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Study Information
Study Attribute Value
CEBS Accession Number: 002-01536-0003-0000-0
Chemical Name: 5-Azacytidine
CASRN: 320-67-2
NTP Study Type: Genetic Toxicology - Micronucleus
NTP Study ID: A95392
Strain and Species: B6C3F1 Mouse
Study Result: Male: Positive

Bone Marrow

Start Date Sample Collection Time Sex Methodology Used Route Dosing Regimen
1993-01-19 48 hour Male Slide Scoring Intraperitoneal Injection Intraperitoneal Injection x 1, 48 hour
  Dose
(mg/kg)		 Animal
Number		 Polychromatic Erythrocytes
Trend P: 0.000
No. Examined Total MN Cells Percent PCE MN Cells
per 1000
Vehicle Control Corn Oil 
 0         
 5750 2000 3 42.0 1.5 
 0         
 5756 2000 2 51.0 1.0 
 0         
 5767 2000 1 53.5 0.5 
 0         
 5774 2000 5 52.0 2.5 
 0         
 5778 2000 6 47.0 3.0
Average ± SEM   49.100 ± 2.080 1.700 ± 0.460
 
Test Chemical 5-Azacytidine 
75         
 5748 2000 22 9.5 11.0 
75         
 5755 2000 17 13.0 8.5 
75         
 5762 2000 5 15.0 2.5 
75         
 5769 2000 13 10.5 6.5 
75         
 5777 2000 33 12.5 16.5
Average ± SEM   12.100 ± 0.970 9.000 ± 2.330
Pairwise P   Value less than 0.0001
 
Test Chemical 5-Azacytidine 
150         
 5751 0 0 0 0.0 
150         
 5757 2000 14 12.5 7.0 
150         
 5765 2000 14 19.0 7.0 
150         
 5771 2000 13 15.5 6.5 
150         
 5779 2000 20 9.5 10.0 
150         
 5783 2000 21 13.0 10.5
Average ± SEM   13.900 ± 1.590 8.200 ± 0.850
Pairwise P   Value less than 0.0001
 
Test Chemical 5-Azacytidine 
300         
 5749 0 0 0 0.0 
300         
 5760 0 0 0 0.0 
300         
 5764 0 0 0 0.0 
300         
 5770 0 0 0 0.0 
300         
 5776 2000 16 31.5 8.0 
300         
 5780 2000 22 12.0 11.0 
300         
 5782 2000 17 9.5 8.5
Average ± SEM   17.670 ± 6.950 9.170 ± 0.930
Pairwise P   Value less than 0.0001
 
Test Chemical 5-Azacytidine 
450         
 5752 0 0 0.0 
450         
 5754 0 0 0.0 
450         
 5759 0 0 0.0 
450         
 5763 0 0 0.0 
450         
 5768 0 0 0.0 
450         
 5772 0 0 0.0 
450         
 5775 0 0 0.0 
450         
 5781 0 0 0.0
Average ± SEM   0.000 ± 0.000 0.000 ± 0.000
 
Positive Control Cyclophosphamide 
25         
 5753 2000 5 46.0 2.5 
25         
 5758 2000 3 55.5 1.5 
25         
 5761 2000 9 55.0 4.5 
25         
 5766 2000 5 43.0 2.5 
25         
 5773 2000 5 43.0 2.5
Average ± SEM   48.500 ± 2.810 2.700 ± 0.490
Pairwise P   0.066
 

Bone Marrow

Start Date Sample Collection Time Sex Methodology Used Route Dosing Regimen
1993-11-16 48 hour Male Slide Scoring Intraperitoneal Injection Intraperitoneal Injection x 1, 48 hour
  Dose
(mg/kg)		 Animal
Number		 Polychromatic Erythrocytes
Trend P: 0.066
No. Examined Total MN Cells Percent PCE MN Cells
per 1000
Vehicle Control Corn Oil 
 0         
 6427 2000 4 76.0 2.0 
 0         
 6432 2000 1 40.0 0.5 
 0         
 6436 2000 1 55.0 0.5 
 0         
 6440 2000 1 29.5 0.5 
 0         
 6444 2000 0 51.0 0.0
Average ± SEM   50.300 ± 7.820 0.700 ± 0.340
 
