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EC number: 200-306-6 | CAS number: 57-00-1
- 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
Partition coefficient
Administrative data
Link to relevant study record(s)
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-16 Decemeber 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- GLP compliance:
- yes
- Type of method:
- flask method
- Partition coefficient type:
- octanol-water
- Analytical method:
- high-performance liquid chromatography
- Key result
- Type:
- log Pow
- Partition coefficient:
- < -2
- Temp.:
- 20 °C
- Remarks on result:
- other: pH value not reported.
- Details on results:
- The mean value of the log Kow (-3.17) is below the applicability range of -2 to 4 of the flask method. Therefore, the log Kow of creatine monohydrate is set to < -2.
The system suitability test prefomred prior to the HPLC analysis has met the acceptance criteria. - Conclusions:
- The log Kow for creatine monohydrate is < -2.
- Executive summary:
In a GLP guideline study according o EU method A.8 the n-octanol/ water partition coefficient of creatine monohydrate (Creapure TM) was determined.
Creatine monohydrate is almost insoluble in n-octanol. Only traces of the test substance could be found in the organic phase, but nearly all of the amount of the test substance could be found in the aqueous phase; the recovery rate was 100 %. The resulting log Kow value of ~ -3.17 is beyond the application range of the used flask shaking method (log Kow range: -2 to 4). Therefore, the log Kow for creatine monohydrate was set to < -2.
In the course of this examination no observations were made which might have influenced the intergrity of the study.
Justification for read-across:
Due to the known, very low solubility of creatine monohydrate in octanol the stock solution was prepared in water pre-saturated with octanol. Subsequently, the aqueous stock solution was equilibrated with octanol. After separation of the two phases (→ centrifugation), the concentration of creatine (not creatine monohydrate!) in both solvents was determined using HPLC.
In addition, the water that is contained in creatine monohydrate is not chemically bound and does not have any influence on the structure of the substance and does not influence the partioning behavior of creatine monohydrate. When dissolved in water there is no chemical difference between creatine and creatine monohydrate as the water crystal water is released from the creatine lattice.
Reference
Table 1: Amount of creatine monohydrate in water and n-octanol
Sample No. |
Amount of |
Nominal amount of test substance [mg] |
Actual amount of test substance1) 2)after equilibrium in |
Recovery as % of used amount |
||
Aqueous stock solution [ml] |
n-octanol [ml] |
Water [mg] |
n-octanol [mg] |
|||
1-1 |
50 |
50 |
10.054 |
10.012 |
0.007 |
99.65 |
1-2 |
50 |
50 |
10.054 |
10.051 |
0.009 |
100.06 |
2-1 |
50 |
100 |
10.054 |
10.036 |
0.011 |
99.93 |
2-2 |
50 |
100 |
10.054 |
10.067 |
0.013 |
100.26 |
3-1 |
100 |
50 |
20.108 |
20.070 |
0.007 |
99.85 |
3-2 |
100 |
50 |
20.108 |
20.103 |
0.006 |
100.00 |
|
|
|
|
Mean recovery: |
99.96 |
1)Mean value of 2 injections
2)Calculated with the concentrations listed in table 2
Table 2: Concentration of creatine monohydrate, partition coefficients
Sample No. |
Actual amount of creatine monohydrate in |
Kow Cn-octanol/ Cwater |
Log Kow |
|
n-octanol [mg/L] |
Water [mg/L] |
|||
1-1 |
0.144 |
200.24 |
0.000719 |
-3.14 |
1-2 |
0.183 |
201.03 |
0.000910 |
-3.04 |
2-1 |
0.113 |
200.72 |
0.000563 |
-3.25 |
2-2 |
0.130 |
201.34 |
0.000646 |
-3.19 |
3-1 |
0.131 |
200.70 |
0.000653 |
-3.19 |
3-2 |
0.119 |
201.03 |
0.000592 |
-3.23 |
|
|
Mean: |
0.000681 |
-3.17 |
Description of key information
In a GLP guideline study according to EU method A.8 the n-octanol/ water partition coefficient of creatine monohydrate
(Creapure TM) was determined to be < -2.
Key value for chemical safety assessment
- Log Kow (Log Pow):
- -2
- at the temperature of:
- 20 °C
Additional information
In a GLP guideline study according to EU method A.8 the n-octanol/ water partition coefficient of creatine monohydrate (Creapure TM) was determined. This information is used for read-across to creatine.
Creatine monohydrate is almost insoluble in n-octanol. Only traces of the test substance could be found in the organic phase, but nearly all of the amount of the test substance could be found in the aqueous phase; the recovery rate was 100 %. The resulting log Kow value of ~ -3.17 is beyond the application range of the used flask shaking method (log Kow range: -2 to 4). Therefore, the log Kow for creatine monohydrate was set to < -2. The same valued is used in the risk assessment of creatine.
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