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EC number: 807-040-5
CAS number: 4538-42-5
Solubility and test
- Based on a pre-test the test
item was found to be soluble in aqueous buffer solutions (including 1 %
acetonitrile) at a concentration of approx. 100 mg/L and clear solutions
- The test item was found to be
soluble in this concentration which fulfills the requirements of OECD
111 and no further solubility test with organic solvent additives > 1%
v/v was performed
- Due to the rapid hydrolysis of
up to > 90 % degradation within less than 30 minutes, biotic degradation
could be excluded
- Therefore a sterility test at
the end of the hydrolysis tests was not necessary and not conducted
Regarding exemplary chromatograms
of the hydrolysis test solutions, the analytical method is sufficiently
sensitive to quantify test item concentrations down to 10% or less of
the initial concentration used in the hydrolysis experiment
The tests were performed based on
OECD Guidelines for Testing of Chemicals, Section 1 – Physical-Chemical
Properties, OECD 111, Council Regulation (EC) No 440/2008, Guideline
Part C – Methods for the Determination of Ecotoxicity, C.7. “Abiotic
Degradation: Hydrolysis as a Function of pH”. As the substance was
expected to undergo fast hydrolysis in aqueous media the hydrolysis
behaviour of the test item was investigated at 20 °C and 10 °C for pH 4,
pH 7 and pH 9 up to a degradation of > 90%. Due to the observed rapid
degradation of the test item within minutes, an exact determination of
half-life time or hydrolysis rate was not possible. Therefore the
halt-life times of PDI are estimated values based on the recoveries
after 5 min hydrolysis time related to the initial value at 0 min, which
was set to 100 %. Due to the poor water solubility of the test item, a
test concentration of approx. 50 mg/L (including 1 % acetonitrile as
organic solvent additive) had to be applied for adequate dissolution.
The low PDI concentration in the hydrolysis test solutions did not allow
the identification of hydrolysis products with the applied analytical
method which has to be used to follow the degradation of the parent
substance. Polymeric or oligomeric ureas as potential hydrolysis
products of PDI could not be determined as they are assumed to be
insoluble in water. The stability was monitored by GC analysis with
At pH 4, 7 and 9 the substance hydrolysed immediately in water at 20 °C. The estimated half-life time was lower than 5 minutes (Neuland, 2016).
"Should read: < 5 min"
At 10 °C and 20 °C a recovery of
the test item about or less than 50 % after 5 min hydrolysis time was
obtained at pH 4, 7 and 9.
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