Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
No significant bioaccumulation of the registration substance, 2,2'-(C12-14 evennumbered alkyl imino) diethanol, is expected as no significant exposure is anticipated and the oxidative degradation metabolism can be derived as the likely elimination pathway.
Exposure to the registration substance by inhalation is very unlikely due to the extremely low vapour pressure. The registration substance is classified as corrosive to skin, so that the required risk minimisation measurement will minimise the dermal exposure. In all available oral toxicity studies, there was no effects indicative of bioaccumulating property.
Based on the information on the metabolism, distribution and excretion of primary fatty amines (EU Risk Assessment: Primary Alkyl Amines, October 2008, Germany), the registration substance is expected to be undergo oxidative degradation. No bioaccumulation is expected.
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Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Discussion on bioaccumulation potential:

No significant bioaccumulation of the registration substance, 2,2'-(C12-14 evennumbered alkyl imino) diethanol, is expected as no significant exposure is anticipated and the oxidative degradation metabolism can be derived as the likely elimination pathway.

- Exposure to the registration substance by inhalation is very unlikely due to the extremely low vapour pressure. The registration substance is classified as corrosive to skin and eye, so that the required risk minimization measurement will minimize the dermal exposure. In all available oral toxicity studies, there was no effects indicative of bioaccumulating property.

- There is no specific information on the metabolism, distribution and excretion for the registration substance or for fatty amine ethoxylates. However there is information on the structurally related primary fatty amines (EU Risk Assessment: Primary Alkyl Amines, October 2008, Germany), which may be applicable also for the fatty amine ethoxylates. Primary fatty amines are oxidatively deaminated by monoaminooxidases with concomitant formation of the corresponding alkylamine aldehyde. Subsequently, the aldehydes are oxidised by aldehyde dehydrogenases to the corresponding carboxylic acids, which, in turn, are further metabolized by beta-oxidation. Likewise, the registration substance is expected to undergo oxidative degradation and therefore to be of low bioaccumulating property.