Test Chemical 5-Azacytidine 
75         
 6433 2000 2 15.5 1.0 
75         
 6434 2000 1 27.0 0.5 
75         
 6439 2000 5 54.0 2.5 
75         
 6447 2000 4 15.5 2.0 
75         
 6448 2000 7 19.0 3.5
Average ± SEM   26.200 ± 7.260 1.900 ± 0.530
Pairwise P   0.103
 
Test Chemical 5-Azacytidine 
150         
 6424 2000 10 14.5 5.0 
150         
 6429 1112 17 11.5 15.3 
150         
 6430 2000 6 6.5 3.0 
150         
 6438 2000 6 11.0 3.0 
150         
 6443 2000 2 14.0 1.0
Average ± SEM   11.500 ± 1.420 4.500 ± 2.540
Pairwise P   0.003
 
Test Chemical 5-Azacytidine 
300         
 6425 2000 6 20.0 3.0 
300         
 6431 2000 4 35.0 2.0 
300         
 6441 2000 7 18.0 3.5 
300         
 6442 2000 2 9.0 1.0 
300         
 6445 0 0 0 0.0
Average ± SEM   20.500 ± 5.390 2.380 ± 0.550
Pairwise P   0.058
 
Positive Control Cyclophosphamide 
25         
 6426 2000 7 76.5 3.5 
25         
 6428 2000 1 71.0 0.5 
25         
 6435 2000 4 75.0 2.0 
25         
 6437 2000 1 39.5 0.5 
25         
 6446 2000 1 58.0 0.5
Average ± SEM   64.000 ± 6.940 1.400 ± 0.600
Pairwise P   0.063
 

Blood

Start Date Sample Collection Time Sex Methodology Used Route Dosing Regimen
1993-01-19 48 hour Male Slide Scoring Intraperitoneal Injection Intraperitoneal Injection x 1, 48 hour
  Dose
(mg/kg)		 Animal
Number		 Polychromatic Erythrocytes
Trend P: 0.844
No. Examined Total MN Cells Percent PCE MN Cells
per 1000
Vehicle Control Corn Oil 
 0         
 5750 2000 5 5.3 2.5 
 0         
 5756 2000 2 3.4 1.0 
 0         
 5767 2000 2 3.9 1.0 
 0         
 5774 2000 6 4.0 3.0 
 0         
 5778 2000 8 4.4 4.0
Average ± SEM   4.200 ± 0.320 2.300 ± 0.580
 
Test Chemical 5-Azacytidine 
75         
 5748 2000 0 1.8 0.0 
75         
 5755 2000 8 3.1 4.0 
75         
 5762 2000 5 2.4 2.5 
75         
 5769 2000 16 2.0 8.0 
75         
 5777 2000 8 2.2 4.0
Average ± SEM   2.300 ± 0.220 3.700 ± 1.300
Pairwise P   0.131
 
Test Chemical 5-Azacytidine 
150         
 5751 2000 0 0.0 0.0 
150         
 5757 2000 4 1.6 2.0 
150         
 5765 2000 4 1.6 2.0 
150         
 5771 2000 1 2.9 0.5 
150         
 5779 2000 10 2.7 5.0 
150         
 5783 2000 5 1.2 2.5
Average ± SEM   2.000 ± 0.340 2.400 ± 0.730
Pairwise P   0.464
 
Test Chemical 5-Azacytidine 
300         
 5749 2000 0 0.0 0.0 
300         
 5760 2000 0 0.0 0.0 
300         
 5764 2000 0 0.0 0.0 
300         
 5770 2000 0 0.0 0.0 
300         
 5776 2000 5 4.1 2.5 
300         
 5780 2000 1 2.9 0.5 
300         
 5782 2000 2 2.6 1.0
Average ± SEM   3.200 ± 0.460 1.330 ± 0.600
Pairwise P   0.798
 
Test Chemical 5-Azacytidine 
450         
 5752 2000 0 0.0 
450         
 5754 2000 0 0.0 
450         
 5759 2000 0 0.0 
450         
 5763 2000 0 0.0 
450         
 5768 2000 0 0.0 
450         
 5772 2000 0 0.0 
450         
 5775 2000 0 0.0 
450         
 5781 2000 0 0.0
Average ± SEM   0.000 ± 0.000 0.000 ± 0.000
 
Positive Control Cyclophosphamide 
25         
 5753 2000 17 3.4 8.5 
25         
 5758 2000 12 1.9 6.0 
25         
 5761 2000 22 5.6 11.0 
25         
 5766 2000 25 3.4 12.5 
25         
 5773 2000 23 2.6 11.5
Average ± SEM   3.380 ± 0.620 9.900 ± 1.180
Pairwise P   Value less than 0.0001
 

