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EC number: 700-102-1 | CAS number: 105112-76-3
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was carried out in compliance with the conditions of GLP and according to the relevant Japanese guidelines for the testing of new chemical substances.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Japan
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline
- EC Number:
- 700-102-1
- Cas Number:
- 105112-76-3
- Molecular formula:
- C24H20N2O2
- IUPAC Name:
- 3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline
- Details on test material:
- - Name of test material (as cited in study report): 4,4'-bis(4-aminophenoxy)biphenyl
- Physical state: White powder
- Analytical purity: 99.98 %
- Lot/batch No.: 89-42001
- Stability under test conditions: stable in water, dimethylsulfoxide and acetone
- Storage condition of test material: room temperature in a dark place
- Other:
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Remarks:
- not available
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Remarks:
- not available
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulfoxide (99.9 %, Wako Pure Chemical Industries)
- Justification for choice of solvent/vehicle: test substance was dissolved in dimethylsulfoxide and acetone, but not in distilled water
Controls
- Untreated negative controls:
- yes
- Remarks:
- vehicle of test substance, dimethylsulfoxide
- Negative solvent / vehicle controls:
- yes
- Remarks:
- see above
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide; sodium azide; 9-aminoacridine; 2-aminoanthracene; benzo[a]pyrene
- Details on test system and experimental conditions:
- 0.1M phosphate buffer solution (pH 7.4) added;
0.1 mL test substance solution added;
0.5 mL of S9 Mix (in case of metabolic activation) added;
0.1 mL of each cell suspension added;
Pre-incubation for 20 min at 37 °C with shaking;
2.0 mL of to agar added and layered over the minimum glucose aga plate after stirring;
Same procedure was conducted in negative and positive control groups. Two minimum glucose agar plates were used for each concentration of the negative (vehicle) control, positive controls, and test substance. A sterility test was conducted with respect to S9 Mix, 0.1M phosphate buffer solution, nutrient broth, and test substance solution of highest concentration. - Evaluation criteria:
- As a rule, the reaction was regarded as positive if the revertant colony count in a group treated with the test substance or a positive control substance showed 2-fold or greater increases compared to the negative (vehicle) control and the increases were dose-related and reproducible.
- Statistics:
- No statistical analysis was made.
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:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of the experiment
Test material concentration (ug/plate) |
Number of revertant colonies/plate (mean of 2) |
||||||
TA 100 |
TA1535 |
WP2 uvr A |
TA98 |
TA1537 |
|||
S9 Mix (—) |
Solvent control |
147 140 (144) |
15 11 (13) |
18 21 (20) |
18 12 (15) |
13 18 (16) |
|
5 |
157 128 (143) |
22 22 (22) |
16 12 (14) |
16 14 (15) |
8 12 (10) |
||
20 |
124 132 (128) |
12 16 (14) |
12 20 (16) |
14 14 (14) |
9 9 (9) |
||
78 |
134 143 (139) |
17 15 (16) |
15 12 (14) |
17 15 (16) |
8 14 (11) |
||
313 |
124 150 (137) |
18 14 (16) |
9 16 (13) |
21 12 (17) |
8 9 (9) |
||
1250 |
151 # 157 # (154) |
20 # 14 # (17) |
11 # 19 # (15) |
20 # 16 # (18) |
15 # 12 # (14) |
||
5000 |
152 # 147 # (150) |
14 # 22 # (18) |
18 # 18 # (18) |
15 # 11 # (13) |
10 # 11 # (11) |
||
S9 Mix (+) |
Solvent control |
149 159 (154) |
15 11 (13) |
15 14 (15) |
21 16 (19) |
11 8 (10) |
|
5 |
161 174 (168) |
13 14 (14) |
14 12 (13) |
17 14 (16) |
8 11 (10) |
||
20 |
151 166 (159) |
17 13 (15) |
14 9 (12) |
26 22 (24) |
8 8 (8) |
||
78 |
167 157 (162) |
11 11 (11) |
11 17 (14) |
20 23 (22) |
