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Study Information
Study Attribute Value
CEBS Accession Number: 002-01787-0006-0000-1
Chemical Name: C.I. Direct brown 95
CASRN: 16071-86-6
NTP Study Type: Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID: 162126
Study Result: Positive


Table Instructions and Notes:
Studies are indicated to be "Nontoxic" when the observed reductions in relative total growth did not indicate that the maximum tolerated dose was achieved.

Nonactivation Trial: 1 Experiment Call: Negative
  Conc.
ug/mL
Cloning
Efficiency
Relative Total
Growth
Mutant Colonies Mutant Frequency Avg Mutant Frequency
Vehicle Control Water
 0         
96 105 50 17 20
    97 96 55 19
    102 116 64 21
    88 83 60 23
Test Chemical C.I. Direct brown 95
125         
86 117 41 16 18
    73# 83 43.5 20
 
250         
72 112 42 19 18
    66 100 33 17
    93 114 46 16
 
500         
56 59 36 21 21
    58 72 49 28
    64 72 25 13
 
1000         
76 44 59 26 24
    75 52 52 23
    62 49 44 24
 
2000         
84 11 54 21 26
    62 4 53 28
    50 5 41 28
 
3000         
88 44 61 23 28
    70 42 77 36
    91 40 70 26
 
5000         
   
   
Positive Control Ethyl Methane Sulfonate
250         
62 49 671 363 523*
    63 35 907 479
    40 22 867 729

Nonactivation Trial: 2 Experiment Call: Negative and Non-Toxic
  Conc.
ug/mL
Cloning
Efficiency
Relative Total
Growth
Mutant Colonies Mutant Frequency Avg Mutant Frequency
Vehicle Control Water
 0         
51# 78 162 105 104
    54 96 164 102
    49r 90 116 79
    56 126 173 104
Test Chemical C.I. Direct brown 95
31.3       
55 105 102 62 54
    45# 103 67 49
    62 102 97 52
 
62.5       
55 122 81 50 39
    56# 120 48 29
 
125         
67 125 95 47 58
    53 123 96 60
    49# 99 97 66
 
250         
59 86 110 63 71
    38 68 102 89
    39 90 71 61
 
500         
56 84 142 85 69
    49 96 116 78
    70# 115 90 43
 
1000         
39 54 95 81 92
    47# 62 158 113
    45 62 111 83
Positive Control Ethyl Methane Sulfonate
250         
31 22 779 833 830*
    35 22 865 828
    10r 5 421.5 1453

Nonactivation Trial: 3 Experiment Call:
  Conc.
ug/mL
Cloning
Efficiency
Relative Total
Growth
Mutant Colonies Mutant Frequency Avg Mutant Frequency
Vehicle Control Water
 0         
50# 79 100 67 67
    52 96 102 65
    45r 86 78 57
    53 125 111 69
Test Chemical C.I. Direct brown 95
31.3       
61 102 74 41 40
    44# 104 45 34
    54 106 74 46
 
62.5       
55# 121 39 24 29
    54 124 55 34
 
125         
47# 98 66 47 43
    52 124 77 50
    65 126 62 32
 
250         
38 91 51 45 50
    58 88 80 46
    37 67 66 60
 
500         
54 85 110 68 47
    48 97 64 44
    69# 117 62 30
 
1000         
47# 64 104 75 64
    43 61 82 64
    41 58 64 53
Positive Control Ethyl Methane Sulfonate
250         
33 22 661 674 685*
    29 22 609 696
    8r 4 345 1500

Induced S9 Trial: 1 Experiment Call: Positive
  Conc.
ug/mL
Cloning
Efficiency
Relative Total
Growth
Mutant Colonies Mutant Frequency Avg Mutant Frequency
Vehicle Control Water
 0         
123r 121 130.5 35 34
    117 103 94 27
    110 97 125 38
    92 100 99 36
Test Chemical C.I. Direct brown 95
15.6       
107 66 149 46 56*
    99# 63 162 55
    81 70 161 66
 
31.3       
89 61 223 84 68*
    90 74 179 66
    112 76 177 53
 
62.5       
82 59 181 73 84*
    96 63 215 74
    79 57 247 105
 
125         
89 58 242 90 99*
    101 53 307 101
    99 64 309 104
 
250         
91 56 168 62 68*
    94# 53 242 86
    93 59 153 55
 
500         
126r 26 234 62 94*
    96 30 247 85
    103# 19 315 102
 
1000         
   
   
Positive Control 3-Methylcholanthrene
2.5       
92 47 682 248 237*
    97 47 620 214
    92 55 689 250

Induced S9 Trial: 2 Experiment Call: Positive
  Conc.
ug/mL
Cloning
Efficiency
Relative Total
Growth
Mutant Colonies Mutant Frequency Avg Mutant Frequency
Vehicle Control Water
 0         
72 102 82 38 38
    78 110 86 37
    67 97 77 38
    62 91 73 39
Test Chemical C.I. Direct brown 95
50         
54 50 144 89 88*
    48 47 135 94
    60 57 148 82
 
100         
62# 55 142 76 68*
    67 75 119 60
    71 60 145 69
 
200         
56 41 107 64 54
    66 24 105 53
    68 41 94 46
 
300         
64 22 168 87 76*
    69 11 155 75
    68 19 134 66
 
400         
84*
    58 29 100 58
    54 4 181 111
 
500         
61 7 121 66
   
   
 
700         
   
   
Positive Control 3-Methylcholanthrene
2.5       
66 63 432 217 212*
    62# 60 383 208

Footnotes:
Asterisks(*) indicate significant responses.
r = rejected value due to quality control criteria
# = reduced sample size because of the loss of one culture dish due to contamination