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Study Information
Study Attribute Value
CEBS Accession Number: 002-01901-0001-0000-4
Chemical Name: Codeine phosphate
CASRN: 52-28-8
NTP Study Type: Genetic Toxicology - Mammalian Cell Cytogenetics
NTP Study ID: 039151_SCE
Study Result: Positive

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

Trial #: 1    Activation: No Activation    Date: 01/05/1984    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 Medium 
0         
 20 409 163 0.399 8.15 25.6 0.000
Test Chemical Codeine phosphate 
1000         
 20 400 173 0.433 8.65 25.6 8.523 
1500         
 20 409 224 0.548 11.20 32.3 37.423 
2000         
 20 417 236 0.566 11.80 32.3 42.008 
2500         
 0 0 0 0.000 0.00 0.0 N/A
Positive Control Mitomycin-C 
 0.0015    
 20 404 289 0.715 14.45 25.6 79.495
Mitomycin-C 
 0.01      
 5 105 252 2.400 50.40 25.6 502.209
Trend: 4.076        
Probability: 0.000        

Trial #: 2    Activation: No Activation    Date: 01/05/1984    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 Medium 
0         
 20 405 173 0.427 8.65 25.6 0.000
Test Chemical Codeine phosphate 
1000         
 20 408 178 0.436 8.90 25.6 2.134 
1500         
 20 402 278 0.692 13.90 32.2 61.893 
2000         
 20 414 305 0.737 15.25 32.2 72.468 
2500         
 0 0 0 0.000 0.00 0.0 N/A
Positive Control Mitomycin-C 
 0.0015    
 20 412 301 0.731 15.05 25.6 71.032
Mitomycin-C 
 0.01      
 5 103 217 2.107 43.40 25.6 393.209
Trend: 7.219        
Probability: 0.000        

Trial #: 3    Activation: No Activation    Date: 12/12/1984    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 Medium 
0         
 50 1023 435 0.425 8.70 25.7 0.000
Test Chemical Codeine phosphate 
1000         
 50 1031 541 0.525 10.82 30.9 23.403 
1500         
 50 1029 560 0.544 11.20 30.9 27.985 
2000         
 50 1012 574 0.567 11.48 30.9 33.388 
2500         
 0 0 0 0.000 0.00 0.0 N/A
Positive Control Mitomycin-C 
 0.0015    
 50 1027 753 0.733 15.06 25.7 72.429
Mitomycin-C 
 0.01      
 5 103 265 2.573 53.00 25.7 505.055
Trend: 4.388        
Probability: 0.000        

Trial #: 1_S9    Activation: Induced Rat Liver S9    Date: 11/30/1983    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 Medium 
0         
 50 1029 462 0.449 9.24 25.4 0.000
Test Chemical Codeine phosphate 
500         
 50 1033 553 0.535 11.06 25.4 19.233 
1700         
 50 1008 603 0.598 12.06 33.9 33.239 
5000         
 50 1015 742 0.731 14.84 33.9 62.821
Positive Control Cyclophosphamide 
 0.4       
 50 1028 733 0.713 14.66 25.4 58.812
Cyclophosphamide 
2         
 5 103 177 1.718 35.40 25.4 282.745
Trend: 8.515        
Probability: 0.000        

Trial #: 2_S9    Activation: Induced Rat Liver S9    Date: 12/12/1983    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 Medium 
0         
 20 403 188 0.467 9.40 25.8 0.000
Test Chemical Codeine phosphate 
8000         
 20 413 248 0.600 12.40 31.0 28.721 
9000         
 20 414 269 0.650 13.45 31.0 39.283 
10000         
 20 410 280 0.683 14.00 31.0 46.393
Positive Control Cyclophosphamide 
 0.4       
 20 415 295 0.711 14.75 25.8 52.378
Cyclophosphamide 
2         
 5 102 208 2.039 41.60 25.8 337.130
Trend: 4.066        
Probability: 0.000        

Trial #: 3_S9    Activation: Induced Rat Liver S9    Date: 01/05/1984    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 Medium 
0         
 20 401 232 0.579 11.60 25.6 0.000
Test Chemical Codeine phosphate 
9000         
 20 402 269 0.669 13.45 25.6 15.660 
9500         
 20 407 279 0.686 13.95 25.6 18.486 
10000         
 20 401 309 0.771 15.45 32.2 33.190
Positive Control Cyclophosphamide 
 0.4       
 20 401 267 0.666 13.35 25.6 15.086
Cyclophosphamide 
2         
 5 103 192 1.864 38.40 25.6 222.196
Trend: 3.220        
Probability: 0.001