Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
Description of key information
The preliminary test (Tier 1) and main study (Tier 2) were performed for the determination of the rate of hydrolysis of Pergafast 425 at pH values normally found in the environment (pH 4-9). The half-life times at 20 ºC were 16 days (pH 4), 30 days (pH 7) and 101 days (pH 9).
Key value for chemical safety assessment
Additional information
The rate of hydrolysis of the substance as a function of pH was determined at pH values normally found in the environment (pH 4-9) following Guidelines C.7 and OECD 111 and GLP principles. In Tier 1, at pH 4, pH 7 and pH 9, a degree of hydrolysis of ≥ 10% was observed after 5 days. Follow-up Tier 2 studies were performed at the 3 pH's and at temperatures of 20, 50 and 60 ºC. Except for pH 9, the mean recoveries of the test item containing buffer solutions at t=0 did not fall within the criterion range of 70-110%. The calculations were therefore related to the initial measured concentrations. The half-life times at 20 ºC were 16 days (pH 4), 30 days (pH 7) and 101 days (pH 9). Based on the uncertainty as to why the recoveries at pH 4 and 7 are low, the results at these pH's have to be taken as indicative. As 12 ºC and pH 7 are standard environmental parameters, the substance can be deemed not to hydrolyze rapidly within these conditions. The study is considered acceptable with restrictions.
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