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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:
From 4 February 1991 until 18 February 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study performed according to Code of Federal Regulations 16:1500.3 and equivalent to OECD Guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations 16:1500.3
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Cerium chloride hydrate
IUPAC Name:
Cerium chloride hydrate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ
- Age at study initiation: no data
- Weight at study initiation: males body weight range: 217 - 228 g; females body weight range: 206-221 g
- Fasting period before study: Rats were fasted on the day before dosing for approximately 18 hours by removing feed from their cages. During fasting, water was provided ad-libitum. After the 18 hour fast period, the rats were examined and weighed again.
- Housing: Individually in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Pelleted Purina Rat Chow ad-libitum
- Water (e.g. ad libitum): Tap water supplied by automatic water system
- Acclimation period: 6, 12 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 °C - 22.8°C
- Humidity (%): No data
- Air changes (per hr): No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% w/w solution in distilled water
- Amount of vehicle (if gavage): 10 g

Doses:
The dose levels were 2500 and 3500 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at 1, 2 and 4 hours after dosing and at least once daily thereafter for signs of gross toxicity and mortality. Body weights were recorded initially and at termination (day 14) or after death.
- Necropsy of survivors performed: yes, all survivors to termination were euthanized by CO2 inhalation. Gross necropsies were performed on all decedents.
Statistics:
LD50 calculated by the Litchfield-Wilcoxon Method of Probit Analysis; J. Pharmacology and Experimental Therapeutics 96: 99-115 (1949)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Based on:
test mat.
95% CL:
2 360 - 3 320
Mortality:
Dosage 2500 mg/kg: 30% mortality occurred by day 2.
Dosage 3500 mg/kg: 90% mortality occurred by day 3.
Clinical signs:
other: Dosage 2500 mg/kg: Following test material administration all animals appeared lethargic. Most had a hunched posture and two had ano-genital staining. All surviving animals recovered from the above symptoms by day 6 and gained weight over the 14-day obser
Gross pathology:
Dosage 2500 mg/kg: Necropsy of the decedents revealed distention of the stomach with reddish-white discoloration of the pyloric region, discoloration of the intestines and dark-colored fluid in the bladder.
Dosage 3500 mg/kg: Necropsy of the decedents revealed distention of the stomach with discoloration of the pyloric region in most animals. Discoloration of the intestines and dark-colored fluid in the bladder was also noted in most animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral, single dose LD50 calculated by Probit Analysis was 2800 mg cerium trichloride per kilogram body weight with 95% confidence limits of 2360 and 3320 mg/kg. Based on the criteria of the CLP Regulation, the substance should not be classified for acute oral toxicity as the LD50 value is > 2000 mg/kg.

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