Registration Dossier
Registration Dossier
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EC number: 500-035-6 | CAS number: 25214-63-5 (>1 <8.5 mol PO)
Categories
- Category name:
- EDA polyols
Justifications and discussions
- Category definition:
- EDA-initiated No Longer Polymer (NLP) Polyols
- Category description:
- Ethylenediamine-initiated No Longer Polymer (NLP) Alkoxylates: Ethylenediamine, Propoxylated; Ethylenediamine, Ethoxylated and Propoxylated and Ethylenediamine+4 Propoxylated
- Category rationale:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
See attached category justification document in 'Reports' section below.
1. CATEGORY HYPOTHESIS
The three substances in the Ethylenediamine (EDA)-initiated NLP alkoxylate category show similar physicochemical and toxicological properties due to similar chemical structures, common functional groups, common precursors and breakdown products.
See attached category justification document in 'Reports' section below for more information.
2. CATEGORY JUSTIFICATION
Based on the available data and similar physicochemical properties, it is concluded that read-across between these substances is acceptable. Based on available data, the substances exhibit low acute, repeat dose and reproductive toxicity, no evidence of genotoxicity and similar irritancy and skin sensitisation behaviours. Therefore, the read-across approach is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the category, and in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
These UVCB/multiconstituent substances are prepared via similar manufacturing process where the initiating core substance, ethylenediamine (EDA), is reacted with structurally similar monomers; the major or sole monomer being propylene oxide (PO). The linkage between the core initiator and the monomers is through the amine group and ether linkage connects the individual repeating units. This group of substances should exhibit similar toxicokinetic properties due to structural similarity and similar physicochemical properties. The three substances are thought to be absorbed by passive diffusion. The category members are expected to share a common breakdown product, the propylene glycol unit.
See attached category justification document in 'Reports' section below for more information.
3. APPLICABILITY DOMAIN OF THE CATEGORY
This category contains three NLP Polyols that are based on the core EDA initiator alkoxylated with either PO only (EDA/PO and EDA+4PO), or mostly PO with smaller % of ethylene oxide (EO) monomers (EDA/EO/PO).
See attached category justification document in 'Reports' section below for more information.
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