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EC number: -
CAS number: -
Dose Formulation Analysis
Concentration analysis of formulation
samples was determined at three concentrations, 25 mg/mL, 75 mg/mL and
250 mg/mL in study weeks 1 and 3. The mean recoveries observed for the
LD dose group were 88.5 % and 104.6 % of the nominal value, 94.8 % and
98.5 % for the MD dose group and 101.0 % and 106.4 % of the nominal
value for HD dose group. The mean recoveries observed in the low dose
(LD), medium dose (MD) and high dose (HD) groups were 96.6 %, 96.7 %,
and 103.7 % of the nominal concentration, respectively.
concentrations were confirmed for all dose groups, as measured
concentrations were within acceptance criterion of 10 %.
The aim of this study was to assess
the possible health hazards which could arise from repeated exposure of
Sa 190 via oral administration to rats over a period of 28 days.
The test item was administered daily
in graduated doses to 3 groups of test animals, one dose level per group
for a treatment period of 28 days. Animals of an additional control
group were handled identically as the dose groups but received corn oil,
the vehicle used in this study. The 4 groups comprised of 5 male and 5
female Wistar rats.
During the period of administration,
the animals were observed precisely each day for signs of toxicity.
Animals that died were examined macroscopically and at the conclusion of
the test, surviving animals were sacrificed and observed macroscopically.
Body weight and food consumption were
At the conclusion of the treatment
period, all animals were sacrificed and subjected to necropsy. The wet
weight of a subset of tissues was taken and a set of organs/tissues was
A full histopathological evaluation of
the tissues was performed on high dose and control animals.
The following doses were evaluated:
Low Dose: 100 mg/kg
Medium Dose: 300 mg/kg
High Dose: 1000
mg/kg body weight
test item was emulsified in corn oil and administered daily during a
28-day treatment period to male and female animals. After stability
testing (Eurofins Munich Study No. 178290) test item formulations were
used within 10 days after preparation. Dosing volumes were
adjusted individually based on weekly body weight measurements.
A single female of the LD group was
euthanized in a bad health condition in this study. Pericardial
inflammation, pleural inflammation and mediastinal inflammation at the
thymus indicated gavage error. Besides, no mortality occurred during the
treatment period of this study. There were no clinical signs of systemic
toxicity in this study. Transiently occurring moving the bedding and
slight salivation were considered to be slight local reactions of Sa 190
almost exclusively at 1000 mg/kg bw/d. No relevant
effects of Sa 190 were observed in any of the parameters of the
functional observation battery. Body weights developed
normally in all groups and no effect on food consumption was seen. There
were no biologically relevant differences in body temperature between
the groups. Sa 190 had no effect on haematological
parameters, coagulation parameters and clinical biochemistry parameters
determined at the end of the treatment period. Urinary parameters were
also not affected by Sa 190.
At necropsy a pericard filled with a
yellow mucoid fluid was found in single female animals of the LD, MD and
HD group, respectively. In absence of histopathological findings of the
heart of HD animals and any other signs of toxicity in this study, this
is not considered adverse in the context of this study. However, a
relation to Sa 190 cannot be excluded. Besides, non-test item related
findings were noted at necropsy.
Independently of dose kidney and liver
weight was slightly higher in male– but not female animals.
Histopathologically, there were no
lesions that distinguished controls from test item-treated animals.
Gavaging error was confirmed
histopathologically as cause of the only mortality in this study.
On the basis of this 28-Day Repeated
Dose Oral Toxicity study with Sa 190 in male and female Wistar rats with
dose levels of 100, 300, and 1000 mg/kgbody weight day, the following
conclusions can be made:
the conditions of this study, the test item Sa 190 did not cause
indicators of toxicity. The NOAEL may be established at 1000 mg/kg bw.
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