Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The Acute Mammalian Toxicity of Rare Earth Nitrates and Oxides
Author:
Bruce D W, Hietbrink BE, Du Bois K P
Year:
1963
Bibliographic source:
Toxicology and Applied Pharmacology 5, 750-759

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five or 10 female Sprague-Dawley rats received a single i.p. dose of 1000 mg/kg bw of Lanthanum oxide as a 50% suspension in an aqueous solution of 0.2% carboxymethylcellulose. The animals were oberved for 30 days for clinical signs of toxicity and mortality.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lanthanum oxide
- Substance type: inorganic oxide
- Physical state: solid
- Analytical purity: > 98%
- Impurities (identity and concentrations): not given
- Source: St. Eloi Corporation, Cincinnati, Ohio

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not stated
- Age at study initiation: adult rats
- Weight at study initiation: 190 to 250 g
- Housing: air conditioned, no further data
- Diet: ad libitum: Rockland Rat diet
- Water: ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
The test substance was administered by i.p. administration of a 50% suspension (homogenized) in carboxymethycellulose 0.2% in water.
Doses:
1000 mg/kg bw
No. of animals per sex per dose:
5 or 10 females
Control animals:
not specified
Details on study design:
Five or 10 female Sprague-Dawley rats received a single oral dose of 1000 mg/kg bw of Lanthanum oxide i.p. as a 50% suspension in an aqueous solution of 0.2% carboxymethylcellulose. The animals were oberved for 30 days for clinical signs of toxicity and mortality.

Results and discussion

Mortality:
No treatment related mortality throughout the 30 d observation period.
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported

Any other information on results incl. tables

The acute LD50 after intraperitoneal administration to female Sprague-Dawley rats was above 1000 mg/kg bw.

Applicant's summary and conclusion

Conclusions:
Lanthanium oxide did not cause mortality in female Sprague-Dawley rats after single i.p. administration of 1000 mg lanthanum oxide/kg bw.
Executive summary:

Lanthanium oxide did not cause mortality in female Sprague-Dawley rats after single i.p. administration of 1000 mg lanthanum oxide/kg bw.