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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Sponsor's identification
Description
Batch number
Date received
Storage conditions
PCMX
cream coloured, crystalline solid
285/13847
27 September 2001
room temperature, in the dark
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
The determination was carried out using Method C7 of Commission Directive 92/69/EEC (which
constitutes Annex V of Council Directive 67 /548/EEC).
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of
5.0 x 10·2 g/l in the three buffer solutions.
The solutions were shielded from light whilst maintained at the test temperature.
Buffers:
The buffer solutions were filtered through a 0.2 μm membrane filter to ensure they were sterile
before commencement of the test. Also these solutions were subjected to ultrasonication and
degassing with nitrogen to minimise dissolved oxygen content.
Details on test conditions:
Aliquots of sample solution were diluted by a factor of two using methanol.
Duplicate standard solutions of test material were prepared in methanol:relevant buffer solution
(50:50 v/v) at a nominal concentration of 25 mg/I.
Duration:
2.4 h
pH:
4
Temp.:
25 °C
Initial conc. measured:
ca. 24.6 mg/L
Remarks:
Mean Peak Area 652.234
Duration:
2.4 h
pH:
7
Temp.:
25 °C
Initial conc. measured:
ca. 24.5 mg/L
Remarks:
Mean Peak Area 650.039
Duration:
2.4 h
pH:
9
Temp.:
25 °C
Initial conc. measured:
ca. 24.5 mg/L
Remarks:
Mean Peak Area 648.952
Duration:
24 h
pH:
7
Temp.:
25 °C
Initial conc. measured:
ca. 25.1 mg/L
Remarks:
Mean Peak Area 643.345
Duration:
24 h
pH:
9
Temp.:
25 °C
Initial conc. measured:
ca. 25.1 mg/L
Remarks:
Mean Peak Area 643.571
Duration:
120 h
pH:
4
Temp.:
25 °C
Initial conc. measured:
ca. 25.7 mg/L
Remarks:
Mean Peak Area 670.365
Duration:
120 h
pH:
7
Temp.:
25 °C
Initial conc. measured:
ca. 24.6 mg/L
Remarks:
Mean Peak Area 648.894
Duration:
120 h
pH:
7
Temp.:
25 °C
Initial conc. measured:
ca. 24.6 mg/L
Remarks:
Mean Peak Area 646.395
Number of replicates:
9
Positive controls:
not specified
Negative controls:
not specified
Preliminary study:
Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5°C for a period of 120 hours.
Test performance:
Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than
1 year at 25°C.
Transformation products:
not measured
Details on hydrolysis and appearance of transformation product(s):
n/a
Key result
pH:
4
Temp.:
50 °C
Half-life:
120 h
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
7
Temp.:
50 °C
Half-life:
120 h
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Key result
pH:
9
Temp.:
50 °C
Half-life:
120 h
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
The test material concentrations at the given time points are shown in Table 4.3, Table 4.4 and
Table 4.5.
Table 4.3 pH 4 at 50.0 ± 0.5°C
Time (Hours)
0 2.4 120
Concentration (g/I) 5.21 x 10·2 4.95 x 10·2 4.95 x 10·2
% of initial 100 95.1 95.I
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than
1 year at 25°C.
Table 4.4 pH 7 at 50.0 ± 0.5°C
Time (Hours)
0 2.4 24 120
Concentration (g/I) 4.90 x 10·2 4.95 x 10·2 4.97 x 10·2 4.93 x 10·2
% of initial 100 101 101 101
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than
1 year at 25°C
Table 4.5 pH 9 at 50.0 ± 0.5°C
Time (Hours)
0 2.4 24 120
Concentration (g/I) 4.94 x 10·2 4.95 x 10·2 4.93 x 10·2 4.92 x 10·2
% of initial 100 100 100 99.7
Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than
1 year at 25°C.
Results with reference substance:
The estimated half-life at 25°C of the test material is shown in Table 4.6.
Table 4.6
pH Estimated half-life at 25°C
4 >l year
7 >l year
9 > l year

The test material concentrations at the given time points are shown in Table 4.3, Table 4.4 and

Table 4.5.

Table 4.3 pH 4 at 50.0 ± 0.5°C

Time (Hours)

0 2.4 120

Concentration (g/I) 5.21 x 10·2 4.95 x 10·2 4.95 x 10·2

% of initial 100 95.1 95.I

Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than

1 year at 25°C.

Table 4.4 pH 7 at 50.0 ± 0.5°C

Time (Hours)

0 2.4 24 120

Concentration (g/I) 4.90 x 10·2 4.95 x 10·2 4.97 x 10·2 4.93 x 10·2

% of initial 100 101 101 101

Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than

1 year at 25°C

Table 4.5 pH 9 at 50.0 ± 0.5°C

Time (Hours)

0 2.4 24 120

Concentration (g/I) 4.94 x 10·2 4.95 x 10·2 4.93 x 10·2 4.92 x 10·2

% of initial 100 100 100 99.7

Result: Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than

1 year at 25°C.

Validity criteria fulfilled:
yes
Conclusions:
Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than
1 year at 25°C.
Executive summary:

Less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than

1 year at 25°C.

Description of key information

Key value for chemical safety assessment

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

Additional information