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EC number: 418-570-8 | CAS number: 25383-07-7
- 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
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1995 - May 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- yes
- Remarks:
- (No replicates were conducted and no data available on analytical method, as recommended in the test guideline).
- GLP compliance:
- yes
- Radiolabelling:
- not specified
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
Preliminary test at 50 ºC at pH 4, 7 and 9. Sampling timers: 2.4, 120 hours
Determination of the reaction order at pH 4 and 55 ºC: sampling time: 0, 2, 3, 5, 8, 23, 25, 26, 47, 52 hours
Determination of the reaction order at pH 4 and 65 ºC: sampling time: 0, 2, 4, 8, 23 hours
Determination of the reaction order at pH 4 and 75 ºC: 0, 1, 2, 3, 4, 6, 8, 23 hours
Determination of the reaction order at pH 7 and 70 ºC: 0, 29, 44, 74, 146 hours
Determination of the reaction order at pH 7 and 80 ºC: 0, 16, 19, 21, 39 hours - Buffers:
- - pH: 4
- Type of buffer: C. Erba cod. n. 486281
- pH: 7
- Type of buffer: C. Erba cod. n. 486421
- pH: 9
- Type of buffer: C. Erba cod. n. 486571 - Estimation method (if used):
- In case of non pseudo-first order the half time (time required for 50% hydrolysis) is graphically estimated.
In case of pseudo-first order, the rate constants k are calculated from the plots of the logarithm of concentration versus time using the expression K = -slope x 2.303. K at 25 ºC is then evaluated by applying the Arrhenius equation. - Details on test conditions:
- TEST MEDIUM
- Preparation of test medium: test substance (Fosfomycin PEA salt) in buffer solutions:
pH 4: C.Erba cod. n. 486281
pH 7: C.Erba cod. n. 486421
pH 9: C.Erba cod. n. 486571
OTHER TEST CONDITIONS
- Adjustment of pH: 4, 7 and 9 - Number of replicates:
- 1
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The test substance can be considered stable at pH 9 (degradation after 120 h = 3.9% < 10%). At this pH no further tests have been carried out.
The hydrolysis reaction order:
- at pH 4 at 55 ºC
- at pH 7 at 70 ºC, in order to have acceptable reaction time (shorter than a week) for > 20% hydrolysis. - Transformation products:
- not measured
- % Recovery:
- 22.7
- pH:
- 4
- Temp.:
- 55 °C
- Duration:
- 52 h
- % Recovery:
- 7.1
- pH:
- 4
- Temp.:
- 65 °C
- Duration:
- 23 h
- % Recovery:
- 1.8
- pH:
- 4
- Temp.:
- 75 °C
- Duration:
- 23 h
- % Recovery:
- 26
- pH:
- 7
- Temp.:
- 70 °C
- Duration:
- 146 h
- % Recovery:
- 42.5
- pH:
- 7
- Temp.:
- 80 °C
- Duration:
- 39 h
- pH:
- 4
- Temp.:
- 55 °C
- Hydrolysis rate constant:
- 0.03 h-1
- DT50:
- 23.4 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: correlation coefficient = 0.994
- pH:
- 4
- Temp.:
- 65 °C
- Hydrolysis rate constant:
- 0.791 h-1
- DT50:
- 9.3 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: correlation coefficient = 0.999
- pH:
- 4
- Temp.:
- 75 °C
- Hydrolysis rate constant:
- 0.163 h-1
- DT50:
- 4.2 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: correlation coefficient = 0.999
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.002 h-1
- DT50:
- 459.6 h
- Type:
- other: Arrhenius relationship
- pH:
- 7
- Temp.:
- 70 °C
- Hydrolysis rate constant:
- 0.008 h-1
- DT50:
- 83.1 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: correlation coefficient = 0.999
- pH:
- 7
- Temp.:
- 80 °C
- Hydrolysis rate constant:
- 0.022 h-1
- DT50:
- 31.1 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: correlation coefficient = 0.997
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- 15 628 h
- Type:
- other: Arrhenius relationship
- Conclusions:
- At pH 4 and 25 ºC, the rate constant is 1.51E-03 h-1 (= 4.19E-07 s-1) and a half-life time of 459.6 hours.
At pH 7 and 25 ºC, the rate constant is 4.43E-05 h-1 (= 1.23E-08 s-1) and a half-life time of 15628 hours. - Executive summary:
The hydrolysis study of Fosfomycin PEA salt was carried out according to EU Method C 7.
