Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes
Remarks:
Testing laboratory not known

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
EC Number:
415-110-8
EC Name:
(R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
Cas Number:
54417-53-7
Molecular formula:
C20H25NO4.HCl
IUPAC Name:
(1R)-1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-1,2,3,4-tetrahydroisoquinoline hydrochloride
Test material form:
solid: crystalline

Results and discussion

Transformation products:
not specified
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
50 °C
DT50:
> 120 h
pH:
7
Temp.:
50 °C
DT50:
> 120 h
pH:
9
Temp.:
50 °C
DT50:
> 120 h
Details on results:
The substance underwent less than 10% hydrolysis after 5 days at 50°C which is equivalent to a half life of greater than 1 year at 25°C

Applicant's summary and conclusion