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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
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Phys chem testing was conducted between 10 March 2011 and 12 April 2012
- 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 not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- 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)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: TM10-099
Description: dark blue powder
Batch number: MB-1
Date received: 4 March 2011
Expiry date: 4 March 2012
Storage conditions: room temperature in the dark
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0 and 120 hours
- Sampling intervals/times for pH measurements: various times - Buffers:
- - pH: 4, 7, 9
- Composition of buffer:
pH 4: Potassium hydrogen phthalate, 0.05 mol/dm3
pH 7: Disodium hydrogen orthophosphate (anhydrous), 0.03 mol/dm3
Potassium dihydrogen orthophosphate, 0.02 mol/dm3
Sodium chloride, 0.02 mol/dm3
pH 9: Disodium tetraborate, 0.01 mol/dm3
Sodium chloride, 0.02 mol/dm3 - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: stoppered glass flasks
- Sterilisation method: The buffer solutions were filtered through a 0.2 µm membrane filter to ensure they were sterile before commencement of the test.
- Lighting: The solutions were shielded from light whilst maintained at the test temperature.
- Measures taken to avoid photolytic effects: not reported
- Measures to exclude oxygen: The solutions were subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen content
- If no traps were used, is the test system closed/open: closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus? not reported
PREPARATION OF SAMPLES
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 1 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.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.02 - 1.09 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.02 - 1.03 g/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.03 - 1.04 g/L
- Number of replicates:
- 2 samples per pH
- Positive controls:
- no
- Negative controls:
- no
Results and discussion
- Preliminary study:
- Less than 10% hydrolysis was observed after 120 hours at 50°C, equivalent to a half-life greater than 1 year at 25°C for pH 4, pH 7 and pH 9.
- Transformation products:
- not specified
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: Based on observation that less than 10% hydrolysis after 120 hours at 50°C
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: Based on observation that less than 10% hydrolysis after 120 hours at 50°C
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- other: Based on observation that less than 10% hydrolysis after 120 hours at 50°C
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
MAJOR TRANSFORMATION PRODUCTS
No data
Any other information on results incl. tables
A peak was observed in the matrix blank solutions at the approximate retention time of the test item. This was consistent and considered to be instrument carry-over. Since the standard and sample responses were corrected for this blank value, there was no
significant impact on the results.
As the test item 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.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life of the test material at 25°C was estimated to be greater than 1 year for pH 4, pH 7 and pH 9.
- Executive summary:
The hydrolysis potential of the test item TM10-099 was determined in a valid GLP study. The determination was carried out using a procedure designed to be compatible with OECD TG No 111.
Duplicate sample solutions with a nominal concentration of 1 g/L with each pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours. Less than 10% hydrolysis was observed after 120 hours at 50 °C, which is equivalent to a half-life greater than 1 year at 25 °C for pH 4, pH 7 and pH 9.
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.
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