Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-281-9 | 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_environmental-fate-and-pathways.png)
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2009-11-16 to 2010-04-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Remarks:
- HPLC Method
- Details on sampling:
- In the preliminary test, solutions of <50 % saturation respectively <0.01 mol/L of the test substancein buffers with pH values of 4, 7 and 9 were kept at 50 + 0.5 °C and the concentration of the test substance was determined after various times up to a maximum of 5 days. Stock solutions of the test substance were prepared by weighing 27.1 mg, 29.3 mg and 33.3 mg of the test substance in 50 mL of the appropriate sterile buffer. 50 mL of each stock solution was filled up to 100 mL with autoclaved water (for analysis,Merck, Lot. No. HC946601) and the recovery of each pH was determined immediately using HPLC.
Afterwards the solutions were divided into 10 amber screw cap vials (total 30 vials a 10 mL) and nitrogen was bubbled through the solutions to exclude oxygen. The concentration of the resulting solutions were lower than 50 % saturation respectively <0.01 mol/L.
The vials were kept in a peltier-cooled incubator (IPP200, Memmert, Germany) at the test temperature in the dark. The temperature (calibrated glass/mercury thermometer No. 249) was recorded during the test. The pH values of the solutions were determined with a pHmeter (ino Lab pH-Level 2; WTVW).
- Sampling method: Portions of the solutions were taken from the individual vials (one vial was taken form the incubator per sampling time and pH).
- Sampling intervals: The samples were measured at 0, 3.5, 23.5, 117.0 and 120.2 hours.
- pH measurements: At each sampling time
- Sample storage conditions before analysis: The concentrations were determined immediatly
- Other observation, if any (e.g.: precipitation, color change etc.): no relevant - Buffers:
- Buffer pH 4: 250 mL 0.1 mol/L potassium dihydrogen citrate (Fluka; Lot. No. 1105996) and 45 mL 0.1 mol/L sodium hydroxide (Titrisol; Merck, Lot. No. HC 811272) filled up to 500 mL with water.
Buffer pH 7: 250 mL 0.1 mol/L potassium dihydrogenphosphate (Merck, Lot. No. A645773) and 148.2 mL 0.1 mol/L sodium hydroxide filled up to 500 mL with water.
Buffer pH 9: 250 mL 0.1 mol/l boric acid (Sigma, Lot. No. 71K2213) in 0.1 mol/L potassium chloride (ApliChem, Lot. No. 9T002282) and 106.5 mL 0.1 mol/L sodium hydroxide filled up to 500 mL with water.
The water (for analysis; Merck; Lot. No. HC946601 was autoclaved before use.
The actual pH for the buffers are shown in the following Table:
target pH actual pH in the preliminary test
4 4.02
7 7.02
9 8.99 - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 10 mL amber screw cap vials
- Sterilisation method: autoclave
- Measures taken to avoid photolytic effects: samples incubated in the dark
- Measures to exclude oxygen: nitrogen was bubbled through the solutions
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no
TEST MEDIUM
- Volume used/treatment 10 mL per vial
- Kind and purity of water: autoclaved water (for analysis, Merck, Lot. No. HC946601)
- Preparation of test medium: Stock solutions of the test substance were prepared by weighing 27.1 mg, 29.3 mg and 33.3 mg of the test substance in 50 mL of the appropriate sterile buffer. 50 mL of each stock solution was filled up to 100 mL with autoclaved water (for analysis, Merck, Lot. No. HC946601) and the recovery of each pH was determined immediately using HPLC. Afterwards the solutions were divided into 10 amber screw cap vials (total 30 vials a 10 mL) and nitrogen was bubbled through the solutions to exclude oxygen. - Duration:
- 120.2 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.284 g/L
- Duration:
- 120.2 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.293 g/L
- Duration:
- 120.2 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 0.36 g/L
- Number of replicates:
- 1 (preliminary test)
2 (final test) - Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- Less than 10 % of the test substance hydrolysed within 5 days at 50 °C, at each of the three pH-values tested.
