Reaction mass of calcium dihydroxide and calcium peroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 December 1988 - 06 January 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

9 animals were used. The eye of 6 rabbits remained unwashed and the eye of 3 were washed 20-30 seconds after treatment.

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Calcium dihydroxide

EC Number:

215-137-3

EC Name:

Calcium dihydroxide

Cas Number:

1305-62-0

Molecular formula:

CaH2O2

IUPAC Name:

calcium dihydroxide

Test material form:

solid

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 (USA).
- Age at study initiation: Young adults
- Weight at study initiation: 2.48 to 3.82 kg
- Housing: Individually in stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23.3
- Humidity (%):32-56
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

1 second

Observation period (in vivo):

22 days

Number of animals or in vitro replicates:

9 (3 male and 6 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
The eyes of six of the rabbits remained unwashed and the eyes of three of the rabbits were gently washed with 100 mL of tap water 20-30 seconds after treatment.

SCORING SYSTEM: Draize method.
The eyes were scored at 1, 24, 48 and 72 hours and on days 4, 7, 10, 13, 16, 19 and 22.
After the 24 hour examination with a penlight type light, the eyes were examined with the aid of 2% sodium fluorescein dye. Test eyes which retained fluorescein at 24 hours were examined with dye at subsequent assessment times until corneal irritation was no longer observed or dye was no longer retained.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 22d

Remarks on result:

other: Unwashed eye

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4d

Remarks on result:

other: Unwashed eye

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

not fully reversible within: 22d

Remarks on result:

other: Unwashed eye

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4d

Remarks on result:

other: Unwashed eye

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4d

Remarks on result:

other: Unwashed eye

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

other: Unwashed eye

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal: #7

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Washed eye

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal: #8

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal: #9

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Washed eye

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 13d

Remarks on result:

other: Unwashed eye

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Unwashed eye

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 16d

Remarks on result:

other: Unwashed eye

Results 13

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Unwashed eye

Results 14

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Unwashed eye

Results 15

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

other: Unwashed eye

Results 16

Irritation parameter:

iris score

Basis:

animal: #7

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Results 17

Irritation parameter:

iris score

Basis:

animal: #8

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Results 18

Irritation parameter:

iris score

Basis:

animal: #9

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 16d

Remarks on result:

other: Unwashed eye

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7d

Remarks on result:

other: Unwashed eye

Results 21

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 16d

Remarks on result:

other: Unwashed eye

Results 22

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10d

Remarks on result:

other: Unwashed eye

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 16d

Remarks on result:

other: Unwashed eye

Results 24

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 10d

Remarks on result:

other: Unwashed eye

Results 25

Irritation parameter:

conjunctivae score

Basis:

animal: #7

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 72h

Remarks on result:

other: Washed eye

Results 26

Irritation parameter:

conjunctivae score

Basis:

animal: #8

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

not fully reversible within: 48h

Remarks on result:

other: Washed eye

Results 27

Irritation parameter:

conjunctivae score

Basis:

animal: #9

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 72h

Remarks on result:

other: Washed eye

Results 28

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 13d

Remarks on result:

other: Unwashed eye

Results 29

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 13d

Remarks on result:

other: Unwashed eye

Results 30

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 13d

Remarks on result:

other: Unwashed eye

Results 31

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 4d

Remarks on result:

other: Unwashed eye

Results 32

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 13d

Remarks on result:

other: Unwashed eye

Results 33

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

not fully reversible within: 13d

Remarks on result:

other: Unwashed eye

Results 34

Irritation parameter:

chemosis score

Basis:

animal: #7

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Washed eye

Results 35

Irritation parameter:

chemosis score

Basis:

animal: #8

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Results 36

Irritation parameter:

chemosis score

Basis:

animal: #9

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Washed eye

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 1 hour scoring and unwashed eyes developed pannus, hemorrhagic conjunctivae, vascularization, blanched areas on the cornea and bulging of the cornea. Washed eyes recovered within 72 hours, however severe irritation persisted in two of the unwashed eyes through study day 22.

Other effects:

All animals remained healthy throughout the study.

Any other information on results incl. tables

Scores (mean 24 -72h):

Animal	Opacity	Iritis	Conjunctivae
			Redness	Chemosis	Discharge
1M	1	0.33	2	1.67	3
2M	1	0.33	2	1	2.67
3M	1.33	0	2.67	2.67	3
4F	1	0	2	2.33	3
5F	1	0	2.33	2.33	2.67
6F	1	0.67	3	1.33	2.67
7F (w)	0.33	0	1.33	0.67	1
8F (w)	0	0	0.33	0	0
9F (w)	0.33	0	1.33	0.33	1

Washed eyes recovered within 72 hours.

Severe irritation persisted in two of the unwashed eyes through study day 22.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance was determined to cause serious eye damage.

Executive summary:

An in-vivo eye irritation/corrosion was performed according to the OECD Guideline 405 (GLP study). Test item was installed into the test eyes of nine New Zealand White rabbits at a dose of 0.1 g. The eyes of six rabbits remained unwashed while the eyes of three rabbits were gently washed with 100 mL of tap water approximately 20 -30 seconds after treatment. Eyes were assessed for irritation using the method of Draize at 1, 24, 48 and 72 hours and at days 4, 7, 10, 13, 16, 19 and 22. 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 1 hour scoring and unwashed eyes developed pannus, hemorrhagic conjunctivae, vascularization, blanched areas on the cornea and bulging of the cornea. The mean 24 -72 scores for cornea were 1, 1 1.33, 1, 1, 1 (unwashed), 0.33, 0, 0.33 (washed); for iritis 0.33, 0.33, 0, 0, 0, 0, 0.67 (unwashed), 0, 0, 0 (washed); for conjunctivae redness 2, 2, 2.67, 2, 2.33, 3 (unwashed), 0.67, 0, 0.33 (washed) and for chemosis 1.67, 1, 2.67, 2.33, 2.33, 1.33 (unwashed), 0.67, 0, 0.67 (washed). Washed eyes recovered within 72 hours, however severe irritation persisted in two of the unwashed eyes through study day 22. Based on these results, the substance was determined to cause serious eye damage.