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EC number: 701-200-7
CAS number: -
hexafluoroaluminate (cryolite) was investigated for prenatal
developmental toxicity in mice in a GLP compliant study according to EPA
Guideline 83 -3. Cryolite
was administered by oral gavage to female CD-1 mice (25/group) at dose
levels of 0, 30, 100 or 300 mg/kg bw/day once daily from gestation days
6 to 15 (WIL Research Laboratories, 1991). There was increased mortality
at 300 mg/kg bw/day. The glandular portion of the stomach was red
beginning at 100 mg/kg bw/day. In addition, females in the 300 mg/kg
bw/day group exhibited dark red contents of the stomach. Fetuses
at 300 mg/kg bw/day exhibited bent ribs and bent limb bones. The
study reveals severe maternal toxicity in terms of mortality and signs
of toxicity in the gastrointestinal tract induced at dosages of >100
mg cryolite/kg bw/day leading to derivation of a NOAEL for maternal
toxicity of 30 mg cryolite/kg bw/day.
Based on the
observation of skeletal anomalies at the dose level of 300 mg
cryolite/kg bw/day also a NOAEL for developmental toxicity of 100 mg
cryolite/kg bw/day can be derived from the study. As these anomalies
were only reported at dose levels showing severe maternal toxicity, the
effects are not considered to be indicative for a substance specific
teratogenic potential of cryolite.
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