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EC number: 204-616-2 | CAS number: 123-30-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP condition
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-aminophenol
- EC Number:
- 204-616-2
- EC Name:
- 4-aminophenol
- Cas Number:
- 123-30-8
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 4-aminophenol
- Details on test material:
- - Physical state: Colorless or pale purple crystal (At the time of the receipt: White powder)
- purity: 99.0%
- Impurities (identity and concentrations): Water(0.16%), 9 ppm Diaminodiphenyl ether
- Lot/batch No.: 89-021 (Mitsui Toatsu Chemicals LTD.)
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- SD Rat (7 week-old, male) liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- -S9 mix; 0, 62.5, 125, 250, 500, 1000 and 2000 μg/plate (TA100, TA1535 and TA1537)
0, 156, 313, 625, 1250, 2500 and 5000 μg/plate (TA98)
0, 313, 625, 1250, 2500 and 5000 μg/plate (WP2 uvrA)
+S9 mix; 0, 156, 313, 625, 1250, 2500 and 5000 μg/plate (TA100, TA1535 and TA1537)
+S9 mix: 0, 313, 625, 1250, 2500 and 5000 μg/plate (TA98 and WP2 uvrA) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix; AF-2 (TA100, TA98 and WP2 uvrA), Sodium azide (TA1535) and 9-Aminoacridine (TA1537)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9 mix; 2-Aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF PLATES: 3
NUMBER OF REPLOCATES: 2
DETERMINATION OF CYTOTOXICITY
- Method: Growth inhibition - Evaluation criteria:
- The chemicals were considered to be mutagenic when a dose-related increase in revertant colony count was observed and the number of revertant colonies per plate with the test substance was more than twice that of the negative control and when a reproducibility of test result was observed. A test substance for which the results do not meet the above criteria is considered non-mutagenic in this test.
- Statistics:
- Statistical analysis was not conducted.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Concentration range: 50 - 5000 μg/plate (common ratio: 3)
Cycotoxic conc.:
-S9 mix: >=1500 μg/plate (TA100, TA1535, TA1537); 5000 μg/plate(TA98)
+S9 mix: 5000 μg/plate(TA100, TA1535, TA1537) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
[1st trial] (See Table1)
-S9 mix: Negative (all tester strains)
+S9 mix: Negative (all tester strains)
[2nd trial] (See Table2)
-S9 mix:
Negative: TA100, TA1535, TA1537, and TA98
Positive: WP2 uvrA (=1250 μg/plate)
+S9 mix: Negative (all tester strains)
[Confirmation test] (See Table3)
Test strain: E. coli WP2 uvr A
Concentration range: 850, 1250, 1650, 2050, 2450 μg/plate (400 μg/plate)
Result: Negative
Table1-1. Mutagenicity of 4-aminophenol in reverse mutation test (1st trial) on bacteria.
