Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance has a low octanol water partition coefficient and the adsorption potential of this substance is related to this parameter
the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption
other:
Justification for type of information:
In accordance with Annex XI, Section 2.0 of the REACH Regulation, the testing is technically not possible.
As shown in GLP study 19-04258-2 (OECD 111, Hydrolysis as a function of pH) the test item Ethanol, 2,2'­oxybis-, reaction products with 3-{triethoxysi/yl}-1-propanamine is hydrolytically unstable at pH 4, 7, and 9 with half-life periods:,; 30 min.
The recommended solvent systems for the EU test method C.19. (Estimation of the adsorption coefficient {Koc) on soil and on sewage sludge using high performance liquid chromatography (HPLC}) contain water and are therefore not suitable for this test item.
In addition, alkanol containing solvent systems will also react with the test item (exchange of alkoxy groups) and are, hence, also not suitable for this test item.
As stated in EU C.19., the method is not applicable for substances which react either with the eluent or the stationary phase (see also "Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance", Version 6.0, July 2017, page 152).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
In accordance with Annex XI, Section 2.0 of the REACH Regulation, the testing is technically not possible.
As shown in GLP study 19-04258-2 (OECD 111, Hydrolysis as a function of pH) the test item Ethanol, 2,2'­oxybis-, reaction products with 3-{triethoxysi/yl}-1-propanamine is hydrolytically unstable at pH 4, 7, and 9 with half-life periods:,; 30 min.
The recommended solvent systems for the EU test method C.19. (Estimation of the adsorption coefficient {Koc) on soil and on sewage sludge using high performance liquid chromatography (HPLC}) contain water and are therefore not suitable for this test item.
In addition, alkanol containing solvent systems will also react with the test item (exchange of alkoxy groups) and are, hence, also not suitable for this test item.
As stated in EU C.19., the method is not applicable for substances which react either with the eluent or the stationary phase (see also "Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance", Version 6.0, July 2017, page 152).