Registration Dossier

Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

Administrative data

Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study design same as that used for water solubility. Conducted under GLP conditions. Limited information on stability of test substance available.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Solubility test according to the shake flask method. Sample analysis using HPLC was repeated after 7 days, thus giving an indication on the substance stability in solution in n-octanol.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Test substance stable:
yes
Transformation products:
not measured

Any other information on results incl. tables

Recovery data for test chemical in octanol showed all components were >97% recovered after 7 days.

Applicant's summary and conclusion

Conclusions:
The test substance is stable when dissolved in n-octanol.
Executive summary:

For the purpose of testing the test substance's solubility in organic solvents, a solution of 1,4 -benzenediamine, N,N'-mixed Ph and tolyl derivs. in n-octanol was prepared using the shake flask method. After 24 hours the solution was analyzed using reversed phase HPLC.

Re-analysis of test solutions after 7 days showed that >97% of all measured constituents were still present in the test solution. It can thus be concluded that the test substance is stable when dissolved in n-octanol.