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Study Information
Study Attribute Value
CEBS Accession Number: 002-01467-0002-0000-2
Chemical Name: 4,4'-Methylenedianiline dihydrochloride
CASRN: 13552-44-8
NTP Study Type: Genetic Toxicology - Mammalian Cell Cytogenetics
NTP Study ID: 204381_CA
Study Result: Positive

Study Result: Positive
Activation Trial Trial Call
No Activation  1  Negative 
Induced Rat Liver S9  1_S9  Positive 
No Activation  2  Weakly Positive* 
Induced Rat Liver S9  2_S9  Weakly Positive* 
Induced Rat Liver S9  3_S9  Weakly Positive* 

Trial #:1   Activation: No Activation    Date: 05/15/1985    Harvest Time: 18 hour(s)   Trial Call: Negative   
  Dose
µg/mL		 Total
Cells Examined		 Total Aberrations Complex Aberrations Simple Aberrations Other Abs
No. of
Abs		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs
Vehicle Control: Medium 
0         
 200 2 0.010 1.0 1 0.005 1.0 1 0.005 1.0 0 0.000 0.0
Test Chemical: 4,4'-Methylenedianiline dihydrochloride 
160         
 200 1 0.005 1.0 0 0.000 0.0 1 0.005 1.0 0 0.000 0.0 
300         
 200 2 0.010 1.0 1 0.005 1.0 1 0.005 1.0 0 0.000 0.0 
500         
 200 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
Positive Control: Mitomycin-C 
 0.125     
 200 178 0.890 53.0 99 0.495 32.0 69 0.345 30.0 10 0.050 1.0
Trend: -1.069 -0.841 -1.069  
Probability: 0.857 0.800 0.857  


Trial #:1_S9   Activation: Induced Rat Liver S9    Date: 06/12/1985    Harvest Time: 15 hour(s)   Trial Call: Positive   
  Dose
µg/mL		 Total
Cells Examined		 Total Aberrations Complex Aberrations Simple Aberrations Other Abs
No. of
Abs		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs
Vehicle Control: Medium 
0         
 200 3 0.015 2.0 0 0.000 0.0 3 0.015 2.0 0 0.000 0.0
Test Chemical: 4,4'-Methylenedianiline dihydrochloride 
400         
 200 3 0.015 2.0 1 0.005 1.0 2 0.010 1.0 0 0.000 0.0 
600         
 200 5 0.025 3.0 1 0.005 1.0 4 0.020 2.0 0 0.000 0.0 
800         
 200 152 0.760 49.0 29 0.145 13.0 123 0.615 44.0 0 0.000 0.0 
1000         
 200 179 0.895 76.0 11 0.055 6.0 145 0.725 65.0 23 0.115 14.0
Positive Control: Cyclophosphamide 
5         
 200 57 0.285 24.0 13 0.065 6.0 44 0.220 20.0 0 0.000 0.0
Cyclophosphamide 
7.5       
 50 35 0.700 50.0 7 0.140 14.0 28 0.560 44.0 0 0.000 0.0
Trend: 19.018 5.471 17.345  
Probability: 0.000 0.000 0.000  


Trial #:2   Activation: No Activation    Date: 07/24/1985    Harvest Time: 15 hour(s)   Trial Call: Weakly Positive*   
  Dose
µg/mL		 Total
Cells Examined		 Total Aberrations Complex Aberrations Simple Aberrations Other Abs
No. of
Abs		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs
Vehicle Control: Medium 
0         
 200 1 0.005 1.0 0 0.000 0.0 1 0.005 1.0 0 0.000 0.0
Test Chemical: 4,4'-Methylenedianiline dihydrochloride 
400         
 200 4 0.020 2.0 3 0.015 2.0 1 0.005 1.0 0 0.000 0.0 
600         
 200 3 0.015 2.0 1 0.005 1.0 2 0.010 1.0 0 0.000 0.0 
800         
 200 36 0.180 15.0 11 0.055 4.0 25 0.125 12.0 0 0.000 0.0 
1000         
 0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
Positive Control: Mitomycin-C 
 0.063     
 200 64 0.320 26.0 35 0.175 16.0 29 0.145 13.0 0 0.000 0.0
Mitomycin-C 
 0.125     
 50 38 0.760 56.0 20 0.400 34.0 18 0.360 32.0 0 0.000 0.0
Trend: 5.906 2.533 5.317  
Probability: 0.000 0.006 0.000  


Trial #:2_S9   Activation: Induced Rat Liver S9    Date: 05/15/1985    Harvest Time: 14.5 hour(s)   Trial Call: Weakly Positive*   
  Dose
µg/mL		 Total
Cells Examined		 Total Aberrations Complex Aberrations Simple Aberrations Other Abs
No. of
Abs		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs
Vehicle Control: Medium 
0         
 200 2 0.010 1.0 0 0.000 0.0 2 0.010 1.0 0 0.000 0.0
Test Chemical: 4,4'-Methylenedianiline dihydrochloride 
160         
 200 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 
300         
 200 6 0.030 3.0 3 0.015 2.0 3 0.015 2.0 0 0.000 0.0 
500         
 200 34 0.170 14.0 10 0.050 5.0 24 0.120 10.0 0 0.000 0.0
Positive Control: Cyclophosphamide 
7.5       
 200 111 0.555 42.0 47 0.235 22.0 64 0.320 28.0 0 0.000 0.0
Cyclophosphamide 
10         
 50 66 1.320 72.0 21 0.420 34.0 45 0.900 62.0 0 0.000 0.0
Trend: 6.290 4.067 5.069  
Probability: 0.000 0.000 0.000  


Trial #:3_S9   Activation: Induced Rat Liver S9    Date: 07/24/1985    Harvest Time: 13.5 hour(s)   Trial Call: Weakly Positive*   
  Dose
µg/mL		 Total
Cells Examined		 Total Aberrations Complex Aberrations Simple Aberrations Other Abs
No. of
Abs		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs		 No. of
Abs.		 Abs
Per
Cell		 % Cells
With
Abs
Vehicle Control: Medium 
0         
 200 3 0.015 2.0 1 0.005 1.0 2 0.010 1.0 0 0.000 0.0
Test Chemical: 4,4'-Methylenedianiline dihydrochloride 
200         
 200 3 0.015 2.0 2 0.010 1.0 1 0.005 1.0 0 0.000 0.0 
400         
 200 3 0.015 1.0 1 0.005 1.0 2 0.010 1.0 0 0.000 0.0 
600         
 200 9 0.045 5.0 4 0.020 2.0 5 0.025 3.0 0 0.000 0.0 
800         
 200 203 1.015 85.0 7 0.035 3.0 71 0.355 26.0 125 0.625 116.0 
1000         
 0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
Positive Control: Cyclophosphamide 
5         
 200 71 0.355 29.0 27 0.135 13.0 44 0.220 20.0 0 0.000 0.0
Cyclophosphamide 
7.5       
 50 16 0.320 30.0 6 0.120 12.0 10 0.200 20.0 0 0.000 0.0
Trend: 17.013 1.665 8.460  
Probability: 0.000 0.048 0.000