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EC number: 215-214-1 | CAS number: 1313-97-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 August 1984 - 3 September 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Neodymium oxide
- EC Number:
- 215-214-1
- EC Name:
- Neodymium oxide
- Cas Number:
- 1313-97-9
- Molecular formula:
- Nd2O3
- IUPAC Name:
- dineodymium(3+) trioxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Albino New Zealand
- Sex: males
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 540 x 360 x 315 mm, with a perforated floor
- Diet: ad libitum, 150 g of complete maintenance food per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 to 14 times per hour (pre-filtered air: 5 - 10 µl)
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 8 August 1984 To: data not available
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- no
- Controls:
- other: the left eye remained untreated and served as control
- Amount / concentration applied:
- Amount applied: 0.1 g in the right eye.
- Duration of treatment / exposure:
- The upper and lower eyelid are held together for 10 seconds to avoid loss of test substance.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no washing
TOOL USED TO ASSESS SCORE: Heine's ophthalmoscope / fluorescein
SCORING SYSTEM:
1. CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3
Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4
IRIS
Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2
CORNEA
Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4
Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4
ULCERATION
No ulceration.................................................................................................................................................0
Presence of ulceration.................................................................................................................................U
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.667
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight iris irritation observed in one rabbit at 24 and 48 hour time points. No other effects observed in any rabbit.
- Other effects:
- No data available.
Any other information on results incl. tables
Table 1 Individual Results
Timepoint (hours) |
Rabbit Number |
Conjunctiva |
Iris Congestion |
Cornea |
|||
Chemosis |
Redness |
Degree of Opacity |
Area |
Ulceration |
|||
24 |
892 |
0 |
0 |
0 |
0 |
0 |
0 |
893 |
0 |
0 |
1* |
0 |
0 |
0 |
|
894 |
0 |
0 |
0 |
0 |
0 |
0 |
|
895 |
0 |
0 |
0 |
0 |
0 |
0 |
|
896 |
0 |
0 |
0 |
0 |
0 |
0 |
|
897 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
0.17 |
0 |
0 |
0 |
|
48 |
892 |
0 |
0 |
0 |
0 |
0 |
0 |
893 |
0 |
0 |
1* |
0 |
0 |
0 |
|
894 |
0 |
0 |
0 |
0 |
0 |
0 |
|
895 |
0 |
0 |
0 |
0 |
0 |
0 |
|
896 |
0 |
0 |
0 |
0 |
0 |
0 |
|
897 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
0.17 |
0 |
0 |
0 |
|
72 |
892 |
0 |
0 |
0 |
0 |
0 |
0 |
893 |
0 |
0 |
0 |
0 |
0 |
0 |
|
894 |
0 |
0 |
0 |
0 |
0 |
0 |
|
895 |
0 |
0 |
0 |
0 |
0 |
0 |
|
896 |
0 |
0 |
0 |
0 |
0 |
0 |
|
897 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
|
*Circumcorneal injection
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to this study, the test material is not classified as an eye irritant.
- Executive summary:
An eye irritation study was conducted in accordance with the standardised guideline OECD 405. 0.1 g of the test material was instilled into the conjunctival sac of the right eye of six male New Zealand white rabbits.
Animals were observed for 21 days. Ocular irritation was scored based on chemosis and changes to the iris, cornea and conjunctivae at 24, 48 and 72 h.
The mean scores for the 6 rabbits across all timepoints were 0 for corneal opacity, 0.66 for iritis, 0 for redness and 0 for chemosis of the conjunctivae.
In this study, the test material was seen to be not irritating to the eye, requiring no classification.
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