Lithium chloride

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-23 to 1999-06-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Version / remarks:

1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

1998

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

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

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
- Weight at study initiation: males: 253 g to 319 g
- Housing: animals were individually housed in stainless steel suspended rat cages
- Diet (e.g. ad libitum): ad libitum, Purina Laboratory Rodent Chow 5001
- Water (e.g. ad libitum): ad libitum, fresh tap water
- Acclimation period: animals were acclimated for a minimum of 5 days prior to study start


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3°C - 20.6°C
- Humidity (%): 53 % - 61 %
- Air changes (per hr): the exposure was conducted for 4 hours. At the end of the exposure, the chamber was cleared for approximately 10 minutes by drawing room air through it at the same flow rate (37.2 litres per minute) prior to removing the animals
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The 11-liter ADG nose-only exposure chamber was made of anodized aluminium and was operated dynamically.
- Source and rate of air: The calculated 99 % equilibrium time for the chamber at a flow rate of 37.2 litres per minute was 1.4 minutes (equivalent to 1 "air change" every 18 seconds).

- Method of holding animals in test chamber: The test animals were assigned to and housed in individual polycarbonate nose-only tubes during the exposure. The tube position assignment ensured equal distribution of both sexes around the chamber.
- Method of particle size determination: The aerodynamic particle size distribution was determined by gravimetric analysis of the amount of test material collected on the impactor stages. The MMAD, GSD and the percent of aerosol less than or equal to 1, 10, and 15 microns in size were determined by logarithmic-probability plotting.

- Treatment of exhaust air: The chamber air was exhaust from the bottom of the chamber and passes through an orifice tube system which continuously monitored airflow and then through a commercial filter box.

- Temperature, humidity, in air chamber: 21.7 °C, 74 %


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Chamber air samples were also taken twice during the exposure to determine the aerodynamic particle size distribution of airbone material. The samples were drawn through a Sierra Series 218 cascade impactor at 2.82 litres per minute.

- MMAD (Mass median aerodynamic diameter)/GSD (Geometric st. dev.): less than or equal to 1, 10, and 15 microns in size were determined by logarithmic-probability plotting

Duration of exposure:

4 h

Concentrations:

mean concentration: 5.57 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

Particle size distributions will be determined, by log-probability plotting of the data and subsequent determination of the MMAD, GSD and other particle size parameters from the data plots. The LC50 and 95 % confidence limits will be determined, if applicable, by a suitable logit or probit analysis.

Results and discussion

Preliminary study:

NA

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.57 mg/L air

Based on:

test mat.

Mortality:

One female died on study day 1.

Clinical signs:

other: Treatment-related clinical signs observed during the study included chromodacryorrhea, chromorhinorrhea, decreased locomotion, dyspnea, lacrimation, oral discharge and squinting eyes. Other signs included abdominogenital staining of the fur, unkempt fur a

Body weight:

Three females lost weight during day 0 through day 7 weighing interval. These same animals gained weight during the day 7 through day 14 weighing interval. The remaining animals exhibited normal increases in body weight during the study.

Gross pathology:

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

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the conditions of this study, the 4-hour LC50 for Lithium chloride is greater than 5.57 mg/L.

Executive summary:

The acute inhalation toxicity of Lithium chloride in Sprague-Dawley rats was determined according to OECD Guideline 403 and EU method B.2. A group of five male and five female Sprague-Dawley rats was exposed to a respirable aerosol of Lithium Chloride. Animals were exposed for 4 hours at a mean concentration of 5.57 mg/L in a dynamically-operated, nose-only inhalation exposure chamber. Gravimetric airborne test material samples were taken frequently during the exposure. Particle size samples were taken twice during the exposure. Observations for toxicity and mortality were performed frequently during the exposure, upon removal of the rats from the chamber, at one hour post-exposure and twice daily thereafter for 14 days. Individual body weights were recorded immediately prior to exposure on day 0 and on days 7 and 14. On day 14, all surviving animals were sacrificed and gross necropsy examinations were performed. Gross necropsies were also performed on animals dying prior to study termination.

One animal died during the study. Treatment-related clinical signs observed during the study included chromodacryorrhea, chromorhinorrhea, decreased locomotion, dyspnea, lacrimation, oral discharge and squinting eyes. Most signs resolved by day 3 post-exposure and all surviving animals were normal from day 10 through study termination. Three females lost weight during the day 0 through day 7 weighing interval. These same animals gained weight during the day 7 through day 14 weighing interval. The remaining animals exhibited normal increases in body weight during the study. There were no gross internal lesions observed in any animal at necropsy.

Under the conditions of this study, the 4-hour LC50 for Lithium chloride is greater than 5.57 mg/L.