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Diss Factsheets
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EC number: 478-270-8 | 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:
- 2006-09-27 to 2007-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 111 (Hydrolysis as a Function of pH) and EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH) without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- : Certificate issued by the United Kingdom GLP monitoring authorities.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): VRT-753136 hcl
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.4% w/w by High Performance Liquid Chromatography (HPLC)
- Impurities (identity and concentrations): individual unknown components were detected at 0.03 area%; isopropanol (residual solvent) at 300 ppm
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: 2006-05-25
- Lot/batch No.: 25515
- Expiration date of the lot/batch: May 2008
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: no data
- 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:
- - Sampling intervals for the parent/transformation products: approx. 5 min, 2.4 and 120 h
- Sampling method: At each sampling time, an aliquot (1 mL) was diluted to volume (10 mL) with mobile phase for analysis by high performance liquid chromatography (HPLC).
- Sampling methods for the volatile compounds, if any: not applicable
- Sampling intervals/times for pH measurements: 0 and 120 h
- Sampling intervals/times for sterility check: not applicable
- Sample storage conditions before analysis: no data
- Other observation, if any: no data - Buffers:
- - pH: 4, 7, 9
- Type and final molarity of buffer: phosphate (pH 4 and 7) and borate (pH 9); no molarity provided
- Composition of buffer:
- pH 4.0 : Potassium dihydrogen orthophosphate (6.0 g) and disodium hydrogen orthophosphate dodecahydrate (12.8 g) were dissolved in purified water (1900 mL), and the pH was adjusted to 4.0 ± 0.05 with orthophosphoric acid. The volume was then adjusted to 2000 mL with purified water.
- pH 7.0 : Potassium dihydrogen orthophosphate (27.2 g) was dissolved in purified water (3800 mL), 1M sodium hydroxide (120 mL) was added and the pH was adjusted to 7.0 ± 0.05 with 1M hydrochloric acid. The volume was then adjusted to 4000 mL with purified water.
- pH 9.0 : Disodium tetraborate decahydrate (66.4 g) and potassium dihydrogen orthophosphate (7.2 g) were dissolved in purified water (3800 mL); and the pH was adjusted to 9.0 ± 0.05 with 1M hydrochloric acid. The volume was then adjusted to 4000 mL with purified water. - Estimation method (if used):
- Not applicable
- Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Wheaton vials, 100 mL
- Sterilisation method: no data
- Lighting: test was performed in the dark
- Measures taken to avoid photolytic effects: incubation performed in the dark
- Measures to exclude oxygen: The test vials were purged of oxygen with nitrogen.
- Details on test procedure for unstable compounds: not applicable
- Details of traps for volatile, if any: not applicable
- If no traps were used, is the test system closed/open: no data
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no data
TEST MEDIUM
- Volume used/treatment: 100 mL (90 mL buffer, 10 mL test solution)
- Kind and purity of water: purified water
- Preparation of test medium: no data
- Renewal of test solution: none
- Identity and concentration of co-solvent: not applicable
OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Dissolved oxygen: no data
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Initial conc. measured:
- 1.07 g/L
- Duration:
- 120 h
- pH:
- 7
- Initial conc. measured:
- 1.07 g/L
- Duration:
- 120 h
- pH:
- 9
- Initial conc. measured:
- 1.07 g/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- no data
Results and discussion
- Preliminary study:
- - Results from the preliminary investigation showed that there was no significant change in the concentration of the test substance when incubated in pH 4, 7 and 9 buffer solutions at 50 ± 0.5 deg C (see Table 2). Less than 10% hydrolysis had occurred after 120 hours (5 days) under these conditions, equivalent to a half-life of greater than 1 year under environmental conditions (25 deg C).
- Test performance:
- - The pH was within 0.1 units of the target buffer pHs at the beginning and end of the 120 h incubation.
- The test temperature was maintained within 0.5 deg C of the target temperature. - Transformation products:
- not measured
- Details on hydrolysis and appearance of transformation product(s):
- Not applicable
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
Dissipation DT50 of parent compound
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: Less than 10% hydrolysis had occurred after 120 hours at pH 4, 7 and 9, equivalent to a half-life >1 year under environmental conditions (25 deg C).
- Other kinetic parameters:
- no data
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: yes, except for sterility which was confirmed
- Anomalies or problems encountered (if yes): not applicable
MAJOR TRANSFORMATION PRODUCTS
- Not applicable
MINOR TRANSFORMATION PRODUCTS
- Not applicable
MINERALISATION
- Not applicable
INDICATION OF UNSTABLE TRANSFORMATION PRODUCTS:
- Not applicable
VOLATILIZATION
- Not applicable
UNIDENTIFIED RADIOACTIVITY
- Not applicable
PATHWAYS OF HYDROLYSIS
- Not applicable
SUPPLEMENTARY EXPERIMENT
- Not applicable
Any other information on results incl. tables
Table 1. Concentration of the test substance in solution at each sampling time in g/L.
0 h | 0 h | 2.4 h | 2.4 h | 120 h | 120 h | |
pH | Measured | Mean | Measured | Mean | Measured | Mean |
4 | 1.07, 1.07 | 1.07 | 1.07, 1.08 | 1.07 | 1.08, 1.07 | 1.07 |
7 | 1.07, 1.07 | 1.07 | 1.08, 1.08 | 1.08 | 1.06, 1.07 | 1.07 |
9 | 1.05, 1.08 | 1.07 | 1.09, 1.13 | 1.11 | 1.08, 1.09 | 1.08 |
Applicant's summary and conclusion
- Conclusions:
- Less than 10% hydrolysis had occurred after 120 hours (5 days) under these conditions, equivalent to a half-life of greater than 1 year under environmental conditions (25 deg C). Therefore, the test substance was determined to be hydrolytically stable under acidic, neutral and basic conditions.
- Executive summary:
Not applicable
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