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EC number: 700-323-3
CAS number: 908020-52-0
The results from an oral 28-day subacute repeated dose toxicity study showed that EEA-NH4 exerted effects on the kidney, liver and stomach. The NOAEL of EEA-NH4 in rats under the present study conditions was estimated to be 5 mg/kg bw/day since absolute and relative kidney weights were increased in males of the 25 mg/kg bw/day group and more.
In a 28-day
repeated oral dose toxicity GLP study according to OECD guideline 407
and EU method B.7, groups of five male and five female Crl: CD(SD) rats
were dosed with EEA-NH4 (Hita Laboratory, 2006). The high dose was set
at 100 mg/kg bw/day, and altogether 3 doses including 25 and 5 mg/kg
bw/day were employed. Recovery groups were also set for the 100 mg/kg
bw/day and vehicle control groups.
In the present
study, no death occurred throughout the study. No abnormalities were
noted in the clinical signs, detailed clinical observations,
sensorimotor function, body weights and food intakes during the dosing
period, and urinalyses at the end of the dosing period.
hematological examinations, decreased RBC, Hb and Ht in males and
females and increased Reticulo in female were observed in the 100 mg/kg
bw/day group. PT was prolonged in males of the 100 mg/kg bw/day group.
blood chemical examinations, increased ALT and A/G ratio and decreased
T-Cho were observed in males of the 100 mg/kg bw/day group.
organ weights, absolute and relative kidney weights were increased in
males of the 25 mg/kg bw/day group and more, and absolute and relative
liver weights were increased in males of the 100 mg/kg bw/day group.
necropsy, elevation of limiting ridge in the forestomach in males and
females and enlargement of the liver in males were observed in the 100
mg/kg bw/day group.
histopathological examinations, hyperplasia of squamous epithelium in
limiting ridge of the forestomach in males and females, diffuse
hypertrophy of hepatocytes with granular degeneration in males and focal
necrosis of hepatocytes in females were observed in the 100 mg/kg bw/day
In the recovery
test, all changes observed at the end of the dosing period were
above-mentioned results showed that EEA-NH4 exerted effects on the
kidney, liver and stomach. The NOAEL of EEA-NH4 in rats under the
present study conditions was estimated to be 5 mg/kg bw/day since
absolute and relative kidney weights were increased in males of the 25
mg/kg bw/day group and more.
Based on the results of the subacute
oral repeated dose toxicity study, classification according
to EU Directive 67/584/EEC and EU Classification, Labelling and
Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is
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