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Environmental fate & pathways

Hydrolysis

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Administrative data

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 March 2004 - 24 June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Purity: Not specified
- Description: light amber coloured, slightly viscous liquid
- Storage: room temperature, in the dark
Radiolabelling:
no
Analytical monitoring:
yes
Buffers:
Buffers
Sterile buffer solutions at pH 4, 7 and 9.
Buffer solution specifications:
- pH 4.0: Potassium hydrogen phthalate, 0.05 mmol dmE-03
- pH 7.0: Disodium hydrogen orthophosphate (anhydrous), 0.03 mmol dmE-03, Potassium dihydrogen orthophosphate, 0.02 mmol dmE-03, Sodium chloride, 0.02 mmol dmE-03
- pH 9.0: Disodium tetraborate, 0.01 mmol dmE-03, Sodium chloride, 0.02 mmol dmE-03
Duration:
3.5 h
pH:
4
Temp.:
15 °C
Duration:
5 h
pH:
4
Temp.:
25 °C
Duration:
6 h
pH:
7
Temp.:
40 °C
Duration:
3.5 h
pH:
7
Temp.:
50
Duration:
6 h
pH:
9
Temp.:
30 °C
Duration:
3.5 h
pH:
9
Temp.:
40 °C
Statistical methods:
- Sample Solution Concentration
The mean peak area of each standard was corrected to a nominal concentration of 2.0 mg/L, and the mean value taken.

The concentration of the sample solutions (g/L) was calculated using the following equation:

Cspl = (Pspl/Pstd) x Cstd x D x (1/100)

where:

Cspl: sample concentration (g/L)
Pspl: mean peak area of sample solution
Pstd: mean peak area of standard solution, corrected to nominal standard concentration
Cstd: nominal standard concentration (2.0 mg/L)
D: sample dilution factor (0.04)
- Estimation of half-life
From the graph of log10 concentration (g/L) versus time, the rate constant was calculated using the following equation:

Kobs = -slope x 2.303

The half-life was obtained from the rate constant using the following equation:

t½ = 0.693 / kobs

where:

kobs = rate constant (hours^-1)
t½ = half-life (hours)
Preliminary study:
Preliminary testing at 50°C indicated that the test material was hydrolytically unstable, defined by the method guideline as less than 90% remaining after 120 hours at 50°C, at all thee pH’s. The results were less than 5% remaining after 2 hours at pH 4, 19.5% remaining after 5 hours at pH 7, and 8.5% remaining after 4 hours at pH 9.
Transformation products:
not specified
pH:
4
Temp.:
25 °C
Hydrolysis rate constant:
0 s-1
DT50:
1.16 h
pH:
7
Temp.:
25 °C
Hydrolysis rate constant:
0 s-1
DT50:
14.3 h
pH:
9
Temp.:
25 °C
Hydrolysis rate constant:
0 s-1
DT50:
10.1 h
Validity criteria fulfilled:
yes
Conclusions:
The half-life of the test substance at 25°C is 1.16 hours at pH 4, 14.3 hours at pH 7, and 10.1 hours at pH 9. The test substance, thererefore, is expected to hydrolyse within the environmental compartment.

Description of key information

The half-life of the test substance at 25°C is 1.16 hours at pH 4, 14.3 hours at pH 7, and 10.1 hours at pH 9. The test substance, thererefore, is expected to hydrolyse within the environmental compartment (SafePharm, 2004).

Key value for chemical safety assessment

Half-life for hydrolysis:
14.3 h
at the temperature of:
25 °C

Additional information