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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Basic Information on the Study:
Six independent stock solutions were prepared by weighing 100 mg of the test item into 50 mL volumetric flasks. Three of the flasks were topped up to the mark with acetonitril, the other three flasks were topped up to the mark with acetone.
2 mL of each stock solution was transferred to 25 mL volumetric flasks and topped up to the mark with acetonitril + 0.2% phosphoric acid. The dilutions were then analyzed by HPLC-UV (“Day 0”).
The stock solutions were stored for one day at room temperature. After one day, again dilutions were prepared in acetonitril + 0.2% phosphoric acid as described above and analyzed by HPLC-UV (“Day 1”).
Stability was evaluated by comparing the peak areas of ethyl 2-cyanoacrylate obtained at “Day 0” and “Day 1”.

Instrument settings:
Column: YMC ODS-A, 150 × 4.6 mm, 5 µm, maintained at 5 °C using a column oven
Injection volume/Flow rate: 20 µL / 1.0 mL/min
UV Detector: 220 nm
Eluent: Acetonitril / Water (44/56 V/V) + 0.2% phosphoric acid
When applying the conditions above, the test item elutes with a retention time of 4.1 minutes.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Test substance stable:
yes
Transformation products:
no

Applicant's summary and conclusion

Conclusions:
The average recovery of Ethyl-2 -cyanoacrylate in acetonitril is 96.5%
The average recovery of Ethyl-2 -cyanoacrylate in acetone is 91.8%
Under the applied conditions, the test item is considered to be stable in organic solvents.