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EC number: 939-967-7 | CAS number: -
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 13 November 1990 - 16 November 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- publication
- Title:
- Acute Toxicological Evaluation of Erbium Oxide
- Author:
- Lambert, C.E., Barnum, E.C. and Shapiro, R.
- Year:
- 1 993
- Bibliographic source:
- Int. J. Toxicol., 12(6): 619
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FHSA 16 CFR 1500.42
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dierbium trioxide
- EC Number:
- 235-045-7
- EC Name:
- Dierbium trioxide
- Cas Number:
- 12061-16-4
- Molecular formula:
- Er2O3
- IUPAC Name:
- Dierbium trioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: pink powdered solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
IN-LIFE DATES: From: To: 25 October 1990 - 16 November 1990
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 g - Duration of treatment / exposure:
- Three of the treated eyes were rinsed 30 seconds post-installation.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6; 3 male, 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): three of the treated eyes were rinsed with 30 cc of saline solution.
- Time after start of exposure: 30 seconds post-exposure.
- Scoring system: according to the method of Draize. Ocular lesions were evaluated at 24, 48 and 72 hours post installation. Fluorescein was used at the 24 hour evaluation.
Draize Scale for Scoring Ocular Irritation
1. CONJUNCTIVAE
(A) 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
(B) 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
(C) Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS
(D) 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
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA
(E) 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
(F) 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
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 110
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- -No corneal opacity was noted in any of the treated eyes.
-Iritis was observed in two unwashed eyes 24 hours post installation and in one eye at 48 hours. By 72 hours all eyes were free of iritis. Iritis was not observed in any of the washed eyes.
-Conjunctival irritation was noted in all eyes 24 and 48 hours after administration. This remained in one unwashed and two washed eyes after 72 hours. - Other effects:
- All animals appeared active and healthy. No signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were observed.
Any other information on results incl. tables
Table 1 Individual Results
Time Point (hours) |
Rabbit Number |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
24 |
7806 7807 7808 7809 7810 7811 |
0 0 0 0 0 0 |
1 0 1 0 0 0 |
2 2 2 2 1 1 |
2 1 1 1 1 1 |
3 2 2 1 2 1 |
48 |
7806 7807 7808 7809 7810 7811 |
0 0 0 0 0 0 |
0 0 1 0 0 0 |
1 2 1 1 1 2 |
1 1 0 1 1 1 |
1 0 0 0 0 0 |
72 |
7806 7807 7808 7809 7810 7811 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 1 0 0 0 1 |
0 1 0 0 1 1 |
0 0 0 0 0 0 |
Rabbits 7809, 7810 and 7811 had the treated eye rinsed with 30 cc of saline solution 30 seconds post-installation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes.
- Executive summary:
The eye irritation potential of the test material was investigated in a study which was broadly conducted in accordance with FHSA guideline16 CFR 1500.42. During the study 0.1 g of the test material was instilled into the left eye of six New Zealand white rabbits, with three of the treated eyes being rinsed after 30 seconds with saline. The animals were observed for three days and the eyes examined at 24, 48 and 72 hours. Irritation was scored according to the method of Draize.
Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes. No classification is required in accordance with EU criteria.
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