Registration Dossier
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EC number: 627-025-5 | CAS number: 101541-04-2
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:
- 12.11.2013 - 15.11.2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of method:
- flask method
- Specific details on test material used for the study:
- Test ITEM batch: LR10271
VOLUFORM is a lipoamino acid (palmitoyl isoleucine: product of the reaction between palmitoyl
chloride and isoleucine). - Key result
- Water solubility:
- ca. 1.1 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- ca. 24 h
- Temp.:
- 30 °C
- pH:
- ca. 6.5
- Key result
- Water solubility:
- ca. 2.4 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- ca. 48 h
- Temp.:
- 30 °C
- pH:
- ca. 6.8
- Key result
- Water solubility:
- ca. 0.9 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- ca. 72 h
- Temp.:
- 30 °C
- pH:
- ca. 6.3
- Conclusions:
- The average solubility of LR10271 Voluform is 1.5mg/L in reverse osmosis-purified water (aqueous
solution pH around 6.5) at 25°C.
Deviation between different flasks is probably due to the lack of homogeneity of solutions. - Executive summary:
The average solubility of LR10271 Voluform is 1.5mg/L in reverse osmosis-purified water (aqueous
solution pH around 6.5) at 25°C.
Deviation between different flasks is probably due to the lack of homogeneity of solutions.
Reference
Deviation of solubility over time can be due to the lack of homogeneity of solutions. Statistical
analysis of the results is done to confirm this hypothesis.
The repeatability and the “reproducibility” of this method are determined in order to estimate the
contribution of analytical method deviation in global result deviation.
Repeatability is the degree of agreement of measurements on replicate specimens.
And reproducibility is, in this study, the degree of agreement of measurements on different samples
by the same operator.
| Average solubility | repeatability standard deviation | reproductibility standard deviation | |
| Flask: presaturation 24h | 1.1 | 6.4% | 19.4% |
| Flask: presaturation 48h | 2.4 | 1% | 11% |
| Flask: presaturation 72h | 0.9 | 6.6% | 16.9% |
The high reproducibility standard deviations show that saturated solutions are not homogeneous
while repeatability of the analytical method is good.
Description of key information
The water solubility of registered substance is equal to 1.5 mg/L.
Key value for chemical safety assessment
- Water solubility:
- 1.5 mg/L
- at the temperature of:
- 25 °C
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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