Registration Dossier
Registration Dossier
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EC number: 232-369-0 | CAS number: 8008-63-7 Extractives and their physically modified derivatives such as proteins, lipids, carbohydrates, nucleic acids, inorganic ions, etc. obtained from mammalian bile.
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:
- from 2018-05-23 to 2019-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient - Shake Flask Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- estimation method (solubility ratio)
- Partition coefficient type:
- octanol-water
- Key result
- Type:
- log Pow
- Partition coefficient:
- < -3.1
- Temp.:
- 20 °C
- pH:
- 7
- Conclusions:
- The partition coefficient of the test item was estimated to be <-3.1.
- Executive summary:
A study was conducted in accordance with OECD TG 107 and Regulation (EC) No 440/2008 method A.8 to determine the partition coefficient of the test substance using the solubility ration between water and 1-octanol. A preliminary test was performed with the test item where 180 mg of the test item were mixed with n-octanol at different volumes and the solubility was observed. In all prepared samples the test item did not dissolve in the 1-octanol. Solubility below 1.5 g/L was estimated. The solubility of the test item in water was estimated to be >1730 g/L. Based on both solubilities, the partition coefficient was estimated to be <-3.1. No main test and no analytical analysis were performed.
Reference
The preliminary test at room temperature showed, that the octanol solubility of the test item was below 1.5 g/L.
Table 1. Preliminary test for the octanol solubility
Amount of test item [mg] |
Total volume of added octanol [mL] |
Stirring time at RT [min] |
Remark |
180 |
10 |
45 |
not dissolved |
30 |
35 |
not dissolved |
|
60 |
70 |
not dissolved |
|
90 |
35 |
not dissolved |
|
120 |
130 |
not dissolved |
With the water solubility of >1730 g/L and the solubility in octanol of <1.5 g/L, the partition coefficient log Pow was estimated to be <-3.1. No main test was performed.
Description of key information
The partition coefficient of the test item was estimated to be <-3.1.
Key value for chemical safety assessment
- Log Kow (Log Pow):
- -3.1
- at the temperature of:
- 20 °C
Additional information
A study was conducted in accordance with OECD TG 107 and Regulation (EC) No 440/2008 method A.8 to determine the partition coefficient of the test substance using the solubility ration between water and 1-octanol. A preliminary test was performed with the test item where 180 mg of the test item were mixed with n-octanol at different volumes and the solubility was observed. In all prepared samples the test item did not dissolve in the 1-octanol. Solubility below 1.5 g/L was estimated. The solubility of the test item in water was estimated to be >1730 g/L. Based on both solubilities, the partition coefficient was estimated to be <-3.1. No main test and no analytical analysis were performed.
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