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Diss Factsheets
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EC number: 481-870-2 | CAS number: -
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Testing was conducted between 28 March 2007 and 24 April 2007.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- 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.
Preparation of samples:
Sample solutions were prepared at a nominal concentration of 10 g/l in the three buffer solutions.
The test solutions were then split into individual sealed glass vessels for each data point.
The solutions were shielded from light whilst maintained at the test temperature.
Preliminary test:
Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5°C for a period of 120 hours.
Analysis of sample solutions:
The sample solutions were taken from the waterbath at various times and the pH of each solution recorded.
The concentration of the sample solution was determined by high performance liquid chromatography (HPLC).
Samples:
Duplicate aliquots (A and B) of sample solution were diluted by a factor of 100 using glass double-distilled water.
Standards:
Duplicate standard solutions of test material were prepared in 1% relevant buffer solution in glass double-distilled water at a nominal concentration of 100 mg/l. - Buffers:
- Buffer Solution (pH 4)
Components: Potassium hydrogen phthalte
Concentration (mol dm-3): 0.05
Buffer Solution (pH7)
Components: Disodium hydrogen orthophosphate (anhydrous), Potassium dihydrogen orthophosphate, Sodium chloride
Concentration (mol dm-3): 0.03, 0.02, 0.02
Buffer Solution (pH9)
Components: Disodium tetraborate, Sodium chloride
Concentration (mol dm-3): 0.01, 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. - Estimation method (if used):
- Not used.
- Details on test conditions:
- Refer to details on sampling and analytical methods.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Initial conc. measured:
- 10 g/L
- Duration:
- 120 h
- pH:
- 7
- Initial conc. measured:
- 10 g/L
- Duration:
- 120 h
- pH:
- 9
- Initial conc. measured:
- 10 g/L
- Number of replicates:
- Duplicate aliquots (A and B) of sample solution were diluted by a factor of 100 using glass double-distilled water.
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- Not specified.
Results and discussion
- Preliminary study:
- The mean peak heights relating to the standard and sample solutions are shown in table 6.2 (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 200 mg/l. This was satisfactory with a correlation coefficient of 1.00 being obtained. - Transformation products:
- not specified
- Details on hydrolysis and appearance of transformation product(s):
- Less than 10% hydrolysis after 5 days at 50°C.
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Other kinetic parameters:
- None.
- Details on results:
- At pH4, 7 and 9 there was less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Any other information on results incl. tables
Table 6.2 - Preliminary test results
Solution |
MeanHeight |
Standard 100 mg/l |
277.173 |
Standard 100 mg/l |
276.847 |
Initial Sample A, pH 4 |
275.433 |
Initial Sample B, pH 4 |
275.805 |
2.4 Hour Sample A, pH 4 |
276.380 |
2.4 Hour Sample B, pH 4 |
275.604 |
Standard 100 mg/l |
277.296 |
Standard 100 mg/l |
277.382 |
Initial Sample A, pH 7 |
276.798 |
Initial Sample B, pH 7 |
273.898 |
2.4 Hour Sample A, pH 7 |
275.030 |
2.4 Hour Sample B, pH 7 |
276.702 |
Standard 100 mg/l |
276.444 |
Standard 100 mg/l |
276.057 |
Initial Sample A, pH 9 |
274.440 |
Initial Sample B, pH 9 |
274.769 |
2.4 Hour Sample A, pH 9 |
276.263 |
2.4 Hour Sample B, pH 9 |
272.834 |
Standard 101 mg/l |
266.033 |
Standard 102 mg/l |
263.087 |
120 Hour Sample A, pH 4 |
263.054 |
120 Hour Sample B, pH 4 |
262.992 |
Standard 101 mg/l |
261.426 |
Standard 102 mg/l |
264.737 |
120 Hour Sample A, pH 7 |
259.836 |
120 Hour Sample B, pH 7 |
263.932 |
Standard 101 mg/l |
262.144 |
Standard 102 mg/l |
264.977 |
120 Hour Sample A, pH 9 |
264.834 |
120 Hour Sample B, pH 9 |
265.466 |
The test material concentrations at the given time points are shown in the following tables:
Table 6.3 pH 4 at 50.0 ± 0.5ºC
|
Time (Hours) |
||
0 |
2.4 |
120 |
|
Concentration (g/l) |
9.98 |
9.99 |
10.1 |
Log10[concentration (g/l)] |
0.999 |
0.999 |
1.00 |
% of initial |
- |
100 |
101 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Table 6.4 pH 7 at 50.0 ± 0.5ºC
|
Time (Hours) |
||||||
0 |
2.4 |
120 |
|||||
Concentration (g/l) |
9.95 |
9.97 |
10.1 |
||||
Log10[concentration (g/l)] |
0.998 |
0.999 |
1.00 |
||||
% of initial |
- |
100 |
101 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Table 6.5 pH 9 at 50.0 ± 0.5ºC
|
Time (Hours) |
||||||
0 |
2.4 |
120 |
|||||
Concentration (g/l) |
9.97 |
9.96 |
10.2 |
||||
Log10[concentration (g/l)] |
0.998 |
0.998 |
1.01 |
||||
% of initial |
- |
100 |
102 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The estimated half-life at 25°C of the test material at pH 4, 7 and 9 is greater than 1 year.
- Executive summary:
Abiotic Degradation, Hydrolysis as a Function of pH.
Assessment of hydrolytic stability was carried out using Method C7 of Commission Directive 92/69/EEC, Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The results are as follows:
pH
Estimated half-life at 25°C
4
>1 year
7
>1 year
9
>1 year
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