Registration Dossier
Registration Dossier
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EC number: 700-485-5 | CAS number: 939402-02-5
Hydrolysis
Administrative data
Link to relevant study record(s)
Description of key information
DVS005u is considered to be hydrolytically unstable according to a study performed in line with GLP and to the standardised guideline OECD 111 with the components of the test material hydrolysing rapidly at pH 4. This conclusion was confirmed in a hydrolysis study performed using simulated gastric fluid.
Key value for chemical safety assessment
Additional information
The key study (Walker and White, 2011) was conducted in line with GLP and a standardised guideline with a sufficient level of detail to assess the quality of the study. The test material was analysed using HLPC at pH 4, 7 or 9 and at both 30 and 40ºC. The substance is considered to be hydrolytically unstable. Hydrolysis of the test material components was found to rapid at pH 4, occurring less rapidly at pH 7 and 9. The half-lives of the three components that could be measured was 22.3-90.5 day at pH 4 and >365 days at pH 7 and 9. No analysis of the fourth component was possible as the analytical method was not considered to be sensitive enough. The study was performed to a good standard and has been assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1997).
Cooper (2010) has been provided a supporting study, which is non-GLP compliant and performed following sound scientific principles. The hydrolysis of the test material was determined in simulated gastric fluid. It was determined that the test material fully hydrolyses within 24 hours with 2,4-di-tert-amylphenol (DTAP) and 4-tert-amylphenol (TAP) identified as the transformation products. The transformation products reached equilibrium at about 12 hours with values of 66% and 13%, respectively. The study was performed to a good standard and has been assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997).
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