| With(+) or Without(-) S9 mix |
Test substance dose (μg/plate) | Revertant colonies per plate [Mean ± S.D.] | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
| S9 mix (-) | 0 | 36, 20, 25 [27 ± 8.2] |
22, 15, 17 [18 ± 3.6] |
|||
| 156 | - | 22, 16, 14 [17 ± 4.2] |
||||
| 313 | 16, 23, 13 [17 ± 5.1] |
9, 20, 21 [17 ± 6.7] |
||||
| 625 | 24, 34, 20 [26 ± 7.2] |
28, 21, 28 [26 ± 4.0] |
||||
| 1250 | 52, 43, 42 [46 ± 5.5] |
14, 17, 21 [17 ± 3.5] |
||||
| 2500 | 35, 37, 50 [41 ± 8.1] |
0*, 0*, 0* [0 ± 0.0] |
||||
| 5000 | 21, 37, 35 [31 ± 8.7] |
0*, 0*, 0* [0 ± 0.0] |
||||
| S9 mix (+) | 0 | 124, 128, 127 [126 ± 2.1] |
12, 6, 16 [11 ± 5.0] |
33, 29, 27 [30 ± 3.1] |
25, 28, 22 [25 ± 3.0] |
8, 9, 8 [8 ± 0.6] |
| 156 | 145, 145, 160 [150 ± 8.7] |
12, 10, 12 [11 ± 1.2] |
- | - | 11, 9, 7 [9 ± 2.0] |
|
| 313 | 145, 141, 143 [143 ± 2.0] |
13, 12, 18 [14 ± 3.2] |
32, 28, 27 [29 ± 2.6] |
27, 19, 30 [25 ± 5.7] |
12, 4, 13 [10 ± 4.9] |
|
| 625 | 110, 122, 119 [117 ± 6.2] |
7, 12, 11 [10 ± 2.6] |
24, 34, 25 [28 ± 5.5] |
27, 15, 39 [27 ± 12.0] |
11, 12, 8 [10 ± 2.1] |
|
| 1250 | 84, 78, 72 [78 ± 6.0] |
3, 4, 4 [4 ± 0.6] |
36, 34, 48 [39 ± 7.6] |
19, 27, 23 [23 ± 4.0] |
13, 9, 16 [13 ± 3.5] |
|
| 2500 | 27, 12, 29 [23 ± 9.3] |
2, 2, 2 [2 ± 0.0] |
46, 48, 53 [49 ± 3.6] |
23, 11, 24 [19 ± 7.2] |
7, 9, 10 [9 ± 1.5] |
|
| 5000 | 22*, 60*, 36* [39 ± 19.2] |
0*, 0*, 0* [0 ± 0.0] |
10, 20, 12 [14 ± 5.3] |
8, 7, 6 [7 ± 1.0] |
0*, 1*, 3* [1 ± 1.5] |
|
| Positive control S9 mix (-) |
Chemical name | AF-2 | AF-2 | |||
| Dose (μg/plate) | 0.01 | 0.1 | ||||
| Number of colonies/plate | 280, 281, 302 [288 ± 12.4] |
640, 613, 635 [629 ± 14.4] |
||||
| Positive control S9 mix (+) |
Chemical name | 2AA | 2AA | 2AA | 2AA | 2AA |
| Dose (μg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
| Number of colonies/plate | 528, 616, 700 [615 ± 86.0] |
324, 360, 340 [341 ± 18.0] |
597, 594, 622 [604 ± 15.4] |
331, 311, 295 [312 ± 18.0] |
337, 317, 325 [326 ± 10.1] |
|
*: Inhibition was observed against growth of the bacteria.
-: Not tested
AF-2; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SA; Sodium azide
9AA; 9-Aminoacridine
Table1-2. Mutagenicity of 4-aminophenol in reverse mutation test (1st trial) on bacteria.
| With(+) or Without(-) S9 mix |
Test substance dose (μg/plate) | Revertant colonies per plate [Mean ± S.D.] | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | TA1537 | ||||
| S9 mix (-) | 0 | 102, 139, 118 [120 ± 18.6] |
15, 11, 6 [11 ± 4.5] |
4, 5, 8 [6 ± 2.1] |
||
| 62.5 | 122, 133, 150 [135 ± 14.1] |
10, 8, 8 [9 ± 1.2] |
9, 9, 8 [9 ± 0.6] |
|||
| 125 | 133, 126, 124 [128 ± 4.7] |
11, 6, 6 [8 ± 2.9] |
7, 7, 6 [7 ± 0.6] |
|||
| 250 | 147, 119, 145 [137 ± 15.6] |
5, 12, 7 [8 ± 3.6] |
8, 11, 4 [8 ± 3.5] |
|||
| 500 | 116, 103, 110 [110 ± 6.5] |
9, 8, 6 [8 ± 1.5] |
6, 3, 4 [4 ± 1.5] |
|||
| 1000 | 97*, 86*, 81* [88 ± 8.2] |
4*, 2*, 8* [5 ± 3.1] |
5, 6, 8 [6 ± 1.5] |
|||
| 2000 | 60*, 51*, 70* [60 ± 9.5] |
0*, 0*, 0* [0 ± 0.0] |
0*, 0*, 0* [0 ± 0.0] |
|||
| Positive control S9 mix (-) |
Chemical name | AF-2 | SA | 9AA | ||
| Dose (μg/plate) | 0.01 | 0.5 | 80 | |||
| Number of colonies/plate | 682, 778, 785 [748 ± 57.6] |
296, 336, 339 [324 ± 24.0] |
1040, 539, 811 [797 ± 250.8] |
|||
*: Inhibition was observed against growth of the bacteria.
