TY  - GEN
AU  - Antony, Benny
AU  - Benny, Merina
TI  - ACUTE AND SUB CHRONIC TOXICITY STUDIES  OF PURIFIED  WITHANIA SOMNIFERA  EXTRACT IN RATS
PY  - 2018///
CY  - M P
PB  - Innovare Academic Sciences Pvt Ltd
KW  - PHARMACEUTICS
N2  - 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
UR  - https://innovareacademics.in/journals/index.php/ijpps/article/view/29493/16284
ER  -