It is estimated that the half-life of the test substance in aqueous solution at 25 °C is greater than one year for each pH value. The test substance was determined to be stable to hydrolysis at pH 4, pH 7 and pH 9 and no main tests were needed to be performed. - Test performance:
- The validity criteria were fulfilled. The method was validated considering:
- ICH HarmonisedTripartite Guideline: "Validation of Analytical Procedures: Textvand Methodology", Q2(R1), Step 4, including an addendum, 2005.ve EC- Working Document SANCO/3030/99 rev. 4, adopted on 11 July 2000,
- Technical Material and Preparations: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex Il (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414. - Transformation products:
- no
- % Recovery:
- ca. 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 0 h
- Remarks on result:
- other: 105 % Recovery
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 0 h
- % Recovery:
- ca. 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 0 h
- Remarks on result:
- other: 108.1 % Recovery
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- > 790 h
- Type:
- other: not applicable
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 8 800 h
- Type:
- other: not applicable
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- > 790 h
- Type:
- other: not applicable
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 8 800 h
- Type:
- other: not applicable
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0 h-1
- DT50:
- > 790 h
- Type:
- other: not applicable
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 8 800 h
- Type:
- other: not applicable
- Details on results:
- The objective of the study was to determine the rate of hydrolysis of the test substance as a function of pH for evaluating its abiotic degradation behaviour according to EU chemical notification requirements. Less than 10 % of the test substance hydrolysed within 5 days at 50 °C, at each of the three pH-values tested.
It is estimated that the half-life of the test substance in aqueous solution at 25 °C is greater than one year for each pH value Therefore, the test sustance is stable to hydrolysis at pH 4, pH 7 and pH 9 and no main tests were performed.
The result of the hydrolysis study is of limited reliability because the purity of the test substance is only 82 % (according to the guideline the purity should be at least 95 %) and a reference substance of higher purity is not available. - Validity criteria fulfilled:
- yes
- Conclusions:
- A hydrolysis study was performed according to (OECD 111 (2004) und die EU Method C.7(2008)). Less than 10 % of the test substance hydrolysed within 5 days at pH 4, pH 7 and pH 9 at 50 °C.
The test substance was determined to be stable to hydrolysis at each pH-value tested and no additional testing was required.
According to the guideline it is estimated that the half-life of the test substance in aqueous solution at 25 °C is greater than one year for pH 4, pH 7 and pH 9. - Executive summary:
A hydrolysis study was performed according to (OECD 111 (2004) und die EU Method C.7(2008)).
The following hydrolytic properties of the test substance were obtained:
pH
temperature
(°C)recovery**
(%)rate constant
(h-1)rate constant
(s-1)half life
(h)4
50
105.0
<0.00088
<0.00000024
>790
25
--
<0.00008*
<0.00000002*
>8800*
7
50
100.0
<0.00088
<0.00000024
>790
25
--
<0.00008*
<0.00000002*
>8800*
9
50
108.1
<0.00088
<0.00000024
>790
25
--
<0.00008*
<0.00000002*
>8800*
* estimated according to the guideline.
** Recoveries should range from 90 % to 110 %.Less than 10 % of the test substance at pH 4, pH 7 and pH 9 hydrolysed within 5 days at 50 °C.
According to the guideline it is estimated that the half-life of the test substance in aqueous solution at 25 °C is greater than one year for pH 4, pH 7 and pH 9. Therefore the test substance was determined to be stable to hydrolysis at each pH-value tested.
The result of the hydrolysis study is of limited reliability because the purity of the test substance is only 82 % (according to the guideline the purity should be at least 95 %) and a reference substance of higher purity is not available.
Reference
Description of key information
A Hydrolysis study was performed according to (OECD 111 (2004) und die EU Method C.7(2008)). Less than 10 % of the test substance hydrolysed within 5 days at pH 4, pH 7 and pH 9 at 50 °C.
The test substance was determined to be stable to hydrolysis at each pH-value tested and no additional testing was required.
According to the guideline it is estimated that the half-life of the test substance in aqueous solution at 25 °C is greater than one year for pH 4, pH 7 and pH 9.
Key value for chemical safety assessment
Additional information
A Hydrolysis study was performed according to (OECD 111 (2004) und die EU Method C.7 (2008)). In the preliminary test, solutions of <50 % saturation respectively <0.01 mol/L of the test substancein buffers with pH values of 4, 7 and 9 were kept at 50 +0.5 °C and the concentration of the test substande was determined after various times up to a maximum of 5 days.
Less than 10 % of the test substance hydrolysed within 5 days at pH 4, pH 7 and pH 9 at 50 °C. The test substance was determined to be stable to hydrolysis at each pH-value tested and no additional testing was required.
According to the guideline it is estimated that the half-life of the test substance in aqueous solution at 25 °C is greater than one year 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.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)