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Diss Factsheets
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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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_environmental-fate-and-pathways.png)
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols with no deviations from standard test guidelines and/or minor methodological deficiences which do not affect the quality of the relevant results
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): INK BH11 M
- Substance type: dark red powder
- Lot/batch No.: MB-1A
- Storage condition of test material: room temperature in the dark
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- Sample vessels 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 high performance liquid chromatography (HPLC).
Samples
Aliquots of each sample solution were diluted by a factor of 50 using 2.5 mM tetrabutylammonium hydroxide aqueous solution. - Buffers:
- - pH: 4
- Type and final molarity of buffer: 0.05 mol dm^-3
- Composition of buffer: potassium hydrogen phthalate
- pH: 7
- Type and final molarity of buffer: 0.03, 0.02, 0.02 mol dm^-3
- Composition of buffer: disodium hydrogen orthophosphate (anhydrous), potassium dihydrogen orthophosphate, sodium chloride
- pH: 9
- Type and final molarity of buffer: 0.01, 0.02 mol dm^-3
- Composition of buffer: disodium tetraborate, sodium chloride
The buffer solutions were filtered through a 0.2 pm 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
- Statistical methods:
- Sample Solution Concentration
Cspl= (Pspl/ Pstdx Cstdx D) / 1000(equation 1)
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 solution (100 mg/L)
D = sample dilution factor (10)
Results and discussion
- Preliminary study:
- Less than 10% hydrolysis after 5 days at 50 C, equivalent to half-life greater than 1 year at 25 C at pH 4, pH 7, and pH 9.
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
Any other information on results incl. tables
The test material concentrations at the given time points are shown in the following tables:
pH 4 at 50.0 ± 0.5°C
Time (Ho urs) |
Concentration (WI) |
Mean % of mean initial concentration |
|
A |
B |
||
0 |
5.21 |
5.19 |
100 |
24 |
5.15 |
5.20 |
99.6 |
120 |
5.09 |
4.73 |
94.5 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
pH 7 at 50.0 ± 0.5°C
Time (Hours) |
Concentration (gll) |
Mean % of mean initial concentration |
|
A |
B |
||
0 |
5.09 |
5.11 |
100 |
24 |
5.24 |
5.22 |
103 |
120 |
5.24 |
5.21 |
102 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
pH 9 at 50.0 ± 0.5°C
Time (Hours) |
Concentration (gll) |
Mean % of mean initial concentration |
|
A |
B |
||
0 |
5.24 |
5.19 |
100 |
24 |
5.32 |
5.25 |
101 |
120 |
5.10 |
5.07 |
97.6 |
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Results from the Preliminary test/Tier 1 showed it was not necessary to undertake further testing at pH 4, pH 7 and pH 9.
No significant peaks were observed at the approximate retention time of the test material on analysis of any matrix blank solutions.
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 200 mg/l in the three buffer matrices. These were satisfactory with correlation coefficients of 1.000 being obtained
- Conclusions:
- As the test material was determined to be hydrolytically stable under acidic conditions (tai > 1 year at 25°C), no additional testing was performed at pH 1.2, 37.0 ± 0.5°C.
The estimated half-fifes at 25°C of the test material are shown in the following table:
pH Estimated half-fife at 25°C
4 >1 year
7 >1 year
9 >1 year - 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 aFunction of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008.
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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