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EC number: 617-769-9 | CAS number: 858956-08-8
- 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
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Dec 2007 - 10 Mar 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 2004
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Food and Consumer Product Safety Authority, Den Haag, The Netherlands; National GLP Compliance Monitoring Authority, Department of Science & Technology, New Dlhi, India
- Radiolabelling:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: immediately after the test substance was placed into the test vessels at Day 0 and when sampled on Day 1, 3 and 5
- Buffers:
- The tests were performed in solutions buffered at pH levels of 4, 7, and 9 (acetate, phosphate, and borate buffers): appropriate volume of each reagent was added to a volumetric flask, diluted to volume with Milli-Q water, where necessary and mixed. After
preparation, the buffer solutions were filter sterilized by passing through 0.2-µm filters under vacuum.
- pH: 4
- Type and final molarity of buffer: Acetate, 0.01 M
- Composition of buffer: 82 mL 0.01M acetic acid solution, 18 mL 0.01 M sodium acetate (final volume: 100 mL), sonicated for about 5 minutes and the pH of the prepared solutions were recorded using a pre-calibrated pH meter
- pH: 7
- Type and final molarity of buffer: Phosphate, 0.01 M
- Composition of buffer: 19.5 mL 0.02 M sodium phosphate manobasic solution, 30.5 mL 0.02 M, Milli-Q-water (final volume: 100 mL), sonicated for about 5 minutes and the pH of the prepared solutions were recorded using a pre-calibrated pH meter
- pH: 9
- Type and final molarity of buffer: Borate, 0.01 M
- Composition of buffer: 2 mL 0.5 M boric acid solution, Milli-Q-water (final volume: 100 mL), sonicated for about 5 minutes and the pH of the prepared solutions were recorded using a pre-calibrated pH meter - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: glass hydrolysis vessels (5 mL capacity) with tightly sealed Teflon-lined caps
- Sterilisation method: autoclaving
- Lighting: dark
TEST MEDIUM
- Volume used/treatment: 4.5 mL
- Kind and purity of water: Milli-Q Water
- Preparation of test medium: 600 µL aliquots of the 14C-DPX-MAT28 stock solution added into three 50 mL volumetric flasks, evaporation of the solvent using a gentle stream of nitrogen gas, residues were reconstituted and flasks were brought to volume with buffer solutions
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Dissolved oxygen: de-oxygenated by bubbling for approximately 5 minutes with nitrogen gas before adding the test item - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 2.03 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 2.03 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 2.03 mg/L
- Number of replicates:
- 8 (2 replicates were removed from the water bath at each interval for each pH)
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- DT50 at pH 4, 7, 9 and 50°C: no calculation, less than 10% degradation after 5 days
- Transformation products:
- no
- % Recovery:
- 96.3
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 99.2
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 89.3
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered: no
SUPPLEMENTARY EXPERIMENT (Testing of Adsorption to Apparatus):
RESULTS: No significant loss of radioactivity due to adsorption to apparatus was observed
Reference
Table 1: Recovery of the test item in pH 4.0 buffer solution incubated at 50 ± 0.5°C expressed as percent of applied radioactivity
COMPOUND |
REPLICATE |
SAMPLING INTERVAL(DAYS) |
|||
0 |
1 |
3 |
5 |
||
DPX-MAT28 |
R1 |
99.2 |
98.0 |
98.6 |
96.1 |
R2 |
100.2 |
98.2 |
98.9 |
96.4 |
|
Mean |
99.7 |
98.1 |
98.8 |
96.3 |
|
Others |
R1 |
0.3 |
0.2 |
0.2 |
0.2 |
R2 |
0.3 |
0.2 |
0.2 |
0.2 |
|
Mean |
0.3 |
0.2 |
0.2 |
0.2 |
|
Total |
R1 |
99.5 |
98.2 |
98.8 |
96.3 |
R2 |
100.5 |
98.4 |
99.1 |
96.6 |
|
Mean |
100.0 |
98.3 |
99.0 |
96.5 |
Table 2: Recovery of the test item in pH 7.0 buffer solution incubated at 50±0.5°C expressed as percent of applied radioactivity
COMPOUND |
REPLICATE |
SAMPLING INTERVAL(DAYS) |
|||
0 |
1 |
3 |
5 |
||
DPX-MAT28 |
R1 |
100.2 |
96.4 |
99.8 |
98.7 |
R2 |
101.1 |
97.1 |
98.1 |
99.7 |
|
Mean |
100.6 |
96.8 |
99.0 |
99.2 |
|
Others |
R1 |
0.2 |
0.1 |
0.2 |
0.3 |
R2 |
0.2 |
0.2 |
0.2 |
0.3 |
|
Mean |
0.2 |
0.2 |
0.2 |
0.3 |
|
Total |
R1 |
100.4 |
96.5 |
100.0 |
99.0 |
R2 |
101.3 |
97.3 |
98.3 |
100.0 |
|
Mean |
100.8 |
96.9 |
99.2 |
99.5 |
Table 3: Recovery of the test item in pH 9.0 buffer solution incubated at 50±0.5°C expressed as percent of applied radioactivity
COMPOUND |
REPLICATE |
SAMPLING INTERVAL(DAYS) |
|||
0 |
1 |
3 |
5 |
||
DPX-MAT28 |
R1 |
100.2 |
96.1 |
99.0 |
89.0* |
R2 |
100.2 |
99.2 |
98.4 |
89.6* |
|
Mean |
100.2 |
97.7 |
98.7 |
89.3* |
|
Others |
R1 |
0.2 |
0.1 |
0.1 |
0.4 |
R2 |
0.1 |
0.1 |
0.2 |
0.2 |
|
Mean |
0.2 |
0.1 |
0.2 |
0.3 |
|
Total |
R1 |
100.4 |
96.2 |
99.1 |
89.4* |
R2 |
100.3 |
99.3 |
98.6 |
89.8* |
|
Mean |
100.4 |
97.8 |
98.9 |
89.6* |
* Althoughmassbalancewasslightlybelow90%,nocomponentotherthan14C-DPX-MAT28 was observed in the radiochemical chromatogram of pH 9 buffersolution.
Description of key information
DT50 > 1 year at 25°C, pH 4, 7, 9 (OECD 111)
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
Additional information
The hydrolytic stability of the test item was investigated in a
GLP study conducted according to OECD 111. Sterile test item solutions
were prepared in 0.01 M acetate buffer (pH 4), 0.01 M phosphate buffer
(pH 7) and 0.01 M borate buffer (pH 9) at a nominal test concentration
of 2.0 µg/mL. The solutions were incubated at 50°C for 5 days. At
selected time intervals, samples were analyzed directly by Liquid
Scintillation
Counting (LSC), to determine the quantity of radioactivity present in
each sample. Radioactivity was quantitatively recovered from each test
solution. The mass balances were in a range between 90.8 and 100.5%.
Test solutions were subjected to chromatographic analysis (HPLC) to
investigate the nature of any hydrolysis products formed. The hydrolysis
of the test item at 50 ± 0.5°C after 5 days of incubation was < 10% in
pH 4, 7 and 9 buffer solutions. The test item is therefore considered to
be stable (t1/2 at 25°C
> 1 year) at pH 4, 7 and 9 and no further tests were performed.
Based on the results of this study, hydrolysis is not expected to
be a relevant route of degradation of the test item in the environment.
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