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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
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- Flash point
- Auto flammability
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- Aquatic toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Additional toxicological data
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Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Niobium oxide
- EC Number:
- 234-808-1
- EC Name:
- Niobium oxide
- Cas Number:
- 12034-57-0
- Molecular formula:
- NbO
- IUPAC Name:
- niobium oxide
- Test material form:
- solid
- Details on test material:
- - Lot/batch No. of test material: SNB10OG200277M
- Expiration date of the lot/batch: 2003-12-31
- Purity: >99%
- Description: black, odourless powder
- Storage condition of test material: dry, room temperatue, closed container
Constituent 1
Test animals / tissue source
- 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
Test system
- 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)
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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