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EC number: 618-561-0 | CAS number: 9046-10-0
- 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:
- 2010-10-04 to 2010-11-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name as cited in study report: POPDa
- Color: clear, colorless
- Purity: 94%
- Lot/Batch number: LL100365
- Label: Jeffamine D-230 lot no.: LL 100365
- Date received: 2010-09-21
- Storage: in the dark - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
Preparation of samples: Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 2 g/l in the three buffer solutions. The test solutions were split into individual vessels for each data point. The solutions were shielded from light whilst maintained at the test temperature.
Preliminary test/Tier 1: Sample solutions at pH 4 were maintained at 50.0 ± 0.5°C for a period of 147 hours. Sample solutions at pH 7 and 9 were maintained at 50.0 ± 0.5°C for a period of 121 hours.
Analysis of sample solutions: The sample solutions were taken from the water bath at various times and the pH of each solution recorded.
The concentration of the sample solution was determined by gas chromatography (GC).
Samples: To duplicate aliquots (A and B, 5 ml), 0.1 ml of diethylamine and approximately 0.5 g sodium chloride were added. The solutions were extracted with three portions (3 x 10 ml) of dichloromethane. The combined extracts were diluted to 50 ml using dichloromethane.
Standards: Duplicate standard solutions of test item were prepared in dichloromethane at a nominal concentration of 400 mg/l.
Matrix blanks: An aliquot (5 ml) of relevant buffer solution was treated as per a sample.- Buffers:
- Specification of buffer solutions
Buffer Solution (pH) Components Concentration
(mol dm-3)
4 Potassium hydrogen phthalate 0.05
7 Disodium hydrogen orthophosphate (anhydrous) 0.03
Potassium dihydrogen orthophosphate 0.02
Sodium chloride 0.02
9 Disodium tetraborate 0.01
Sodium chloride 0.02
The buffer solutions were filtered through a 0.2 µm membrane filter to ensure they were sterile before commencement of the test. Also these solutions were subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen content. - Details on test conditions:
- Refer to details on sampling and analytical methods.
- Duration:
- 121 h
- pH:
- 4
- Initial conc. measured:
- ca. 2 g/L
- Duration:
- 121 h
- pH:
- 7
- Initial conc. measured:
- ca. 2 g/L
- Duration:
- 121 h
- pH:
- 9
- Initial conc. measured:
- ca. 2 g/L
- Number of replicates:
- Duplicate aliquots of sample were taken for analysis.
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- Preliminary test/Tier 1
The mean peak areas relating to the standard and sample solutions are shown in tables. (please see remarks on results including tables and figures section).
The test item concentrations at the given time points at pH 4, 7 and 9 are shown in tables: (please see remarks on results including tables and figures section). - Test performance:
- Validation:
The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 1.6 x 103 mg/l. This was satisfactory with correlation coefficients of 1.000 being obtained for Peak No.1, 2 and 3, and 0.998 for Peak No.4.
Recovery of analysis of the sample procedure was assessed and proved adequate for the test. Recovery data is shown in the following table:( please see remarks on results including tables and figures section) - Transformation products:
- not specified
- Details on hydrolysis and appearance of transformation product(s):
- Less than 10% hydrolysis after 121 hours at 50°C.
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- 1 yr
- Type:
- not specified
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 1 yr
- Type:
- not specified
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 1 yr
- Type:
- not specified
- Details on results:
- At pH4, 7 and 9 there was less than 10% hydrolysis after 121 hours at 50°C, equivalent to a half-life greater than 1 year at 25°C.
- Validity criteria fulfilled:
- yes
- Remarks:
- See test performance - remarks
- Conclusions:
- The test item was determined to be hydrolytically stable at pH 4, 7 and 9, with estimated half-lives of greater than 1 year at 25°C.
- Executive summary:
Assessment of hydrolytic stability was carried out using a procedure designed to be compatible with Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008.
The test item was determined to be hydrolytically stable at pH 4, 7 and 9, with estimated half-lives of greater than 1 year at 25°C.
