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Environmental fate & pathways

Hydrolysis

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Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Incubation time: 5 days
Buffers:
Buffer solutions:
- 0.05 M acetate buffer solution pH 4
- 0.05 M phosphate buffer solution pH 7
- 0.05 M borate buffer pH 9

Buffer solutions for calibration of pH meter and electrode:
- standard buffer solutions pH 4 (Art. 33543), pH 7 (Art. 33546), pH 9 (Art. 33548)

Details on test conditions:
- alliquots of test item filled into sterilized 5 ml autosampler vials, lightly closed with screw caps
- incubated at 50 +/- 0.1 °C in a thermostatic water bath for 5 days
- pH values measured at the start of incubation and at the end of hydrolysis experiment
- possible photolytic degradation was prevented by exclusion of light from the hydrolysis solutions by using a thermostatic bath made of stainless steel with metal cover
- after 5 days the samples were analyzed by HPLC
Duration of testopen allclose all
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
ca. 10 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
ca. 10 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
ca. 10 mg/L
Number of replicates:
The initial concentration was measured in triplicate

Results and discussion

Preliminary study:
No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 ± 0.1 °C.
Transformation products:
no
Total recovery of test substance (in %)open allclose all
% Recovery:
100.4
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
101
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
99.9
pH:
9
Temp.:
50 °C
Duration:
5 d
Dissipation half-life of parent compound
pH:
7
Temp.:
25 °C
Half-life:
> 1 yr
Remarks on result:
other: "considered to" be acc. to the EC-Test Guideline
Details on results:
The data show that at pH 4, 7 and 9 essentially no hydrolysis occured within 5 days at 50 +/- 0.1 °C. Therefore the test item is considered to be hydrolytically stable (t1/2 > 1 year at 25 °C) and no further testing is necessary.

Applicant's summary and conclusion

Conclusions:
Androst-4-ene-3,17-dione which is structurally similar to 5(10)-Estrene-3,17-dione can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.
Executive summary:

The rate of hydrolysis of Androst-4-ene-3,17-dione in aqueous solution buffered to pH values of 4, 7 and 9 was studied according to EU testing guideline C.7. No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 ± 0.1 °C (pretest). Therefore Androst-4-ene-3,17-dione can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.