Lithium chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-10-13 to 1995-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

1984

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 0997

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: Young adult
- Weight at study initiation: 242 g to 299 g
- Housing: individually housed in stainless steel suspended rat cages
- Diet (e.g. ad libitum): ad libitum, Purina Rodent Chow 5001 (pellets)
- Water (e.g. ad libitum): ad libitum, fresh tap water
- Acclimation period: The animals were acclimated for a minimum of 5 calendar days prior to study start.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6°C - 21.2°C
- Humidity (%): 56 % - 61%
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent/ 12 hours dark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dermal application on intact skin
- Type of wrap if used: 4 ply 4x4 inch gauze pad, hypoallergenic tape, elastic bandage, lined with plastic


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material will be wiped away with a clean gauze pad moistened with tap water.
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

Doses corresponding to a dosage level of 2000 mg/kg were individually calculated based on the body weight of each animal on the day of dosing.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for toxicity: approximately 0.5, 1, 2, 3, 4 and 6 hours following dosing and daily thereafter for 14 days; body weights: on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, local irritation, necropsy

Statistics:

Not performed

Results and discussion

Preliminary study:

NA

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: All rats remained healthy during the study.

Gross pathology:

There were no gross internal lesions observed in any animal at necropsy.

Other findings:

NA

Any other information on results incl. tables

Mean body weights:

	Day 0	Day 7	Day 14
Female	295 ± 6.9	342 ± 7.9	397 ± 10.2
Female	263 ± 15.9	270 ± 18.8	287 ± 14.2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the LD50 is greater than 2000 mg/kg in male and female rats when topically applied.

Executive summary:

The toxic effects of Lithium chloride in Sprague-Dawley rats were investigated according to OECD Guideline 402 and EU method B.3 on acute dermal toxicity. Lithium Chloride (moistened with tap water) was topically applied to five Sprague-Dawley rats/sex at a dosage level of 2000 mg/kg. The test material was in contact with the intact skin for 24 hours under an occlusive wrap. Observations for toxicity were conducted at approximately 0.5, 1, 2, 3, 4 and 6 hours following dosing and daily thereafter for 14 days. A description of local irritation was recorded on days 1, 3, 7 and 14. Body weights were recorded on days 0, 7 and 14 of the study. A gross necropsy was performed on all animals.

There were no deaths. All rats remained healthy and gained weight during the study. No irritations were noted on any of the test sites. All animals appeared normal at necropsy.

Under the conditions of this study, the LD50 is greater than 2000 mg/kg in male and female rats when topically applied.