Registration Dossier

Diss Factsheets

Administrative data

bioaccumulation in aquatic species: fish
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
No experimental data on the bioaccumulation potential of the substance are available. Due to the fact that the substance is surface active the prediction of the bioaccumulation potential on the basis of the octanol-water partitioning coefficient is considered as not reliable (ECHA 2010, Chapter R.11) and currently guidelines do not exisit for testing of UVCB substances in fish or other aquatic organisms. Higher organisms possess a range of enzymes to attack the functional groups of the substance, such as amides and ether moieties, which should lead to a rapid metabolism of the substance in organisms. Standard tests demonstrated that the substance is readily biodegradable under aerobic and anaerobic conditions showing that microorganisms possess similar capabilities of rapidly degrading the substance. This indicates that the substance should have low potential for bioaccumulation. Evidence for low bioaccumulation potential of the substance is available from information about the bioaccumulation potential of the different components of AA 15. The substance is mainly composed of polyoxyethylene chains with alkyl, amide and hydroxyl functional groups, an ether and amide component with a hydroxyl functional group and a quantity of non-reacted alcohol. The available information about the bioconcentration potential of a variety of substances with polyoxyethylene chains gives evidence that these substances tend to have relatively low bioconcentration factors below 500 L/kg. These substances should be regarded as not bioaccumulative. The alcohol used in the manufacture of AA 15 has a bioconcentration factor <100 L/kg according to information provided by the supplier and therefore is not bioaccumulative. In conclusion, AA 15 is considered as not bioaccumulative based on the qualitative information about the substance’s components and the organisms' demonstrated capability of readily degrading the substance.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion