Lithium carbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-21 to 1988-01-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium carbonate

EC Number:

209-062-5

EC Name:

Lithium carbonate

Cas Number:

554-13-2

Molecular formula:

CH2O3.2Li

IUPAC Name:

dilithium carbonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Lithium carbonate, Technical Grade
- Physical state: White solid
- Analytical purity: 99 %

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: 2.83 kg to 3.15 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum, Purina High Fiber Rabbit Chow 5326
- Water (e.g. ad libitum):ad libitum, fresh tap water


ENVIRONMENTAL CONDITIONS
- Temperature (degree C): 20 - 21.7
- Humidity (%): 33 - 48
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g per test eye

Duration of treatment / exposure:

The test material was tapped off a piece of weighing paper into the lower conjunctival sac which was formed when the lower eyelid was pulled away from the test eye. The upper and lower lids were then brought together and held closed for one second and released. The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 sec after treatment.

Observation period (in vivo):

The animals were weighted once on the day before dosing. Clinical signs were recorded as noted.

Number of animals or in vitro replicates:

4 (3 male, 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 sec after treatment. The rate of application of the wash water was approximately 100 mL/min.
- Time after start of exposure: 20 - 30 sec

SCORING SYSTEM: The eyes were scored for irritation potential at 1, 24, 48 and 72 hours and on day 4 and 7 using the method of Draize.

TOOL USED TO ASSESS SCORE: After the 24 hour examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 7

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 7

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: day 4

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

chemosis score

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

All animals remained healthy throughout the study.
One hour after dosing, unwashed eyes had mild corneal opacities, iritis, moderate conjunctivitis and white and hemorrhagic areas on the conjunctivae. Washed eyes had slight corneal opacities and slight conjunctivitis. At the 24-hour scoring, both washed and unwashed eyes had mild corneal opacities and moderate conjunctivitis. Irritation gradually resolved; washed eyes recovered by day 4, and unwashed eyes recovered by day 7. Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of this study, the test material is irritating to eyes.

Executive summary:

An acute eye irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 405. Lithium carbonate Technical Grade was instilled into the test eyes of 4 New Zealand White rabbits at a dose of 0.1 g. The eyes of two rabbits remained unwashed while the eyes of the remaining two rabbits were gently washed with 100 mililitres 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 after installation, as well as on days 4 and 7. Slight to mild corneal opacities, iritis and slight to moderate conjunctivitis were noted in all eyes. Unwashed eyes also had hemorrhages and white areas on the conjunctivae. Washing the eyes with tap water shortly after exposure decreased both the severity and the duration of the irritation observed. Irritation gradually resolved; washed eyes recovered by day 4 and unwashed eyes recovered by day 7. Based on the results obtained with unwashed eyes, lithium carbonate has to be classified and labelled as Cat.2 (H319) in respect to eye irritation according to the Regulation (EC) No 1272/2008 (CLP).