ACUTE TOXICITY
PsP acute toxicity test was conducted on 30 BALB/C rats that were divided into 4 treatment groups, i.e. 625, 1250, 2500 and 5000 mg/kg BW. The results demonstrated that:
- all dose groups were declared safe and did not cause acute toxicity effects such as tremor, hypersalivation, lacrimation, convulsions, diarrhea, lethargy, weakness, coma and severe stress
- the overall physical appearance of the rats were good, with flat fur, clear eyes and no wounds were found in either ears or tail
- in this acute toxicity test, no Lethal Dose 50 (LD50) was found although being administered with the largest dose of 5000 mg/kg BW
SUBCHRONIC TOXICITY
The Effect of PsP on Liver
STAGES
80 rats were randomly divided into four groups of female rats and four groups of male rats (10 animals/group).
The four groups of male and female rats were respectively subdivided into:
- 3 treatment groups that received PsP at a dose of 300, 600 and 1200 mg/kg BW/day
- one control group.
BIOMARKERS
The measured biomarkers after 90 days PsP administration were :
- Enzymes level :
– aspartate aminotransferase (AST)
– alanine aminotransferase (ALT)
– alkaline phosphatase (ALP) - Examination of histopathological changes covered:
– the numbers of cells undergoing cloudy, ballooning degeneration
– the numbers of Kupferr cells, inflammatory cells and cells undergoing necrosis
RESULTS
One way analysis of variance test (ANOVA) indicates that:
- levels of AST, ALT and ALP in the group that received PsP did not differ significantly from the control group
- the anatomy of the liver histopathology did not show any difference from the control group
These data showed that PsP at a dose of 300, 600 and 1200 mg/kg BW/day did not give any harmful impact to functions and liver tissue
The Effect of PsP on Kidneys
STAGES
80 male and female Wistar rats, age 2-3 months, weighing 200-300 g, were divided into 4 groups:
- 3 treatment groups that received PsP at a dose of 300, 600 and 1200 mg/kg BW/day
- one control group.
BIOMARKERS
The measured biomarkers after 90 days PsP administration were:
- urea and creatinine levels
- histopathology.
RESULTS
The results indicated that:
- the highest urea levels was found in the group of female Wistar rats that received PsP at a dose of 300 mg/kg BW/day with an average urea concentration of 33.2 mg/dL
- creatinine levels were high in the groups that receive PsP at a dose of 1200, 600, and 300 mg/kg BW/day with an average concentration of creatinine at 0.3 mg/dL
- on histopathologic examination no morphological abnormalities was found
- one-way ANOVA test result showed that there was no significant difference among all groups receiving PsP
Therefore, it can be concluded that PsP administration with 3 variants of the above mentioned doses does not cause any dysfunction and histological damage that affects the kidney function.
The Effect of PsP on the Hematologic Profile
STAGES
80 rats were randomly divided into 4 groups of female rats and 4 groups of male rats (10 rats/group). The four groups of male and female rats were subdivided into:
- 3 treatment groups that received PsP at a dose of 300, 600 and 1200 mg/kg BW/day for 90 days
- 1 control group.
BIOMARKERS
The hematologic profile parameters measured after 90 days were:
- Leukocytes
- Platelets
- Erythrocytes
- Plateletcrit (PCT)
- Mean corpuscular volume (MCV)
- Mean corpuscular hemoglobin (MCH)
- Red cell distribution width (RDW)
RESULTS
One-way test of the analysis of variance test (ANOVA) showed that:
- There was no significant difference in the value of leukocytes between the control group and the treatment group receiving 3 variants of the PsP dose.
- Significant differences occurred in the value of erythrocytes and platelets, PCT, MCV, MCH and RDW levels between the control group and the three treatment groups, but the difference was still within the normal range.
These data suggest that PsP with a dose of 300, 600 and 1200 mg/kg BW/day do not have a harmful effect on blood components (haematological profile).