Registration Dossier
Registration Dossier
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EC number: 226-733-8 | CAS number: 5459-93-8
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7.8.- 14.8.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- Cyclohexyl(ethyl)amine
- EC Number:
- 226-733-8
- EC Name:
- Cyclohexyl(ethyl)amine
- Cas Number:
- 5459-93-8
- Molecular formula:
- C8H17N
- IUPAC Name:
- N-ethylcyclohexanamine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): N-ethylcyclohexylamine
- Physical state: clear colourless liquid
- Analytical purity: 99.5% (w/w)
- Impurities (identity and concentrations): cyclohexanol 0.22% (w/w), alifatic amines 0.23% (w/w), water 0.07% (w/w)
- Lot/batch No.: 89002001
- Expiration date of the lot/batch: 12/2012
- Storage condition of test material: in fridge at the temperature about 5°C
Constituent 1
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficient
- Type:
- log Pow
- Partition coefficient:
- 1.027
- Temp.:
- 25 °C
- pH:
- 7.75
Applicant's summary and conclusion
- Conclusions:
- In accordance with the estimated value of log Pow, it was decided to use HPLC method for determination of partition coefficient.
The partition coefficient of test substance N-ethylcyclohexylamine is: log Pow = 1.027+/-0.746 (25 °C, pH = 7.75)
The value is given with the extent of uncertainty (95%). - Executive summary:
The procedure was performed according to Method A.8, Partition coefficient, Council Regulation (EC) No 440/2008, Published in O.J. L 142, 2008.
In accordance with the estimated value of log Pow (2.16 +/- 0.2), it was decided to use HPLC method for determination of partition coefficient.
The partition coefficient of test substance N-ethylcyclohexylamine is: log Pow = 1.027 +/- 0.746 (25 °C, pH = 7.75)
The value is given with the extent of uncertainty (95%).
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