In a preliminary test, the test substance is considered stable at pH 9 (degradation after 120 h = 3.9% < 10%). At this pH no further tests have been carried out and the hydrolysis reaction orders were 55 ºC at pH 4 and 70 ºC at pH 7, in order to have acceptable reaction time (shorter than a week) for > 20% hydrolysis.
The rate constants and the half-life times were calculated, at pH 4 and 7 (the test substance is stable at pH 9).
The hydrolysis reactions at pH 4 (55, 65 and 75 ºC) and pH 7 (70 and 80 ºC) can be considered a pseudo-first order reactions.
Therefore, the rate constant were calculated by the least square method from the slope.
The evaluation of rate constants at pH 4 and 7 (25 ºC) were estimated through the use of the Arrhenius relationship.
The results of the study were:
At pH 4 and 25 ºC the rate constant is 1.51E-03 h-1 (= 4.19E-07 s-1) and a half-life time of 459.6 hours.
At pH 7 and 25 ºC the rate constant is 4.43E-06 h-1 (= 1.23E-08 s-1) and a half-life time of 15628 hours.
Reference
Table 1. Preliminary test
pH of the solution |
Degradation (%) |
|
After 24h |
After 120h |
|
4.0 |
5.1 |
85.8 |
7.0 |
< 1 |
11.4 |
9.0 |
< 1 |
3.9 |
Table 2. Determination of the reaction order at pH 4 and 55ºC.
Time (h) |
Conc. (mg/L) |
Degrad. (%) |
0 |
1733.1 |
0.0 |
2 |
1665.6 |
3.9 |
4 |
1590.5 |
8.2 |
5 |
1575.3 |
9.1 |
8 |
1399.3 |
19.3 |
23 |
973.9 |
43.8 |
25 |
890.8 |
48.6 |
26 |
870.1 |
49.8 |
47 |
411.5 |
76.3 |
52 |
393.4 |
77.3 |
Table 3. Determination of rate of hydrolysis at pH 4 at 65ºC.
Time (h) |
Conc. (mg/L) |
Degrad. (%) |
0 |
1786.2 |
0.0 |
2 |
1596.4 |
10.6 |
4 |
1342.2 |
24.7 |
8 |
1037.8 |
44.5 |
23 |
323.4 |
84.4 |
Table 4. Determination of rate of hydrolysis at pH at 75ºC.
Time (h) |
Conc. (mg/L) |
Degrad. (%) |
0 |
1842.8 |
0.0 |
1 |
1597.0 |
13.3 |
2 |
1273.6 |
30.7 |
3 |
1094.7 |
42.8 |
4 |
920.5 |
53.0 |
6 |
666.0 |
67.1 |
8 |
468.7 |
77.5 |
23 |
43.1 |
98.2 |
Table 5. Evaluation of rate constant at pH 4 at 25ºC.
Temperature (ºC) |
Rate constant (h-1) |
Half-life time (h) |
|
75 |
1.63 E-1 |
(exp.) |
4.2 |
65 |
7.49 E-2 |
(exp.) |
9.3 |
55 |
2.96 E-2 |
(exp.) |
23.4 |
25 |
1.51 E-3 (4.19 E-7 s-1) |
(calc.) |
459.6 |
Table 6. Determination of the reaction order at pH 7 and 70ºC.
Time (h) |
Conc. (mg/L) |
Degrad. (%) |
0 |
1802.2 |
0.0 |
29 |
1355.8 |
24.6 |
44 |
1220.9 |
32.1 |
74 |
952.7 |
50.0 |
146 |
525.8 |
74.0 |
Table 7. Determination of rate of hydrolysis at pH 7 at 80ºC.
Time (h) |
Conc. (mg/L) |
Degrad. (%) |
0 |
1706.2 |
0.0 |
16 |
1235.7 |
27.4 |
19 |
1125.1 |
33.9 |
21 |
1052.8 |
38.1 |
39 |
785.2 |
57.5 |
Table 8. Evaluation of rate constant at pH 7 and 25ºC.
Temperature (ºC) |
Rate constant (h-1) |
Half-life time (h) |
|
80 |
2.23 E-2 |
(exp.) |
31 |
70 |
8.34 E-3 |
(exp.) |
83 |
25 |
4.43 E-6 (1.23 E-8 s-1) |
(calc.) |
15628 |
Description of key information
Key study: Test method according to EU Method C.7 with deviations. GLP study.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 15 628 h
- at the temperature of:
- 25 °C
Additional information
Key study: Test method according to EU Method C.7 with deviations. GLP study. At pH 7 and 25 ºC the rate constant is 4.43E-06 h-1 (= 1.23E-08 s-1) and a half-life time of 15628 hours.
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