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EC number: 424-110-7 | CAS number: 194602-23-8 UK-143,108
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 25 November and 9 December 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out in accordance with method C7 of commission directive 92/69/EEC and in accordance with GLP. The test material was well characterised
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Principles of method if other than guideline:
- Hydrolysis of test substance at either pH 4, pH 7 or pH 9 over 5 days.
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Intended use: Pharmaceutical intermediate
Appearance: White powder
Storage conditions: Room temperature
Sample reference: CPI/96/070
Expiry date: Not supplied
Purity: 99.4%
Date received: 2 October 1996
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
acetylsalicylic acid - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- HPLC method validated in the water solubility study performed on this compound.
- Buffers:
- pH 4 buffer
Potassium dihydrogen citrate (23.03 g) was d issolved in distilled water (900 ml) and the pH of the solution adjusted to 4.0 with I M aq ueous sodium hydroxide at elevated temperature (50°C ± 5°C). The solution was then diluted to 1000 ml with distilled water.
pH 7 buffer
Potassium dihydrogen orthophosphate (13.66 g) was dissolved in distilled water (900 ml) and the pH of the solution adjusted to 7.0 with l M aqueous sodium hydroxide at elevated temperature (50°C ± 5°C). The solution was then diluted to 1000 ml with distilled water.
pH 9 buffer
Potassium chloride (7.82 g) and boric acid (6.22 g) were dissolved in distilled water (900 m l) and the pH of the solution adjusted to 9.0 with J M aqueous sodium hydroxide at elevated temperature (50°C ± 5°C). The solution was then diluted to 1000 ml with distilled water.
pH 2 buffer
Potassium dihydrogen orthophosphate (2.72 g, 1.36 g and 1.45 g) was dissolved in distilled water (2 litres, 1 litre and 1 litre respectively). The solutions were adjusted to pH 2.0 with l M hydrochloric acid. These pH 2 buffer solutions were used to prepare mobile phase. - Details on test conditions:
- Ni ne I00 ml volumetric flasks were calibrated at 50°C by heating I00 ml of distilled water at 20°C to 50°C in a water bath. The flasks were then marked at their new level.
Prior to the test, the recalibrated vol umetric flasks were rinsed with ethanol and allowed to drip dry. The buffer solutions were autoclaved at 122°C for 15 minutes and then purged with nitrogen for 5 min utes prior to use. The pH value of each buffer solution was then rechecked at 50°C and was seen to be 4.00, 7.03 and 9.04 respectively.
PER 21/970568
Test substance (approximately 0.1 g) was weighed accurately into each of 6 volumetric flasks. The test substance was dissolved in buffer at 50°C to produce 2 solutions at each pH. The remaining 3 flasks were filled with buffer to act as blanks at each pH.
An al iquot from each solution was then poured into a polystop bottle and allowed to cool in a water bath at 20°C.
The flasks containing the remainder of each sol ution were stoppered, covered in aluminium foil and placed in a water bath at 50°C.
After 2.4 hours and 5 days a further aliquot of each solution was taken and cooled as before prior to analysis.
Duration of testopen allclose all
- Duration:
- 2.4 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 155.48 other: ug/ml
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 164.48 other: ug/ml
- Number of replicates:
- 2
- Positive controls:
- yes
- Negative controls:
- no
- Statistical methods:
- used but not described
Results and discussion
- Preliminary study:
- No preliminary study was performed
- Test performance:
- Under the test cond itions UK-143,108 was found to undergo no significant hydrolysis after 5 days at pH 4, 7 or 9.
- Transformation products:
- no
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 100
- pH:
- 4
- Temp.:
- 50 °C
- % Recovery:
- 98.4
- pH:
- 7
- Temp.:
- 50 °C
- % Recovery:
- 100
- pH:
- 9
- Temp.:
- 50
Dissipation DT50 of parent compoundopen allclose all
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 7
- Temp.:
- 25
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Details on results:
- No significant peaks were seen in any of the blank chromatograms
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- UK-143,108 has been found to undergo no significant hydrolysis at pH 4, 7 or 9 over 5 days at 50°C.
The results indicate that at 25°C, the test substance will possess a half-life of greater than one year at pH 4, 7 and 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.
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