Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

REACH_data waiving | Repro tox screening test

Link to relevant study records
screening for reproductive / developmental toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
Effect on fertility: via oral route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1-propanamine (CAS 152261-43-3) is a complex reaction mixture (UVCB) of 3-aminopropyltriethoxysilane (CAS 919-30-2) and diethylene glycol (2,2'-oxydiethanol, CAS111-46-6). Diethylene glycol is the main component besides smaller amounts of ethanol (CAS 64-17-5). No free 3-aminopropyltriethoxysilane is detectable, because it is covalently bound to the oligomeric structures of the reaction product.

Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1-propanamine is unstable upon contact with moisture. lt undergoes further condensation reactions that form highly polymerized poly silicic acids while liberating the diethylene glycol, that was initially bound to the oligomeric structures. The underlying chemistry is commonly known as sol-gel reaction. The poly silicic acid moieties are not stable and prone to further condensation generatingwaterinsoluble, resinous polymers. The molecular weight of the resulting polymers is predicted to be over 1000. These polymers are stable and not bioavailable.

Due to the reactivity of Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1-propanamine screening for reproductive/developmental toxicity cannot be performed.

Because 3-aminopropyltriethoxysilane is completely consumed into polymer matrix the toxicological profile of Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1-propanamine will be mainly determined by diethylene glycol and to a lesser extent by ethanol.

Both solvents are not classified regards reproductive toxicity. Diethylene glycol was assessed within the Community rolling action plan (CoRAP). It was concluded that there is no specific concern related to reproductive and developmental toxicity of diethylene glycol (Substance evaluation conclusion and report for 2,2’-oxydiethanol, 2016). Adverse reproductive effects from exposure to ethanol are only seen after deliberate and repeated oral consumption of large quantities (see REACH registration dossier, ECHA dissemination site, OECD SIDS Dossier, ethanol, 2004).