Reference
Preliminary test/Tier 1
The mean peak areas relating to the standard and sample solutions are shown in the following table:
Solution |
MeanArea |
|||
Peak No.1 |
Peak No.2 |
Peak No.3 |
Peak No.4 |
|
Standard 394 mg/l |
5.201 x 105 |
4.048 x 105 |
1.384 x 105 |
3.047 x 104 |
Standard 398 mg/l |
5.032 x 105 |
3.903 x 105 |
1.326 x 105 |
2.930 x 104 |
Initial Sample A, pH 4 |
1.203 x 105 |
1.586 x 105 |
5.933 x 104 |
1.233 x 104 |
Initial Sample B, pH 4 |
6.064 x 105 |
1.080 x 105 |
5.179 x 104 |
1.155 x 104 |
Initial Sample A, pH 7 |
1.562 x 105 |
1.677 x 105 |
5.612 x 104 |
1.016 x 104 |
Initial Sample B, pH 7 |
1.531 x 105 |
1.690 x 105 |
5.760 x 104 |
1.148 x 104 |
Initial Sample A, pH 9 |
1.583 x 105 |
1.727 x 105 |
5.780 x 104 |
1.173 x 104 |
Initial Sample B, pH 9 |
1.598 x 105 |
1.687 x 105 |
5.576 x 104 |
1.139 x 104 |
Standard 422 mg/l |
5.259 x 105 |
4.097 x 105 |
1.395 x 105 |
3.052 x 104 |
Standard 488 mg/l |
6.153 x 105 |
4.804 x 105 |
1.660 x 105 |
3.703 x 104 |
22-Hour Sample A, pH 4 |
1.419 x 105 |
1.635 x 105 |
5.756 x 104 |
1.141 x 104 |
22-Hour Sample B, pH 4 |
1.366 x 105 |
1.617 x 105 |
5.708 x 104 |
1.112 x 104 |
22-Hour Sample A, pH 7 |
1.647 x 105 |
1.678 x 105 |
5.556 x 104 |
1.072 x 104 |
22-Hour Sample B, pH 7 |
1.640 x 105 |
1.668 x 105 |
5.578 x 104 |
1.126 x 104 |
22-Hour Sample A, pH 9 |
1.547 x 105 |
1.608 x 105 |
5.421 x 104 |
1.119 x 104 |
22-Hour Sample B, pH 9 |
1.637 x 105 |
1.687 x 105 |
5.533 x 104 |
1.143 x 104 |
Standard 392 mg/l |
4.719 x 105 |
3.697 x 105 |
1.247 x 105 |
2.624x 104 |
Standard 396 mg/l |
4.680 x 105 |
3.661 x 105 |
1.241 x 105 |
2.712 x 104 |
96-Hour Sample A, pH 4 |
1.361 x 105 |
1.430 x 105 |
5.260 x 104 |
1.034 x 104 |
96-Hour Sample B, pH 4 |
1.335 x 105 |
1.429 x 105 |
5.514 x 104 |
1.063 x 104 |
96-Hour Sample A, pH 7 |
1.191 x 105 |
1.294 x 105 |
5.045 x 104 |
8.925 x 103 |
96-Hour Sample B, pH 7 |
1.471 x 105 |
1.383 x 105 |
5.198 x 104 |
8.847 x 103 |
96-Hour Sample A, pH 9 |
1.425 x 105 |
1.298 x 105 |
5.162 x 104 |
8.417 x 103 |
96-Hour Sample B, pH 9 |
1.533 x 105 |
1.410 x 105 |
5.302 x 104 |
9.269 x 103 |
Solution |
MeanArea |
|||
Peak No.1 |
Peak No.2 |
Peak No.3 |
Peak No.4 |
|
Standard 392 mg/l |
4.725 x 105 |
3.703 x 105 |
1.248 x 105 |
2.636 x 104 |
Standard 396 mg/l |
4.681 x 105 |
3.655 x 105 |
1.234 x 105 |
2.690 x 104 |
121-Hour Sample A, pH 4 |
1.416 x 105 |
1.656 x 105 |
5.820 x 104 |
1.132 x 104 |
121-Hour Sample B, pH 4 |
1.400 x 105 |
1.666 x 105 |
5.807 x 104 |
1.100 x 104 |
121-Hour Sample A, pH 7 |
1.472 x 105 |
1.601 x 105 |
5.520 x 104 |
1.102 x 104 |
121-Hour Sample B, pH 7 |
1.475 x 105 |
1.650 x 105 |
5.409 x 104 |
1.043 x 104 |
121-Hour Sample A, pH 9 |
1.508 x 105 |
1.593 x 105 |
5.388 x 104 |
1.071 x 104 |
121-Hour Sample B, pH 9 |
1.450 x 105 |
1.621 x 105 |
5.529 x 104 |
1.104 x 104 |
Standard 481 mg/l |
5.978 x 105 |
4.659 x 105 |
1.579 x 105 |
3.376 x 104 |
Standard 434 mg/l |
5.507 x 105 |
4.300 x 105 |
1.469 x 105 |
3.158 x 104 |
147-Hour Sample A, pH 4 |
1.415 x 105 |
1.620 x 105 |
5.669 x 104 |
1.076 x 104 |
147-Hour Sample B, pH 4 |
1.295 x 105 |
1.574 x 105 |
5.891 x 104 |
1.142 x 104 |
The test item concentrations at the given time points at pH 4 are shown in the following tables:
pH 4 at 50.0 ± 0.5ºC ¿ Peak No.1
Time (Hours) |
Mean Concentration (g/l) |
% of mean 22-Hour concentration |
|||||||
A |
B |
A |
B |
||||||
0 |
0.932 |
0.470 |
- |
- |
|||||
22 |
1.13 |
1.09 |
- |
- |
