Registration Dossier
Registration Dossier
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EC number: 434-630-6 | CAS number: 60372-77-2
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-08-04, 2000-08-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- A guideline study with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
- Specific details on test material used for the study:
- L.A.E.
Appearance: White solid
Batch: 2625
Expiry date: April 2001
Purity: 92-94% - Key result
- Water solubility:
- > 247 g/L
- Temp.:
- 20 °C
- pH:
- 4.3
- Conclusions:
- The water solubility is greater than 247 g/L at 20ºC.
- Executive summary:
The water solubility test of Nα-Lauroyl-L-arginine ethyl ester monohydrochloride was performed according to OECD 105 guideline and EU method A.6, and was determined to be greater than 247 g/L at 20ºC.
Reference
Due to the known high water solubility of LAE and the difficult handling conditions of saturated solutions a modified water solubility determination was adopted.
Test substance(ca 2g)was combined with distilled water (6 ml) in a flask. The flask was firmly stoppered and wrapped in aluminium foil to exclude light. The contents were stirred at 30°C forca 2hours prior to equilibrium at the test temperature of 20°C for 16 hours.
ANALYSIS
An amount (0.09972 and 0.10309g, A and B respectively) of the test solution was weighed into a 20 ml volumetric flask and made to volume with methanol/acetonitrile 50/50. Aliquots (2 ml) of these solutions were subsequently pipetted into 25 ml volumetric flasks and made to volume with acetonitrile.
The diluted test solutions were analysed by HPLC.
Description of key information
Key study: Test method OECD 105 and EU method A.6. GLP Study. The water solubility of Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) was determined to be greater than 247 g/L at 20º
Key value for chemical safety assessment
- Water solubility:
- 247 g/L
- at the temperature of:
- 20 °C
Additional information
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