Registration Dossier
Registration Dossier
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EC number: 259-234-9 | CAS number: 54571-67-4
Water solubility
Administrative data
Link to relevant study record(s)
Description of key information
The water solubility of the test material was determined to be in the range of 84.2 to 86.6 % w/w at 20.0 ± 0.5 ºC, EU Method A.6., Butler (2008).
Key value for chemical safety assessment
Additional information
This endpoint has been adressed with 2 studies, one key and one supporting.
The key study (Butler & White, 2008) was conducted under GLP conditions and in line with EU Method A. 6, according to the shake flask method. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997). No analysis could be performed due to the high solubility of the test material, producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.
Under the conditions of the study, the water solubility of the test material was determined to be in the range of 84.2 to 86.6 % w/w at 20.0 ± 0.5 ºC.
The supporting study (Savari, 2013b) was performed using read across substance, sodium 5-oxo-L-prolinate, which is the L- isomeric form of the substance. Read-across is considered to be suitable based on the structural similarities between the read across substance (sodium 5-oxo-L-prolinate) and the substance to be registered (sodium 5-oxo-DL-prolinate), which is a racemic mixture of the D- and L- isomeric forms of the substance. As such the difference in isomeric forms of the substance is unlikely to affect the physico-chemical properties. The study was conducted under GLP conditions and in accordance with standardised guidelines. The study was assigned a reliability score of 2 in line with the principles for assessing data quality as defined by Klimisch (1997).
Under the conditions of the study, the solubility of the test material was determined to be 613 ± 68 g/L at 20 °C ± 1° and is considered to be very soluble.
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