9 13 (11) |
||
313 |
172 142 (157) |
11 15 (13) |
8 12 (10) |
20 12 (16) |
6 7 (7) |
||
1250 |
191 # 185 # (188) |
18 # 10 # (14) |
18 # 18 # (18) |
22 # 18 # (20) |
13 # 17 # (15) |
||
5000 |
189 # 160 # (175) |
12 # 14 # (13) |
14 # 16 # (15) |
34 # 30 # (32) |
8 # 5 # (7) |
||
Positive control |
S9 Mix (—) |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
9AA |
Concentration (ug/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80.0 |
||
Number of colonies/plate |
743 749 (746) |
299 304 (302) |
111 126 (119) |
377 458 (418) |
618 665 (642) |
||
S9 Mix (+) |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
|
Concentration (ug/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
||
Number of colonies/plate |
451 479 (465) |
181 225 (203) |
418 506 (462) |
354 356 (355) |
60 67 (64) |
||
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide; NaN3: sodium azide; 9AA: 9-aminoacridine; B[a]P: benzo[a]pyrene; 2AA: 2-aminoanthracene; #: precipitate
Table 2: Results of the experiment
Test material concentration (ug/plate) |
Number of revertant colonies/plate (mean of 2) |
||||||
TA 100 |
TA1535 |
WP2 uvr A |
TA98 |
TA1537 |
|||
S9 Mix (—) |
Solvent control |
113 143 (128) |
22 17 (20) |
26 26 (26) |
25 28 (27) |
9 9 (9) |
|
331 |
155 184 (170) |
12 17 (15) |
27 21 (24) |
21 16 (19) |
11 14 (13) |
||
325 |
122 152 (137) |
15 16 (16) |
30 24 (27) |
25 27 (26) |
12 14 (13) |
||
1250 |
159 # 165 # (162) |
18 # 11 # (15) |
21 # 31 # (26) |
17 # 28 # (23) |
10 # 6 # (8) |
||
2500 |
180 # 120 # (150) |
21 # 13 # (17) |
26 # 33 # (30) |
18 # 20 # (19) |
10 # 7 # (9) |
||
5000 |
145 # 140 # (143) |
21 # 15 # (18) |
23 # 24 # (24) |
16 # 18 # (17) |
8 # 4 # (6) |
||
S9 Mix (+) |
Solvent control |
164 150 (157) |
26 14 (20) |
23 23 (23) |
21 22 (22) |
16 11 (14) |
|
331 |
147 184 (166) |
24 24 (24) |
15 15 (15) |
36 32 (34) |
17 12 (15) |
||
325 |
160 191 (176) |
12 13 (13) |
20 21 (21) |
25 31 (28) |
13 7 (10) |
||
1250 |
205 # 171 # (188) |
16 # 11 # (14) |
17 # 34 # (26) |
29 # 27 # (28) |
8 # 9 # (9) |
||
2500 |
125 # 151 # (138) |
12 # 14 # (13) |
17 # 22 # (20) |
24 # 21 # (23) |
8 # 11 # (10) |
||
5000 |
129 # 177 # (153) |
15 # 11 # (13) |
18 # 28 # (23) |
25 # 32 # (29) |
6 # 7 # (7) |
||
Positive control |
S9 Mix (—) |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
9AA |
Concentration (ug/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80.0 |
||
Number of colonies/plate |
729 801 (765) |
369 414 (392) |
155 128 (142) |
455 552 (504) |
691 779 (735) |
||
S9 Mix (+) |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
|
Concentration (ug/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
||
Number of colonies/plate |
452 488 (470) |
249 300 (275) |
668 699 (684) |
389 437 (413) |
72 77 (75) |
||
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide; NaN3: sodium azide; 9AA: 9-aminoacridine; B[a]P: benzo[a]pyrene; 2AA: 2-aminoanthracene; #: precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline did not induce reverse mutation under the present test conditions. - Executive summary:
The ability of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline to induce reverse mutation was evaluated with the Ames test using Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvrA in compliance with the relevant Japanese guidelines and according to GLP (Japan Biological Science 1996).
The test substance did not increase the reverse mutation colony count with any tester strain in either the presence or absence of a metabolic activation system. The test substance precipitated at 1250 µg/plate or higher concentrations in both the presence and absence of metabolic activation. Based on these findings, it was concluded that the test substance 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline does not induce reverse mutation under the conditions used in the study.
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