Registration Dossier
Registration Dossier
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EC number: 231-113-5 | CAS number: 7440-03-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-31 to 2009-10-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- Niobium
- EC Number:
- 231-113-5
- EC Name:
- Niobium
- Cas Number:
- 7440-03-1
- Molecular formula:
- Nb
- IUPAC Name:
- Niobium
- Test material form:
- solid: compact
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 Deutschland, Sulzfeld, Germany
- Age at study initiation: 23 weeks
- Weight at study initiation: > 2kg
- Housing: ABS plastic rabbit cages, floor 4200 cm2
- Diet (ad libitum): ad libitum
- Water ( ad libitum):ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+-3
- Humidity (%): 55+-10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2009-09-14 To: 2009-09-18
Test system
- Vehicle:
- physiological saline
- Controls:
- other: untreated eyes of the animals served as control
- Amount / concentration applied:
- 0.1 mL of test item extract
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- Reading time points: 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
treated in sequential manner (according to guideline)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- mean of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: grade 1 at 24 h scoring time point
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal # 1 and 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification according to Regulation (EC) No 1272/2008
- Conclusions:
- Not irritating to the eyes according to EU and GHS
CLP: not classified
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