ACUTE AND SUB CHRONIC TOXICITY STUDIES OF PURIFIED WITHANIA SOMNIFERA EXTRACT IN RATS
Antony, Benny
ACUTE AND SUB CHRONIC TOXICITY STUDIES OF PURIFIED WITHANIA SOMNIFERA EXTRACT IN RATS - Vol.10(12) - M P Innovare Academic Sciences Pvt Ltd 2018 - 41-46p.
Objective:
The objective of
the present study was to evaluate the acute and
sub
-chronic (
90
d;
repeated dose
) toxicity of
Withania somnifera
(ashwagandha)
extract
in rats.
Method
s:
The acute
toxicity was evaluated as per OECD (Organisation for Economic Co
-operation and Development)
guidelines 423. P
urified
ashwagandha extract (PAE)
was fed at 2000 mg/kg body weight (bw)
to overnight fasted
female
rats.
The animals were observed daily
for
clinical
signs of abnormality/mortality. After 1
4 d
, animals were sacrificed and
gross pathologic
al changes were recorded. Sub
-chronic toxicity of PAE was
studied by feeding the extract at 100, 500 and 1000 mg/kg
bw
daily to rats
as per OECD guidelines 408
. After 9
0 d
feeding
, heamatological
and
biochemical parameters
of treated rats
were compared wit
h control animals. Histopathology of all the major organs was also studied.
Result
s:
In the acute toxicity study, no mortality or clinical signs of toxicity were observed in any of the animals at maximum
recommended dose level
of 2000 mg/kg b
w;
therefore the LD50 is
>2000 mg/kg bw in rats.
The repeated administration of PAE
for 9
0 d
in rats at the maximum
dose level of
1000
mg/kg
bw
did not induce any observable toxic
effects,
when compared to its corresponding control animals.
The hematology
and biochemistr
y
profile of treated
rats was similar to control animals
and
difference
was non
-significant (p>0.05). The histopathology of
major organs of
all the control
and treated animals w
as
normal.
In this study
the NOAEL
(No Observed Adverse Effect Level) was calcu
lated as 1000
mg/kg
bw
daily for rats.
Conclusio
n:
The present study clearly indicates that
PAE
does not have any toxic effects in animals at the dose evaluated as evidenced by acute
and
sub chronic
toxicity studies in rats
PHARMACEUTICS
ACUTE AND SUB CHRONIC TOXICITY STUDIES OF PURIFIED WITHANIA SOMNIFERA EXTRACT IN RATS - Vol.10(12) - M P Innovare Academic Sciences Pvt Ltd 2018 - 41-46p.
Objective:
The objective of
the present study was to evaluate the acute and
sub
-chronic (
90
d;
repeated dose
) toxicity of
Withania somnifera
(ashwagandha)
extract
in rats.
Method
s:
The acute
toxicity was evaluated as per OECD (Organisation for Economic Co
-operation and Development)
guidelines 423. P
urified
ashwagandha extract (PAE)
was fed at 2000 mg/kg body weight (bw)
to overnight fasted
female
rats.
The animals were observed daily
for
clinical
signs of abnormality/mortality. After 1
4 d
, animals were sacrificed and
gross pathologic
al changes were recorded. Sub
-chronic toxicity of PAE was
studied by feeding the extract at 100, 500 and 1000 mg/kg
bw
daily to rats
as per OECD guidelines 408
. After 9
0 d
feeding
, heamatological
and
biochemical parameters
of treated rats
were compared wit
h control animals. Histopathology of all the major organs was also studied.
Result
s:
In the acute toxicity study, no mortality or clinical signs of toxicity were observed in any of the animals at maximum
recommended dose level
of 2000 mg/kg b
w;
therefore the LD50 is
>2000 mg/kg bw in rats.
The repeated administration of PAE
for 9
0 d
in rats at the maximum
dose level of
1000
mg/kg
bw
did not induce any observable toxic
effects,
when compared to its corresponding control animals.
The hematology
and biochemistr
y
profile of treated
rats was similar to control animals
and
difference
was non
-significant (p>0.05). The histopathology of
major organs of
all the control
and treated animals w
as
normal.
In this study
the NOAEL
(No Observed Adverse Effect Level) was calcu
lated as 1000
mg/kg
bw
daily for rats.
Conclusio
n:
The present study clearly indicates that
PAE
does not have any toxic effects in animals at the dose evaluated as evidenced by acute
and
sub chronic
toxicity studies in rats
PHARMACEUTICS