Lithium chloride

Endpoint summary

Description of key information

Based on the result of the eye irritation study with lithium chloride, the test substance is to be considered irritating.  Based on the result of the skin irritation study with lithium chloride, the test substance is to be considered not irritating to skin. Although the animal data would not require classification with regard to skin irritation, based on experiences with lithium chloride in humans at production sites the substance is classified as skin irritant.

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 1988-03-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: keep containers tightly closed
- Stability under test conditions: stable

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: 3.05 kg to 3.20 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 (°C): 20°C - 21.7°C
- Humidity (%): 33 % - 59 %
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

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

Number of animals:

3 (1 male, 2 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 (if done): 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 30 minute delay was instituted to allow for regression of pressure and hydration effects. The sites were evaluated daily thereafter for 14 days.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

probability of mild irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

NA

Other effects:

The mean body weight was 3.14 ± 0.081 kg on the day prior to dosing. All animals remained healthy throughout the study.

No other information

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 chloride anhydrous 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 after the end of the exposure period, the test sites were scored for irritation using the method of Draize. The test sites were scored daily thereafter for 14 days.

Mild to moderate erythema and slight edema were noted on the test sites 4.5 hours post-dosing. Two rabbits had complete recovery on the test sites within 72-hours, at which time the third rabbit had developed eschar on one test site. Eschar persisted on this animal through day 14 of the study.

Although the animal data would not require classification with regard to skin irritation, based on experiences with lithium chloride in humans at production sites, the substance is classified as skin irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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 1988-03-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable

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: 3.09 kg to 3.44 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum, Purina High Fiber Rabbit Chow 5326
- Water: ad libitum, fresh tap water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C - 21.7°C
- Humidity: 28 % - 59 %
- Photoperiod: 12 hours fluorescent light and 12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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 weighed once on the day before dosing. Clinical signs were recorded as noted.

Number of animals or in vitro replicates:

4 (1 male, 3 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, 7, 10, 13 and 16 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

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

washed eye

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 13

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #4

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day7

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

washed eye

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Remarks:

washed eye

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: day 7

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

One hour post-dosing, slight to mild corneal opacities, iritis and severe conjunctivitis were noted in all eyes. At the 48-hour scoring, mild opacities and moderate conjunctivitis were observed; one animal also had hemorrhagic conjunctivae and one had brown areas on the conjunctivae. By day 7, washed eyes had recovered, unwashed eyes had mild conjunctivitis, one of which had white, brown and hemorrhagic areas on the conjunctivae. Unwashed eyes recovered by day 16, at which time the test was terminated. Washing the eyes with tap water shortly after exposure decreased the duration of the irritation observed.

Other effects:

The mean body weight of the animals was 3.25 ± 0.145 kg on the day prior to dosing.
All animals remained healthy throughout the study.

No other information

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 Chloride Anhydrous Technical 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 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 after installation, as well as on days 4, 7, 10, 13 and 16.

Slight to mild corneal opacities, iritis and moderate to severe conjunctivitis was noted in both washed and unwashed eyes during the study. White, brown and hemorrhagic areas were noted on the conjunctivae of two rabbits. Irritation was greatest 1 -hour after dosing, then gradually subsided. Washed eyes recovered by day 7, and unwashed eyes recovered by day 16. Washing the eyes with tap water shortly after exposure decreased the duration of the irritation observed.

The used scores of the US scheme were adapted to the EU scheme.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

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 chloride anhydrous 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 after the end of the exposure period, the test sites were scored for irritation using the method of Draize. The test sites were scored daily thereafter for 14 days.

Mild to moderate erythema and slight edema were noted on the test sites 4.5 hours post-dosing. Two rabbits had complete recovery on the test sites within 72-hours, at which time the third rabbit had developed eschar on one test site. Eschar persisted on this animal through day 14 of the study.

Although the animal data would not require classification with regard to skin irritation, based on experiences with lithium chloride in humans at production sites, the substance is classified as skin irritant.

Eye irritation

An acute eye irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 405. Lithium Chloride Anhydrous Technical 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 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 after installation, as well as on days 4, 7, 10, 13 and 16.

Slight to mild corneal opacities, iritis and moderate to severe conjunctivitis was noted in both washed and unwashed eyes during the study. White, brown and hemorrhagic areas were noted on the conjunctivae of two rabbits. Irritation was greatest 1 -hour after dosing, then gradually subsided. Washed eyes recovered by day 7, and unwashed eyes recovered by day 16. Washing the eyes with tap water shortly after exposure decreased the duration of the irritation observed.

Justification for classification or non-classification

The scores of the test system (US scheme) were adapted to the EU scheme. Based on the results obtained, lithium chloride has to be classified and labelled into Cat. 2 (H319) in respect to eye irritation according to the Regulation (EC) No 1272/2008 (CLP).

Although the animal data would not require classification with regard to skin irritation, based on experiences with Lithium chloride in humans at production sites the substance is classified as skin irritant: Cat. 2 (H315) according to the Regulation (EC) No 1272/2008 (CLP).