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EC number: 202-429-0 | CAS number: 95-53-4
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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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: guideline study with restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Mutation tests with Salmonella using the plate-incorporation assay
- Author:
- Rexroat MA and Probst GS
- Year:
- 1 985
- Bibliographic source:
- Progress in Mutation Research 5, 201-212
- Reference Type:
- publication
- Title:
- o-TOLUIDINE CAS No: 95-53-4 SIDS Initial Assessment Report.
- Author:
- OECD SIDS
- Year:
- 2 006
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Toxicity was not reached, no data on purity of the test substance
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- o-toluidine
- EC Number:
- 202-429-0
- EC Name:
- o-toluidine
- Cas Number:
- 95-53-4
- Molecular formula:
- C7H9N
- IUPAC Name:
- 2-methylaniline
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): o-toluidine
- Analytical purity: no data
Constituent 1
Method
- Target gene:
- his+
Species / strain
- Species / strain / cell type:
- other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix liver homogenates from Aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- 0, 50, 100, 500, 1000, 5000 µg/plate in DMSO
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine; 2-Nitrofluorene; N-Methyl-N'-nitro-N-nitrososguanidine. 2-Aminoanthracene
- Details on test system and experimental conditions:
- plate-incorporation assay
- Evaluation criteria:
- Criteria for a positive rsponse: A chemical was judged to have induced a positive response when a dose -related increase in revertants was observed in which the number of revertants exceeded the control values by at least tow-fold in at least two successive concentrations of the test chemical
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- > 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- The positive controls increased mutant counts to well over those of the negative controls, and thus demonstrated the system's sensitivity and the
activity of the S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Tab 1. Evaluation of o-toluidine for induction of bacterial mutation using the Ames test
Treatment |
µg/plate |
Revertant colony counts (mean ± SD)a |
||||
|
TA1535 |
TA1537 |
TA1538 |
TA98 |
TA100 |
|
Test without metabolic activation |
||||||
DMSOb |
0.05 ml |
18 ± 5 |
6 ± 1 |
15 ± 3 |
27 ± 6 |
141 ± 12 |
DMSOc |
0.05 ml |
18 ± 2 |
8 ± 4 |
13 ± 1 |
23 ± 2 |
138 ± 13 |
o-toluidine |
50 |
18 ± 6 |
6 ± 1 |
13 ± 3 |
25 ± 5 |
146 ± 7 |
|
100 |
25 ± 3 |
10 ± 3 |
11 ± 4 |
32 ± 7 |
141 ± 16 |
|
500 |
28 ± 3 |
8 ± 4 |
14 ± 3 |
20 ± 1 |
140 ± 18 |
|
1000 |
27 ± 5 |
8 ± 2 |
12 ± 6 |
24 ± 3 |
130 ± 6 |
|
5000 |
35 ± 11 |
6 ± 1 |
16 ± 2 |
22 ± 7 |
153 ± 12 |
MNNGd |
2.5 |
1728 ± 131 |
|
|
|
|
MNNG |
5 |
3319 ± 56 |
|
|
|
|
9AmAcd |
50 |
|
141 ± 28 |
|
|
|
9AmAc |
100 |
|
1433 ± 47 |
|
|
|
2-NFd |
0.5 |
|
|
105 ± 4 |
64 ± 10 |
|
2-NF |
5 |
|
|
900 ± 36 |
603 ± 66 |
|
Test with metabolic activation |
||||||
DMSOb |
0.05 ml |
20 ± 1 |
8 ± 2 |
23 ± 3 |
31 ± 11 |
102 ± 7 |
DMSOc |
0.05 ml |
17 ± 1 |
7 ± 1 |
20 ± 3 |
32 ± 1 |
118 ± 3 |
o-toluidine |
50 |
15 ± 1 |
9 ± 4 |
19 ± 7 |
29 ± 3 |
118 ± 13 |
|
100 |
13 ± 4 |
8 ± 3 |
19 ± 4 |
32 ± 6 |
107 ± 4 |
|
500 |
13 ± 4 |
4 ± 1 |
19 ± 2 |
36 ± 1 |
117 ± 5 |
|
1000 |
16 ± 2 |
8 ± 2 |
21 ± 3 |
33 ± 1 |
127 ± 3 |
|
5000 |
14 ± 3 |
12 ± 2 |
22 ± 3 |
40 ± 9 |
142 ± 8 |
2-AAd |
2.5 |
176 ± 15 |
259 ± 22 |
1700 ± 99 |
1922 ± 20 |
2370 ± 37 |
2-AA |
5 |
202 ± 30 |
156 ± 38 |
1791 ± 88 |
2905 ± 53 |
2849 ± 100 |
a Mean ± SD deviation of counts from triplicate plates. Values represent corrected counts fro 100% of the plate area.
b DMSO control value for the tester strain plated at the initiation of plating ; c DMSO control value fo tester strain plated at the termination of plating; d In the nonactivated test MNNG served as the positive control for strains TA 1535 and TA 100; 9 AmAc was the positve control for the strain TA1537; and 2 NF served as the positive control for the strains TA1538 and TA 98. In the activated test, 2AA served as the positive control for all test strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
o-toluidine was tested for the induction of bacterial mutation using five histidine auxotrophs of Salmonella typhimurium TA135, TA1537, TA1538, TA100, TA98 according to OECD guideline 471 (plate incorporation methodology) with acceptable deviations (Toxicity was not reached, no data on purity of the test substance). The test was conducted with and without metabolic activation using an S9 fraction prepared from the livers of Aroclor-1254-induced rats. N-Methyl-N´-nitro-N-nitrosoguanidine (MNNG), 2-nitrofluorene (2NF), and 9-aminoacridine (9AmAc) served as the positive controls for the nonactivated test, while 2-aminoanthracene (2AA) served as the positive control for the activated test. Either with or without metabolic activation no revertants were induced by treatment with o-toluidine.
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