Registration Dossier

Diss Factsheets

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine is the salt of its different Fatty acids with oleylamine.

 

Once the substance is entering the aquatic environment it is expected that the substance with a surplus of water due to its salt like character may dissociate into its components Fatty acid dimer and trimer components, tall oil components and their counterpart oleylamine. Based on this assumption the components will be evaluated either on a weight of evidence approach for a similar substance or individually with regard to their biodegradation behavior in the environment.

 

No biodegradation test result is available for the test item itself. Therefore, the evaluation is based on a weight of evidence approach to a closely related substance as well as on the individual components:

 

Available aquatoxicity data for the components

 

Fatty acid dimer and trimer compounds:

Three biodegradation studies are available for the fatty acid dimers with coco alkylamine: In a Manometric Respirometry Test (OECD 301F) the test item reached a biodegradation rate of 27% based on CO2 after 28d. In a second study an enhanced CO2- Headspace test (OECD 310) covering a period of 60 days, the test item reached a biodegradation rate of 27% based on CO2 after 28d and 39 % based on CO2 after 60d. In a third study, a BODIS test (ISO10708), the test item reached a biodegradation rate of 40% based on THOD after 28d.

 

Additionally, different groups of fatty acids dimers were analyzed for biodegradation by the HPV consortium “Fatty acids Dimers and Trimers”. The biodegradation data show that none of these substances are substantially biodegradable in the environment with degradation rates of < 10%.

The dimer and trimer fatty acid components are therefore considered to be not or only moderately degradable.

 

Fatty acids, Tall oil:

For the major component in tall oil - olic acid - experimental results are available: In an OECD 301 D test biodegradation results of >90% were measured after 28d and fulfilling the 10d window. The substance was therefore evaluated to be readily biodegradable.

Additionally, the tall oil was assessed for biodegradation using QSAR modelling with Biowin 4.10 by US-EPA. In all 6 models of Biowin 4.10 tall oil was assessed to be readily biodegradable.

 

Oleylamine:

Oleylamine is found to be readily biodegradable but failing the 10d window under OECD 301 screening conditions. In an EU Risk assessment of primary alkylamines “Primary Alkyl Amines, 2008” (Draft) and in a RAC opinion “Background document to the opinion proposing harmonized classification and labelling at Community level of amines, coco alkyl”, it is concluded, that in the majority of the tests the pass level for ready biodegradability (60% CO2 evolution or O2 consumption) was reached within the test period (generally 28 days), but not within the 10-days window…. Based on the results of all tests the primary alkyl amines could be classified as “readily degradable, but failing the 10-days window”. These results are supported by Biowin vs. 4.10 calculations indicating that Oleylamine is readily biodegradable.

 

Conclusion:

Based on the available data, it can be concluded that fatty acid dimer and trimer components are not or only moderately biodegradable, whereas tall oil fatty acids and oleylamine are readily biodegradable or readily biodegradable but fail the 10d window.

 

Biodegradation in water and sediment: simulation tests

In accordance with column 2 of REACH Annex IX, the simulation testing on ultimate degradation in surface waters and sediment simulation testing does not need to be conducted if the substance is readily biodegradable or highly insoluble in water.

As the substance is the salt of the components fatty acids and their counter ion oleylamine, which are expected dissociate in water, the individual components are evaluated separately: Components like oleylamine and tall oil are readily biodegradable whereas the components (Fatty acids, dimer and trimer components) are not readily biodegradable but highly insoluble in water. Therefore, further simulation testing is not justified.

 

Biodegradation in soil

In accordance with column 2 of REACH annex IX, further degradation testing does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation. This holds true for the Fatty acid components (no biodegradation, however, aquatox > 1000 mg/L).

Oleylamine is readily biodegradable. In Annex IX column 2 of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), it is suggested, that a study on "soil simulation testing" does not need to be conducted if "the substance is readily biodegradable”.Therefore, further degradation testing in soil is not provided.