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Registration Dossier
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EC number: 215-213-6 | CAS number: 1313-96-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-07-24 to 2001-06-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diniobium pentaoxide
- EC Number:
- 215-213-6
- EC Name:
- Diniobium pentaoxide
- Cas Number:
- 1313-96-8
- Molecular formula:
- Nb2O5
- IUPAC Name:
- diniobium(5+) pentaoxidandiide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.3 to 3.0kg
- Housing: metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet)
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes of the animals served as control
- Amount / concentration applied:
- 100mg
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were evaluated at 1, 24, 48 and 72 hours after instillation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- - Corneal opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Remarks:
- - Iridal lesions
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- - Conjuctival redness
- Basis:
- mean
- Remarks:
- (mean of three animals and of three timepoints)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
| Rabbit no. & sex | Region of eye | 1h | 24h | 48h | 72h | |
| 1391 Male | Cornea | Density | 0 | 0 | 0 | 0 |
| Area | 0 | 0 | 0 | 0 | ||
| Iris | 0 | 0 | 0 | 0 | ||
| Conjuctiva | Redness | 2 | 1 | 0 | 0 | |
| Chemosis | 1 | 0 | 0 | 0 | ||
| 1460 Male | Cornea | Density | 0 | 0 | 0 | 0 |
| Area | 0 | 0 | 0 | 0 | ||
| Iris | 0 | 0 | 0 | 0 | ||
| Conjuctiva | Redness | 1 | 1 | 1 | 0 | |
| Chemosis | 1 | 0 | 0 | 0 | ||
| 1461 Male | Cornea | Density | 0 | 0 | 0 | 0 |
| Area | 0 | 0 | 0 | 0 | ||
| Iris | 0 | 0 | 0 | 0 | ||
| Conjuctiva | Redness | 1 | 0 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | ||
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- Not irritating to the eyes according to EU and GHS
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