Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31st August 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study. This study was performed in compliance with the GLP regulations. Only memorandum available; no full study report.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
not specified
Principles of method if other than guideline:
No further details were provided.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
PTH-Decahydroamide
IUPAC Name:
PTH-Decahydroamide
Constituent 2
Reference substance name:
Ro 31-9373/000
IUPAC Name:
Ro 31-9373/000
Details on test material:
No further details were provided.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No further details were provided.
Radiolabelling:
not specified

Study design

Analytical monitoring:
not specified
Details on sampling:
No further details were provided.
Buffers:
No further details were provided.
Estimation method (if used):
No further details were provided.
Details on test conditions:
No further details were provided.
Duration of test
Initial conc. measured:
other: No further details were provided.
Number of replicates:
No further details were provided.
Positive controls:
not specified
Negative controls:
not specified
Statistical methods:
No further details were provided.

Results and discussion

Preliminary study:
No further details were provided.
Test performance:
No further details were provided.
Transformation products:
not specified
Details on hydrolysis and appearance of transformation product(s):
No further details were provided.
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
50 °C
Type:
other: hydrolytically stable
pH:
7
Temp.:
50 °C
Type:
other: hydrolytically stable
pH:
9
Temp.:
50 °C
Type:
other: hydrolytically stable
Other kinetic parameters:
No further details were provided.
Details on results:
PTH-Decahydroamide (Ro 31-9373/000) is hydrolytically stable at pH 4, 7 and 9 under the conditions of the test. The test was performed at 50.0 + 0.5 ⁰C.

Any other information on results incl. tables

PTH-Decahydroamide (Ro 31-9373/000) is hydrolytically stable at pH 4, 7 and 9 under the conditions of the test. The test was performed at 50.0 + 0.5 ⁰C.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
PTH-Decahydroamide (Ro 31-9373/000) is hydrolytically stable at pH 4, 7 and 9 under the conditions of the test. The test was performed at 50.0 + 0.5 ⁰C.
Executive summary:

The determination of the hydrolysis of PTH-decahydroamide (Ro 31-9373/ 000) at different pH was performed on the basis of EC directive 92/69/ EEC, C. 7 (1992).

PTH-Decahydroamide (Ro 31-9373/000) is hydrolytically stable at pH 4, 7 and 9 under the conditions of the test. The test was performed at 50.0 + 0.5⁰C.