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Partition coefficient

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Description of key information

Log Pow < 1.0, EU Method A. 8, OECD 117, Sárvári 2013a.

Key value for chemical safety assessment

Additional information

The key study (Sárvári, 2013a) was performed under GLP conditions and in accordance with standardised guidelines. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch (1997). Under the conditions of the study, the retention time of the test material was determined to be 1.87 minutes. This value was lower than that of the first eluting standard, thiourea (2.22 min) and thus outside of the calibration range. On this basis, the log Pow of the test material was estimated to be < 1.0.

The supporting study (Butler, 2008) was performed using information on the read across substance, sodium 5-oxo-DL-prolinate, which is a racemic mixture of the D- and L- isomeric forms of the substance. Read-across is considered to be suitable based on the structural similarities between the supporting substance (sodium 5-oxo-DL-prolinate) and the substance to be registered (sodium 5-oxo-L-prolinate), which is the L- isomer only. 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 mean partition coefficient of the test material was determined to be < 7.62 x 10-3, and log10 Pow < -2.12. These results are in good agreement, and support, the findings presented in the key study.