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EC number: 404-520-2 | CAS number: 139893-43-9 SIMVASTATIN AMMONIUM SALT
- 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
Adsorption / desorption
Administrative data
Link to relevant study record(s)
- Endpoint:
- adsorption / desorption, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24th June 2010 to 26th November 2010
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.19 (Estimation of the Adsorption Coefficient (KOC) on Soil and Sewage Sludge Using High Performance Liquid Chromatography (HPLC))
- GLP compliance:
- yes
- Type of method:
- HPLC estimation method
- Test temperature:
- 25oC
- Details on study design: HPLC method:
- The sorption behaviour of the test substance on soil can be investigated using high performance liquid chromatography (HPLC). This is performed on commercially available analytical columns packed with a solid phase containing a moderately polar stationary phase with lipophilic and polar moieties (e.g. cyano-propyl bonded phase). The chemicals injected onto the column move along it by partitioning between the mobile phase and the stationary phase. The velocity of each component thereby depends on the degree of adsorption on the stationary phase. The dual nature of the stationary phase allows for interaction of polar and apolar parts of a molecule in a similar way as is the case for soil. This enables the relationship between the retention time on such a column and the adsorption coefficient on the organic parts of the soil to be established.
Since the test substance is an ionisable substance, separate tests were conducted, as follows,
at each of pH 4, 7 and 9:
In order to correlate the measured capacity factor (k) of the test material with its Koc, six reference materials were selected from a list of recommended compounds. These reference compounds were selected to have log10Koc values between 1.3 and 5.6. An internal standard (formamide) with no retention on the HPLC column was used to determine the deadtime of the HA solution of Simvastatin ammonium salt (approximately 50 mg/l in HPLC mobile phase, and also containing I.D.S. at the same concentration as in the reference mixture) was prepared and chromatographed in duplicate, bracketed by samples of the reference mixture, using the following conditions. PLC system. - Key result
- Sample No.:
- #3
- Type:
- log Koc
- Value:
- 1.3 <
- pH:
- 9
- Temp.:
- 25 °C
- Key result
- Sample No.:
- #2
- Type:
- log Koc
- Value:
- 1.3 <
- pH:
- 7
- Temp.:
- 25 °C
- Key result
- Sample No.:
- #1
- Type:
- log Koc
- Value:
- 2.4
- pH:
- 4
- Temp.:
- 25 °C
- Validity criteria fulfilled:
- yes
- Conclusions:
- Simvastatin ammonium salt was determined to have log10Koc values of 2.4, < 1.3 and < 1.3 at
pH 4, 7 and 9 respectively (equivalent Koc = 260, < 20 and < 20).
Reference
Description of key information
Key value for chemical safety assessment
- Koc at 20 °C:
- 1.3
Additional information
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