are used to calculate the mean value for each skin lesion for each individual animal.
The same classification is necessary if a lower effect is not reversible within the 14 day observation period.
OTHER EXAMINATIONS:
- Body Weight: Body weights were recorded on the day of administration and at the end of the observation period
- Clinical observations and mortality: The animals were monitored for general clinical signs on the day of administration and once daily thereafter. - 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.
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-02 to 2003-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, 97320 Sulzfeld, Germany
- Hygiene staus upon supply: SPF
- Weight at study initiation: 2268 - 3105 g
- Housing: Cages of stainless steel with bottom grid of oval steel and with tub for faeces, dimensions of cages: 50 x 55 x 40 cm
- Diet (e.g. ad libitum): ad libitum, ALTROMIN 2123, standard diet for rabbits
- Water (e.g. ad libitum): ad libitum, tap water
- Bedding: ALTROMIN Type S8/15, granulated soft wood bedding
- Acclimation period: 2 - 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single treatment, after 24 hours the treated eye was washed
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with deionised water
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize method
EVALUATION CRITERIA
The evaluation of results was carried out according to Appendix 6 to Directive 2001/59/EU of August 06, 2001.
The following criteria should be fulfilled within 72 hours after instillation and persist for at least 24 hours in a test using three animals for classification of a substance as eye irritant and for the labelling with R36 (significant ocular lesions):
In at least two animals redness of conjunctivae ≥2.5, chemosis of conjunctivae ≥2.0, cornea opacity ≥2.0 < 3, iris lesion ≥1.0 < 2 and for labeling with R41 (severe ocular lesions) in at least two animals cornea opacity ≥3.0, iris lesions =2.0.
All responses scored at 24, 48 and 72 hours after instillation are used to calculate the mean value for each ocular lesion for each individual animal.
The classification as eye irritant and labelling with R41 (severe ocular lesions) is also necessary if a lower effect is not reversible in the 21 day observation period or an irreversible coloration of the cornea or iris are induced.
TOOL USED TO ASSESS SCORE: hand-slit lamp (Heine OPTOTECHNIK) - 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.
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
The target 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 target substance. 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.
Justification for classification or non-classification
Based on the available data and according to regulation (EC) No. 1272/2008, no classification of niobium oxide for skin and eye irritation is warranted.
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