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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 Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-01-19 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection 0.000
  Dose (mg/kg) Number of Animals Scored Mean MN-PCE/1000 PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 1.700 ± 0.460
Test Chemical 5-Azacytidine 
75         
 5 9.000 ± 2.330 Value less than 0.0001 
150         
 5 8.200 ± 0.850 Value less than 0.0001 
300         
 3 9.170 ± 0.930 Value less than 0.0001 
450         
 0.000 ± 0.000
Positive Control Cyclophosphamide 
25         
 5 2.700 ± 0.490 0.066

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-01-19 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection
  Dose (mg/kg) Number of Animals Scored Mean Percent PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 49.100 ± 2.080
Test Chemical 5-Azacytidine 
75         
 5 12.100 ± 0.970 
150         
 5 13.900 ± 1.590 
300         
 3 17.670 ± 6.950 
450         
 0.000 ± 0.000
Positive Control Cyclophosphamide 
25         
 5 48.500 ± 2.810

Bone Marrow

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-11-16 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection 0.066
  Dose (mg/kg) Number of Animals Scored Mean MN-PCE/1000 PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 0.700 ± 0.340
Test Chemical 5-Azacytidine 
75         
 5 1.900 ± 0.530 0.103 
150         
 5 4.500 ± 2.540 0.003 
300         
 4 2.380 ± 0.550 0.058
Positive Control Cyclophosphamide 
25         
 5 1.400 ± 0.600 0.063

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-11-16 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection
  Dose (mg/kg) Number of Animals Scored Mean Percent PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 50.300 ± 7.820
Test Chemical 5-Azacytidine 
75         
 5 26.200 ± 7.260 
150         
 5 11.500 ± 1.420 
300         
 4 20.500 ± 5.390
Positive Control Cyclophosphamide 
25         
 5 64.000 ± 6.940

Blood

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-01-19 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection 0.844
  Dose (mg/kg) Number of Animals Scored Mean MN-PCE/1000 PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 2.300 ± 0.580
Test Chemical 5-Azacytidine 
75         
 5 3.700 ± 1.300 0.131 
150         
 5 2.400 ± 0.730 0.464 
300         
 3 1.330 ± 0.600 0.798 
450         
 0.000 ± 0.000
Positive Control Cyclophosphamide 
25         
 5 9.900 ± 1.180 Value less than 0.0001

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-01-19 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection
  Dose (mg/kg) Number of Animals Scored Mean Percent PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 4.200 ± 0.320
Test Chemical 5-Azacytidine 
75         
 5 2.300 ± 0.220 
150         
 5 2.000 ± 0.340 
300         
 3 3.200 ± 0.460 
450         
 0.000 ± 0.000
Positive Control Cyclophosphamide 
25         
 5 3.380 ± 0.620

Blood

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-11-16 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection 0.002
  Dose (mg/kg) Number of Animals Scored Mean MN-PCE/1000 PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 1.500 ± 0.270
Test Chemical 5-Azacytidine 
75         
 4 4.000 ± 1.550 0.029 
150         
 3 4.830 ± 1.740 0.010 
300         
 4 6.260 ± 1.970 0.001
Positive Control Cyclophosphamide 
25         
 5 6.800 ± 1.680 Value less than 0.0001

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1993-11-16 48 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 48 hour Intraperitoneal Injection
  Dose (mg/kg) Number of Animals Scored Mean Percent PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 1.240 ± 0.410
Test Chemical 5-Azacytidine 
75         
 4 0.250 ± 0.060 
150         
 3 0.630 ± 0.380 
300         
 4 0.430 ± 0.110
Positive Control Cyclophosphamide 
25         
 5 1.540 ± 0.170

Blood

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1994-01-04 72 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 72 hour Intraperitoneal Injection 0.000
  Dose (mg/kg) Number of Animals Scored Mean MN-PCE/1000 PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 1.500 ± 0.450
Test Chemical 5-Azacytidine 
150         
 0.000 ± 0.000 
300         
 0.000 ± 0.000
Positive Control Cyclophosphamide 
25         
 5 2.800 ± 0.960 0.024

Start Date Sample Collection Time Sex Cell Methodology Used Dosing Regimen Route Trend Test P-Value
1994-01-04 72 hour Male PCE Slide Scoring Intraperitoneal Injection x 1, 72 hour Intraperitoneal Injection
  Dose (mg/kg) Number of Animals Scored Mean Percent PCE ± SEM Pairwise P
Vehicle Control Corn Oil 
 0         
 5 2.320 ± 0.170
Test Chemical 5-Azacytidine 
150         
 0.000 ± 0.000 
300         
 0.000 ± 0.000
Positive Control Cyclophosphamide 
25         
 5 1.640 ± 0.230