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EC number: 231-218-6 | CAS number: 7450-69-3
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-11-20 - 2012-06-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 487
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Phenyl diamidophosphate
- EC Number:
- 231-218-6
- EC Name:
- Phenyl diamidophosphate
- Cas Number:
- 7450-69-3
- Molecular formula:
- C6H9N2O2P
- IUPAC Name:
- [(diaminophosphoryl)oxy]benzene
- Test material form:
- solid: crystalline
- Details on test material:
- Name PPDA
Composition contains 5.1% ammonium chloride and 2.5% phenol
CAS No. 7450-69-3
EINECS-No. 231-218-6
Molecular formula C6H9N2O2P
Molecular weight 172.1 g/mol
Purity 92.4% (HPLC)
Constituent 1
Method
- Target gene:
- Human peripheral blood lymphocytes
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9, produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intra-peritoneally.
- Test concentrations with justification for top dose:
- Experiment I
Without S9 mix / 4 ± 1 hrs exposure: 1720, 860 and 430 µg/mL nominal
With S9 mix / 4 ± 1 hrs exposure: 1720, 860 and 430 µg/mL nominal
Experiment II
Without S9 mix / 22 ± 2 hrs exposure: 1720, 860 and 430 µg/mL nominal
With S9 mix / 4 hrs exposure: 1720, 860 and 430 µg/mL nominal - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Test System
Human peripheral blood lymphocytes were obtained from adequate donors (healthy, non-smoking, no known recent exposures to genotoxic chemicals or radiation, see below). Blood samples were drawn by venous puncture and collected in heparinized tubes. Blood cultures were set up within 24 hours after sample collection. - Evaluation criteria:
- see below
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- 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
Genotoxicity Results Experiment I
Treatment |
Average CBPI |
Cytostasis (%) |
Total No. of BNC examined |
Total No. of MBNC |
% MBNC |
Experiment I: exposure period 4±1 hrs without S9 |
|||||
Solvent controlDMSO |
1.84 |
-- |
2057 |
5 |
0.24 |
Positive control MMC |
1.80 |
5.4% |
2204 |
74 |
3.36 |
Test item 1721mg/mL |
1.83 |
1.2% |
2083 |
5 |
0.24 |
Test item 860mg/mL |
1.81 |
4.3% |
2045 |
13 |
0.64 |
Test item 430mg/mL |
1.81 |
4.4% |
2082 |
5 |
0.24 |
Experiment I: exposure period 4±1 hrs with S9 |
|||||
Solvent controlDMSO |
1.85 |
-- |
2057 |
8 |
0.39 |
Solvent control NaCl 0.9 % |
1.92 |
-- |
2080 |
2 |
0.10 |
Positive control CPA |
1.79 |
14.7% |
2151 |
66 |
3.07 |
Test item 1721mg/mL |
1.87 |
1.87% |
2120 |
18 |
0.85 |
Test item 860mg/mL |
1.88 |
1.88% |
2066 |
7 |
0.34 |
Test item 430mg/mL |
1.87 |
1.87% |
2066 |
14 |
0.68 |
Results Experiment II
Concentrations (µg/ml) |
Average CBPI |
Cytostasis (%) |
Total No. of BNC examined |
Total No. of MBNC |
% MBNC |
|
Experiment II: exposure period 20± 2hrs without S9 |
||||||
Solvent controlDMSO |
1.97 |
-- |
2068 |
16 |
0.77 |
|
Positive control MMC |
1.90 |
7.3% |
2102 |
71 |
3.38 |
|
Test item 1721mg/mL |
1.72 |
25.9% |
2033 |
11 |
0.54 |
|
Test item 860mg/mL |
1.91 |
6.3% |
2089 |
11 |
0.53 |
|
Test item 430mg/mL |
1.96 |
1.0% |
2057 |
8 |
0.39 |
|
Experiment II: exposure period 4±1 hrs with S9 |
||||||
Solvent controlDMSO |
1.90 |
-- |
1495 |
7 |
0.47 |
|
Solvent control NaCl 0.9 % |
1.97 |
-- |
2078 |
4 |
0.19 |
|
Positive control CPA |
1.76 |
21.4% |
2251 |
60 |
2.67 |
|
Test item 1721mg/mL |
1.89 |
5.4% |
1240 |
9 |
0.73 |
|
Test item 860mg/mL |
1.97 |
-3.3% |
2118 |
17 |
0.80 |
|
Test item 430mg/mL |
2.00 |
-6.7% |
2095 |
11 |
0.53 |
|
Test item215 µg/mL |
2.01 |
-7.6% |
2125 |
17 |
0.80 |
|
Test item108 µg/mL |
1.89 |
5.4% |
2033 |
18 |
0.89 |
|
Test item54 µg/mL |
1.95 |
-1.5% |
2061 |
17 |
0.82 |
|
Test item27 µg/mL |
1.97 |
-3.4% |
2047 |
22 |
1.07 |
|
Test item13 µg/mL |
1.95 |
-1:6% |
2090 |
22 |
1.05 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions reported, the test item PPDA did not show any evidence of genotoxic activity in this in vitro test for the induction of micronuclei. - Executive summary:
This study was performed in order to evaluate the mutagenic potential of PPDA to induce formation of micronuclei in human lymphocytes
The lymphocytes, in whole blood culture, were stimulated to divide by addition of phytohaemagglutinin and exposed to the test item both in absence and presence of an exogenous metabolic activation system (liver S9 mix from male rats, treated with Aroclor 1254). The proportion of cells containing micronuclei was determined.
Two independent experiments were performed. In each experimental group, all cell cultures were set up in duplicates. In order to asses the toxicity of the test solution to cultured human lymphocytes, the cytokinesis-block proliferation index was calculated in a pre-experiment. On the basis of this data, the following concentrations were selected for micronuclei scoring:
Experiment I
Without S9 mix / 4±1 hrs exposure: 1720, 860 and 430µg/mL nominal
With S9 mix / 4±1 hrs exposure: 1720, 860 and 430µg/mL nominal
Experiment II
Without S9 mix / 22±2 hrs exposure: 1720, 860 and 430µg/mL nominal
With S9 mix / 4 hrs exposure: 1720, 860 and 430µg/mL nominal
In both experiments with and without metabolic activation, no concentration showed cytotoxicity.
All positive control compounds caused large, statistically significant increases in the proportion of micronucleated cells, demonstrating the sensitivity of the test system.
In conclusion, under the experimental conditions reported, PPDA does not induce the formation of micronuclei in human lymphocytesin vitro.
The test item PPDA is considered as “not genotoxic under the conditions of the test”.
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