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EC number: - | 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
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Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/12/2008 to 17/02/2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- yes
- Remarks:
- As the test material was determined to be hydrolytically stable under acidic conditions (t1/2 > 1 year at 25°C), no additional testing was performed at pH 1.2, 37.0 ± 0.5°C.
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable. - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- Two sample vessels were taken from the waterbath at each time-point, and the pH of each solution recorded. The concentration of the sample solution was determined by high performance liquid chromatography (HPLC) (see below). An aliquot of each sample solution was analysed without any further treatment. Duplicate standard solutions of test material were prepared in the respective buffer solution at a nominal concentration of 500 mg/l.
- Buffers:
- Buffer solution pH 4: Citric acid - 0.06 mol dm-3
Sodium chloride - 0.04 mol dm-3
Sodium hydroxide - 0.07 mol dm-3
Buffer solution pH 7: Disodium hydrogen orthophosphate (anhydrous) - 0.03 mol dm-3
Potassium dihydrogen orthophosphate - 0.02 mol dm-3
Sodium chloride - 0.02 mol dm-3
Buffer solution pH 9: Disodium tetraborate - 0.01 mol dm-3
Sodium chloride - 0.02 mol dm-3
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):
- nda
- Details on test conditions:
- Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 0.5 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.
Sample solutions at pH 4 and 7 were maintained at 50.0 ± 0.5°C for a period of at least 120 hours. Sample solutions at pH 9 were maintained at 50.0 ± 0.5°C for a period of 168 hours.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.5 - 0.506 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.494 - 0.498 g/L
- Duration:
- 168 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.51 - 0.518 g/L
- Number of replicates:
- Two for each time and pH.
- Positive controls:
- yes
- Remarks:
- Analytical standards
- Negative controls:
- yes
- Remarks:
- Matrix blanks of respective buffer solution
- Statistical methods:
- Cspl = (Pspl/Pstd) x Cstd x D x 1/1000
Cspl = sample concentration (g/l)
Pspl = mean peak area of sample solution
Pstd = mean peak area of standard solution, corrected to nominal standard concentration
Cstd = nominal standard concentration (500 mg/l)
D = sample dilution factor (1)
Results and discussion
- Preliminary study:
- Sample solutions at pH 4 and 7 were maintained at 50.0 ± 0.5°C for a period of at least 120 hours. Sample solutions at pH 9 were maintained at 50.0 ± 0.5°C for a period of 168 hours.
The estimated half-lives at 25°C of the test material are shown in the following table
pH Estimated half-life at 25°C
4 > 1 year
7 > 1 year
9 > 1 year - Test performance:
- No significant peaks were observed at the approximate retention time of the test material on analysis of any matrix blank solutions.
As the test material was determined to be hydrolytically stable under acidic conditions (t1/2 > 1 year at 25°C), no additional testing was performed at pH 1.2, 37.0 ± 0.5°C.
The analytical method was based on a method supplied by the Sponsor; the complex chromatographic profile was considered to be due to the complex nature of the test material. The large changes in chromatographic profile across the three test pH's were considered to be due to the test pH, as the profiles were consistent for the standards and samples for each test pH.
The test guideline states that the C7 test is not really applicable to mixtures. However, on review, it was decided that the chromatographic profiles for the standards were extremely similar to those for the respective samples; thus, it was considered that the results and conclusions were valid in this case. - Transformation products:
- not measured
- Details on hydrolysis and appearance of transformation product(s):
- Recovery ranges are due to testing done in duplicate
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 101
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 96.5 - 97.8
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 97.5 - 98
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 168 h
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Other kinetic parameters:
- no data available
- Details on results:
- See 'Preliminary study' above.
Any other information on results incl. tables
Duplicate standard solutions of test material were prepared in the respective buffer solution at a nominal concentration of 500 mg/l. the initial concentrations are given as a range as the testing is done in duplicate.
The test material concentrations at the given time points are shown in the following tables:
pH 4
Time (Hours) | Concentration (g/l) | Log10 [concentration (g/l)] | % of mean initial concentration |
|||
A | B | A | B | A | B | |
0 | 0.5 | 0.506 | -0.301 | -0.296 | 99.4 | 101 |
24* | 0.425 | 0.426 | -0.372 | -0.37 | 84.4 | 84.7 |
48 | 0.503 | 0.509 | -0.299 | -0.293 | 99.9 | 101 |
120 | 0.508 | 0.51 | -0.294 | -0.292 | 101 | 101 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-lifegreater than 1 year at 25°C.
pH 7
Time (Hours) | Concentration (g/l) | Log10 [concentration (g/l)] | % of mean initial concentration | |||
A | B | A | B | A | B | |
0 | 0.498 | 0.494 | -0.302 | -0.306 | 100 | 99.6 |
24 | 0.482 | 0.478 | -0.317 | -0.321 | 97.2 | 96.2 |
120 | 0.486 | 0.479 | -0.314 | -0.32 | 97.8 | 96.5 |
Results: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-lifegreater than 1 year at 25°C.
pH 9
Time (Hours) | Concentration (g/l) | Log10 [concentration (g/l)] | % of mean initial concentration | |||
A | B | A | B | A | B | |
0 | 0.51 | 0.518 | -0.293 | -0.286 | 99.2 | 101 |
24* | 0.441 | 0.444 | -0.355 | -0.353 | 85.9 | 86.4 |
120 | 0.49 | 0.49 | -0.31 | -0.31 | 95.3 | 95.3 |
168 | 0.501 | 0.504 | -0.3 | -0.298 | 97.5 | 98 |
Results: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
* considered to be an outlier, as out of agreement with other timepoint samples
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 1.00 x 10^3 mg/l. These were satisfactory with correlation coefficients of ≥ 0.992 being obtained
- Conclusions:
- The half-life of the test material was considerd to be > 1 year at pHs 4, 7 and 9.
- Executive summary:
In a determination of general physico-chemical properties study (Harlan project number: 0959/0224) the test material is estimated to have a half life of greater than 1 year at pHs of 4, 7 and 9 at 25°C.
The determination was carried out using Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008.
The mean total peak area of each standard was corrected to nominal concentration and the mean value taken.
The concentration of the sample solutions (g/l) was calculated using the following equation:Cspl= (Pspl/Pstd) x Cstdx D x 1/1000
where:
Cspl= sample concentration (g/l)
Pspl= mean peak area of sample solution
Pstd= mean peak area of standard solution, corrected to nominal standard concentration
Cstd= nominal standard concentration (500 mg/l)
D = sample dilution factor (1)
The estimated half-lives at 25°C of the test material are shown in the following table:
4 >1 year
7 >1 year
9 >1 year
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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