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Study Information
Study Attribute Value
CEBS Accession Number: 002-02737-0002-0000-3
Chemical Name: Promethazine hydrochloride
CASRN: 58-33-3
NTP Study Type: Genetic Toxicology - Mammalian Cell Cytogenetics
NTP Study ID: 641980_CA
Study Result: Negative

Study Result: Negative
Activation Trial Trial Call
No Activation  1  Negative 
Induced Rat Liver S9  1_S9  Negative 
No Activation  2  Negative 
Induced Rat Liver S9  2_S9  Negative 

Trial #:1   Activation: No Activation    Date: 09/16/1982    Harvest Time: 14 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: Water 
0         
 100 4 0.040 4.0 0 0.000 0.0 4 0.040 4.0 0 0.000 0.0
Test Chemical: Promethazine hydrochloride 
5         
 100 10 0.100 8.0 0 0.000 0.0 10 0.100 8.0 0 0.000 0.0 
10         
 100 8 0.080 7.0 0 0.000 0.0 8 0.080 7.0 0 0.000 0.0 
15         
 100 7 0.070 6.0 0 0.000 0.0 7 0.070 6.0 0 0.000 0.0 
20         
 100 10 0.100 8.0 1 0.010 1.0 9 0.090 7.0 0 0.000 0.0
Positive Control: Mitomycin-C 
 0.15      
 50 26 0.520 40.0 5 0.100 10.0 21 0.420 32.0 0 0.000 0.0
Trend: 0.726 1.232 0.511  
Probability: 0.234 0.109 0.305  


Trial #:1_S9   Activation: Induced Rat Liver S9    Date: 09/16/1982    Harvest Time: 14 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: Water 
0         
 100 3 0.030 3.0 0 0.000 0.0 3 0.030 3.0 0 0.000 0.0
Test Chemical: Promethazine hydrochloride 
10         
 100 5 0.050 5.0 1 0.010 1.0 4 0.040 4.0 0 0.000 0.0 
20         
 100 11 0.110 10.0 3 0.030 3.0 8 0.080 8.0 0 0.000 0.0 
30         
 100 8 0.080 8.0 0 0.000 0.0 8 0.080 8.0 0 0.000 0.0 
40         
 100 7 0.070 7.0 2 0.020 2.0 5 0.050 5.0 0 0.000 0.0 
50         
 100 7 0.070 7.0 1 0.010 1.0 6 0.060 6.0 0 0.000 0.0
Positive Control: Cyclophosphamide 
15         
 100 21 0.210 18.0 6 0.060 5.0 15 0.150 13.0 0 0.000 0.0
Trend: 1.410 0.705 1.185  
Probability: 0.079 0.240 0.118  


Trial #:2   Activation: No Activation    Date: 04/29/1982    Harvest Time: 14 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: Water 
0         
 100 7 0.070 7.0 2 0.020 2.0 5 0.050 5.0 0 0.000 0.0
Test Chemical: Promethazine hydrochloride 
1.6       
 100 10 0.100 10.0 1 0.010 1.0 9 0.090 9.0 0 0.000 0.0 
5         
 100 4 0.040 4.0 0 0.000 0.0 4 0.040 4.0 0 0.000 0.0 
16         
 100 12 0.120 11.0 4 0.040 4.0 8 0.080 8.0 0 0.000 0.0
Positive Control: Mitomycin-C 
 0.15      
 50 23 0.460 30.0 7 0.140 10.0 16 0.320 22.0 0 0.000 0.0
Trend: 0.502 0.860 0.368  
Probability: 0.308 0.195 0.356  


Trial #:2_S9   Activation: Induced Rat Liver S9    Date: 04/29/1982    Harvest Time: 14 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: Water 
0         
 100 8 0.080 8.0 2 0.020 2.0 6 0.060 6.0 0 0.000 0.0
Test Chemical: Promethazine hydrochloride 
5         
 100 5 0.050 5.0 0 0.000 0.0 5 0.050 5.0 0 0.000 0.0 
16         
 100 13 0.130 11.0 4 0.040 4.0 9 0.090 8.0 0 0.000 0.0 
50         
 100 9 0.090 7.0 4 0.040 4.0 5 0.050 4.0 0 0.000 0.0
Positive Control: Cyclophosphamide 
15         
 100 28 0.280 23.0 9 0.090 9.0 19 0.190 16.0 0 0.000 0.0
Trend: 0.256 1.435 -0.283  
Probability: 0.399 0.076 0.612