|||||
96 |
1.14 |
1.12 |
103 |
101 |
|||||
121 |
1.19 |
1.17 |
107 |
106 |
|||||
147 |
1.13 |
1.03 |
101 |
92.9 |
pH 4 at 50.0 ± 0.5ºC ¿ Peak No.2
Time (Hours) |
Mean Concentration (g/l) |
% of mean 22-Hour concentration |
||
A |
B |
A |
B |
|
0 |
1.58 |
1.08 |
- |
- |
22 |
1.67 |
1.65 |
- |
- |
96 |
1.53 |
1.53 |
92.1 |
92.1 |
121 |
1.78 |
1.79 |
107 |
107 |
147 |
1.65 |
1.61 |
99.4 |
96.6 |
pH 4 at 50.0 ± 0.5ºC ¿ Peak No.3
Time (Hours) |
Mean Concentration (g/l) |
% of mean initial concentration |
||
A |
B |
A |
B |
|
0 |
1.75 |
1.52 |
- |
- |
22 |
1.72 |
1.70 |
106 |
105 |
96 |
1.67 |
1.75 |
103 |
108 |
121 |
1.85 |
1.85 |
114 |
114 |
147 |
1.70 |
1.77 |
105 |
109 |
pH 4 at 50.0 ± 0.5ºC ¿ Peak No.4
Time (Hours) |
Mean Concentration (g/l) |
% of mean initial concentration |
||
A |
B |
A |
B |
|
0 |
1.64 |
1.53 |
- |
- |
22 |
1.54 |
1.50 |
97.3 |
94.8 |
96 |
1.53 |
1.57 |
96.5 |
99.2 |
121 |
1.68 |
1.63 |
106 |
103 |
147 |
1.51 |
1.60 |
95.1 |
101 |
Result: Less than 10% hydrolysis after at least 125 hours at 50°C, equivalent to a half-life greater than 1 year at 25°C.
The test item concentrations at the given time points at pH 7 are shown in the following tables:
pH 7 at 50.0 ± 0.5ºC ¿ Peak No.1
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.21 |
1.19 |
- |
- |
22 |
1.31 |
1.31 |
110 |
109 |
96 |
0.999 |
1.23 |
83.4 |
103 |
121 |
1.23 |
1.24 |
103 |
103 |
pH 7 at 50.0 ± 0.5ºC ¿ Peak No.2
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.67 |
1.69 |
- |
- |
22 |
1.72 |
1.71 |
102 |
102 |
96 |
1.39 |
1.48 |
82.6 |
88.3 |
121 |
1.72 |
1.77 |
102 |
105 |
pH 7 at 50.0 ± 0.5ºC ¿ Peak No.3
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.64 |
1.69 |
- |
- |
22 |
1.66 |
1.66 |
99.6 |
100 |
96 |
1.60 |
1.65 |
96.2 |
99.1 |
121 |
1.75 |
1.72 |
105 |
103 |
pH 7 at 50.0 ± 0.5ºC ¿ Peak No.4
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.47 |
1.52 |
- |
- |
22 |
1.45 |
1.52 |
96.8 |
102 |
96 |
1.32 |
1.31 |
88.3 |
87.5 |
121 |
1.63 |
1.54 |
109 |
103 |
Result: Less than 10% hydrolysis after 121 hours at 50°C, equivalent to a half-life greater than 1 year at 25°C.
The test item concentrations at the given time points at pH 9 are shown in the following tables:
pH 9 at 50.0 ± 0.5ºC ¿ Peak No.1
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.23 |
1.24 |
- |
- |
22 |
1.23 |
1.31 |
100 |
106 |
96 |
1.20 |
1.29 |
97.1 |
104 |
121 |
1.26 |
1.22 |
103 |
98.7 |
pH 9 at 50.0 ± 0.5ºC ¿ Peak No.2
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.72 |
1.68 |
- |
- |
22 |
1.64 |
1.73 |
96.6 |
101 |
96 |
1.39 |
1.51 |
81.8 |
88.8 |
121 |
1.71 |
1.74 |
100 |
102 |
pH 9 at 50.0 ± 0.5ºC ¿ Peak No.3
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.69 |
1.63 |
- |
- |
22 |
1.62 |
1.65 |
97.3 |
99.3 |
96 |
1.64 |
1.68 |
98.5 |
101 |
121 |
1.71 |
1.76 |
103 |
106 |
pH 9 at 50.0 ± 0.5ºC ¿ Peak No.4
Time (Hours) |
MeanArea |
% of mean initial peak area |
||
A |
B |
A |
B |
|
0 |
1.56 |
1.51 |
- |
- |
22 |
1.51 |
1.54 |
98.5 |
101 |
96 |
1.24 |
1.37 |
81.2 |
89.4 |
121 |
1.59 |
1.64 |
103 |
107 |
Result: Less than 10% hydrolysis after 121 hours at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Description of key information
A test was conducted following EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH; Butler & White, 2010). The substance is hydrolytically stable at all pH's.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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