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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (comparable to guidelines/standards)
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guideline of the Department of Transportation (D.O.T), Code of Federal Regulations, Title 49, Part 173
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Rare Earth Carbonate #1451
- Molecular formula (if other than submission substance): La2(CO3)3*H2O
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms Inc.
- Weight at study initiation: males: 113 g, females: 109 g
- Fasting period before study: overnight
- Housing: 5 per wire mesh suspended cage
- Diet: Purina laboratory Chow, freely available
- Water: freely available
- Acclimation period: 7 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 6.0 -7.5 mL
Doses:
Range finding: 3980, 6320 and 10000 mg/kg
Main study: 31600 mg/kg
No. of animals per sex per dose:
Range finding: 2 (no information about sex)
Main test: 5
Control animals:
no
Details on study design:
- Clinical signs were noted immediately after dosing and at 4, 24 and 48 hours
- Body weight were recorded at dosing and at 48 h
- Animals found dead or terminated after 48 h were subjected to a macroscopic examination of the viscera

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 30 404 mg/kg bw
Remarks on result:
other: recalculated value to Lanthanum carbonate
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 31 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original value: Lanthanum carbonate monohydrate
Mortality:
Range finding: no mortality after 48 h
Main study: no mortality after 48 h
Clinical signs:
Animals appeared normal after dosing
Body weight:
No effects
(Weight at termination of the study: males: 128 g, females 122 g)
Gross pathology:
Macroscopic changes were not observed in the viscera.

Applicant's summary and conclusion