Lithium fluoride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-18 to 1999-04-06

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 402 (Acute Dermal Toxicity)

Version / remarks:

February 24th 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

January 1993

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium bromide

EC Number:

231-439-8

EC Name:

Lithium bromide

Cas Number:

7550-35-8

Molecular formula:

BrLi

IUPAC Name:

lithium bromide

Test material form:

solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: stable for a minimum of 30 days
- 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 adults
- Weight at study initiation: 229-270 g
- Housing: individually housed in stainless steel, suspended cages
- Diet (e.g. ad libitum): Purina Rodent Chow 5001 (pellets), ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-69
- Humidity (%): 51-56
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: moistened with water (0.5 mL)

Details on dermal exposure:

TEST SITE
- Area of exposure: scapular to pelvic region
- Type of wrap if used: hypoallergenic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.46-0.54 g (Doses were based on individual body weights)
- Constant volume or concentration used: yes, a constant concentration was used.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

five animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs (local irritation excluded) 0.5,1,2, 3,4, and 6 hours following dosing, and daily thereafter for 14 days. Weighing was performed on days 0, 7, 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, local Irritation (was recorded on days 1, 3, 7, 14)

Statistics:

The dermal LD50 value and corresponding 95% confidence limits were calculated using a modified Logit-Linear Regression Program written by Jim Gibbons, Texas Instruments Calculator Products Division.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were noted.

Clinical signs:

other: All rats remained healthy during the study.

Gross pathology:

No gross internal lesions were observed in any animal during necropsy.

Other findings:

Local irritation: The only irritation noted during the study was erythema on study day 1 in six animals and desquamation in four animals on day 3 and in one animal on day 7. All irritation resolved by study day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the acute dermal toxicity study with lithium bromide, a LD50 greater than 2000 mg/kg in both male and female rats was derived.

Executive summary:

The acute dermal toxicity according to OECD guideline 402 and EU method B.3 was performed with lithium bromide. Lithium bromide (anhydrous) was topically applied to five Sprague-Dawley rats per sex at a dosage level of 2000 mg/kg. The test material was in contact with the skin under an occlusive wrap for 24 hours. Observations for toxicity were conducted 0.5,1, 2, 3, 4, and 6 hours post-dosing, and daily thereafter for fourteen days. Dermal irritation was recorded on days 1, 3, 7 and 14. Body weights were recorded weekly. Gross necropsies were performed on all animals. No deaths were noted. All rats remained healthy and gained weight by day 14 of the study. The only irritation noted during the study was erythema on study day 1 in six animals and desquamation in four animals on day 3 and in one animal on day 7. All irritation resolved by study day 14. No gross lesions were revealed during necropsy. The LD50 of lithium bromide is greater than 2000 mg/kg in both male and female rats when topically applied. (FMC, 1999)