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EC number: 203-468-6
CAS number: 107-15-3
In a three month dietary study, male and
female rats were fed targeted doses of 0, 50, 250 or 1000 mg/kg bw/day
of EDA-2HCl . There were no deaths and no abnormal clinical signs noted
during the study. Body weight gains were significantly decreased in the
high dose group which affected a number of absolute and relative organ
weights in both males and females. Water consumption was comparable to
control values at all dose levels in males but was decreased in a
dose-response manner in female rats at all 3 dose levels.
Slight reductions in serum glucose levels
and an elevation of alkaline phosphatase, ASAT and ALAT activities were
observed in the high dose group. An elevation of ALAT activity was also
observed in the intermediate dose male rats. Urinary pH in the high dose
group was decreased in both males and females. There were no
dose-related gross lesions in any animal on the study. The most
significant histopathological lesion, hepatocellular pleomorphism, was
observed primarily in the high dose females and to a lesser extent in
The LOAEL was 250 mg/kg bw/day in 13 -week
study in rats. Since the water consumption was only slightly decreased
in females at 50 mg/kg/day, the No-Observed-Adverse-Effect-Level (NOAEL)
was considered to be 50 mg/kg/day of EDA*2HCl. Re-calculated to EDA this
corresponds to 22 mg/kg/day. The LOAEL level corresponds to 114
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