Registration Dossier
Registration Dossier
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EC number: 800-984-9 | CAS number: 1428547-35-6
Endpoint summary
Administrative data
Description of key information
Additional information
The registered substance is a salt composed of a primary alkyl amine and a fatty acid. Information concerning the bioaccumulation of both elements is available, showing that the salt can be considered as not bioccumulable.
Weight of Evidence Approach (WoE) for the aquatic bioaccumulation of primary alkyl amines:
None of the approaches described in the chapter 5.3.1 used to derive the BCF of Primary alkyl amines can give reliable results which addresses the full ADME process especially for fish. Therefore a Weight of Evidence Approach has to be applied for these substances:
1) The test design for an OECD 305 test for the measuring of theBCF is not suitable. The result from this preliminary test has an uncertainty which cannot be judged.
2) The ADME model of Arnot & Gobas (2003) can address the ADME process but only for the unprotonated amine. Due to the relatively high metabolic rate from an in vitro measurement low BCF are predicted based on uptake of the unprotonated C16 amine which is considered as a worst case assumption.
3) Classical BCF estimation methods based on Log Kow, predict higher BCF values for the unprotonated than for the protonated C16 amine
4) The model of Fu et al (2009) is the only model which can address the coexisting protonated and unprotonated C16 amine as function of pH. Unfortunately it does address only the Adsorption of the ADME process and in addition it is not known if it is valid for cationic surfactants.
The most suitable approach to derive aBCF for Primary alkyl amines is the ADME Model of Arnot and Gobas (2003) for the unprotonated C16 amine. Most likely this is conservative when the values are compared with the pH dependent results from Fu et al (2009).
Overall conclusion:
C16 amine is a model compound for the Primary alkyl amines. Therefore it is proposed to usefor the Primary alkyl amines a BCFof 173 L/kgas estimated by the ADME Model of Arnot & Gobas (2003) on basis of a Weight of Evidence.
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