Registration Dossier

Administrative data

Endpoint:
hydrolysis
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
There are technical issues that limit the possibilities to analyse and quantify.

We are not dealing with a monoconstituent substance for which standard test methods were developed, but with a UVCB, which in addition has limited solubility if any (< 0.115 mg/L). However as such not specifically quantifiable as 'highly insoluble' (which is considered an acceptable adaptation to the standard information requirement), but at least of very low solubility.

UVCB implies:
1. variability in the fatty acid composition in the raw material soybean oil, with associated variations in the low/very low solubilities
2. variability in the molecular structure of the parent material SSO, introduced by the production process (formation of cyclic structures and possible cross links);
This combination of variabilities poses problems in identifying and quantifying the products and thus also in determining their decline. The large range of possible structures results in unknown concentrations of each individual molecular structure, posing additional analytical challenges.
There is no option for a 14C-labeled parent (no strategic location in the molecule, and no reasonable production method for the natural material).

It is concluded the study is not feasible.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion