Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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 for cross-reference:
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
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

Constituent 1
Reference substance name:
Lanthanum carbonate
IUPAC Name:
Lanthanum carbonate
Constituent 2
Reference substance name:
54451-24-0
EC Number:
611-146-5
Cas Number:
54451-24-0
IUPAC Name:
54451-24-0
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 or test system 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:
other: Animals appeared normal after dosing
Gross pathology:
Macroscopic changes were not observed in the viscera.

Applicant's summary and conclusion