Registration Dossier
Registration Dossier
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EC number: 617-191-7 | CAS number: 81060-07-3
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20.02.2003 - 21.02.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The Study was done in accordance with the Study Protocol CH - 26/2003 and the following guidelines: - OECD Guidelines for Testing Chemicals. Testing Guideline No. 107, Paris, 1981 - Official Journal ofthe European Communities No. L 383/A, 29.12.92: Methods for the Determination of Physical-Chemical Properties: A.8 "Partition Coefficient - Shake flask method"
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- shake-flask method to: flask method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- Bromohexine hydrobromide
- IUPAC Name:
- Bromohexine hydrobromide
- Details on test material:
- - Lot/batch No.: 02070864
- Storage condition of test material: stored at room temperature in the dark
Constituent 1
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficientopen allclose all
- Type:
- log Pow
- Partition coefficient:
- 0.57
- Temp.:
- 22 °C
- Remarks on result:
- other: n-octanol / water ratio 1:1
- Type:
- log Pow
- Partition coefficient:
- 0.73
- Temp.:
- 22 °C
- Remarks on result:
- other: n-octanol / water ratio 1:2
- Type:
- log Pow
- Partition coefficient:
- 0.51
- Temp.:
- 22 °C
- Remarks on result:
- other: n-octanol / water ratio 2:1
Applicant's summary and conclusion
- Conclusions:
- From the experimental data obtained, the quality criteria of the method (variation of log Pow
value ± 0.3 on the three different ratios) are confirmed.
Therefore, we can conclude that the affinity of the bromohexine hydrobromide sample for n-octanol
is higher than the affinity for water, as shown by the partition coefficient (n-octanol /
water) results, but also a strong dependence from the amount solvent ratios was observed.
Mean logPow = 0.60
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