Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The substance Fatty acids C18- unsat, dimers compd. with coco alkylamine is the salt of the componentsFatty acids C18-unsat, dimers (C36) and coco alkylamine (CAS:61788-46-3).Fatty acids C18-unsat, dimers (C36)itself consists of 2 moleculesFatty acid C18-unsat, dimer (C18) (CAS: 61788-89-4). OnceFatty acids C18- unsat, dimers compd. with coco alkylamineis entering the aquatic environment it is expected that the substance with a great surplus of water molecules dissociates into its two main componentsFatty acids C18- unsat, dimers (C36)and coco alkylamine. Based on this assumption both components will be evaluated with regard to their behavior in the environment individually.

 

No studies with relevance to the terrestrial compartment are available for Fatty acid C18- unsat, dimer compd. with coco alkylamine. However, data are available for the two main components. Furthermore, as concluded in chapter “aquatic toxicity” the intrinsic toxic properties of Fatty acids C18- unsat, dimers compd. with coco alkylamineare driven by the component coco alkylamine,it is expected that effects in the terrestrial compartment will also be driven by the toxic properties of coco alkylamine. Therefore, the evaluation of effects in the terrestrial compartment will be related to coco alkylamine.

 

Fatty acids C18-unsat., dimers (C36)

Although Fatty acids C18-unsat., dimers (C36) have a high KOC and are not readily biodegradeable, they display no toxic properties as shown in acute toxicity test with fish, daphnia and algae with L(E)C50 values of > 1000 mg/l. The risk assessment based on the EPM method revealed for this component no indication for further testing. 

This assumption is confirmed by a newly available chronic earthworm test according to OECD 222. After 56 d exposure the NOEC with regard to reproduction was >= 1000 mg/kg soil dw. 

Coco alkylamine:

Although, coco alkylamine is the driving force with regard to ecotoxic properties, the substance is readily biodegradable. In accordance with Guidance on information and chemical safety assessment Chap. R.7c -Endpoint specific guidance, there is no need to perform further testing on terrestrial organisms if the substance is readily biodegradable and not directly applied to soil. Based on the uses of Fatty acid C18- unsat, dimer compd. with coco alkylamine there is no direct or indirect exposure of the terrestrial compartment for the component coco alkylamine.

 

However, in the EU risk assessment for primary alkylamine also for the terrestrial compartment a PNEC soil was deviated based on available information for the alkylamines. The EU risk assessments refers to a valid chronic earthworm study in which a NOEC of 200 mg/kg was derived. The PNEC is indicated to be 2 mg/kg d.w. based on an AF of 100. As a worse case szenario, this value is also used for the risk assessment of the soil compartment forFatty acid C18- unsat, dimer compd. with coco alkylamine.

Conclusion:

Although for the substance Fatty acids C18- unsat, dimers compd. with coco alkylamine are no terrestrial test available, it was discussed why no further terrestrial tests are necessary:

Data for the two main components are available. The component which is not readily biodegradable, has a low aquatic toxicity which is also confirmed in a chronic earthworm test according to OECD 222 with an NOEC for reproduction of > 1000 mg/kg soil dw. The other component which is assummed to trigger the toxicity is readily biodegradable and therefore does not require a further testing. The terrestrial PNEC was deviated from a chronic earthworm test of this component. The resulting risk assessement finally indicates no requirement for additional testing in other terrestrial organisms like plant, mircoorganisms and arthropods.