Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Stability

The hydrolysis test was waived in accordance with column 2 of Annex VIII of Regulation 1907/2006/EC as the substance was readily biodegradable.

Biodegradation

In a biodegradation study according to OECD TG 301D (GLP, reliability 1) 69% oxidation was found after 28 days. The study demonstrates that the substance is readily biodegradable.

Bioaccumulation

The BCF was estimated to 613 L/kg ww with Arnot&Gobas BCFBAF method. Together with the estimated log Kow of 5.4 this indicates that C16 -22 might have a bioaccumulation potential. However, it is well known that the BCF of polar substance like C16 -22 alkylamine is difficult to predict. Performance of a standard aquatic exposure based OECD 305 test is however not considered as the substance sorbs easily to negatively charged surfaces like glassware, clay etc. and the substance will also biodegrade. Standard OECD 305 tests are therefore technically not feasible with these strongly sorbing degradable substances. In addition is the route of exposure unrealistic because the substance will either be sorbed or biodegraded in a natural environment.

For this reason and also for ethical reasons it would be better to evaluate if the substance is metabolized by an hepatic S9 fraction of rainbow trout. At the moment the substance is metabolized, the chance of accumulation of C16 -22 akylamine in fish is considered to be small (WOE-approach). The bioaccumulation potential of the C16-22 alkylamine is considered to be significantly lower than predicted based on the calculated Log Kow. This is because biotransformation of the C16-22 primary alkyl amines is considered to be very likely, as biotransformation has been observed for the C16 constituent (Perdu-Durand et al 2006). As the C16 -22 alkylamine is readily biodegradable it is also unlikely that the substance will accumulate in the food chain.

In conclusion the Arnot&Gobas BCFBAF estimation method, the biodegradation profile and the observed biotransformation of the C16 constituent indicate that the substance in not bioaccumulative despite having a log Kow >4.5.

Transport and distribution

The adsorption desorption was started but shown to be non feasible for this substance as described in section 5.4.1 of this dossier. Instead, a Log Koc was calculated as a weighted average based on data from US KOWWIN for respectively average of the ionic amine RNH3+ and neutral amine RNH2 constituents. The calculated Log Koc was 4.61.