Table 12: Percentage of Cells with Non-Diploid Chromosome Nos

 

A Cytogenetic Study in Rats with Five Daily doses of 323U68-HCl

(Bupropion:  Containing impurities)

 

 

PERCENTAGE OF CELLS WITH NON-DIPLOID CHROMOSOME NUMBERS (MUT 223)

 

Dose

(mg/kg)

 

% Cells:

 

24 Hr. Sacrifice

 

 

Males

Females

Combined

 

0

Hypodiploid:

 

14.8

7.6

11.2

 

 

Hyperdiploid:

 

0.0

0.0

0.0

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

0

Hypodiploid

 

6.8

8.4

7.6

 

 

Hyperdiploid:

 

0.4

0.0

0.2

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

100

Hypodiploid

 

12.8

16.0

14.4

 

 

Hyperdiploid:

 

0.4

1.2

0.8

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

200

Hypodiploid

 

14.4

11.2

12.8

 

 

Hyperdiploid:

 

0.0

0.0

0.0

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

300

Hypodiploid

 

10.8

8.8

9.8

 

 

Hyperdiploid:

 

0.8

0.4

0.8

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

300*

Hypodiploid

 

11.2

6.8

9.0

 

 

Hyperdiploid:

 

0.0

0.4

0.2

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

Positive Control

Hypodiploid

 

10.4

12.0

11.2

 

(CP: 30 mg/kg)

Hyperdiploid:

 

0.4

0.4

0.4

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

Positive Control

Hypodiploid

 

18.0

16.8

16.4

 

(CP: 40 mg/kg)

Hyperdiploid:

 

1.2

0.0

0.6

 

 

Polyploid:

 

0.0

0.0

0.0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Test compound used for this group was the material presently used in clinics.

 

TTEP/93/0058                                                                       32


 


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