Lithium fluoride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-12-28 to 1989-01-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

November 1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lithium fluoride

EC Number:

232-152-0

EC Name:

Lithium fluoride

Cas Number:

7789-24-4

Molecular formula:

FLi

IUPAC Name:

lithium(1+) fluoride

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot No.of test material: Lot 129, Drums 1 - 10

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, New York
- Weight at study initiation: 201 - 291 g
- Fasting period before study: overnight prior to dosing
- Housing: the animals were individually housed in stainless steel suspended rat cages
- Diet: Purina Laboratory Rodent Chow 5001 ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 66 °F - 73 °F
- Humidity: 24 % to 63 %
- Photoperiod: 12 hour fluorescent light and 12 hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % (weight/volume) solution with tap water

Doses:

males: 500, 700, 1000 mg/kg
females: 500, 1000, 2000 mg/kg

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: the animals were observed for mortality and clinical signs at 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter for thirteen days; on day 14 they were observed once. Body weights were taken on days 0, 7 and 14 of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

608 mg/kg bw

Based on:

test mat.

95% CL:

ca. 448 - <= 768

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 004 mg/kg bw

Based on:

test mat.

95% CL:

ca. 472 - <= 1 535

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

706 mg/kg bw

Based on:

test mat.

95% CL:

ca. 453 - <= 959

Mortality:

Mortality in males
500 mg/kg bw dose group - 1/5
700 mg/kg bw dose group - 4/5
1000 mg/kg bw dose group - 5/5
Mortality in females
500 mg/kg bw dose group - 1/5
1000 mg/kg bw dose group - 2/5
2000 mg/kg bw dose group - 5/5

Clinical signs:

other: Clinical signs commonly observed during the study included ataxia, tremors, diarrhea, abdominogenital staining, chromorhinorrhea and chromodacryorrhea. The onset of signs began approximately 1 hour after dosing and continued to be observed until day 6 of

Gross pathology:

Gross internal necropsy findings observed in decedents included blood in the intestines of several rats, one of which also had a stomach which was distended with gas. All surviving animals appeared normal at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of the study, a male LD50 value of 608 mg/kg bw, a female LD50 value of 1004 mg/kg bw, and a combined LD50 value of 706 mg/kg bw were obtained when orally administered as a 25 % (weight/volume) solution in tap water.

Executive summary:

Groups of Sprague-Dawley rats consisting of five males and/or five females were orally administered graded dosages of the test substance as a 25 % (weight/volume) solution in tap water by gavage according to OECD Guideline 401. Males were administered with 500, 700 and 1000 mg/kg bw. Females were administered with 500, 700 and 2000 mg/kg bw.

Mortality occurred in all dose groups. By male rats in dose groups 500, 700 and 1000 mg/kg bw out of 5 rats per dose group 1, 4, 5 rats died respectively. By female rats in dose groups 500, 1000 and 2000 mg/kg bw out of 5 rats per dose group 1, 2, 5 rats died respectively. The predominant clinical signs were ataxia, tremors, diarrhea, abdominogenital staining, chromorhinorrhea and chromodacryorrhea. Most signs of toxicity subsided by day 6 of the study. All surviving animals gained weight by day 14 of the study.

Gross internal necropsy findings observed in decedents included blood in the intestines of several rats, one of which also had a stomach which was distended with gas. Animals which survived treatment and were sacrificed on day 14 appeared normal when necropsied.

Under the conditions of the study, a male LD50 value of 608 mg/kg bw, a female LD50 value of 1004 mg/kg bw, and a combined LD50 value of 706 mg/kg bw were obtained when orally administered as a 25 % (weight/volume) solution in tap water.