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EC number: 701-200-7
CAS number: -
In a two-generation
reproduction study performed according to GLP and EPA Guideline 83 -4,
Sprague-Dawley rats (30 per group) were administered trisodium
hexafluoroaluminate (cryolite) in the diet at dose levels of 0, 200,
600, or 1800 ppm (representing
0, 14, 42, and 128 mg/kg/day for males and 0, 16, 49, and 149 mg/kg/day
for females, respectively).
Compound-related systemic toxicity was observed in a dose related manner
among both sexes and generations at all dose levels as evidenced
was observed at 1800 ppm as evidenced by significantly decreased pup
body weights during lactation days 7, 14, and 21 (82%-88% of control in
F1 offspring) and days 4, 7, 14, and 21 (74%-89% of control in F2
offspring). Gross findings were also observed in pups of both
generations at 1800 ppm by the time of weaning. They were manifested as
pale kidneys, pale livers and enlarged hearts and were considered to be
compound related. No effects were observed on parental reproductive
From this study a
NOAEL for fertility of >1800 ppm corresponding to >128
mg cryolite/kg bw/day can be derived. Besides
dental fluorosis and teeth whitening, no other compound-related systemic
toxic effects could be revealed from this study with daily dosages of up
to and including 128 mg cryolite/kg bw/day.
on the observed decreased mean body weights during lactation for both
the F1 and F2 litters and an increased incidence of F1 and F2 animals
with pale/white livers and/or
kidneys and enlarged hearts at weaning at 1800 ppm, a NOAEL for
developmental toxicity of 600 ppm (42
mg cryolite/kg bw/day)
is derived from this study.
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