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Study Information
Study Attribute Value
CEBS Accession Number: 002-02088-0002-0000-2
Chemical Name: Diphenhydramine hydrochloride
CASRN: 147-24-0
NTP Study Type: Genetic Toxicology - Mammalian Cell Cytogenetics
NTP Study ID: 195192_CA
Study Result: Positive

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

Trial #:1   Activation: No Activation    Date: 09/05/1984    Harvest Time: 18.5 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: Negative (Not Specified)
0         
100 2 0.020 1.0 0 0.000 0.0 2 0.020 1.0 0 0.000 0.0
Test Chemical: Diphenhydramine hydrochloride
100         
100 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
161         
100 3 0.030 3.0 0 0.000 0.0 3 0.030 3.0 0 0.000 0.0
181         
27 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
201         
67 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
Positive Control: Mitomycin-C
5         
100 580 5.800 92.0 73 0.730 37.0 60 0.600 33.0 447 4.470 51.0
Trend: 0.435 0.000 0.435  
Probability: 0.332 0.000 0.332  


Trial #:1_S9   Activation: Induced Rat Liver S9    Date: 07/26/1984    Harvest Time: 12 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: Negative (Not Specified)
0         
100 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
Test Chemical: Diphenhydramine hydrochloride
30.3       
100 2 0.020 2.0 0 0.000 0.0 2 0.020 2.0 0 0.000 0.0
101         
100 3 0.030 3.0 0 0.000 0.0 3 0.030 3.0 0 0.000 0.0
300         
100 3 0.030 2.0 2 0.020 2.0 1 0.010 1.0 0 0.000 0.0
Positive Control: Cyclophosphamide
50         
100 60 0.600 32.0 23 0.230 20.0 16 0.160 16.0 21 0.210 3.0
Trend: 1.209 1.876 0.760  
Probability: 0.113 0.030 0.224  


Trial #:2   Activation: No Activation    Date: 10/10/1984    Harvest Time: 22 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: Negative (Not Specified)
0         
100 2 0.020 2.0 1 0.010 1.0 1 0.010 1.0 0 0.000 0.0
Test Chemical: Diphenhydramine hydrochloride
100         
100 22 0.220 13.0 8 0.080 7.0 14 0.140 10.0 0 0.000 0.0
125         
100 14 0.140 12.0 1 0.010 1.0 13 0.130 11.0 0 0.000 0.0
150         
41 18 0.439 44.0 2 0.049 5.0 16 0.390 39.0 0 0.000 0.0
Positive Control: Mitomycin-C
5         
15 128 8.533 93.0 7 0.467 13.0 1 0.067 7.0 120 8.000 12.0
Trend: 5.466 0.362 5.497  
Probability: 0.000 0.359 0.000  


Trial #:3   Activation: No Activation    Date: 08/23/1984    Harvest Time: 18.5 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: Negative (Not Specified)
0         
100 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
Test Chemical: Diphenhydramine hydrochloride
10         
100 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0 0 0.000 0.0
50         
100 1 0.010 1.0 0 0.000 0.0 1 0.010 1.0 0 0.000 0.0
100         
100 1 0.010 1.0 1 0.010 1.0 0 0.000 0.0 0 0.000 0.0
150         
100 9 0.090 8.0 1 0.010 1.0 8 0.080 7.0 0 0.000 0.0
200         
100 29 0.290 17.0 10 0.100 8.0 19 0.190 12.0 0 0.000 0.0
Positive Control: Mitomycin-C
5         
100 540 5.400 81.0 52 0.520 28.0 34 0.340 17.0 454 4.540 49.0
Trend: 5.171 3.248 4.399  
Probability: 0.000 0.001 0.000  


Trial #:4   Activation: No Activation    Date: 07/26/1984    Harvest Time: 10.5 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: Negative (Not Specified)
0         
100 16 0.160 4.0 4 0.040 3.0 12 0.120 2.0 0 0.000 0.0
Test Chemical: Diphenhydramine hydrochloride
15.2       
100 1 0.010 1.0 0 0.000 0.0 1 0.010 1.0 0 0.000 0.0
50.5       
100 2 0.020 2.0 0 0.000 0.0 2 0.020 2.0 0 0.000 0.0
150         
100 1 0.010 1.0 1 0.010 1.0 0 0.000 0.0 0 0.000 0.0
300         
39 1 0.026 3.0 0 0.000 0.0 1 0.026 3.0 0 0.000 0.0
Positive Control: Mitomycin-C
5         
100 52 0.520 38.0 28 0.280 24.0 24 0.240 18.0 0 0.000 0.0
Trend: -0.846 -1.490 -0.370  
Probability: 0.801 0.932 0.644