Registration Dossier
Registration Dossier
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EC number: 934-407-8 | CAS number: -
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/06/2015 - 05/06/2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient - Shake Flask Method)
- Version / remarks:
- Preliminary test
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- estimation method (solubility ratio)
- Partition coefficient type:
- octanol-water
Test material
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:PREVOR, batch 040801#
Test item tested as received.
Study design
- Analytical method:
- other: the preliminary test result showed that no complementary test was possible (HPLC method cannot be used).
Results and discussion
Partition coefficient
- Key result
- Type:
- log Pow
- Partition coefficient:
- -5
- Remarks on result:
- other: estimated value because the test item remained undissolved into octanol up to the concentration limit
Any other information on results incl. tables
Estimation of partition coefficient with the shake flask method:
| Solvent | Mass of sample (mg) | Solvent volume (ml) | Estimated solubility (g/l) | Log P |
| Water | 5002 | 5.011 | 998.20 | -5.0 |
| Octanol | 0.4 | 40 | 0.01 |
Octanol Sample Preparation: Approximately 2 mg of X300 was added to a 40 mL clear glass vial, followed by Octanol 40 mL. The sample was shaken, sonicated and warmed to approximately 40°C. The sample remained undissolved. The preparation above was repeated using 0.40 mg of X300. The second X300 sample remained undissolved. At concentrations below 10 mg/L it was difficult to accurately determine the presence X300. Therefore it is not known if the sample is soluble below this concentration or if this is the limit of detection for the visualisation of X300 in octanol.
Applicant's summary and conclusion
- Conclusions:
- The estimated partition coefficient Log Pow = -5
- Executive summary:
The partition coefficient was estimated using the shake flask method according to the EU A.8 test guideline. The estimated value was: Log Pow = -5
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