3.6. Acute toxicity experiment of Cry1Ab/Ac protein in KM mice
In the acute toxicity experiment, control mice treated with
5000 mg kg1 BSA (negative controls) or water at 20 mL kg1
(blank controls) showed no visible signs of systemic toxicity. In
this study, there was no mortality or toxic effect in mice after acute
oral administration of the Cry1Ab/Ac protein at 5000 mg kg1 body
weight.
3.6.1. Clinical observations and body weight
During the course of the experiment, no treatment-related signs
of adverse effects in clinical appearance of the animals were observed.
Both of the body weights of male and female mice in
Cry1Ab/Ac groups were comparable with control groups at the
beginning and the end of the experiment (Table 1).
3.6.2. Blood biochemistry and haematology
Results for blood biochemistry and haematology for males and
females, measured at study termination (day 15), are listed in Tables
2 and 3, respectively. There were no statistically significant
difference between male and female Cry1Ab/Ac protein groups and
the controls groups for most of the parameters measured (p < 0.05
experimental group compared to blank control group or negative
control group but not for both for only three parameters). PLT
showed statistically significant differences in males of BSA group
but females are statistically different in water group. And for males
BSA group showed statistically different from water. But all the results
obtained in this study were comparable with Schrøder et al.
(2007) and He et al. (2008)). So the significant fines are only chance
events. The statistically difference on MCV is only for males with
BSA group and the differences are less than 10%. And there is statistically
different between water group and BSA group for females
too. So the differences have no practical significance. The normal
range for E and B is 0.0–0.2. Some mice had those kinds of cells
but others didn’t have them, which could affect the result very significantly.
And the statistically difference was just for females of
BSA group, furthermore there are statistically differences between
water group and BSA group too, so the deference could not be related
with Cry1Ab/Ac protein.
3.6.3. Organ weights, gross necropsy and histopathology
There were no group-related alterations or statistically identified
difference in organ weights of male and female mice given
Cry1Ab/Ac protein versus the control groups (Table 1). All observations
were considered to be the result of spontaneous alterations,
unassociated with exposure to the Cry1Ab/Ac protein (only five
of the experimental group compared to blank control group or negative
control group p < 0.05 but not for both). Although organ/body
weights of liver were larger in both Cry males and females, the histopathology
and alanine aminotransferase (ALT) for liver had no
differences and the mice liver in Cry1Ab/Ac protein had no problem.
Female lungs were statistically different from water group