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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 C.

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 + 0.5C.