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Stability in organic solvents and identity of relevant degradation products

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Reference
Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 November 2006 and 11 January 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Analysis conducted in-house by a well-developed method that has been used in the Quality Assurance Laboratory of PFW Aroma Chemicals BV.
Principles of method if other than guideline:
AHTN was dissolved in a typical organic solvent. It was analysed by gas chromatography on 16 November 2006 and 11 January 2010.
GLP compliance:
no
Test substance stable:
yes
Transformation products:
no

The peaks positions and their corresponding concentrations of IPM and AHTN substances are the same considering the standard deviation of the analysis (max. 0.1%).

The table below shows that Tonalid (AHTN) remains stable over a period of more than 3 years.

Date analysis

16-10-2006

11-01-2010 

 

Retention
time

Concentration

Retention
time

Concentration

Substance

minutes

%

minutes

%

IPM

21.46

46.87

21.44

46.95

Tonalid

22.00

37.05

21.97

37.04

Some grass peaks could be observed, but their concentrations are max. 0.02%.

Conclusions:
No degradation of AHTN in IPM has been observed and no significant degradation products can be observed after a storage period of more than 3 years. AHTN proved to be very stable.
Executive summary:

The stability of AHTN in an organic solvent was studied. Based on the practical experience gained over the years, isopropyl Myristate (IPM) was selected, since this is a suitable and typical organic solvent.

AHTN and another fragrance ingredient (Phantolid) was dissolved in IPM. It was analysed by gas chromatography on 16 November 2006 and 11 January 2010. The peaks positions and the corresponding concentrations of IPM and AHTN substances are the same in both chromatograms. No degradation of AHTN in IPM has been observed and no significant degradation products can be found after a storage period of more than 3 years.

Description of key information

The test item is stable in isopropyl myristate.

Additional information

A retained sample in which the test item that was dissolved in isopropyl myristate (plus another fragrance ingredient) has been analysed twice by Gas Chromatography with a time interval of more than 3 years. No degradation was observed. It was concluded that the test item remained very stable.