Registration Dossier

Administrative data

Endpoint:
hydrolysis
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
Hydrolysis as a Function of pH
Summary
No investigation of the hydrolysis characteristics of the test item was considered valid or feasible by Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. This was since the test item was a complex reaction mixture for which hydrolysis could not be readily monitored analytically.
The method guidelines are intended for pure substances only. In this case, hydrolysis, if occurring, may result in a subtle change in composition only, as hydrolysis products would likely be lower molecular weight components already present in the test item. As such, an attempt to quantify hydrolysis rates by shifts in the chromatographic profile was considered beyond the scope of the methods. Preparation of sample solutions would also be significantly hampered by the selective solubility characteristics of the test item, with a number of test item components demonstrated to have essentially negligible solubility in water, further complicating fortification of aqueous sample solutions with a relevant concentration of test item, representative of the test item composition as a whole

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
EC No. 440/2008 of 30 May 2008
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
13 April 2004
GLP compliance:
yes (incl. certificate)

Test material

Specific details on test material used for the study:
Information as provided by the Sponsor.
Identification: 1,3-Benzenedimethanamine, reaction products with glycidyl tolyl ether
Appearance/Physical state: clear, colorless, viscous liquid
Batch: WA 1508
Purity: 100% UVCB
Expiry date: 01 January 2021
Storage conditions: room temperature, in the dark

Results and discussion

Applicant's summary and conclusion

Conclusions:
The method guidelines are intended for pure substances only. In this case, hydrolysis, if occurring, may result in a subtle change in composition only, as hydrolysis products would likely be lower molecular weight components already present in the test item. As such, an attempt to quantify hydrolysis rates by shifts in the chromatographic profile was considered beyond the scope of the methods
Executive summary:

The general physico-chemical properties of 1,3-Benzenedimethanamine, reaction products with glycidyl tolyl ether have been determined.

Abiotic Degradation, Hydrolysis as a Function of pH. No investigation of the hydrolysis characteristics of the test item was considered valid or feasible by Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. This was since the test item was a complex reaction mixture for which hydrolysis could not be readily monitored analytically. The method guidelines are intended for pure substances only. In this case, hydrolysis, if occurring, may result in a subtle change in composition only, as hydrolysis products would likely be lower molecular weight components already present in the test item.  As such, an attempt to quantify hydrolysis rates by shifts in the chromatographic profile was considered beyond the scope of the methods.