Registration Dossier
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EC number: 421-320-0 | CAS number: 118289-55-7 CP-89,575
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 March - 18 June 1996
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive 92/69/EEC, Method A8 (shake-flask method)
- Principles of method if other than guideline:
- Test temperature: 20°C ± 0.5°C
Test I: octanol stock solution ( 10 ml) and water saturated with octanol (50 ml) were combined in a screw-capped glass jar. The jar was mechanically shaken for 15 minutes and the test phases separated by centrifuging at 2800 rpm for 15 minutes. The test was performed in duplicate.
Test 2: as for test 1 except that octanol stock solution (20 ml) was used. Test 3: as for test 1 except that octanol stock solution (40 ml) was used.
Blank test: as for test 2 except that water saturated octanol was used in place of the octanol stock solution. - GLP compliance:
- yes
- Type of method:
- shake-flask method to: flask method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- 6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
- EC Number:
- 421-320-0
- EC Name:
- 6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
- Cas Number:
- 118289-55-7
- Molecular formula:
- Hill formula: C10 H9 Cl2 N O CAS formula: C10 H9 Cl2 N O
- IUPAC Name:
- 6-chloro-5-(2-chloroethyl)-2,3-dihydro-1H-indol-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Intended use: Pharmaceutical intermediate
Storage conditions: Dark at 4°C
Date received:2 February 1996
Constituent 1
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficient
- Type:
- log Pow
- Partition coefficient:
- 2.93
- Temp.:
- 20 °C
- Remarks on result:
- other: No Ph Data was available
- Details on results:
- The concentration of test substance in the octanol stock solution was determined as 1049.2 J..lg/ml (mean of individual determinations 1049.4 and 1048.9 J.lg/ml). The concentration of test substance based on mass oftest substance used was 1037.5 J..lg/ml.
CONCENTRATION AND TOTAL MASS OF TEST SUBSTANCE IN AQUEOUS AND ORGANIC TEST PHASES AFTER PARTITION
The aqueous phase concentrations ranged from 1.1142 - 1.3057 J..lg/ml, with pH values of 6.80 - 7.21. The organic phase concentrations ranged from 1011.8- 1040.5 J..lg/ml.
Quality control data for the aqueous phase analysis are given in Table 10, giving recoveries of 96.9% and 97.6%.
No peaks were observed at the retention volume of the test substance in any of the blank solutions indicating that the analytical method was free from interferences
Applicant's summary and conclusion
- Conclusions:
- The partition coefficient (n-octanol/water) of CP-89,575 has been determined as:
Log P = 2.93 at 20°C
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