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EC number: 477-690-9 | CAS number: 874819-71-3
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
- Study period:
- 2004-08-24 - 2004-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD 471 (1997)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 477-690-9
- EC Name:
- -
- Cas Number:
- 874819-71-3
- Molecular formula:
- Hill formula: C6H9N4O3P CAS formula: C6H9N4O3P
- IUPAC Name:
- N-(diaminophosphoryl)-2-nitroaniline
- Test material form:
- solid: crystalline
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:
- S9 liver microsomal fraction
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: dimethyl sulfoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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 valid
- Positive controls validity:
- not 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
- Additional information on results:
- Observations:
An increase in revertant numbers was observed at concentrations from 5000 to 500 µg/plate of the test item
in the bacterial strain Salmonella typhimurium TA 1537
in the experiments without metabolic activation as well
as in the plate incorporation test and in the preincubation
test and in the bacterial strain Salmonella typhimurium
TA 98 in all test variants.
This increase was confirmed by a repetition of all positive
experiments. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Bacteria tester strain |
MA |
Exp. |
Mean numb |
ers of revertants per plate |
Evaluation |
||||||
Controls |
µg test item per plate |
||||||||||
UTC |
VC |
PC |
5000 |
1000 |
500 |
100 |
50 |
||||
Salmonella typhimurium |
|||||||||||
TA1535 |
no |
1St |
17.3 |
16.0 |
1616.0 |
14.3 |
15.7 |
14.3 |
17.7 |
19.3 |
- |
no |
2nd |
8.0 |
7.3 |
710.0 |
8.0 |
10.7 |
11.3 |
11.0 |
8.0 |
- |
|
yes |
1st |
21.0 |
13.0 |
162.7 |
15.0 |
17.0 |
16.3 |
12.3 |
15.0 |
- |
|
yes |
2nd |
11.3 |
11.7 |
156.3 |
8.0 |
11.0 |
13.7 |
9.0 |
10.0 |
- |
|
TA1537 |
no |
1st |
7.7 |
7.3 |
1973.3 |
15.7 |
9.7 |
13.0 |
10.7 |
6.0 |
+ |
no |
1str |
16.3 |
20.7 |
2368.0 |
34.0 |
18.3 |
n.e. |
n.e. |
n.e. |
+ |
|
no |
2nd |
12.3 |
11.3 |
2789.3 |
72.3 |
23.7 |
21.0 |
17.0 |
12.7 |
+ |
|
no |
2r |
11.3 |
13.7 |
1170.7 |
72.3 |
26.3 |
n.e. |
n.e. |
n.e. |
+ |
|
yes |
1st |
14.7 |
9.0 |
478.0 |
16.3 |
9.7 |
10.3 |
11.7 |
11.7 |
- |
|
yes |
2nd |
10.3 |
9.7 |
384.0 |
14.3 |
7.7 |
12.7 |
7.0 |
6.3 |
- |
|
TA98 |
no |
2St |
16.7 |
19.7 |
473.7 |
80.7 |
40.3 |
27.0 |
20.3 |
20.0 |
+ |
no |
1st1r |
18.3 |
20.3 |
566.7 |
71.0 |
36.3 |
26.3 |
n.e. |
n.e. |
+ |
|
no |
2"d |
21.7 |
20.3 |
476.0 |
176.0 |
55.0 |
33.0 |
27.3 |
31.3 |
+ |
|
no |
2ndr |
17.3 |
9.7 |
504.0 |
166.0 |
53.7 |
19.3 |
n.e. |
n.e. |
+ |
|
vcs |
1st |
27.7 |
27.0 |
2245.3 |
66.7 |
38.7 |
26.7 |
29.7 |
22.0 |
t- |
|
ves |
1str |
31.7 |
23.7 |
2245.3 |
75.7 |
28.7 |
27.3 |
32.7 |
n.e. |
+ |
|
yes |
2nd |
12.7 |
11.3 |
2688.0 |
29.0 |
18.0 |
13.0 |
12.3 |
11.3 |
+ |
|
yes |
2ndr |
33.0 |
29.0 |
2634.7 |
52.3 |
41.7 |
29.0 |
22.7 |
n.e. |
+ |
|
TA100 |
no |
1st |
192.0 |
192.3 |
1701.3 |
191.3 |
174.3 |
192.7 |
188.0 |
183.3 |
- |
no |
2nd |
129.3 |
111.0 |
1552.0 |
152.7 |
111.3 |
125.3 |
120.0 |
128.3 |
- |
|
yes |
1st |
168.7 |
149.3 |
1365.3 |
188.0 |
164.7 |
184.7 |
158.3 |
150.0 |
- |
|
yes |
2nd |
130.3 |
122.3 |
2613.3 |
136.7 |
122.7 |
133.3 |
120.0 |
116.3 |
- |
|
Escherichia coli |
|||||||||||
WP2 uvrA |
no |
1st |
29.0 |
21.0 |
304.3 |
17.3 |
19.7 |
27.7 |
29.7 |
26.3 |
- |
no |
2nd |
30.0 |
33.3 |
521.3 |
21.7 |
26.0 |
26.3 |
24.7 |
35.0 |
- |
|
yes |
1st |
32.3 |
35.3 |
131.3 |
28.3 |
30.0 |
28.3 |
31.3 |
28.0 |
- |
|
yes |
2nd |
28.0 |
32.7 |
155.3 |
30.5 |
31.3 |
31.7 |
40.7 |
36.0 |
- |
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results :
positive
N-(2-Nitrophenyl)phosphoric triamide induces gene mutation in Salmonella Typhimurium TA 1537 and TA 98 under the experimental conditions described. - Executive summary:
N-(2-Nitrophenyl)phosphoric triamide was tested for a possible potential to induce gene mutation in bacteria according to OECD guideline 471.
As test organisms theSalmonella typhimuriumstrains TA 98, TA 100, TA 1535, TA 1537 and theEscherichia colistrain WP2uvrA were used. The bacteria were exposed toN-(2-Nitrophenyl)phosphoric triamideboth, in the presence and absence of rat liver S9 metabolic activation. Two independent experiments were performed according to the standard plate incorporation method (experiment I) or the pre-incubation method (experiment II), respectively.
The concentrations 5000, 1000, 500, 100 and 50 µg/plate were chosen for the experiments according to the standard plate incorporation method and for the experiments according to the pre-incubation method.
Not any cytotoxicity or precipitation was observed in all experiments.
An untreated, a vehicle control and appropriate positive controls were included into the experimental design. Triplicate plates were scored for each experimental point.
The revertant frequencies of the negative controls were within the expected range and the positive control chemicals induced marked increases in revertant colonies.
N-(2-Nitrophenyl)phosphoric triamideinduced at some experimental points (from 5000 to 500 µg/plate) a reproducible, dose dependent, statistically significant increase of revertant numbers for the bacterial strainSalmonella typhimuriumTA 1537 in the experiments without metabolic activation as well as in the plate incorporation test and in the pre-incubation test and for the bacterial strainSalmonella typhimuriumTA 98 in the experiments with and without metabolic activation as well as in the plate incorporation test and in the pre-incubation test.
Based on the results of the reported study it is concluded that N-(2-Nitrophenyl)phosphoric
triamide induces gene mutation inSalmonella typhimurium under the experimental conditions described.
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