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Study Information
Study Attribute Value
CEBS Accession Number: 002-01877-0001-0000-6
Chemical Name: Chlorpheniramine maleate
CASRN: 113-92-8
NTP Study Type: Genetic Toxicology - Mammalian Cell Cytogenetics
NTP Study ID: 982295_SCE
Study Result: Positive

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

Trial #: 1    Activation: No Activation    Date: 02/06/1984    Trial Call: Negative   
  Dose
µg/mL
Number
Cells
Examined
Number
Chromosomes
Examined
Total
Number
SCEs
SCE /
Chromosome
SCE /
Cell
Hours in
BRDU
% Increase
Over Solvent
Control
Vehicle Control Negative (Not Specified)
0         
50 1030 337 0.327 6.74 26.5 -17.313
Dimethyl Sulfoxide
0         
50 1021 404 0.396 8.08 26.5 0.000
Test Chemical Chlorpheniramine maleate
 0.5       
50 1034 408 0.395 8.16 26.5 -0.280
1.6       
50 1047 412 0.394 8.24 26.5 -0.552
5         
50 1043 419 0.402 8.38 26.5 1.525
16         
50 1039 449 0.432 8.98 26.5 9.213
50         
0 0 0 0.000 0.00 0.0 N/A
160         
0 0 0 0.000 0.00 0.0 N/A
Positive Control Mitomycin-C
 0.001     
50 1049 1394 1.329 27.88 26.5 235.839
Mitomycin-C
 0.01      
10 210 752 3.581 75.20 26.5 804.988
Trend: 1.284        
Probability: 0.100        

Trial #: 2    Activation: No Activation    Date: 03/21/1984    Trial Call: Weakly Positive   
  Dose
µg/mL
Number
Cells
Examined
Number
Chromosomes
Examined
Total
Number
SCEs
SCE /
Chromosome
SCE /
Cell
Hours in
BRDU
% Increase
Over Solvent
Control
Vehicle Control Negative (Not Specified)
0         
50 1044 394 0.377 7.88 26.0 -7.529
Dimethyl Sulfoxide
0         
50 1034 422 0.408 8.44 26.0 0.000
Test Chemical Chlorpheniramine maleate
16         
50 1036 444 0.429 8.88 26.0 5.010
25         
50 1033 433 0.419 8.66 26.0 2.706
50         
50 1035 424 0.410 8.48 26.0 0.377
100         
50 1040 511 0.491 10.22 31.0 20.391
200         
0 0 0 0.000 0.00 0.0 N/A
Positive Control Mitomycin-C
 0.001     
50 1039 1303 1.254 26.06 26.0 207.282
Mitomycin-C
 0.01      
10 204 510 2.500 51.00 26.0 512.559
Trend: 2.410        
Probability: 0.008        

Trial #: 3    Activation: No Activation    Date: 04/02/1985    Trial Call: Positive   
  Dose
µg/mL
Number
Cells
Examined
Number
Chromosomes
Examined
Total
Number
SCEs
SCE /
Chromosome
SCE /
Cell
Hours in
BRDU
% Increase
Over Solvent
Control
Vehicle Control Dimethyl Sulfoxide
0         
50 1047 419 0.400 8.38 26.0 0.000
Test Chemical Chlorpheniramine maleate
75         
50 1050 496 0.472 9.92 31.0 18.039
125         
50 1049 546 0.520 10.92 31.0 30.062
150         
50 1048 519 0.495 10.38 31.0 23.748
Positive Control Mitomycin-C
 0.001     
50 1050 561 0.534 11.22 26.0 33.508
Mitomycin-C
 0.005     
10 210 250 1.190 25.00 26.0 197.477
Trend: 3.759        
Probability: 0.000        

Trial #: 1_S9    Activation: Induced Rat Liver S9    Date: 02/07/1984    Trial Call: Negative   
  Dose
µg/mL
Number
Cells
Examined
Number
Chromosomes
Examined
Total
Number
SCEs
SCE /
Chromosome
SCE /
Cell
Hours in
BRDU
% Increase
Over Solvent
Control
Vehicle Control Dimethyl Sulfoxide
0         
50 1040 457 0.439 9.14 26.0 0.000
Negative (Not Specified)
0         
50 1047 469 0.448 9.38 26.0 1.940
Test Chemical Chlorpheniramine maleate
5         
50 1046 457 0.437 9.14 26.0 -0.574
16         
50 1038 444 0.428 8.88 26.0 -2.657
50         
50 1046 454 0.434 9.08 26.0 -1.226
160         
50 1047 443 0.423 8.86 26.0 -3.712
500         
0 0 0 0.000 0.00 0.0 N/A
Positive Control Cyclophosphamide
 0.3       
50 1035 567 0.548 11.34 26.0 24.669
Cyclophosphamide
2         
10 208 247 1.188 24.70 26.0 170.241
Trend: -0.553        
Probability: 0.710        

Trial #: 2_S9    Activation: Induced Rat Liver S9    Date: 03/21/1984    Trial Call: Test Failure   
  Dose
µg/mL
Number
Cells
Examined
Number
Chromosomes
Examined
Total
Number
SCEs
SCE /
Chromosome
SCE /
Cell
Hours in
BRDU
% Increase
Over Solvent
Control
Vehicle Control Dimethyl Sulfoxide
0         
50 1046 443 0.424 8.86 26.0 0.000
Negative (Not Specified)
0         
50 1040 449 0.432 8.98 26.0 1.939
Test Chemical Chlorpheniramine maleate
200         
50 1045 407 0.389 8.14 26.0 -8.038
300         
50 1042 444 0.426 8.88 26.0 0.610
400         
50 1049 465 0.443 9.30 26.0 4.666
500         
50 1043 491 0.471 9.82 26.0 11.154
Positive Control Cyclophosphamide
 0.3       
50 1047 527 0.503 10.54 26.0 18.848
Cyclophosphamide
2         
10 211 256 1.213 25.60 26.0 186.474
Trend: 2.266        
Probability: 0.012