-: Not tested
AF-2; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SA; Sodium azide
9AA; 9-Aminoacridine
Table2-1. Mutagenicity of 4-aminophenol in reverse mutation test (2nd trial) on bacteria.
| With(+) or Without(-) S9 mix |
Test substance dose (μg/plate) | Revertant colonies per plate [Mean ± S.D.] | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
| S9 mix (-) | 0 | 24, 26, 20 [23 ± 3.1] |
21, 12, 24 [19 ± 6.2] |
|||
| 156 | - | 22, 17, 20 [20 ± 2.5] |
||||
| 313 | 27, 23, 21 [24 ± 3.1] |
20, 17, 22 [20 ± 2.5] |
||||
| 625 | 40, 31, 34 [35 ± 4.6] |
14, 19, 26 [20 ± 6.0] |
||||
| 1250 | 48, 41, 51 [47 ± 5.1] |
9, 23, 22 [18 ± 7.8] |
||||
| 2500 | 51, 34, 45 [43 ± 8.6] |
0*, 0*, 0* [0 ± 0.0] |
||||
| 5000 | 36*, 29*, 32* [32 ± 3.5] |
0*, 0*, 0* [0 ± 0.0] |
||||
| S9 mix (+) | 0 | 157, 14, 161 [153 ± 10.6] |
11, 12, 17 [13 ± 3.2] |
24, 27, 20 [24 ± 3.5] |
25, 29, 22 [25 ± 3.5] |
13, 14, 12 [13 ± 1.0] |
| 156 | 146, 157, 151 [151 ± 5.5] |
9, 11, 13 [11 ± 2.0] |
- | - | 8, 11, 13 [11 ± 2.5] |
|
| 313 | 182, 178, 184 [181 ± 3.1] |
7, 10, 5 [7 ± 2.5] |
23, 33, 28 [28 ± 5.0] |
27, 35, 26 [29 ± 4.9] |
8, 11, 7 [9 ± 2.1] |
|
| 625 | 155, 154, 161 [157 ± 3.8] |
8, 7, 8 [8 ± 0.6] |
18, 24, 28 [23 ± 5.0] |
20, 30, 25 [25 ± 5.0] |
11, 15, 4 [10 ± 5.6] |
|
| 1250 | 101, 97, 91 [96 ± 5.0] |
7, 6, 8 [7 ± 1.0] |
43, 49, 40 [44 ± 4.6] |
28, 18, 25 [24 ± 5.1] |
5, 5, 6 [5 ± 0.6] |
|
| 2500 | 22, 19, 23 [21 ± 2.1] |
1, 0, 1 [1 ± 0.6] |
41, 38, 42 [40 ± 2.1] |
22, 15, 20 [19 ± 3.6] |
3, 7, 4 [5 ± 2.1] |
|
| 5000 | 42*, 57*, 40* [46 ± 9.3] |
0*, 0*, 0* [0 ± 0.0] |
6, 11, 14 [10 ± 4.0] |
5, 9, 11 [8 ± 3.1] |
0*, 0*, 1* [0 ± 0.6] |
|
| Positive control S9 mix (-) |
Chemical name | AF-2 | AF-2 | |||
| Dose (μg/plate) | 0.01 | 0.1 | ||||
| Number of colonies/plate | 290, 311, 324 [308 ± 17.2] |
629, 623, 632 [628 ± 4.6] |
||||
| Positive control S9 mix (+) |
Chemical name | 2AA | 2AA | 2AA | 2AA | 2AA |
| Dose (μg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
| Number of colonies/plate | 760, 868, 809 [812 ± 54.1] |
270, 281, 304 [285 ± 17.3] |
643, 534, 563 [580 ± 56.5] |
297, 294, 301 [297 ± 3.5] |
262, 275, 290 [276 ± 14.0] |
|
*: Inhibition was observed against growth of the bacteria.
