Registration Dossier

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

A study was performed to determine the rate of hydrolysis of MIRAMER M140 as a function of pH. The test was conducted in accordance with the preliminary test as described in Commission Regulation (EC) No. 440/2008 (Method C.7) and the OECD Guidelines for Testing of Chemicals (Method 111).. The study was conducted in compliance with GLP.

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information

A preliminary study showed that at pH 4 and 50 +/- 0.5ºC, less than 10% hydrolysis had occurred after 5 days, equivalent to a half-life of greater than 1 year under environmental conditions (25°C).

At each of pH 7 and 9 and 50 +/- 0.5ºC, more than 10% hydrolysis had occurred after 5 days, equivalent to a half-life of less than 1 year under environmental conditions (25°C).

MIRAMER M140 was determined to be hydrolytically stable under acidic conditions, but unstable under neutral and basic conditions.

Estimation by SPARC using SMILES notation for the substance gave a hydrolytic half-life =150 d at pH=7, which is

is in compliance with screening study (hydrolytic half-life < 1 year at pH=7).