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Description of key information

Based on the results of one skin irritation and one eye irritation study with lithium carbonate, the test substance is not to be considered irritating to skin  but irritating to eyes.

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:
1988-01-21 to 1988-01-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
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: 3.19 kg to 3.33 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 °C
- Humidity (%): 36 - 48
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
The animals were weighed once on the day before dosing. Clinical signs were recorded as noted. Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of Draize.
Number of animals:
3 (2 male, 1 female)
Details on study design:
TEST SITE
- Area of exposure: The clipped area extended from the scapular to the pelvic region. One test site was located on each side of the spinal column.
- Type of wrap if used: semi-occlusive cheesecloth bandage


REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: exposure-time: 4 hours


SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of Draize. The sites were evaluated daily thereafter for 5 days.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All animals remained healthy throughout the study.
One rabbit had slight erythema on study days 1 - 4. All irritation had resolved by study day 5 which time the test was terminated.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study , the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours.
Executive summary:

An acute skin irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 404. Three New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of lithium carbonate Technical Grade was placed in contact with each 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 material removed. Approximately 30 minutes, 24, 48, 72 hours after the end of the exposure period, the test sites were scored for irritation using the method of Draize. Irritation observed in one of the three animals (scored 1 for erythema) had resolved by the end of the study (day 5). Under the conditions of this study, the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours. The used scores of the test system (US scheme) were adapted to the EU scheme. Thus, based on the results obtained lithium carbonate has not to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP).

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:
1988-01-21 to 1988-01-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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
- 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
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.
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
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
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
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
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
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
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
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
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
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
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
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
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.
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).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

An acute skin irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 404. Three New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of lithium carbonate technical Grade was placed in contact with each 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 material removed. Approximately 30 minutes, 24, 48, 72 hours after the end of the exposure period, the test sites were scored for irritation using the method of Draize. Irritation observed in one of the three animals (scored 1 for erythema) had resolved by the end of the study (day 5). Under the conditions of this study, the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours. The used scores of the test system (US scheme) were adapted to the EU scheme. Thus, based on the results obtained lithium carbonate has not to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP).

Eye:

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).


Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation/corrosion, the test item is not to be considered irritating to the skin but irritating to the eyes. In conclusion, lithium carbonate is not classified according to Regulation (EC) No 1272/2008 (CLP) with regard to skin irritation. With respect to eye irritation, lithium carbonate has to be classified into cat. 2 (H319) according to the Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.

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