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EC number: 444-960-2 | CAS number: 39148-16-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Feb - 7 Apr 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1997) and current version of 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (adopted 1993)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- (adopted 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 444-960-2
- EC Name:
- -
- Cas Number:
- 39148-16-8
- Molecular formula:
- C2H6O3P.Na
- IUPAC Name:
- sodium ethyl phosphonate
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli strain)
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
Each batch was checked by the manufacturer for sterility, protein content, ability to convert ethidium bromide and cyclophosphamide to bacterial mutagens, and cytochrome P-450-catalysed enzyme activities (alkoxyresorufin-O-dealkylase activities). - Test concentrations with justification for top dose:
- Range finding experiment (with and without metabolic activation, performed only in TA100):
1.6, 8, 40, 200, 1000 and 5000 µg/plate
Experiment I: (with and without metabolic activation):
1.6, 8, 40, 200, 1000 and 5000 µg/plate
Experiment II: (with and without metabolic activation):
156.25, 312.5, 625, 1250, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene (AAN)
- Details on test system and experimental conditions:
- Range Finding Experiment and Main Experiments:
METHOD OF APPLICATION: in agar (plate incorporation, range finding experiment, experiment I and experiment II without S9 mix) and pre-incubation (experiment II with S9 mix)
DURATION
- Preincubation period: 1 h
- Exposure duration: 72 h
NUMBER OF REPLICATIONS: triplicates (test item and positive controls), quintuplicate (solvent control) in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method:other: inspection of the background lawn - Rationale for test conditions:
- according to OECD guideline
- Evaluation criteria:
- A test item is considered as mutagenic if:
- the assay is considered as valide
- the results revealed statistical significance (p ≤ 0.01) and a significant dose-relation ship was present
- positive responses were reproducible
Acceptability
The assay is considered valid if the following criteria were met:
1. the mean negative control counts fell within the range of historical controls
2. the positive control substances induce clear increases in revertants confirming discrimination between different strains and an active S9-mix
3. no more than 5% of the plates were lost through contamination or some other unforeseen event - Statistics:
- Individual plate counts were determined separately and the mean and standard deviations of plate counts for each treatment were calculated.
Statistical analysis were performed by m-statistic (to prove Poisson-distribution) and Dunnett's test (comparison of counts from each dose with the control) and linear regression analysis (prove of dose-response).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test substance was completely soluble in water.
- Precipitation: No precipitation was observed at any concentration.
RANGE-FINDING/SCREENING STUDIES:
A range finding study was performed initially in tester strain TA100 to determine cytotoxicity. As the study design of experiment I was similar to the range finding test, the obtained mutagenicity data were included in experiment I (please refer to Table 1).
COMPARISON WITH HISTORICAL CONTROL DATA:
The number of revertants obtained for solvent and positive controls lay within the range of historical control data. Thus, the study was considered as valide.
