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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976-10-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24th, 1987
Deviations:
yes
Remarks:
Four rabbits per dose (two rabbits per sex) instead of five rabbits per dose were used in the study. Two instead of three dose levels were tested in the study.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium carbonate
EC Number:
209-062-5
EC Name:
Lithium carbonate
Cas Number:
554-13-2
Molecular formula:
CH2O3.2Li
IUPAC Name:
dilithium carbonate
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 2.42-2.82 kg
- Fasting period before study: No
- Housing: Individullay housed in suspended, wire-bottomed cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: The whole back
- % coverage: 30 % of the total body surface area
- Type of wrap if used: Impervious plastic sheeting

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24h after treatment

TEST MATERIAL
- Amount(s) applied: 2000, 3000 mg/kg bw
- Constant volume or concentration used: Yes
- For solids, paste formed: Yes, an aqueous slurry

VEHICLE
- water
Duration of exposure:
24 hours
Doses:
2000, 3000 mg/kg bw
No. of animals per sex per dose:
2 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations for mortality, local skin reactions and behavioural abnormalities
- Necropsy of survivors performed: Yes
- clinical signs: Daily
- body weight: Initial, 7- and 14-day body weights were recorded

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Remarks:
Li2CO3
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks:
Li2CO3
Mortality:
No mortality occured within the 2000 mg/kg bw testing group.
One animal of the 3000 mg/kg bw testing group died. The cause of death was not evident.
Clinical signs:
The test material showed no irritating properties to the skin of the albino rabbit.
Body weight:
All animals gained weight throughout the study period.
Gross pathology:
Necropsy examination revealed advanced post mortem autolysis in the early died rabbit of the 3000 mg/kg bw testing group. No gross pathologic alterations were noted in any of the other rabbits.
Other findings:
No pharmacotoxic symptoms were exhibited by the rabbits following dermal exposure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal toxicity study an LD50 value of above 3000 mg/kg bw was determined.
Executive summary:

The acute dermal toxicity study was performed with lithium carbonate. Four male and four female New Zealand white rabbits were treated (a 24-hour occlusive dermal application) with an aqueous lithium carbonate slurry at dose levels of 2000 mg/kg bw and 3000 mg/kg bw. One animal from the 3000 mg/kg bw testing group died under non-evident circumstances. Clinical signs or dermal symptoms were not observed during the 14 days post-treatment observation period. No effects on body weight gain were noted for these groups. Specific macroscopic alterations related to the toxic effect of lithium carbonate were not found. The acute dermal LD50 value was determined to be above 3000 mg/kg bw in male and female New Zealnd white rabbits and 2000 mg/kg bw can be determined as the discriminating dose.