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EC number: 630-337-4
CAS number: 39211-00-2
In a GLP
compliant 28 day sub-acute study performed according to OECD 407, cesium
fluoro aluminate complex was administered daily by oral gavage to Wistar
rats. The animals (5 per sex per dose) were exposed to 0 (control), 30,
150 and 750 mg/kg/day.
Clinical signs, functional observations,
body weight and food consumption were monitored during the study.
Haematology and blood chemistry was evaluated for all animals at the end
of the study. All animals were subjected to a gross necropsy examination
and a histopathological evaluation of tissues was performed.
No mortality occurred in the low and mid
dose and control animals. Treatment related mortality was seen among
animals receiving 750 mg/kg/day during the study. The incidence of
mortality was 4/5 for males and 3/5 for females. Animals were found dead
between days 15 and 29 (day of scheduled necropsy). A fourth female died
during blood sampling on day 29. The lesions in the stomach of these
animals were indicative of irritating properties of the test substance
to the stomach and were considered to have contributed to the cause of
death. Moreover, the animals showed uraemia, correlating the microscopic
lesions in the kidneys and alterations in several blood parameters, and
reduced haempoiesis in the spleen, correlating the reduced size of this
organ seen at necropsy. The changes in clinical appearance, motor
activity and body weights were secondary to the stomach, renal and/or
splenic lesions and considered indicative of a poor condition of these
animals. Macroscopic and/or microscopic changes were also found in the
heart, testes and lymph nodes of the high dose animals. The fact that
lesions were found in several organs may indicate that there is no
specific target organ for or mechanism of toxicity of cesium fluoro
aluminate complex. The observed effects in the rats treated at 150
mg/kg/day consisted of findings in the stomach, kidneys and spleen,
which were similar to those found in the high dose animals, but at a
lower incidence and/or severity. No correlating changes were found in
the blood parameters, except for decreased serum protein concentrations
The findings in the animals treated at 30
mg/kg/day comprised of a few clinical signs during week 2, which had
disappeared after continuation of treatment, and effects in the stomach.
The effects in the stomach were characteristic of an (adaptive) effect
of the irritating properties of the test substance and are commonly seen
after treatment by gavage. The symptoms were of minor severity and were
not supported by organ dysfunction. No treatment related changes were
found in body weights, food consumption, clinical laboratory
investigations and organ weights.
From the results of this study a NOAEL for
cesium fluoro aluminate complex of 30 mg/kg/day was concluded.
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