Cerium trinitrate

Acute Toxicity: oral

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

Test material information

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:

other: 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.

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.