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EC number: 604-045-2 | CAS number: 137862-53-4
- 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
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 1995
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- Aliquots of each test solution were analysed in time intervals using the analytical method as described later in this report.
- Buffers:
- Buffer solutions with the following concentrations were used for experiments:
pH4.0: 0.40 vol% 0.1 M NaOH
50.00 vol% 0.1 M potassium biphthalate
49.60 vol% double distilled water
pH7.0: 29.63 vol% 0.1 M NaOii
50.00 vol% 0.1 M monopotassium phosphate
20.37 vol% double distilled water
pH9.0: 21.30 vol% 0.1 M NaOH
50.00 vol% 0.1 M boric acid
28.70 vol% double distilled water
The pH of each buffer solution was checked with a calibrated pH meter at rerequired temperature to a precision of at least ± 0 .1 before and after addition of the test article. - Estimation method (if used):
- A preliminary test was performed at 50 °C ± 0.1 °Cat pH 4.0, pH 7.0 and pH 9.0, each. Aliquots of each test solution were analysed in time intervals using the analytical method as described later in this report.
- Details on test conditions:
- As described in the guideline, in accordance with the RCC Umweltchemie Standard Operating Procedures. Incubation time of 5 days.
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 25 °C
- Initial conc. measured:
- >= 0.127 - <= 42.7 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 25 °C
- Initial conc. measured:
- >= 0.127 - <= 42.7 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 25 °C
- Initial conc. measured:
- >= 0.127 - <= 42.7 mg/L
- Preliminary study:
- The preliminary test for a hydrolysis reaction of CGP 48933 Step 9 at pH 4.0, pH 7.0 and pH 9.0 was performed according to the OECD guideline no. 111: "Hydrolysis as a function of pH" {1981) and the EEC directive 92/69, C.7: " Abiotic degradation: hydrolysis as a function of pH" (1992).
- Transformation products:
- not specified
- % Recovery:
- <= 10
- pH:
- 4
- Temp.:
- 25 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- <= 10
- pH:
- 7
- Temp.:
- 25 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- % Recovery:
- <= 10
- pH:
- 9
- Temp.:
- 25 °C
- Duration:
- 5 d
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- Type:
- not specified
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- Type:
- not specified
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- Type:
- not specified
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- The results showed no significant degradation of CGP 48933 Step 9. Because less than 10 % of the hydrolysis reaction was observed after 5 days at pH 4.0, pH 7.0 and pH 9.0 respectively, CGP 48933 Step 9 was considered to be hydrolytically stable. Therefore no further testing was necessary at these pH values.
The half-life times of CGP 48933 Step 9 at pH 4.0, pH 7.0 and pH 9.0 were estimated to be longer than one year at 25 °C (tv. (25 °C) > 1 year). - Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec 2018 - March 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- The concentration of the test item in the test samples was determined immediately after preparation (t=0) and after 2.4 hours and 5 days. The samples taken after 2.4 hours and 5 days were cooled to room temperature using running tap water.
- Buffers:
- Acetate buffer pH 4, 0.1 M
Solution of 16.7% 0.1 M sodium acetate in water and 83.3% 0.1 M acetic acid in water. Buffer contained 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.1 M
Solution of 0.1 M potassium di-hydrogenphosphate in water adjusted to pH 7 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide.
Borate buffer pH 9, 0.1 M
Solution of 0.1 M boric acid in water and 0.1M potassium chloride in water adjusted to pH 9 using 10N sodium hydroxide. Buffer contained 0.0009% (w/v) sodium azide. - Details on test conditions:
- The buffer solutions were filter-sterilised through a 0.2 μm FP 30/0.2 CA-S filter (Whatman, Dassel, Germany) and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. The test item was spiked to the solutions at a target concentration of 2 mg/L using a spiking solution in acetonitrile. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 mL test solution and placed in
the dark in a temperature controlled environment at 50.0°C.
The spiking volume was < 1% of the sample volume. Nominal concentrations were not corrected for the spiking volume.
The concentration of the test item in the test samples was determined immediately after preparation (t=0) and after 2.4 hours and 5 days. The samples taken after 2.4 hours and 5 days were cooled to room temperature using running tap water.
Analysis was performed on subsamples of 500 μL. The samples were diluted in a 1:1 (v:v) ratio with 1% ortho-phosphoric acid in acetonitrile and analyzed.
Blank buffer solutions containing a similar content of blank spiking solution were treated similarly as the test samples and analyzed at t=0.
The pH of each of the test solutions (except for the blanks) was determined at each sampling time. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 25 °C
- Initial conc. measured:
- >= 0.1 - <= 100 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 25 °C
- Initial conc. measured:
- >= 0.1 - <= 100 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 25 °C
- Initial conc. measured:
- >= 0.1 - <= 100 mg/L
- Number of replicates:
- Buffer pH 4 and Buffer pH 9: 2
Buffer pH 7: 5 - Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- not specified
- % Recovery:
- 4.5
- St. dev.:
- 0
- pH:
- 4
- Temp.:
- 23 °C
- Duration:
- 5 d
- % Recovery:
- 2.6
- St. dev.:
- 0
- pH:
- 7
- Temp.:
- 23 °C
- Duration:
- 5 d
- % Recovery:
- 1.5
- St. dev.:
- 0
- pH:
- 9
- Temp.:
- 23 °C
- Duration:
- 5 d
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- Type:
- not specified
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- Type:
- not specified
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- Type:
- not specified
- Remarks on result:
- hydrolytically stable based on preliminary test
- Validity criteria fulfilled:
- yes
- Conclusions:
- The preliminary test (Tier 1) was performed for the determination of the rate of hydrolysis of VALSARTAN/DS at pH values normally found in the environment (pH 4-9).
At each pH value a degree of hydrolysis of < 10% was observed after 5 days. According to the guideline, performance of the main study (Tier 2) was not required.
Referenceopen allclose all
Description of key information
No hydrolysis.
The half-life times of Valsartan at pH 4.0, pH 7.0 and pH 9.0 were estimated to be longer than one year at 25 °C (tv. (25 °C) > 1 year) in both studies.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
The results showed no significant degradation of CGP 48933 Step 9. Because less than 10 % of the hydrolysis reaction was observed after 5 days at pH 4.0, pH 7.0 and pH 9.0 respectively, CGP 48933 Step 9 was considered to be hydrolytically stable. Therefore no further testing was necessary at these pH values.
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