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Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.05 - 03.06.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD guideline and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Constituent 1
Reference substance name:
L-Lysine HCl
IUPAC Name:
L-Lysine HCl
Details on test material:
- Name of test material (as cited in study report): L-Lysine Monohydrochloride
- Molecular formula: C6H14N2O2HCl
- Molecular weight: 182.65
- Physical state: Solid
- Analytical purity: 99.%
- Lot/batch No.: 0085
- Expiration date of the lot/batch: 23.03.2013
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Study design

Analytical method:
other: ion chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
< -3.3
Temp.:
24 °C
pH:
5.88 - 6.26
Details on results:
Before performing the partition coefficient test the log Pow value was calculated using the ALOGPS 2.1 program. This calculated value was -3.76. The experimental Pow should be calculated by dividing the determined n-octanol concentration by the determined water concentration. However, the determined n-octanol concentration was below the LOQ. Therefore, the determined log Pow value for the test substance was < -3.3.

Applicant's summary and conclusion

Conclusions:
The determined log Pow value for L-lysine HCl was < -3.3.

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