Registration Dossier

Administrative data

Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
The Hydrolysis study is being waived, please see below and the document in the attached justification:

The substance, Bis-Aminopropyl Diglycol Dimaleate; (EC Number 818-033-1; CAS Number 1629579-82-3) is not readily biodegradable and is not highly insoluble in water, however the hydrolysis study is being waived for the following reasons:

• Use of existing data: There is no existing data for this substance as the molecule is new, novel product.

• Weight of evidence: There is no existing data for this substance as the molecule is a new, novel product. Weight of evidence has been further considered under Read-across to other similar substances.

• (Q)SAR: The hydrolysis on the registered substance cannot be determined through QSAR modelling as the molecule does not fall into the applicability and validity domain of any known QSAR model. QSAR modelling requires the SMILES code for a substance to be modelled. The SMILES code and its fragments are not suitable for the HYDROWIN model. Other hydrolysis models are not available.

• in vitro methods: Not applicable for this substance as all test methods do not require vertebrate animal models.

• Grouping of substances: Due to the novel nature of this substance the grouping approach cannot be used.

• Read-across approach: The two substances that have been considered as suitable for Read-Across, and have been used as Read-Across in preparation of this dossier are: 3,3'-oxybis(ethyleneoxy)bis(propylamine); (EC 224-207-2; CAS 4246-51-9) and Maleic acid (EC 203-742-5; CAS 110-16-7). However, the Hydrolysis study has been waived for 3,3'-oxybis(ethyleneoxy)bis(propylamine): “Hydrolysis is not expected due to the absence of hydrolysable groups” and waived for Maleic acid: “Maleic acid is readily biodegradable (see section 5.2.1). In accordance with REACH Annex VIII column 2, the study does not need to be conducted if the substance is readily biodegradable.” Neither of these two waivers are relevant or suitable for the substance Bis-Aminopropyl Diglycol Dimaleate (please see attached justification for further information).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion