Registration Dossier

Toxicological information

Eye irritation

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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:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
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

Constituent 1
Chemical structure
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

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):
72hs
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to the eyes according to EU and GHS