Reaction mass of calcium dihydroxide and calcium peroxide

Endpoint summary

Description of key information

Key study: OECD Guideline 404. GLP study. The test item was determined to be not irritating to the skin. No irritation was notes on any of the test sites during any of the scoring intervals (erythema and edema scores of 0). All the animals remained healthy throughout the study.

Key study: OECD Guideline 405. GLP study. The substance was determined to cause serious eye damage since opacity was not fully reversible in 2 from 9 rabbits within 22 days of observation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 December 1988 - 18 December 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Young adult
- Weight at study initiation: 2.64 kg to 2.97 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 (%): 34-47
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

physiological saline

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): Saline (just for moisturising)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Trunk (from the scapular to the pelvic region).
- % coverage: 100
- Type of wrap if used: Cheesecloth bandage
0.5 g test item was applied to 2 x 2 gauze pad and moistened with physiological saline. The gauze pad was secured to each test site with hypoallergenic tape. The entire trunk was wrapped with a semi-occlusive cheesecloth bandage. The animals were fitted with plastic collars to prevent disturbance of the test sites.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with clean gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30 min after unwrapping, at 24, 48 and 72 hours.

SCORING SYSTEM:
- Method of calculation: Draize method.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No irritation was noted on any of the test sites during any of the scoring intervals.

Other effects:

All the animals remained healthy throughout the study.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was determined to be not irritating to the skin.

Executive summary:

An in-vivo skin irritation/corrosion test was performed according to the OECD Guideline 404 (GLP study). Three male and three female New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of test item was place in contact with eact test site. The test sites were covered with gauze patches and the trunk of each animal was wrapped with a sheet of cheesecloth. The test material was in contact with the skin for 4 hours, after which the animals were unwrapped and the test item removed. The test sites were scored for irritating using the method of Draize at 30 minutes after unwrapping, at 24, 48 and 72 hours. No irritation was notes on any of the test sites during any of the scoring intervals (erythema and edema scores of 0). All the animals remained healthy throughout the study. Based on these results, the test item was determined to be not irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Unwashed eye

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Unwashed eye

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

Irritation parameter:

iris score

Basis:

animal: #7

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Irritation parameter:

iris score

Basis:

animal: #8

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

Irritation parameter:

iris score

Basis:

animal: #9

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Irritation parameter:

chemosis score

Basis:

animal: #8

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Washed eye

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Additional information

Eye irritation: 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. 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. Although the corneal opacity was < 3 and iritis < 1.5, since in at least one animal effects on the cornea did not reverse or have not fully reversed within an observation period of 22 days, the substance is determined to cause serious eye damage.

Justification for classification or non-classification

Skin irritation: Based on the available information (erythema and edema scores of 0), the substance is not classified for skin irritation according to the CLP Regulation (EC) no. 1272/2008.

Eye irritation: Based on the available information (corneal opacity not fully reversible within 22 days), the substance is classified for eye damage category 1 (H318) according to the CLP Regulation (EC) no. 1272/2008.