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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
Study period:
data not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Scientifically sound study with methods similar to OECD 401 with the following deviations: The number of deaths at each dose were not reported; the specific doses (mg/kg) were not provided; individual clinical observations, body weights, pathology were not reported; sex of the animals was not provided
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The Acute Mammalian Toxicity of Rare Earth Nitrates and Oxides
Author:
Bruce DW
Year:
1963
Bibliographic source:
Toxicol Appl Pharmac, 5, 750-759

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Cerium nitrate, hexahydrate
IUPAC Name:
Cerium nitrate, hexahydrate
Test material form:
not specified
Details on test material:
- Test material identity: Cerium nitrate, as cerium (III) nitrate hexahydrate
- Analytical purity: > 98%
- Impurities: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other information: Ce(NO3)3.6H2O were obtained from the Lindsay Chemical Company, West Chicago, Illinois, and the K and K Laboratories, Jamaica, New York.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data available
- Age at study initiation: no data available
- Weight at study initiation: 190 g to 250 g
- Fasting period before study: no data available
- Housing: the animals were housed in air-conditioned quarters
- Diet (e.g. ad libitum): yes, ad libitum (food: Rockland rat diet or Rockland mouse pellets)
- Water (e.g. ad libitum): yes, ad libitum
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light):no data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The solution was given in single dose orally by stomach tube to female rats as 50% aqueous solution.
No. of animals per sex per dose:
5 or 10 animals by groups
Details on study design:
- Duration of observation period following administration: 30 days

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
4 200 mg/kg bw
95% CL:
3 684 - 4 788
Remarks on result:
other: LD50 calculated according to Litchfied and Wilcoxon.
Mortality:
The animals were observed for 30 days although no deaths occurred later than 4 days after administration of the nitrate salts by the oral route.
Clinical signs:
Within 1 to 2 hours after oral administration of the rare earth nitrates most of the rats were depressed, and animals that received a lethal dose showed little activity during the survival period.
Body weight:
no data
Gross pathology:
Throughout the observation period no gross pathologic changes were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 (female rat) was 4200 mg/kg on the basis of 50% aqueous solution. Based on the criteria in the CLP Regulation, the test substance is not to be classified as acute oral toxicant.
Executive summary:

In an acute oral toxicity study (Bruce, 1963), groups of female rats (5 to 10 females/group) were given a single oral dose of cerium nitrate (purity > 98 %) at 50% aqueous solution and observed for 30 days. Animals were then observed for 30 days.

No deaths occurred later than 4 days after administration of the nitrate salts by the oral route.

Oral LD50 Females was 4200 mg/kg bw with 95% confidence limits of 3684 -4788 mg/kg bw.