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EC number: 947-340-4 | CAS number: -
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:
- 2009-02-26 - 20009-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are given in detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(2-hydroxyethyl) (6H-dibenz[c,e][1,2]oxaphosphorin-6-ylmethyl)succinate P-oxide
- EC Number:
- 264-313-6
- EC Name:
- Bis(2-hydroxyethyl) (6H-dibenz[c,e][1,2]oxaphosphorin-6-ylmethyl)succinate P-oxide
- Cas Number:
- 63562-34-5
- Molecular formula:
- C21H23O8P
- IUPAC Name:
- Butanedioic acid, 2-[(6-oxido-6H-dibenz[c,e][1,2]oxaphosphorin-6-yl)methyl]-, 1,4-bis(2-hydroxyethyl) ester
- Test material form:
- solid: crystalline
- Details on test material:
- Name: Ukanol FR 70
Batch no.: 4251318
Appearance: white solid
Composition: 9,10-Dihydro-9-oxa~10-[2,3-Di-(2-hydroxyethoxy) carbonylpropyl]-10-phosphaphenanthren-10-oxid; Bis(2-hydroxyethyl)-(6H-dibenz[c,e][1,2]oxaphos-phorin-6-yl-methyl)succinat-P-oxide
CAS No.: 63562-34-5
EINECS-No.: 264-313-6
Molecular formula: C21H23O8P
Molecular weight: 434 g/mo
Purity: app. 90% (HPLC)
Homogeneity: homogeneous
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa.
- 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 intraperitoneally.
- Test concentrations with justification for top dose:
- First Experiment:
1501 / 500 / 150 / 50 /15 µg/plate
Second Experiment:
1502 / 751 / 376 / 188 / 94 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, 2-Amino-anthracene,
- Details on test system and experimental conditions:
- On the day of the start of the first experiment, a stock solution containing 50 g/L of the test item in DMSO was prepared.
In the second experiment, a stock solution containing 15 g/L of the test item in DMSO was prepared.
DMSO was chosen as solvent, because the test item was completely soluble, and this solvent doesn't have any effects on the viability of the bacteria or the number of spontaneous revertants. The stock solutions were used to prepare the geometric series of the concentrations to be tested. Each solution was membrane filtrated to accomplish sterility.
One day before the start of each experiment, one pellet per strain to be used was put into a culture vessel containing nutrient broth. For the incubation of strains TA97a, TA98, TA100 and TA102, ampicilline was added to the medium (25 mg/L). For the incubation of strain TA102, additionally, tetracycline was added (20 mg/L). TA1535 was incubated without addition of antibiotica, as this strain doesn't carry a resistance plasmid.
After incubation for 10 hours at 37 °C, the cultures were used in the experiment. During the test, the cultures were stored at room temperature as to prevent changes in the titre. - Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor > 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- 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 98
- 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 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
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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 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
Any other information on results incl. tables
The mean revertant values of the four replicates are presented in the following table.
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1 |
535 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H20 |
Mean |
n.t. |
n.t. |
n.t. |
n.t. |
114 |
n.t. |
n.t. |
n.t. |
10 |
n.t. |
sd |
n.t. |
n.t. |
n.t. |
n.t. |
15.3 |
n.t. |
n.t. |
n.t. |
3.3 |
n.t. |
|
DMSO |
Mean |
103 |
97 |
10 |
8 |
99 |
131 |
209 |
215 |
9 |
11 |
sd |
5.8 |
13.0 |
5.4 |
3.9 |
7.4 |
17.7 |
65.4 |
26.7 |
3.1 |
3.3 |
|
Pos.Contr. |
Mean |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
sd |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
m |
9.72 |
10.32 |
100.1 |
125.1 |
8.78 |
7.64 |
4.79 |
4.66 |
100.1 |
91.00 |
|
1502|jg/pl. |
Mean |
86 |
82 |
7 |
6 |
105 |
111 |
152 |
181 |
11 |
8 |
sd |
5 |
6 |
2 |
1 |
17 |
18 |
10 |
64 |
4 |
2 |
|
m |
0.83 |
0.85 |
0.70 |
0.75 |
1.06 |
0.85 |
0.73 |
0.84 |
1.22 |
0.73 |
|
751Mg/pi. |
Mean |
109 |
88 |
6 |
6 |
95 |
114 |
132 |
222 |
8 |
14 |
sd |
5 |
20 |
1 |
1 |
20 |
6 |
20 |
19 |
1 |
6 |
|
m |
1.06 |
0.91 |
0.60 |
0.75 |
0.96 |
0.87 |
0.63 |
1.03 |
0.89 |
1.27 |
|
376ng/pi. |
Mean |
83 |
87 |
8 |
6 |
120 |
99 |
236 |
201 |
11 |
11 |
sd |
8 |
15 |
4 |
1 |
6 |
15 |
72 |
22 |
2 |
1 |
|
m |
0.81 |
0.90 |
0.80 |
0.75 |
1.21 |
0.76 |
1.13 |
0.93 |
1.22 |
1.00 |
|
188Mg/pl- |
Mean |
123 |
111 |
6 |
6 |
104 |
92 |
134 |
175 |
10 |
12 |
sd |
11 |
6 |
2 |
5 |
22 |
15 |
5 |
45 |
3 |
5 |
|
m |
1.19 |
1.14 |
0.60 |
0.75 |
1.05 |
0.70 |
0.64 |
0.81 |
1.11 |
1.09 |
|
94jig/pi. |
Mean |
106 |
100 |
9 |
5 |
150 |
99 |
157 |
213 |
13 |
10 |
sd |
8 |
16 |
2 |
3 |
11 |
1 |
13 |
9 |
3 |
2 |
|
m |
1.03 |
1.03 |
0.90 |
0.63 |
1.52 |
0.76 |
0.75 |
0.99 |
1.44 |
0.91 |
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
Under the test conditions, the test item 9,10-Dihydroxy-9-oxa-10-[2,3-Di-(2-hydroxyethoxy)carbonylpropyl]-10-phosphaphenanthren-10-oxid is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471, strains TA 1535, TA 97, TA98,TA100 and TA 102 of S. typhimurium were exposed to 9,10-Dihydroxy-9-oxa-10-[2,3-Di-(2-hydroxyethoxy)carbonylpropyl]-10-phosphaphenanthren-10-oxid.
The test item didn't show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only). Cytotoxicity of the test item was not detected: The background lawn was visible and the number of revertants was not significantly decreased. Therefore it can be stated, that under the test conditions, the test item 9,10-Dihydroxy-9-oxa-10-[2,3-Di-(2-hydroxyethoxy)carbonylpropyl]-10-phosphaphenanthren-10-oxid is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535.
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