Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, equivalent or similar to OECD and EU guideline.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Toxicity studies of cesium and rubidium compounds
Author:
Johnson, G.T.; Lewis, R.T. and Perone, V.P.
Year:
1975
Bibliographic source:
Toxicology and applied pharmacology 32, 239-245 (1975)
Reference Type:
publication
Title:
Unnamed
Year:
1972

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
, e.g. 9 instead of 10 animals
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
Remarks:
, e.g. 9 instead of 10 animals
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
other: Charles River albino rats
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, cesarian-derived albino rats
- Weight at study initiation: 175 -250 g
- Fasting period before study: yes (overnight, 16 h)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: good solubility in water
Doses:
First main test: 820, 1170, 1660, 2350, 3340, 4750 mg/kg
Second main test: 1890, 2120, 2515, 2680, 3010 mg/kg
No. of animals per sex per dose:
9 male rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 and 4 h following administration and dayly thereafter for the 14-day period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology, behavioral observations
Statistics:
The LD50 values and their 95% confidence limits were calculated by probit analysis of Finney (1971).

Results and discussion

Preliminary study:
not applicable; however, range finding study was performed:
The test material was administered as a single dose, orally by stomach tube, to caesarean-derived rats weighing between 175 and 250 grams. Eight test groups of three animals per group (24 total) were used. The animals were fasted from food for approximately 16 hours prior to dosing. The test material was dissolved in deionized and distilled water. Observations for morbidity and mortality were recorded at 1 and 4 hours following administration and daily thereafter for the 7-day period. Gross necropsy observations were made on all animals which died or were sacrificed at the end of the 7-day observation period.
Results: Doses (died animals/3): 180 (0/3 deaths), 301 (0/3), 502 (0/3), 838 (0/3), 1400 (0/3), 2338 (2/3), 3904 (3/3) and 6520 (3/3) mg/kg)
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 386 mg/kg bw
Based on:
test mat.
95% CL:
2 310 - 2 467
Mortality:
All deaths occured within the first 72 h after dosing.
Clinical signs:
Clinical signs: weakness and listlessness
Body weight:
No data on body weight.
Gross pathology:
congested, cyanotic lungs with petechial hemorrhages and a fluid-distended stamach which appeared to result from spasm of the pyloric sphincter
following the dosing
Other findings:
Behavioral effects noted for survivors: week, thin and some exhibited bloody nasal exudate and eye discharge at sacrifice

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of cesium iodide in albino rats was determined to be 2386 mg/kg bw.
Executive summary:

In an acute oral toxicity study, groups of 9 fasted male albino rats were given a single oral dose of cesium iodide (> 99 %) in water at 11 different doses and observed for 14 days.

Oral LD50 Males = 2386 mg/kg bw (95% C.L: 2310 - 2467 mg/kg)

Cesium iodide is not classified after oral administration based on the LD50 obtained in male rats.