Blood

Start Date Sample Collection Time Sex Methodology Used Route Dosing Regimen
1993-11-16 48 hour Male Slide Scoring Intraperitoneal Injection Intraperitoneal Injection x 1, 48 hour
  Dose
(mg/kg)		 Animal
Number		 Polychromatic Erythrocytes
Trend P: 0.002
No. Examined Total MN Cells Percent PCE MN Cells
per 1000
Vehicle Control Corn Oil 
 0         
 6427 2000 3 2.5 1.5 
 0         
 6432 2000 5 0.6 2.5 
 0         
 6436 2000 3 1.9 1.5 
 0         
 6440 2000 2 0.3 1.0 
 0         
 6444 2000 2 0.9 1.0
Average ± SEM   1.240 ± 0.410 1.500 ± 0.270
 
Test Chemical 5-Azacytidine 
75         
 6433 2000 4 0.3 2.0 
75         
 6434 2000 14 0.4 7.0 
75         
 6439 2000 10 0.2 5.0 
75         
 6447 130 3 0.3 23.1 
75         
 6448 997 0 0.1 0.0
Average ± SEM   0.250 ± 0.060 4.000 ± 1.550
Pairwise P   0.029
 
Test Chemical 5-Azacytidine 
150         
 6424 2000 16 0.2 8.0 
150         
 6429 2000 9 0.3 4.5 
150         
 6430 2000 4 1.4 2.0 
150         
 6438 487 1 0.2 2.1 
150         
 6443 58 0 0.0 0.0
Average ± SEM   0.630 ± 0.380 4.830 ± 1.740
Pairwise P   0.010
 
Test Chemical 5-Azacytidine 
300         
 6425 2000 16 0.7 8.0 
300         
 6431 2000 21 0.3 10.5 
300         
 6441 2000 7 0.5 3.5 
300         
 6442 1503 3 0.2 2.0 
300         
 6445 0 0 0 0.0
Average ± SEM   0.430 ± 0.110 6.260 ± 1.970
Pairwise P   0.001
 
Positive Control Cyclophosphamide 
25         
 6426 2000 22 1.1 11.0 
25         
 6428 2000 20 2.1 10.0 
25         
 6435 2000 13 1.6 6.5 
25         
 6437 2000 4 1.3 2.0 
25         
 6446 2000 9 1.6 4.5
Average ± SEM   1.540 ± 0.170 6.800 ± 1.680
Pairwise P   Value less than 0.0001
 

Blood

Start Date Sample Collection Time Sex Methodology Used Route Dosing Regimen
1994-01-04 72 hour Male Slide Scoring Intraperitoneal Injection Intraperitoneal Injection x 1, 72 hour
  Dose
(mg/kg)		 Animal
Number		 Polychromatic Erythrocytes
Trend P: 0.000
No. Examined Total MN Cells Percent PCE MN Cells
per 1000
Vehicle Control Corn Oil 
 0         
 6524 2000 4 2.2 2.0 
 0         
 6526 2000 2 2.9 1.0 
 0         
 6530 2000 1 1.9 0.5 
 0         
 6533 2000 2 2.4 1.0 
 0         
 6539 2000 6 2.2 3.0
Average ± SEM   2.320 ± 0.170 1.500 ± 0.450
 
Test Chemical 5-Azacytidine 
150         
 6531 0 0 0 0.0 
150         
 6534 0 0 0 0.0 
150         
 6535 0 0 0 0.0 
150         
 6537 0 0 0 0.0 
150         
 6543 0 0 0 0.0
Average ± SEM   0.000 ± 0.000 0.000 ± 0.000
 
Test Chemical 5-Azacytidine 
300         
 6525 0 0 0.0 
300         
 6527 0 0 0.0 
300         
 6532 0 0 0.0 
300         
 6541 0 0 0.0 
300         
 6542 0 0 0.0
Average ± SEM   0.000 ± 0.000 0.000 ± 0.000
 
Positive Control Cyclophosphamide 
25         
 6528 2000 3 1.1 1.5 
25         
 6529 2000 6 2.0 3.0 
25         
 6536 2000 8 1.1 4.0 
25         
 6538 2000 0 1.8 0.0 
25         
 6540 2000 11 2.2 5.5
Average ± SEM   1.640 ± 0.230 2.800 ± 0.960
Pairwise P   0.024