Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
July 2009 - january 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In compliance with GLP guidance

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Good Laboratory Practice Standards (Directive 2004/10/EC)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Isosorbide Diesters
EC Number:
700-073-5
Cas Number:
1215036-04-6
Molecular formula:
As it is an UVCB, we can not provide the exact molecular formula.
IUPAC Name:
Isosorbide Diesters
Details on test material:
Identification DIESTER D'ISOSORBIDE
Identification of the flask ROQUETTE Diester d'isosorbide, lot Fal/07/25,
LAB. 3822, Réf. 806297
Batch Fal 07/25
Expiry date Not provided
Supplier ROQUETTE FRERES
Appearance Colourless limpid liquid
Packaging 1 white plastic flask
1 transparent soft plastic flask
Quantity received 1 x 1.2 L
1 x 3 kg
Date of the reception 30 May 2007 and 09 July 2008
Storage in darkness at room temperature
Identification number for the study 07-066

Results and discussion

Test substance stable:
yes

Applicant's summary and conclusion

Conclusions:
The test item was considered to be stable.
Executive summary:

CHEMICAL STABILITY IN DIFFERENT SOLVENTS

The objective of the test is to determine the chemical stability of the test item in different solvents.

The chemical stability of the diester d’isosorbide is studied in four solvents which are petroleum ether, diisopropylether, ethanol and methanol.

An analytical quantification is done in the samplings issued from the degradation study. The isosorbide diesters is analysed as a silyl derivative by gas chromatography using a FID detector. Methyl-alpha-D-glucopyranoside is used in order to normalize the quantification.

Conclusion:

Before the storage procedure for 28 days at 30 ± 0.5 °C

The content of diester d’isosorbide in methanol was: 85.5 mg/L

The content of diester d’isosorbide in diisopropylether was: 82.8 mg/L

The content of diester d’isosorbide in petroleum ether was: 82.9 mg/L

The content of diester d’isosorbide in ethanol was: 84.3 mg/L

After the storage procedure for 4 days at 30 ± 0.5 °C

The content of diester d’isosorbide in methanol was: 81.9 mg/L

After the storage procedure for 8 days at 30 ± 0.5 °C

The content of diester d’isosorbide in methanol was: 87.9 mg/L

The content of diester d’isosorbide in diisopropylether was: 91.1 mg/L

The content of diester d’isosorbide in petroleum ether was: 86.9 mg/L

The content of diester d’isosorbide in ethanol was: 86.5 mg/L

After the storage procedure for 14 days at 30 ± 0.5 °C

The content of diester d’isosorbide in methanol was: 79.6 mg/L

The content of diester d’isosorbide in diisopropylether was: 91.0 mg/L

The content of diester d’isosorbide in petroleum ether was: 90.9 mg/L

The content of diester d’isosorbide in ethanol was: 83.5 mg/L

After the storage procedure for 28 days at 30 ± 0.5 °C

The content of diester d’isosorbide in methanol was: 83.5 mg/L

The content of diester d’isosorbide in diisopropylether was: 83.3 mg/L

The content of diester d’isosorbide in petroleum ether was: 84.0 mg/L

The content of diester d’isosorbide in ethanol was: 81.8 mg/L

No significant change was observed in the content of diester d’isosorbide in the four solvents after the storage procedure for 28 days at 30 ± 0.5 °C. The test item was considered to be stable.