Registration Dossier
Registration Dossier
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EC number: 257-843-4 | CAS number: 52315-75-0
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.11.2014 to 13.11.2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Siemens AG, Prozess-Sicherheit, Industriepark Höchst, B 596 & B 598, D-65926 Frankfurt/M., Germany
- Type of method:
- column elution method
Test material
- Reference substance name:
- N6-(1-oxododecyl)-L-lysine
- EC Number:
- 257-843-4
- EC Name:
- N6-(1-oxododecyl)-L-lysine
- Cas Number:
- 52315-75-0
- Molecular formula:
- C18H36N2O3
- IUPAC Name:
- N6-(1-oxododecyl)-L-lysine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1, Kyobashi 1-chome, Chuo-Ku, Tokyo 104-8315 (Japan)/Batch No.: 130918
- Expiration date of the lot/batch: 17.09.2017
- Purity test date: 30.06.2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature (10-30°C)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
Results and discussion
Water solubility
- Key result
- Water solubility:
- < 0.187 mg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- 5.7 - 5.8
Applicant's summary and conclusion
- Conclusions:
- The water solubility was determined to be <0.187 mg/L at 20°C based on HPLC measurements.
- Executive summary:
The water solubility of lauroyl L-lysine was investigated in a study conducted according to OECD Guideline 105 (Water Solubility; 1995) and EU Method A.6 (Water Solubility; 2008). Based on results of preliminary tests, the column elution method was used for the determination of the water solubility in the main test. The water solubility of lauroyl L-lysine was determined to be <0.187 mg/L at 20°C based on HPLC measurements. The validity of the analytical method and the test was demonstrated.
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