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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:
- Between 4 March 2009 and 29 May 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted GLP compliant study using the most recent test methods
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:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
none - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0, 2.4, 24, 120, 144
- Sampling method:
The whole sample was passed through a previously primed Strata X (60 mg/ 3 ml) solid phase extraction cartridge. The sample vessel was rinsed with 10 ml of reverse osmosis water, transferring the rinsings to the cartridge and then the cartridge was dried with nitrogen. The analyte was eluted with 5 ml of tetrahydrofuran into a 10 ml volumetric flask and diluted to the mark with reverse osmosis water
- Sampling methods for the volatile compounds, if any: not applicable
- Sampling intervals/times for pH measurements: 0, 2.4, 24, 120, 240
- Sampling intervals/times for sterility check: not applicable
- Sample storage conditions before analysis: not applicable
- Other observation, if any (e.g.: precipitation, color change etc.): none reported - Buffers:
- pH: 4
- Composition of buffer: Potassium hydrogen phthalate; 2.5 mmol/ cubic dm
- pH: 7
- Composition of buffer:
Disodium hydrogen orthophosphate (anhydrous); 1.5 mmol/ cubic dm
Potassium dihydrogen orthophosphate; 1.0mmol/ cubic dm
Sodium chloride; 1.0mmol/ cubic dm
- pH: 9
- Composition of buffer:
Disodium tetraborate; 0.5mmol/ cubic dm
Sodium chloride; 1.0mmol/ cubic dm
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- Details on test conditions:
- Aliquots (35 ml) of each buffer were transferred to individual glass vessels. Test material dissolved in tetrahydrofuran (1.01 mg/l) was added to each individual sample in the proportion of 1% (i.e. 0.350 ml) to give a nominal concentration of 1.01 x 10"5 g/l in the three buffer solutions.
The solutions were shielded from light whilst maintained at the test temperature.
Preliminary test
Tier 1
Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5°C for a period of 144 hours.
Tier 2
Results from the Preliminary test/Tier 1 showed it was not necessary to undertake further testing at pH 4, pH 7 and pH 9.
Results and discussion
- Transformation products:
- no
Total recovery of test substance (in %)open allclose all
- % Recovery:
- >= 83.1 - <= 85.4
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 6 d
- % Recovery:
- >= 89.4 - <= 106
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 6 d
- % Recovery:
- >= 85.2 - <= 94.4
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 6 d
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 linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 5.0 x 10 -2mg/l. This was satisfactory with a correlation coefficient of 0.997 being obtained. Recovery of analysis of the sample procedure was assessed and proved adequate for the test.
Applicant's summary and conclusion
- Conclusions:
- The test substance is considered to be hydrolytically stable and not prone to hydrolysis, with a half life at pH 4,7 and 9 above 1 year at ambient
- Executive summary:
The hydrolysis has been assessed using HPLC-MS method according to EU method C7 in compliance with GLP. Measurements for the recovery of test material was calculated by comparison of the recorded peak area of test sample with the recorded peak area of the standards. The test substance is considered to be hydrolytically stable and not prone to hydrolysis, with a half life at pH 4,7 and 9 above 1 year at ambient
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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