-: Not tested
AF-2; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SA; Sodium azide
9AA; 9-Aminoacridine
Table2-2. Mutagenicity of 4-aminophenol in reverse mutation test (2nd trial) on bacteria.
| With(+) or Without(-) S9 mix |
Test substance dose (μg/plate) | Revertant colonies per plate [Mean ± S.D.] | ||||
| Base-pair substitution type | Frameshift type | |||||
| TA100 | TA1535 | TA1537 | ||||
| S9 mix (-) | 0 | 115, 148, 138 [134 ± 16.9] |
11, 10, 10 [10 ± 0.6] |
12, 12, 11 [12 ± 0.6] |
||
| 62.5 | 119, 125, 99 [114 ± 13.6] |
8, 5, 14 [9 ± 4.6] |
12, 9, 8 [10 ± 2.1] |
|||
| 125 | 137, 132, 135 [135 ± 2.5] |
8, 5, 10 [8 ± 2.5] |
10, 10, 7 [9 ± 1.7] |
|||
| 250 | 127, 142, 128 [132 ± 8.4] |
11, 9, 5 [8 ± 3.1] |
8, 13, 8 [10 ± 2.9] |
|||
| 500 | 118, 129, 135 [127 ± 8.6] |
8, 10, 8 [9 ± 1.2] |
10, 4, 8 [7 ± 3.1] |
|||
| 1000 | 106*, 101*, 100* [102 ± 3.2] |
6*, 3*, 3* [4 ± 1.7] |
16, 4*, 6* [9 ± 6.4] |
|||
| 2000 | 0*, 0*, 0* [0 ± 0.0] |
0*, 0*, 0* [0 ± 0.0] |
0*, 0*, 0* [0 ± 0.0] |
|||
| Positive control S9 mix (-) |
Chemical name | AF-2 | SA | 9AA | ||
| Dose (μg/plate) | 0.01 | 0.5 | 80 | |||
| Number of colonies/plate | 788, 741, 788 [772 ± 27.1] |
315, 319, 336 [323 ± 11.2] |
932, 845, 841 [873 ± 51.4] |
|||
*: Inhibition was observed against growth of the bacteria.
-: Not tested
AF-2; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SA; Sodium azide
9AA; 9-Aminoacridine
Table3. Mutagenicity of 4-aminophenol in confirmation test of reverse mutation test on bacteria.
| With(+) or Without(-) S9 mix |
Test substance dose (μg/plate) | Revertant colonies per plate [Mean ± S.D.] | ||||
| Base-pair substitution type | ||||||
| WP2uvrA | ||||||
| S9 mix (-) | 0 | 19, 24, 31 [25 ± 6.0] |
||||
| 850 | 25, 16, 31 [24 ± 7.5] |
|||||
| 1250 | 31, 46, 43 [40 ± 7.9] |
|||||
| 1650 | 41, 42, 38 [40 ± 2.1] |
|||||
| 2050 | 41, 36, 30 [36 ± 5.5] |
|||||
| 2450 | 32, 41, 35 [36 ± 4.6] |
|||||
| Positive control S9 mix (-) |
Chemical name | AF-2 | ||||
| Dose (μg/plate) | 0.01 | |||||
| Number of colonies/plate | 280, 235, 254 [256 ± 22.6] |
|||||
AF-2; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
Applicant's summary and conclusion
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