Lithium acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium acetate dihydrate

Cas Number:

6108-17-4

Molecular formula:

C2H7LiO4

IUPAC Name:

Lithium acetate dihydrate

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Reference No.: 434-01A; - FMC-T#: 1562

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage: Room temperature
- Stability: Stable for a minimum of 30 days

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: Adult
- Weight at study initiation: 200-300 g
- Housing: Individually housed in stainless steel, suspended cages containing DACB indirect bedding.
- Diet: Purina Rodent Chow 5001 (pellets), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 20.6 °C
- Humidity: 51 - 56 %
- Photoperiod: 12-hour fluorescent light/dark cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: From the Scapula to the pelvic region.
- % coverage: At least 10 % of the body surface
- Type of wrap if used: Gauze pad was secured with hypoallergenic tape and was covered with an elastic, plastic-lined bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Test sites were rinsed with water
- Time after start of exposure: 24 h

VEHICLE
- Amount(s) applied: 0.50 mL tap water

Duration of exposure:

24 hours

Doses:

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: Observations for toxicity were conducted 0.5, 1, 2, 3, 4 and 6 hours post-dosing, and daily thereafter. Dermal irritation were recorded on days 1, 3, 7 and 14. Body weights were recorded weekly.
- Necropsy of survivors performed: yes

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:

All rats remained healthy during the study.

Body weight:

Immediately prior to dosing, body weights ranged from 223-266 g. All but one rat gained weight by day 14 of the study; this rat lost weight through day 7, then regained weight to return to its' pre-dosing weight.

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 in one female on study day 1.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the test material is greater than 2000 mg/kg.

Executive summary:

The acute dermal toxicity was assessed equivalent or similar to OECD guideline 402. Lithium acetate dihydrate 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 14 days. Dermal irritation was recorded in day 1, 3, 7 and 14. Body weights were recorded weekly. Gross necropsies were performed on all animals. No death were noted. All rats remained healthy during the study. All but one rat gained weight by day 14 of the study; this rat lost weight through day 7, then regained weight to return to its' pre-dosing weight. The only dermal irritation noted was erythema in one female on day 1. No gross lesions were revealed during necropsy. The dermal LD50 of the test item is greater than 2000 mg/kg.