Lithium chloride

Skin irritation / corrosion

Administrative data

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

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium chloride

EC Number:

231-212-3

EC Name:

Lithium chloride

Cas Number:

7447-41-8

Molecular formula:

ClLi

IUPAC Name:

lithium chloride

Test material form:

solid

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

Test animals

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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.

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

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.