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Environmental fate & pathways

Hydrolysis

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: German standard method DIN EN ISO/IEC 17025
Deviations:
no
GLP compliance:
yes
Radiolabelling:
no
Details on sampling:
Approx. 14.5 mg of the sample were dissolved in 150 ml of the corresponding buffer solution in an Erlenmeyer flask.. An aliquot of the sample was immediately analysed. The Erlenmeyer flask was maintained at 25 °C in a water bath in the dark for 6 days. An aliquot was analysed after 2 hours, 3 days and 6 days.
Duration:
6 d
pH:
4
Temp.:
25
Initial conc. measured:
105.02 mg/L
Duration:
6 d
pH:
7
Temp.:
25
Initial conc. measured:
99.59 mg/L
Duration:
6 d
pH:
9
Temp.:
25
Initial conc. measured:
99.01 mg/L
Preliminary study:
The hydrolysis behaviour of the test item was investigated at 25 °C and pH 4, pH 7 and pH 9 over a period of 6 days. For pH 4, pH 7 and pH 9 no abiotic degradation of the test item was observed after 6 days at 25 °C.
Test performance:
No further test is performed after the preliminary test.
Transformation products:
no
% Recovery:
99.9
pH:
4
Temp.:
25 °C
Duration:
6 d
% Recovery:
101.1
pH:
7
Temp.:
25 °C
Duration:
6 d
% Recovery:
100.9
pH:
9
Temp.:
25 °C
Duration:
6 d
Remarks on result:
hydrolytically stable based on preliminary test
Details on results:
For pH 4, pH 7 and pH 9 no abiotic degradation of the test item was observed after 6 days at 25°C. Therefore no further testing was required.
Conclusions:
1,2-Propanediamine, N1-(2-aminoethyl)-3-(4-ethoxyphenyl)-, dihydrochloride, (2S)- can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.
Executive summary:

The rate of hydrolysis of 1,2-Propanediamine, N1-(2-aminoethyl)-3-(4-ethoxyphenyl)-, dihydrochloride, (2S)- in aqueous solution buffered to pH values of 4, 7 and 9 was studied according to OECD Guideline 111 (Hydrolysis as a Function of pH). No hydrolytic degradation was observed within 6 days at pH 4, 7 and 9 at 25 °C (pretest).

Description of key information

For pH 4, pH 7 and pH 9 no abiotic degradation of 1,2-Propanediamine, N1-(2-aminoethyl)-3-(4-ethoxyphenyl)-, dihydrochloride, (2S)- was observed after 6 days at 25 °C.

Key value for chemical safety assessment

Additional information

No hydrolytic degradation was observed within 6 days at pH 4, 7 and 9 at 25 °C (pretest). Therefore no further testing is required.