Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- Mar. 2018 - Apr. 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
- Version / remarks:
- from 27. July 1995
- Deviations:
- yes
- Remarks:
- please refer to "Principles of method if other than guideline"
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient - Shake Flask Method)
- Version / remarks:
- Council Regulation (EC) No 440/2008 of 30. May 2008, published on 31. May 2008
- Deviations:
- yes
- Remarks:
- please refer to "Principles of method if other than guideline"
- Principles of method if other than guideline:
- Following the guideline, the flask method is applicable when the log POW value falls within the range -2 to 4. As the estimated log Pow value lay outside this range, no main test was performed.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Partition coefficient type:
- octanol-water
- Analytical method:
- other: visually
- Type:
- log Pow
- Partition coefficient:
- < -2
- Temp.:
- 20 °C
- Remarks on result:
- other: pH not determined
- Details on results:
- The solubility of the test item in n-octanol was estimated during the preliminary test as < 0.5 g/L at 20.0 °C (mean value). The water solubility of the test item was determined in the study no. 17072401G910 as > 1000 g/L.
The log POW was estimated from the ratio of the solubility values of the test item in pure solvents.
Pow < 0.5 / 1000 = 0.0005, Log Pow < -3.3
As the value lay outside the range of -2 to 4, the log POW was stated as < -2 with Pow < 0.01. - Conclusions:
- The solubility of the test item in n-octanol was estimated during the preliminary test as < 0.5 g/L at 20.0 °C (mean value). The water solubility of the test item was determined in the study no. 17072401G910 as > 1000 g/L.
The log Pow was estimated from the ratio of the solubility values of the test item in pure solvents as < -2. - Executive summary:
The study was performed under GLP conditions and according to OECD guideline 107 and EU Method A.8.
The solubility of the test item in n-octanol was estimated during the preliminary test as < 0.5 g/L at 20.0 °C (mean value). The water solubility of the test item was determined in the study no. 17072401G910 as > 1000 g/L.
The log POW was estimated from the ratio of the solubility values of the test item in pure solvents as < -2. No main test according to guideline was performed, because the flask method is applicable when the log POW value falls within the range -2 to 4.
No observations were made which might cause doubts concerning the validity of the study outcome.
Reference
The following results were observed in the preliminary test:
| Total Volume n-Octanol [ml] | Time Ultrasonic [min] | Observations |
10 |
10 | dissolution was not complete |
| 20 | 10 | dissolution was not complete |
| 30 | 10 | dissolution was not complete |
| 40 | 10 | dissolution was not complete |
| 50 | 10 | dissolution was not complete |
| 60 | 10 | dissolution was not complete |
| 70 | 10 | dissolution was not complete |
| 80 | 10 | dissolution was not complete |
| 90 | 10 | dissolution was not complete |
| 100 | 30 | dissolution was not complete |
Description of key information
The study was performed under GLP conditions and according to OECD guideline 107 and EU Method A.8.
The solubility of the test item in n-octanol was estimated during the preliminary test as < 0.5 g/L at 20.0 °C (mean value). The water solubility of the test item was determined in the study no. 17072401G910 as > 1000 g/L.
The log POWwas estimated from the ratio of the solubility values of the test item in pure solvents as < -2. No main test according to guideline was performed, because the flask method is applicable when the log POWvalue falls within the range -2 to 4.
No observations were made which might cause doubts concerning the validity of the study outcome.
Key value for chemical safety assessment
- Log Kow (Log Pow):
- -2
- at the temperature of:
- 20 °C
Additional information
The log POW is below -2, nevertheless -2 is used as key value for the CSA because this value shows that the substance is very hydrophilic.
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