Table
11: Summary of Structural Aberrations
A Cytogenetic Study in Rats
with Five Daily Doses of 323U66-HCl (Bupropion: Containing Impurities)
SUMMARY OF STRUCTURAL
ABERRATIONS (MUT 223)
|
Dose |
% Aberrant Cells |
No. Aberrations/var 1?0
Cells |
(unreadable) Index (%) |
||||||
|
(mg/kg) |
Males
|
Females
|
Combined
|
Males
|
Females
|
Combined
|
Males
|
Females
|
Combined
|
|
0 |
0.0 |
0.0 |
0.4 |
1.2 |
0.0 |
0.6 |
2.96 |
2.52 |
2.74 |
|
0 |
0.0 |
0.4 |
0.2 |
0.0 |
0.4 |
0.2 |
2.80 |
4.66 |
3.73 |
|
100 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
3.80 |
3.28 |
3.54 |
|
200 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
3.08 |
2.44 |
2.76 |
|
300 |
0.4 |
0.0 |
0.2 |
0.8 |
0.0 |
0.4 |
2.18 |
2.60 |
2.39 |
|
300* |
0.4 |
0.4 |
0.4 |
0.4 |
0.4 |
0.4 |
2.18 |
2.44 |
2.31 |
|
Positive
Control (CP:
30 mg/kg) |
8.0 |
7.2” |
6.6 |
18.0 |
14.4 |
16.2 |
1.06 |
1.92 |
1.49 |
|
Positive
Control (CP:
40 mg/kg) |
26.8** |
15.6** |
21.2 |
115.2 |
52.0 |
83.6 |
0.84 |
0.28 |
0.40 |
|
*Test compound used for this group was the
material presently used in clinics. |
|||||||||
|
**p<0.05,
each test dose group was compared with the polled vehicle control males or
females for statistical significance (See Appendix 3). |
|||||||||
TTEP/93/0058 31
ITEM
5
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