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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
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:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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:
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: 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: 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: 72 h
Score:
0 - 28.3
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: 22 d
Score:
0 - 8.3
Max. score:
110
Remarks on result:
other: score: washed / unwashed
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.