Any other information on results incl. tables
Table 1. Test results of experiment I
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate ± SD |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 1001 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
||
– |
water (100 µL) |
108 ± 14 |
23 ± 9 |
19 ± 5 |
34 ± 13 |
11 ± 3 |
– |
1.6 |
115 ± 16 |
27 ± 7 |
17 ± 5 |
65 ± 3 |
13 ± 1 |
– |
8 |
96 ± 12 |
23 ± 6 |
15 ± 6 |
63 ± 10 |
15 ± 3 |
– |
40 |
105 ± 10 |
25 ± 6 |
16 ± 4 |
59 ± 18 |
20 ± 7 |
– |
200 |
125 ±32 |
20 ± 4 |
18 ± 10 |
45 ± 7 |
13 ± 3 |
– |
1000 |
108 ± 13 |
17 ± 7 |
20 ± 2 |
61 ± 4 |
12 ± 5 |
– |
5000 |
113 ± 7 |
20 ± 6 |
18 ± 8 |
47 ± 17 |
19 ± 3 |
– |
Positive controls |
NaN3 |
NaN3 |
NQO |
2NF |
AAC |
Mean No. of colonies/plate ± SD |
700± 58 |
598± 17 |
559± 66 |
953± 22 |
194 ± 50 |
|
+ (1.6%) |
water (100 µL) |
112 ± 10 |
21 ± 4 |
25 ± 6 |
36 ± 7 |
14 ± 3 |
+ (1.6%) |
1.6 |
104 ± 14 |
22 ± 8 |
32 ± 6 |
36 ± 9 |
13 ± 2 |
+ (1.6%) |
8 |
106 ± 8 |
20 ± 4 |
25 ± 1 |
50 ± 7 |
12 ± 2 |
+ (1.6%) |
40 |
114 ± 7 |
25 ± 8 |
22 ± 3 |
46 ± 5 |
7 ± 5 |
+ (1.6%) |
200 |
115 ± 23 |
22 ± 2 |
27 ± 8 |
39 ± 6 |
12 ± 2 |
+ (1.6%) |
1000 |
113 ± 1 |
23 ± 5 |
28 ± 3 |
41 ± 4 |
11 ± 4 |
+ (1.6%) |
5000 |
127 ± 8 |
26 ± 5 |
23 ± 3 |
33 ± 8 |
13 ± 4 |
+ (1.6%) |
Positive controls |
AAN |
AAN |
AAN |
B[a]P |
AAN |
Mean No. of colonies/plate ± SD |
2218 ± 71 |
234 ± 10 |
54 ± 20 |
288 ± 40 |
281 ± 14 |
1: Mutagenicity data for TA100 were provided by the range finding test.
NaN3 = sodium azide
AAC = 9-aminoacridine
4NQO = 4-nitroquinoline 1-oxide
2NF = 2-nitro-fluorene
B[a]P = Benzo(a)pyrene
AAN = 2-aminoanthracene
SD = standard deviation
Table 2. Test results of experiment II
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate ± SD |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
||
– |
water (100 µL) |
89 ± 9 |
24 ± 4 |
11 ± 3 |
26 ± 8 |
12 ± 5 |
– |
156.25 |
100 ± 3 |
21 ± 2 |
10 ± 1 |
25 ± 5 |
10 ± 3 |
– |
312.5 |
100 ± 15 |
16 ± 0 |
9 ± 1 |
23 ± 7 |
11 ± 2 |
– |
625 |
100 ± 8 |
17 ± 7 |
11 ± 6 |
34 ± 15 |
12 ± 2 |
– |
1250 |
83 ± 7 |
24 ± 11 |
6 ± 3 |
27 ± 4 |
13 ± 2 |
– |
2500 |
100 ± 10 |
13 ± 5 |
10 ± 5 |
23 ± 5 |
9 ± 7 |
– |
5000 |
80 ± 8 |
17 ± 4 |
10 ± 3 |
36 ± 7 |
13 ± 4 |
– |
Positive controls |
NaN3 |
NaN3 |
NQO |
2NF |
AAC |
Mean No. of colonies/plate ± SD |
683± 36 |
634± 20 |
922± 88 |
1081± 115 |
141 ± 8 |
|
+ (1.6%) |
water (100 µL) |
97 ± 17 |
16 ± 3 |
15 ± 5 |
34 ± 8 |
11 ± 3 |
+ (1.6%) |
156.25 |
111 ± 8 |
15 ± 1 |
17 ± 5 |
36 ± 6 |
13 ± 1 |
+ (1.6%) |
312.5 |
110 ± 4 |
14 ± 2 |
15 ± 6 |
28 ± 12 |
14 ± 3 |
+ (1.6%) |
625 |
111 ± 5 |
19 ± 1 |
9 ± 1 |
31 ± 9 |
16 ± 4 |
+ (1.6%) |
1250 |
100 ± 16 |
