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EC number: 219-755-4 | CAS number: 2524-04-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with current guidelines.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- O,O-diethyl phosphorochloridothioate
- EC Number:
- 219-755-4
- EC Name:
- O,O-diethyl phosphorochloridothioate
- Cas Number:
- 2524-04-1
- Molecular formula:
- C4H10ClO2PS
- IUPAC Name:
- O,O-diethyl chlorophosphonothioate
- Details on test material:
- - Name of test material (as cited in study report): EP-2, CAS No 2524-04-1, Phosphorochloridothioic acid,O,O-diethyl ester
- Physical state: Pale yellow liquid
- Analytical purity: > 99 +/- 0.3%
- Lot/batch No.: 2010021503
- Storage condition of test material: at approximately 4°C in the dark
Constituent 1
Method
- Target gene:
- Type of mutations indicated: frame shift mutations and base-pair substitutions
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 mix from the livers of male rats
- Test concentrations with justification for top dose:
- preliminary toxicity test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
Main mutation experiment 1 (plate incorporation method): 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
Main mutation experiment 2 (pre-incubation method): 0.5 - 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
acetone
- Justification for choice of solvent/vehicle:
The test item was immiscible in dimethyl sulphoxide at 50 mg/ml but was fully miscible in acetone at the same concentration in solubility checks performed. Acetone was therefore selected as the vehicle. Following solubility information provided by the sponsor, sterile distilled water was not evaluated as a potential vehicle in this test system.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9: N-ethyl-N-nitro-N-nitrosoguanidine, 9-Aminoacridine, 4-Nitroquinoline-1-oxide; with S9: 2-Aminoanthracene, Benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment 1 was performed as plate incorporation assay and experiment 2 was performed as preincubation assay
DURATION
- Preincubation period: 20 minutes (preincubation assay only)
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following may be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (DeSerres and Shelby (1979)).
2. A reproducible increase at one or more concentrations.
3 Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- No data
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:
- cytotoxicity
- Remarks:
- plate incorporation assay: from 500 µg/plate onwards, pre-incubation assay: from 150 µg/plate onwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation assay: from 500 µg/plate onwards, pre-incubation assay: from 150 µg/plate onwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The test item was cytotoxic initially at and above 500 μg/plate to the strains of bacteria used (TA100 and WP2uvrA). The test item formulation and S9-mix used in this experiment were both shown to be sterile.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the first experiment (plate incorporation), the test item caused a visible reduction in the growth of the bacterial background lawn in all of the tester strains (with and without metabolic activation) initially at 500 μg/plate. However, in the second experiment (pre-incubation method) the test item caused a visible reduction in the growth of the bacterial background lawn to all of the tester strains (with and without metabolic activation) initially at 150 μg/plate.
No test item precipitate was observed on the plates at any of the doses tested in either the presence or the absence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Preliminary toxicity test: Numbers of revertant colonies for the toxicity assay:
S9 mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
122 |
127 |
115 |
105 |
104 |
120 |
124 |
116 |
118 S |
60 V |
46 V |
+ |
TA100 |
110 |
99 |
101 |
93 |
107 |
113 |
86 |
101 |
104 |
88 S |
77 S |
- |
WP2uvrA |
48 |
61 |
44 |
43 |
46 |
43 |
58 |
40 |
43 |
28 S |
29 S |
+ |
WP2uvrA |
43 |
63 |
66 |
40 |
60 |
69 |
43 |
37 |
55 |
61 |
39 S |
S Sparse bacterial background lawn
V Very weak bacterial background lawn
Experiment 1: Plate incorporation assay – without S9 mix
EP-2 concentration [µg/plate] |
Mean number of revertants per plate |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
0 |
100 |
17 |
54 |
23 |
16 |
5 |
100 |
19 |
47 |
25 |
15 |
15 |
97 |
16 |
49 |
26 |
13 |
50 |
102 |
17 |
48 |
27 |
10 |
150 |
106 |
14 |
51 |
22 |
14 |
500 |
101 S |
14 S |
42 |
21 S |
9 |
1500 |
68 V |
13 S |
42 S |
18 S |
6 S |
5000 |
0 T |
7 V |
31 S |
8 S |
2 V |
Positive control (name) |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentration [µg/plate] |
3 |
5 |
2 |
0.2 |
80 |
Colonies/plate |
310 |
123 |
327 |
142 |
2648 |
S Sparse bacterial background lawn
V Very weak bacterial background lawn
T Toxic; no bacterial background lawn
ENNG N-ethyl-N-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
Experiment 1: Plate incorporation assay – with S9 mix
EP-2 concentration [µg/plate] |
