Registration Dossier

Environmental fate & pathways

Hydrolysis

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Description of key information

A GLP study is scientifically unjustified.

Key value for chemical safety assessment

Additional information

The registered substance contains no organic functional groups that may hydrolyze under environmental condition like alkyl halides, amides, amines, epoxides, esters. The test substance consists only of organic functional groups that are relatively or completely inert with respect of hydrolysis. Based on the chemical structure an estimation of the hydrolysis rate is not possible. This statement is supported by one hydrolysis study performed on the registered substance according to a method similar to OECD Guideline 111 but without GLP statement.

The disappearance of the parent compound after 5 and 28 days at 40 °C and at environmentally relevant pH is less than 10%, but almost 50 % at extreme pH (2 and 12). Therefore, at environmentally relevant pH, the registered substance is considered hydrolytically stable. In conclusion, a GLP study is scientifically unjustified.