15 ± 4 |
10 ± 2 |
39 ± 11 |
19 ± 12 |
+ (1.6%) |
2500 |
93 ± 1 |
17 ± 5 |
11 ± 1 |
30 ± 3 |
15 ± 5 |
+ (1.6%) |
5000 |
88 ± 26 |
19 ± 7 |
11 ± 5 |
35 ± 6 |
14 ± 2 |
+ (1.6%) |
Positive controls |
AAN |
AAN |
AAN |
B[a]P |
AAN |
Mean No. of colonies/plate ± SD |
161 ± 26 |
68 ± 12 |
75 ± 22 |
140 ± 37 |
101 ± 27 |
NaN3 = sodium azide
AAC = 9-aminoacridine
4NQO = 4-nitroquinoline 1-oxide
2NF = 2-nitro-fluorene
B[a]P = Benzo(a)pyrene
AAN = 2-aminoanthracene
SD = standard deviation
In experiment II, only a weak positive control response was observed in strain TA100 in the presence of S9 mix for AAN. However, concurrent control treatments with this strain in the absence of S9 (as well as the negative controls in the presence of S9), and other strains in the presence of S9, served to otherwise confirm the correct strain and assay functioning, together with the metabolic activity of the S9 mix. It was therefore considered that this weak positive control response was not indicative of any strain or assay failure, and the data from these treatments were therefore accepted as valid.
Table 3: Historical control values
|
Strain |
S9 |
N |
Revertant colonies per plate ± SD |
Range |
|
Lower |
Upper |
|||||
Solvent controls |
TA98 |
- |
20 |
47.4 ± 10 |
33.6 |
61.4 |
+ |
20 |
44.3 ± 8.4 |
31.6 |
55.0 |
||
TA100 |
- |
20 |
117.1 ± 19.4 |
92.8 |
156.2 |
|
|
+ |
20 |
125.1 ± 21.0 |
97.2 |
153.4 |
|
TA1535 |
- |
20 |
19.5 ± 5.5 |
14.0 |
26.2 |
|
|
+ |
20 |
19.3 ± 5.1 |
14.0 |
25.6 |
|
TA1537 |
- |
19 |
14.4 ± 5.6 |
7.4 |
25.0 |
|
|
+ |
18 |
14.2 ± 5.1 |
7.2 |
19.0 |
|
WP2 uvrA |
- |
20 |
16.4 ± 4.5 |
11.8 |
21.0 |
|
|
+ |
20 |
20.4 ± 7.4 |
10.0 |
27.2 |
|
Positive controls |
TA98 |
- (2NF) |
18 |
303.6 ± 197.0 |
147.1 |
947.5 |
|
+ (B[a]P) |
20 |
141.2 ± 75.5 |
80.0 |
377.1 |
|
TA100 |
- (NaN3) |
20 |
603.4 ± 87.9 |
368.9 |
694.2 |
|
|
+ (AAN) |
19 |
1886.7 ± 368.1 |
1330.7 |
2548.2 |
|
TA1535 |
- (NaN3) |
20 |
604.4 ± 77.4 |
448.5 |
744.9 |
|
|
+ (AAN) |
20 |
157.6 ± 46.6 |
90.2 |
253.0 |
|
TA1537 |
- (AAC) |
19 |
196.2 ± 95.6 |
52.5 |
314.7 |
|
|
+ (AAN) |
18 |
241.6 ± 75.2 |
87.5 |
354.0 |
|
WP2 uvrA |
- (NQO) |
19 |
793.2 ± 131.3 |
601.3 |
1056.8 |
|
|
+ (AAN) |
20 |
127.5 ± 69.1 |
43.9 |
267.3 |
1: Mutagenicity data for TA100 were provided by the range finding test.
NaN3 = sodium azide
AAC = 9-aminoacridine
4NQO = 4-nitroquinoline 1-oxide
2NF = 2-nitro-fluorene
B[a]P = Benzo(a)pyrene
AAN = 2-aminoanthracene
SD = standard deviation
Applicant's summary and conclusion
- Conclusions:
- Under the conditions chosen, the test substance was not mutagenic in this bacterial reverse mutation assay.
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