Mean number of revertants per plate |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
0 |
96 |
19 |
53 |
26 |
13 |
5 |
94 |
20 |
50 |
26 |
13 |
15 |
99 |
20 |
50 |
31 |
14 |
50 |
103 |
22 |
53 |
25 |
15 |
150 |
98 |
19 |
54 |
26 |
13 |
500 |
93 S |
19 |
48 |
23 |
13 |
1500 |
78 S |
13 S |
46 |
25 |
11 |
5000 |
50 V |
11 S |
46 S |
21 |
12 S |
Positive control (name) |
2AA |
2AA |
2AA |
BP |
2AA |
Concentration [µg/plate] |
1 |
2 |
10 |
5 |
2 |
Colonies/plate |
1105 |
50 |
229 |
169 |
335 |
S Sparse bacterial background lawn
V Very weak bacterial background lawn
T Toxic; no bacterial background lawn
2AA 9-Aminoanthracene
BP Benzo(a)pyrene
Experiment 2: Plate incorporation assay – without S9 mix
EP-2 concentration [µg/plate] |
Mean number of revertants per plate |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
0 |
119 |
15 |
30 |
21 |
12 |
0.5 |
128 |
13 |
30 |
17 |
11 |
1.5 |
125 |
15 |
29 |
19 |
10 |
5 |
124 |
14 |
28 |
20 |
12 |
15 |
106 |
14 |
27 |
20 |
13 |
50 |
102 |
11 |
31 |
18 |
11 |
150 |
53 S |
4 V |
23 S |
0 V |
0 V |
500 |
0 T |
0 T |
0 T |
0 T |
0 T |
Positive control (name) |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentration [µg/plate] |
3 |
5 |
2 |
0.2 |
80 |
Colonies/plate |
497 |
162 |
283 |
116 |
2530 |
S Sparse bacterial background lawn
V Very weak bacterial background lawn
T Toxic; no bacterial background lawn
ENNG N-ethyl-N-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
Experiment 2: Plate incorporation assay – with S9 mix
EP-2 concentration [µg/plate] |
Mean number of revertants per plate |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
0 |
111 |
20 |
50 |
25 |
11 |
0.5 |
111 |
N/T |
N/T |
N/T |
N/T |
1.5 |
114 |
N/T |
N/T |
N/T |
N/T |
5 |
111 |
15 |
49 |
24 |
12 |
15 |
113 |
15 |
51 |
23 |
12 |
50 |
105 |
16 |
49 |
27 |
10 |
150 |
107 S |
16 |
46 |
26 |
9 |
500 |
0 V |
13 S |
30 S |
18 |
5 S |
1500 |
N/T |
0 V |
17 V |
11 S |
0 T |
5000 |
N/T |
0 T |
13 V |
12 S |
0 T |
Positive control (name) |
2AA |
2AA |
2AA |
BP |
2AA |
Concentration [µg/plate] |
1 |
2 |
10 |
5 |
2 |
Colonies/plate |
801 |
366 |
341 |
186 |
343 |
S Sparse bacterial background lawn
V Very weak bacterial background lawn
T Toxic; no bacterial background lawn
N/T Not tested at this dose level
2AA 9-Aminoanthracene
BP Benzo(a)pyrene
Results of the negative controls (spontaneous mutation rates):
Mean number of revertants per plate |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
Experiment 1: |
||||
97 |
23 |
46 |
22 |
13 |
Experiment 2: |
||||
-- |
17 |
49 |
24 |
20 |
111* |
15* |
33* |
26* |
11* |
* experiment performed at a later date, due to the toxicity in the original pre-incubation test
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
EP-2 is considered to be non-mutagenic both in the presence and in the absence of metabolic activation, but was found to be cytotoxic at 500 µg/plate and 150 µg/plate onwards in the plate incorporation assay and pre-incubation assay, respectively. - Executive summary:
The study was conducted in order to identify possible mutagic activities of EP-2 and was performed according to OECD guideline 471 and EU method B13/14.
In a preliminary toxicity test, Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2uvrA were treated at EP-2 concentrations in the range of 0.15 - 5000 µg/plate to determine the dose range to be tested.
The same bacterial strains were treated with EP-2 in the presence and in the absence of metabolic activation (S9 -mix) both in the plate incorporation and in the pre-incubation assay with test concentrationsin the range of 5 - 5000 µg/plate and 0.5 - 5000 µg/plate, respectively. The tester strains without treatment or treated at the vehicle (acetone) alone served as negative controls and appropriate positive controls (with and withot S9 -mix) were examined in the same assays.
Results revealed counts of revertants in the normal range for vehicle control plates. All of the positive control chemicals used in the assays induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
In the first experiment (plate incorporation assay), EP-2 caused a visible reduction in the growth of the bacterial background lawn in all of the tester strains, both in the presence and absence of S9 -mix, initially at 500 µg/plate. In the second experiment (pre-incubation assay), EP-2 caused a visible reduction in the growth of the bacterial background lawn to all of the tester strains, with and without metabolic activation, initially at 150 µg/plate. Thus, EP-2 is cytotoxic at concentrations of 500 µg/plate and 150 µg/plate onwards in the plate incorporation assay and the pre-incubation assay, respectively.
No test item precipitate was observed on the plates at any concentration tested either in the presence or in the absence of metabolic activation.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of EP-2 either with or without metabolic activation or exposure method used. It is therefore concluded that EP-2 is non-mutagenic under the conditions of this test.
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