Registration Dossier
Registration Dossier
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EC number: 469-500-8 | CAS number: 857035-95-1
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 October 2006 to 02 November 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- other: calculation
- Partition coefficient type:
- octanol-water
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas
Results and discussion
Partition coefficient
- Type:
- log Pow
- Partition coefficient:
- < -2.8
- Details on results:
- In the preliminary test, the solubility of IMEXINE OBH in n-octanol was found to be < 1 g/L at room temperature.
The solubility of IMEXINE OBH in water was found to be > 603 g/L (CV = 3%) at room temperature (CIT/Study No. 32042 PSE).
log Pow = log (C n-octanol / C water)
where:
C n-octanol = concentration of the test item in n-octanol (g/L)
C water = concentration of the test item in water (g/L)
Thus:
log Pow = log (1/603)
log Pow < -2.8
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- As the HPLC method enables partition coefficient to be determined in the log Pow range between 0 and 6 and as the shake-flask method enables partition coefficient to be determined in the log Pow range between -2 and 4, the estimation of log Pow of test item was carried out using the solubility of test item in n-octanol and water.
log Pow <-2.8
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