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EC number: 908-749-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to internationally accepted protocol. No deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Calcium peroxide
- EC Number:
- 215-139-4
- EC Name:
- Calcium peroxide
- Cas Number:
- 1305-79-9
- Molecular formula:
- CaO2
- IUPAC Name:
- calcium peroxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: tan powder
- Analytical purity: 82.1%
- Reference number: 804-26
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania
- Age at study initiation: young adult
- Weight at study initiation: 2.48 - 3.82 kg
- Housing: individually, in stainless steel rabbit cages
- Diet (e.g. ad libitum): Furina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): tab water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65 - 74 °F
- Humidity (%): 32 - 56 %
- Photoperiod (hrs dark / hrs light): 12h fluorescent light, / 12h dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.10 g - Duration of treatment / exposure:
- The eyes of six of he rabbits remained unwashed.
The eyes of 3 of the rabbits were gently washed with 100 mL of tap water approximately 20-30 seconds after treatment. - Observation period (in vivo):
- 22 days
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes of six of he rabbits remained unwashed. The eyes of 3 of the rabbits were gently washed with 100 mL of tap water approximately 20-30 seconds after treatment.
SCORING SYSTEM: Method of Draize
TOOL USED TO ASSESS SCORE: penlight type light, 2% sodium fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- other: 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- other: 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- other: 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.3 - 28.7
- Max. score:
- 110
- Remarks on result:
- other: score: washed / unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- other: 22 d
- Score:
- 0 - 8.3
- Max. score:
- 110
- Remarks on result:
- other: score: washed / unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 0 - 22.8
- Max. score:
- 110
- Remarks on result:
- other: score: washed / unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 14 - 33.2
- Max. score:
- 110
- Remarks on result:
- other: score: washed / unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 10 - 23.7
- Max. score:
- 110
- Remarks on result:
- other: score: washed / unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary Eye Irritation Index
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0 - 28.3
- Max. score:
- 110
- Remarks on result:
- other: score: washed / unwashed
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- other: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- other: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- other: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: 0
- Irritant / corrosive response data:
- One hour post-dosing slight corneal opacities, iritis and moderate to severe conjunctivitis was noted in unwashed eyes. Washed eyes had mild conjunctivitis. Irritation worsened after the 1-hour scoring and unwashed eyes developed pannus, hemorrhagic conjuctivae, vascularization, blanched areas on the cornea and bulging of the cornea.
Washed eyes recovered within 72 hours. However, severe irritation persisted in 2 of the unwashed eyes througout study day 22.
Any other information on results incl. tables
Cornea effects (opacity and area):
# |
Wash |
24h |
48h |
72h |
mean |
||||
|
|
Opac. |
Area |
Opac. |
Area |
Opac. |
Area |
Opac. |
Area |
1 |
No |
1 |
3 |
1 |
4 |
1 |
3 |
1 |
3.3 |
2 |
No |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
3 |
No |
2 |
4 |
2 |
2 |
1 |
4 |
1.6 |
3.3 |
4 |
No |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
5 |
No |
1 |
1 |
1 |
3 |
1 |
2 |
1 |
2 |
6 |
No |
1 |
3 |
1 |
3 |
1 |
3 |
1 |
3 |
7 |
Yes |
1 |
1 |
0 |
0 |
0 |
0 |
0.3 |
0.3 |
8 |
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
Yes |
1 |
1 |
0 |
0 |
0 |
0 |
0.3 |
0.3 |
Iritis:
# |
Wash |
24h |
48h |
72h |
Mean |
1 |
No |
0 |
0 |
1 |
0.3 |
2 |
No |
1 |
0 |
0 |
0.3 |
3 |
No |
0 |
0 |
0 |
0 |
4 |
No |
0 |
0 |
0 |
0 |
5 |
No |
0 |
0 |
0 |
0 |
6 |
No |
1 |
0 |
1 |
0.6 |
7 |
Yes |
0 |
0 |
0 |
0 |
8 |
Yes |
0 |
0 |
0 |
0 |
9 |
Yes |
0 |
0 |
0 |
0 |
Effects on the conjuncitvae (redness, chemosis and discharge):
# |
Wash |
24h |
48h |
72h |
Mean |
||||||||
|
|
R |
C |
D |
R |
C |
D |
R |
C |
D |
R |
C |
D |
1 |
No |
2 |
3 |
3 |
2 |
1 |
3 |
2 |
1 |
3 |
2 |
1.6 |
3 |
2 |
No |
2 |
2 |
3 |
2 |
1 |
3 |
2 |
0 |
2 |
2 |
1 |
2.6 |
3 |
No |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
2 |
3 |
2.6 |
2.6 |
3 |
4 |
No |
2 |
3 |
3 |
2 |
2 |
3 |
2 |
2 |
3 |
2 |
2.3 |
3 |
5 |
No |
2 |
3 |
3 |
2 |
2 |
3 |
3 |
2 |
3 |
2.3 |
2.3 |
3 |
6 |
No |
3 |
2 |
3 |
3 |
1 |
2 |
3 |
1 |
3 |
3 |
1.3 |
3 |
7 |
Yes |
3 |
2 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0.6 |
1 |
8 |
Yes |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.3 |
0 |
0 |
9 |
Yes |
3 |
1 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
1.3 |
0.3 |
1 |
Reversibility of effects: all parameters on day 22:
# |
Wash |
Cornea |
Iris |
Conjunctivae |
|||
|
|
Opac. |
Area |
|
R |
C |
D |
1 |
No |
2 |
2 |
0 |
0 |
0 |
0 |
2 |
No |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
No |
3 |
2 |
0 |
0 |
0 |
0 |
4 |
No |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
No |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
No |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study , the test material is judged to be severely irritating to unwashed eyes.
- Executive summary:
Calcium peroxide was instilled into the eyes of 9 New Zealand White rabbits at a dose of 0.10 g. The eyes of 6 rabbits remained unwashed while the eyes of 3 rabbits were gently washed with 100 mL of tap water approx. 20 -30 secondes after treatment. The eyes were assessed using the method of Draize and Primary Eye Irritation Indexes were calculated.
Under the conditions of this study, the test material is judged to be severely irritating to unwashed eyes.
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