Registration Dossier
Registration Dossier
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EC number: 603-373-3 | CAS number: 129909-90-6
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A modern guideline study performed to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA Guideline Subdivision N 161-1 (Hydrolysis)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- EC Number:
- 603-373-3
- Cas Number:
- 129909-90-6
- Molecular formula:
- C10H19N5O2
- IUPAC Name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- Details on test material:
- Specific activity 22.7 mCi/mmole.
Constituent 1
- Radiolabelling:
- yes
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate units at 0, 6, 10, 15, 20, 24 and 30 days after application.
- Buffers:
- pH 5.0 buffer - 0.01M sodium acetate adjusted to pH 5.0 with 0.01 M acetic acid solution and 1.0 M sodium hydroxide solution.
pH 7.0 buffer - 0.01 M sodium acetate adjusted to pH 7 with 0.01M acetic acid solution.
pH 9.0 buffer - 0.01M sodium borate adjusted to pH 9 with 1.0 M acetic acid solution. - Details on test conditions:
- Untis maintained in the dark at 25 degrees C +/- 1.0.
Duration of testopen allclose all
- Duration:
- 30 d
- pH:
- 5
- Temp.:
- 25
- Initial conc. measured:
- 1.1 other: ppm
- Duration:
- 30 d
- pH:
- 7
- Temp.:
- 25
- Initial conc. measured:
- 1.1 other: ppm
- Duration:
- 30 d
- pH:
- 9
- Temp.:
- 25
- Initial conc. measured:
- 1.1 other: ppm
- Number of replicates:
- Duplicated units
Results and discussion
- Test performance:
- Average mass balance of between 100.5 to 101.0% for each pH buffer indicating no volatiles produced.
- Transformation products:
- yes
Identity of transformation products
- No.:
- #1
Reference
- Reference substance name:
- Unnamed
- IUPAC name:
- DCA MKH 3586
- Identifier:
- other:
- Identity:
- DCA MKH 3586
- Details on hydrolysis and appearance of transformation product(s):
- DCA MKH 3586 major metabolite in pH 9 buffer at 28.5% at 30 days.
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 100.5
- pH:
- 5
- Temp.:
- 25 °C
- Duration:
- 30 d
- % Recovery:
- 101.5
- pH:
- 7
- Temp.:
- 25 °C
- Duration:
- 30 d
- % Recovery:
- 72.1
- pH:
- 9
- Temp.:
- 25 °C
- Duration:
- 30 d
Dissipation DT50 of parent compound
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 65.25 d
- St. dev.:
- 0.998
- Type:
- (pseudo-)first order (= half-life)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- [Triazolinone-5-14C]MKH 3586 is stable at pHs 5 and 7 but had a half live in pH 9 of 65 days. The major degradate produced at pH 9 was DCA MKH 3586.
- Executive summary:
The hydrolysis of radiolabelled MKH 3586 was studied at pH 5, 7 and 9 at 25 degrees C in the dark for 30 days.
The test compound was stabe at pH 5 and 7. At pH 9 the test compound had a half life of 65 days and the major degradate was DCA MKA 3586 which accounted for 28.5% applied radioactivity at 30 days.
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